DARUNAVIR 75 mg Film-Coated Tablets

Зміст інструкції

1. Darunavir Viatris 75 mg film-coated tablets
   1. What is Darunavir Viatris and what is it used for What is Darunavir Viatris
   2. What you need to know before taking Darunavir Viatris
   3. How to take Darunavir Viatris
   4. Possible side effects
   5. How to store Darunavir Viatris
   6. Contents of the pack and other information
2. Darunavir Viatris 150 mg film-coated tablets
   1. What is Darunavir Viatris and what is it used for
   2. What you need to know before taking Darunavir Viatris
   3. How to take Darunavir Viatris
   4. Possible side effects
   5. How to store Darunavir Viatris
   6. Package contents and other information
3. Darunavir Viatris 300 mg film-coated tablets
   1. What is Darunavir Viatris and what is it used for
   2. What you need to know before taking Darunavir Viatris
   3. How to take Darunavir Viatris
   4. Possible side effects
   5. How to store Darunavir Viatris
   6. Contents of the pack and other information
4. Darunavir Viatris 400 mg film-coated tablets
   1. What is Darunavir Viatris and what it is used for
   2. What you need to know before taking Darunavir Viatris
   3. How to take Darunavir Viatris
   4. Possible side effects
   5. How to store Darunavir Viatris
   6. Package contents and other information
5. Darunavir Viatris 600 mg film-coated tablets
   1. What is Darunavir Viatris and what is it used for
   2. What you need to know before you take Darunavir Viatris
   3. How to take Darunavir Viatris
   4. Possible side effects
   5. How to store Darunavir Viatris
   6. Contents of the pack and other information
6. Darunavir Viatris 800 mg film-coated tablets
   1. What is Darunavir Viatris and what is it used for
   2. What you need to know before you take Darunavir Viatris
   3. How to take Darunavir Viatris
   4. Possible side effects
   5. How to store Darunavir Viatris
   6. Package contents and other information

Darunavir Viatris 75 mg film-coated tablets

darunavir

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Darunavir Viatris is and what it is used for
• 2. What you need to know before you take Darunavir Viatris
• 3. How to take Darunavir Viatris
• 4. Possible side effects
• 5. How to store Darunavir Viatris
• 6. Contents of the pack and other information

1. What is Darunavir Viatris and what is it used for What is Darunavir Viatris

Darunavir Viatris contains the active ingredient darunavir.
Darunavir is an antiretroviral medicine, used in the treatment of human immunodeficiency virus (HIV) infection. It belongs to a group of medicines called protease inhibitors. Darunavir works by reducing the amount of HIV in the body, improving the immune system and reducing the risk of developing diseases related to HIV infection.

What it is used for
Darunavir is used for the treatment of adult and children patients aged 3 years or older and with a minimum weight of 15 kg (kilograms) with HIV infection and who have already used other antiretroviral medicines.
Darunavir must be taken in association with a low dose of ritonavir and other anti-HIV medicines. The doctor will discuss with you the best combination of medicines for you.

2. What you need to know before taking Darunavir Viatris

Do not take Darunavir Viatris

• If you are allergicto darunavir, or to any of the other ingredients of this medicine (listed in section 6) or to ritonavir.
• If you have severe liver (hepatic) problems. Ask your doctor for advice if you are not sure about the severity of your liver disease. Further tests may be necessary.

Do not take Darunavir Viatris with any of the following medicines
If you are taking any of these medicines, ask your doctor how to switch to another medicine.

Do not combine darunavir with products containing St John's Wort (Hypericum perforatum).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Darunavir Viatris.
Darunavir is not a cure for HIV infection.
People taking darunavir may also develop infections or other diseases associated
with HIV infection. You should stay in regular contact with your doctor.
Patients taking darunavir may develop a rash. Rarely, the rash
may become severe or potentially life-threatening. Contact your doctor whenever you
develop a rash.
In patients taking darunavir and raltegravir (for HIV infection), rashes
(usually mild or moderate) may occur more frequently than in patients taking
each medicine separately.

Tell your doctor about your condition BEFORE and DURING treatment
Make sure you check the following points and tell your doctor if any of these apply to you.

• Tell your doctor if you have suffered from liver disorders, including hepatitis B or C. The doctor can assess the severity of your liver disease before deciding whether to give you darunavir.
• Tell your doctor if you have diabetes. Darunavir may increase blood sugar levels.
• Tell your doctor immediately if you notice any signs of infection(e.g. swollen lymph nodes and fever). In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur shortly after starting anti-HIV treatment. These symptoms are thought to be due to an improvement in the body's immune response, which allows the body to fight infections that may have been present without causing noticeable symptoms.
• In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy tissue in the body) may also occur after you have started taking medicines to treat HIV infection. The disorders

autoimmune may occur many months after starting treatment. If you notice any
symptoms of infection or other symptoms such as muscle weakness, initial weakness in hands and
feet that rises towards the trunk of the body, palpitations, tremors or hyperactivity, tell
your doctor immediately for necessary treatment.

• Tell your doctor if you have hemophilia. Darunavir may increase the risk of bleeding.
• Tell your doctor if you are allergic to sulfonamides(used to treat some infections).
• Tell your doctor if you notice any musculoskeletal problems. Some patients taking a combination of antiretroviral medicines may develop a bone disease called osteonecrosis (bone tissue death caused by lack of blood supply to the bone). Some of the many risk factors for developing this disease may be the duration of use of antiretrovirals in combination, the use of corticosteroids, alcohol consumption, severe immunodeficiency, a high body mass index. Signs of osteonecrosis are joint stiffness, pain and aches (especially in the hip, knee and shoulder) and difficulty moving. If you notice any of these symptoms, tell your doctor immediately.

Elderly
Darunavir has been given to a limited number of patients aged 65 years or older. If
you belong to this age group, consult your doctor before taking Darunavir Viatris.

Children
Darunavir is not indicated for use in children under 3 years of age or weighing less than 15 kg
(kilograms).

Other medicines and Darunavir Viatris
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines.
There are some medicines that must not be takenwith darunavir. These have been listed previously
under the heading “ Do not take Darunavir Viatris with any of the following medicines”.
In most cases, darunavir can be combined with anti-HIV medicines that belong to
another class [e.g. NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs
(non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists and FIs (fusion inhibitors). Darunavir in combination with ritonavir has not been studied with all PIs (protease inhibitors) and should not be used with other HIV PIs. In some cases, the dose of other medicines may need to be adjusted. Therefore, always tell your doctor if you are taking other
anti-HIV medicines and carefully follow your doctor's instructions on which medicines you can take.
The effects of darunavir may be reduced if you take any of the following medicines. Tell
your doctor if you take:

• Phenobarbital, phenytoin(to prevent seizures)
• Dexamethasone(a corticosteroid)
• Efavirenz(to treat HIV infection)
• Rifapentine, rifabutin(medicines to treat some infections such as tuberculosis)
• Saquinavir(to treat HIV infection).

The effects of other medicines may be affected by taking darunavir and your doctor
may require further blood tests. Tell your doctor if you take:

• Amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, lidocaine, metoprolol,mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil(for heart disease), as the therapeutic effect or side effects of these medicines may be altered.
• Apixaban, dabigatran etexilate, edoxaban, rivaroxaban, warfarin, clopidogrel(to reduce blood clotting), because both the therapeutic effect and side effects may be altered.
• Hormonal contraceptives based on estrogens or hormone replacement therapy. Darunavir may reduce their effectiveness. When hormone therapy is used for contraceptive purposes, the use of other methods of contraception is recommended.
• Ethinylestradiol/drospirenone.Darunavir may increase the risk of an increase in potassium levels due to drospirenone.
• Atorvastatin, pravastatin, rosuvastatin(to lower cholesterol levels). It may increase the risk of muscle damage. Your doctor will assess which medicine to lower cholesterol is most suitable for you.
• Clarithromycin(antibiotic).
• Cyclosporine, everolimus, tacrolimus, sirolimus(to reduce the activity of the immune system), as the therapeutic effect or side effects of these medicines may be increased.
• Corticosteroids, including betamethasone, budesonide, fluticasone, mometasone, prednisone,triamcinolone.These medicines are used in the treatment of allergies, asthma, inflammatory bowel diseases, skin, eye, joint and muscle inflammatory conditions and other types of inflammatory diseases. These medicines are generally taken orally, by inhalation, injection or applied to the skin. If alternative treatments cannot be used, these medicines may only be taken after assessment by the doctor and under close monitoring by the doctor for side effects due to corticosteroids.
• Buprenorphine/naloxone(to treat opioid dependence).
• Salmeterol(for the treatment of asthma).
• Artemether/lumefantrine(a combination of medicines for the treatment of malaria).
• Dasatinib, everolimus, irinotecan, nilotinib, vinblastine, vincristine(for the treatment of cancer).
• Sildenafil, tadalafil, vardenafil(for erectile dysfunction or for the treatment of a heart or lung condition called pulmonary arterial hypertension).
• Glecaprevir/pibrentasvir(for the treatment of hepatitis C infection)
• Fentanyl, oxycodone, tramadol(for the treatment of pain).
• Fesoterodine, solifenacin(to treat urological disorders).

Your doctor may require further blood tests and the dosage of other medicines may
be modified because the therapeutic effect and side effects of these medicines or of
darunavir may be affected if taken together.
Tell your doctor if you take:

• Dabigatran etexilate, edoxaban, warfarin(to reduce blood clotting)
• Alfentanil(strong short-acting injectable painkiller used for surgery)
• Digoxin(for the treatment of some heart disorders)
• Clarithromycin(antibiotic)
• Itraconazole, isavuconazole, fluconazole, posaconazole, clotrimazole(to treat fungal infections) Voriconazole may only be taken after assessment by the doctor.
• Rifabutin(against bacterial infections)
• Sildenafil, vardenafil, tadalafil(for erectile dysfunction or for high blood pressure in the pulmonary circulation)
• Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone(for the treatment of depression and anxiety)
• Maraviroc(to treat HIV infection)
• Methadone(to treat opioid dependence)
• Carbamazepine, clonazepam(to prevent seizures or to treat some types of neuropathic pain)
• Colchicine(to treat gout or Familial Mediterranean fever)
• Bosentan(to treat high blood pressure in the pulmonary circulation).
• Buspirone, clorazepate, diazepam, estazolam, flurazepam, midazolam when used in the formof injection, zolpidem(sedatives).
• Perphenazine, risperidone, thioridazine(to treat psychiatric conditions).

This is nota complete list of medicines. Tell your doctor about allthe medicines you are
taking.

Darunavir Viatris with food and drink
See section 3 “How to take Darunavir Viatris”.

Pregnancy and breastfeeding
Tell your doctor immediately if you are pregnant or planning to become pregnant.
Pregnant women should not take darunavir with ritonavir, unless they receive
specific instructions from their doctor. Pregnant women should not take darunavir with
cobicistat.
Because of the possibility of adverse effects in infants, women should not breastfeed if they are receiving
Darunavir Viatris.
Breastfeeding is not recommended in women with HIV infection as the infection may be
transmitted to the child in breast milk. If you are breastfeeding or think you might be, talk to your doctor
as soon as possible.

Driving and using machines
Do not use machines or drive if you feel dizzy after taking darunavir.

Darunavir Viatris contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, therefore it is essentially
“sodium-free”.

3. How to take Darunavir Viatris

Take this medicine always exactly as your doctor, pharmacist or
nurse has told you. If you have doubts, ask your doctor, pharmacist or nurse.
Even if you feel better, do not stop taking Darunavir Viatris and ritonavir without talking to your
doctor.
After starting therapy, you must not change the dose, dosage form or stop the
therapy without your doctor’s instructions.

Dose for children aged 3 years or older and weighing at least 15
kilograms who have not previously taken antiretroviral medicines (your child’s
doctor will determine this condition)
The doctor will calculate the correct daily dose each time based on the child’s body weight
(see the following table). This dose must not exceed the recommended dose for adults, which is
800 milligrams of darunavir together with 100 milligrams of ritonavir once a day.
The doctor will tell you how many darunavir tablets and how much ritonavir (capsules, tablets or
solution) your child should take.

Dose for children aged 3 years or older and weighing at least 15 kg
(kilograms) who have previously taken antiretroviral medicines (your child’s
doctor will determine this condition)
The doctor will calculate the appropriate dose based on the child’s weight (see the table below). The
doctor will decide whether the once-daily or twice-daily dose is appropriate for the child. This dose must not exceed the recommended dose for adults, which corresponds to
600 milligrams of darunavir together with 100 milligrams of ritonavir twice a day or 800
milligrams of darunavir together with 100 milligrams of ritonavir once a day.
The doctor will tell you how many darunavir tablets and how much ritonavir (capsules, tablets or
solution) your child should take. The tablets are available in other strengths and your doctor may
prescribe a combination of tablets to achieve the appropriate dosage regimen.

Other formulations of this medicine may be more appropriate for children: ask your
doctor or pharmacist.
Twice-daily dose
Once-daily dose

Instructions for children

• The child must always take darunavir together with ritonavir. Darunavir cannot work effectively without ritonavir.
• The child must take the appropriate doses of darunavir and ritonavir twice a day or once a day. If darunavir is prescribed twice a day, the child must take one dose in the morning and one dose in the evening. The doctor will determine which regimen is most appropriate for the child.
• The child must take darunavir with food. Darunavir cannot work effectively without food. The type of food is not important.
• The child must swallow the tablets with a drink such as water or milk.

Dose for adults who have never taken antiretroviral medicines (this will be determined by your doctor)
Different dosages of darunavir may be needed that cannot be administered with these
75 mg tablets. Other strengths of Darunavir Viatris are available.

Dose for adults who have previously taken antiretroviral medicines (this will be determined by the
doctor)
The doses are:

• 600 milligrams of darunavir (2 tablets containing 300 milligrams of darunavir, or one tablet containing 600 milligrams of darunavir) together with 100 milligrams of ritonavir, twice a day. OR
• 800 milligrams of darunavir (2 tablets containing 400 milligrams of darunavir or 1 tablet containing 800 milligrams of darunavir) together with 100 milligrams of ritonavir, once a day. Darunavir Viatris 400 milligram and 800 milligram tablets should only be used to build the 800 milligram once-daily regimen.

Discuss with your doctor which dose is most correct.

Instructions for adults

• Always take darunavir with ritonavir. Darunavir does not work properly without ritonavir.
• In the morning, take 600 milligrams of darunavir together with 100 milligrams of ritonavir.
• In the evening, take 600 milligrams of darunavir together with 100 milligrams of ritonavir.
• Take darunavir with food. Darunavir does not work properly without food. The type of food taken is not important.
• Swallow the tablets with a drink such as water or milk.

• Darunavir Viatris 75 milligram and 150 milligram tablets have been developed for use in children, but they may also be used in some cases in adults.

If you take more Darunavir Viatris than you should
Tell your doctor, pharmacist or nurse immediately.

If you forget to take Darunavir Viatris
If you realise within 6 hours, you should take the tablets immediately. Always take the
tablets together with ritonavir and food. If you realise after 6 hours, skip the dose and take the
next dose as usual. Do not take a double dose to make up for a forgotten dose.

In case of vomiting after taking Darunavir Viatris and ritonavir
If you vomit within 4 hoursof taking the medicine, you should take another dose of
Darunavir Viatris and ritonavir with food as soon as possible. If vomiting occurs more than 4 hours
after taking the medicine, you do not need to take another dose of Darunavir Viatris and
ritonavir until the time scheduled for your next dose.
Contact your doctor if you have any doubtsabout what to do if you forget a dose or vomit.

Do not stop treatment with Darunavir Viatris without first consulting your doctor
Anti-HIV medicines can make you feel better. Do not stop taking darunavir, even if
you feel better. Consult your doctor first.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

During HIV therapy, an increase in weight and levels of lipids and glucose in the blood may occur.
This is partly related to the restoration of health and lifestyle and, in the case of blood lipids, sometimes to the HIV medications themselves. The doctor will check these changes.
Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Tell your doctor if you develop any of the following side effects
Liver problems have been reported that can rarely be serious. The doctor will need to perform blood tests before starting darunavir. If you have chronic hepatitis B or C, the doctor should check your blood tests more often, because you are more likely to develop liver problems. Talk to your doctor about the signs and symptoms of liver problems.
These may include yellowing of the skin or whites of the eyes, dark urine (tea-colored), pale stools (bowel movements), nausea, vomiting, loss of appetite, or pain, tenderness or discomfort on the right side under the ribs.
Skin rashes (more frequent when used in combination with raltegravir), itching. These rashes are usually mild or moderate in severity. A rash can also be a symptom of a rare serious condition. It is therefore important that you consult your doctor if you develop a rash. The doctor will advise you on how to treat the symptoms or whether darunavir should be discontinued.
Other serious side effects were diabetes (common) and inflammation of the pancreas (uncommon).
Very common side effects (may affect more than 1 in 10 people)

• diarrhea.

Common side effects (may affect up to 1 in 10 people)

• vomiting, nausea, abdominal pain or distension, dyspepsia (indigestion), flatulence
• headache, fatigue, dizziness, drowsiness, numbness, tingling or pain in the hands or feet, loss of strength, difficulty falling asleep.

Uncommon side effects (may affect up to 1 in 100 people)

• chest pain, changes in electrocardiogram, rapid heartbeat
• decreased or abnormal skin sensitivity, tingling sensation, attention disorders, memory loss, difficulty with balance
• difficulty breathing, cough, nosebleeds, sore throat
• inflammation of the stomach or mouth, heartburn, retching, dry mouth, abdominal discomfort, constipation, belching
• kidney failure, kidney stones, difficulty urinating, frequent or excessive urination, sometimes at night
• urticaria, severe swelling of the skin and other tissues (especially lips and eyes), eczema, excessive sweating, night sweats, hair loss, scaly skin, nail pigmentation
• muscle pain, muscle cramps or weakness, pain in the extremities, osteoporosis
• slowing of thyroid function. This can be demonstrated through a blood test.
• high blood pressure, hot flashes
• red or dry eyes
• fever, leg swelling due to fluid retention, malaise, irritability, pain
• infection symptoms, herpes simplex
• erectile dysfunction (problems with erection), breast enlargement
• sleep disturbances, drowsiness, depression, anxiety, altered dreams, decreased sexual desire

Rare side effects (may affect up to 1 in 1,000 patients)

• a reaction called DRESS [severe rash that may be accompanied by fever, fatigue, swelling of the face or lymph nodes, increased eosinophils (a type of white blood cell), effects on liver, kidneys or lungs]
• heart attack, slow heartbeat, palpitations
• vision disorders
• chills, feeling unwell
• a feeling of confusion or disorientation, altered mood, restlessness
• fainting, seizures, change or loss of taste
• mouth ulcers, vomiting blood, inflammation of the lips, dry lips, coated tongue
• runny nose
• skin lesions, dry skin
• stiffness of muscles or joints, joint pain with or without inflammation
• changes in certain blood or chemical values. These can be seen in blood and/or urine tests. The doctor will explain these results to you. Examples are: increased levels of certain white blood cells
• deposition of darunavir crystals in the kidney leading to kidney disease.

Some side effects are typical of HIV medicines from the same family as darunavir. These are the
following:

• muscle pain, fragility or weakness. In rare cases, these muscle disorders have been severe.

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Darunavir Viatris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package, blister and
bottle after Exp. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
For the bottles: once opened, use within 100 days.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Darunavir Viatris contains

• The active ingredient is darunavir. Each tablet contains 75 milligrams of darunavir.
• The other ingredients are colloidal anhydrous silica, microcrystalline cellulose, crospovidone, sodium starch glycolate, hypromellose, magnesium stearate. The film coating contains partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol and talc.

Description of the appearance of Darunavir Viatris and contents of the pack
Darunavir Viatris 75 mg tablets are film-coated, from white to off-white in colour,
oval with two curved sides, with M imprinted on one side and DV1 on the other.
Darunavir Viatris 75 mg film-coated tablets are available in blisters containing 480
tablets and in plastic bottles containing 480 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park,
Mulhuddart,
Dublin 15,
DUBLIN,
Ireland

Manufacturer
Mylan Hungary Kft
H-2900 Komárom, Mylan utca 1 Hungary
McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Viatris
Tél/Tel: + 32 (0)2 658 61 00

Lietuva
Viatris UAB
Tel: +370 5 205 1288

България
Майлан ЕООД
Тел.: +359 2 44 55 400

Luxembourg/Luxemburg
Viatris
Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika
Viatris CZ.s.r.o.
Tel: 420 222 004 400

Magyarország
Viatris Healthcare Kft.
Tel.: + 36 1 465 2100

Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Malta
V.J. Salomone Pharma Ltd
Tel: + 356 21 22 01 74

Deutschland
Viatris Healthcare GmbH
Tel: +49 800 0700 800

Nederland
Mylan BV
Tel: + 31 (0)20 426 3300

Eesti
Viatris OÜ
Tel: +372 6363 052

Norge
Viatris AS
Tlf: + 47 66 75 33 00

Ελλάδα
Viatris Hellas Ltd
Τηλ: +30 2100 100 002

Österreich
Viatris Austria GmbH
Tel: +43 1 86390

España
Viatris Pharmaceuticals, S.L.
Tel: + 34 900 102 712

Polska
Viatris Healthcare Sp. z o.o.
Tel.: + 48 22 546 64 00

France
Viatris Santé
Tél: +33 4 37 25 75 00

Portugal
Mylan, Lda.
Tel: + 351 214 127 200

Hrvatska
Viatris Hrvatska
Tel: +385 1 23 50 599

România
BGP Products SRL
Tel: +40 372 579 000

Ireland
Viatris Limited
Tel: +353 1 8711600

Slovenija
Viatris d.o.o.
Tel: + 386 1 23 63 180

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Viatris Italia S.r.l
Tel: + 39 (0) 2 612 46921

Suomi/Finland
Viatris Oy
Puh/Tel: +358 20 720 9555

Κύπρος
GPA Pharmaceuticals Ltd
Τηλ: + 357 22863100

Sverige
Viatris AB
Tel: +46 (0)8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

United Kingdom (Northern Ireland)
Mylan IRE Healthcare Limited
Tel: +353 18711600

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu .

Darunavir Viatris 150 mg film-coated tablets

darunavir

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Darunavir Viatris is and what it is used for
• 2. What you need to know before you take Darunavir Viatris
• 3. How to take Darunavir Viatris
• 4. Possible side effects
• 5. How to store Darunavir Viatris
• 6. Contents of the pack and other information

1. What is Darunavir Viatris and what is it used for

What is Darunavir Viatris
Darunavir Viatris contains the active substance darunavir. Darunavir is an antiretroviral medicine,
used in the treatment of human immunodeficiency virus (HIV) infection. It belongs to
a group of medicines called protease inhibitors. Darunavir works by reducing the amount of
HIV in the body, improving the immune system and reducing the risk of developing
diseases related to HIV infection.

What is it used for
Darunavir is used for the treatment of adult and children patients aged 3 years or older and
with a minimum weight of 15 kg (kilograms) with HIV infection and who have already used other
antiretroviral medicines.
Darunavir must be taken in combination with a low dose of ritonavir and other anti-
HIV medicines. The doctor will discuss with you the best combination of medicines for you.

2. What you need to know before taking Darunavir Viatris

Do not take Darunavir Viatris:

• if you are allergicto darunavir or to any of the other ingredients of this medicine (listed in section 6) or to ritonavir.
• If you have severe liver problems(hepatic). Ask your doctor for advice if you are not sure about the severity of your liver disease. Further tests may be necessary.

Do not combine Darunavir Viatris with any of the following medicines
If you are taking any of these medicines, ask your doctor how to switch to another medicine.

Do not combine darunavir with products containing St John's Wort (Hypericum perforatum).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Darunavir Viatris.
Darunavir is not a cure for HIV infection.
People taking darunavir may also develop infections or other diseases associated
with HIV infection. You should be in regular contact with your doctor.
Patients taking darunavir may develop a rash. Rarely the rash
may become severe or potentially life-threatening. Contact your doctor whenever you
develop a rash.
In patients taking darunavir and raltegravir (for HIV infection), rashes
(usually mild or moderate) may occur more frequently than in patients taking
each medicine separately

Tell your doctor about your condition BEFORE and DURING treatment
Make sure you check the following points and tell your doctor if any of these apply to you.

• Tell your doctor if you have suffered from liver disorders, including hepatitis B or C. The doctor can assess the severity of your liver disease before deciding whether to give you darunavir.
• Tell your doctor if you have diabetes. Darunavir may increase blood sugar levels.
• Immediately tell your doctor if you notice any symptoms of infection(e.g. swollen lymph nodes and fever). In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur shortly after starting anti-HIV treatment. These symptoms are thought to be due to an improvement in the body's immune response, which allows the body to fight infections that may have been present without causing obvious symptoms.
• In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy tissue in the body) may also occur after you have started taking medicines to treat HIV infection. Autoimmune disorders can occur many months after starting treatment. If you notice any symptoms of infection or other symptoms, such as muscle weakness, initial weakness in hands and feet that rises towards the body trunk, palpitations, tremors or hyperactivity, tell your doctor immediately to request the necessary treatment.
• Tell your doctor if you have hemophilia. Darunavir may increase the risk of bleeding.
• Tell your doctor if you are allergic to sulfonamides(used to treat some infections).
• Tell your doctor if you notice any musculoskeletal problems. Some patients taking a combination of antiretroviral medicines may develop a bone disease called osteonecrosis (bone tissue death caused by a lack of blood supply to the bone). Some of the many risk factors for developing this disease may be the duration of use of antiretrovirals in combination, the use of corticosteroids, alcohol consumption, severe immunodeficiency, a high body mass index. Signs of osteonecrosis are joint stiffness, pain and aches (especially in the hip, knee and shoulder) and difficulty moving. If you notice any of these symptoms, tell your doctor immediately.

Elderly
Darunavir has been given to a limited number of patients aged 65 years or older. If
you belong to this age group, consult your doctor before taking Darunavir Viatris.

Children
Darunavir is not indicated for use in children under 3 years of age or weighing less than 15 kg
(kilograms).

Other medicines and Darunavir Viatris
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
There are some medicines that must not be combinedwith darunavir. These have been listed previously
under the heading “ Do not combine Darunavir Viatris with any of the following medicines”.
In most cases, darunavir can be combined with anti-HIV medicines that belong to
another class [e.g. NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs
(non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists and FIs (fusion inhibitors]. Darunavir in combination with ritonavir has not been studied with all PIs (protease inhibitors) and should not be used with other HIV PIs. In some cases, the dose of other medicines may need to be modified. Therefore, always tell your doctor if you are taking other
anti-HIV medicines and carefully follow your doctor's instructions on which medicines you can take.
The effects of darunavir may be reduced if you take any of the following medicines. Tell
your doctor if you take:

• Phenobarbital, phenytoin(to prevent seizures)
• Dexamethasone(a corticosteroid)
• Efavirenz(to treat HIV infection)
• Rifapentine, rifabutin(medicines to treat some infections such as tuberculosis)
• Saquinavir(to treat HIV infection)

The effects of other medicines may be affected by taking darunavir and your doctor
may require further blood tests. Tell your doctor if you take:

• Amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, lidocaine, metoprolol,mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil(for heart disease), as the therapeutic effect or side effects of these medicines may be altered.
• Apixaban, dabigatran etexilate, edoxaban, rivaroxaban, warfarin, clopidogrel(to reduce blood clotting), because both the therapeutic effect and side effects may be altered.
• Hormonal contraceptives containing estrogens or hormone replacement therapy. Darunavir may reduce their effectiveness. When hormone therapy is used for contraceptive purposes, the use of other methods of contraception is recommended.
• Ethinylestradiol/drospirenone. Darunavir may increase the risk of an increase in potassium levels due to drospirenone.
• Atorvastatin, pravastatin, rosuvastatin(to lower cholesterol levels). It may increase the risk of muscle damage. The doctor will assess which medicine to lower cholesterol level is most suitable for you.
• Clarithromycin(antibiotic).
• Cyclosporine, everolimus, tacrolimus, sirolimus(to reduce the activity of the immune system), as the therapeutic effect or side effects of these medicines may be increased.
• Corticosteroids, including betamethasone, budesonide, fluticasone, mometasone, prednisone,triamcinolone. These medicines are used in the treatment of allergies, asthma, inflammatory bowel disease, inflammatory skin, eye, joint and muscle diseases and other types of inflammatory diseases. These medicines are generally taken orally, by inhalation, injection or applied to the skin. If alternative treatments cannot be used, these medicines may only be taken after assessment by the doctor and under close monitoring by the doctor for side effects due to corticosteroids.
• Buprenorphine/naloxone(to treat opioid dependence).
• Salmeterol(for the treatment of asthma).
• Artemether/lumefantrine(a combination of medicines for the treatment of malaria).
• Dasatinib, everolimus, irinotecan, nilotinib, vinblastine, vincristine(to treat cancer).
• Sildenafil, tadalafil, vardenafil(for erectile dysfunction or for the treatment of a heart or lung condition called pulmonary arterial hypertension).
• Glecaprevir/pibrentasvir(for the treatment of hepatitis C infection).
• Fentanyl, oxycodone, tramadol(for the treatment of pain).
• Fesoterodine, solifenacin(to treat urological disorders).

Your doctor may require further blood tests and the dosage of other medicines may
be modified because the therapeutic effect and side effects of these medicines or
darunavir may be affected if taken together.
Tell your doctor if you take:

• Dabigatran etexilate, edoxaban, warfarin(to reduce blood clotting).
• Alfentanil(strong short-acting injectable painkiller used for surgery).
• Digoxin(for the treatment of some heart disorders).
• Clarithromycin(antibiotic).
• Itraconazole, isavuconazole, fluconazole, posaconazole, clotrimazole(to treat fungal infections). Voriconazole can only be taken after assessment by the doctor.
• Rifabutin(against bacterial infections).
• Sildenafil, vardenafil, tadalafil(for erectile dysfunction or for high blood pressure in the pulmonary circulation).
• Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone(for the treatment of depression and anxiety).
• Maraviroc(to treat HIV infection).
• Methadone(to treat opioid dependence).
• Carbamazepine, clonazepam(to prevent seizures or to treat some types of neuropathic pain).
• Colchicine(for the treatment of gout or Familial Mediterranean fever).
• Bosentan(for the treatment of high blood pressure in the pulmonary circulation).
• Buspirone, clorazepate, diazepam, estazolam, flurazepam, midazolam when used in the formof injection, zolpidem(sedatives).
• Perphenazine, risperidone, thioridazine(to treat psychiatric conditions).

This is nota complete list of medicines. Tell your doctor about all the medicines you are
taking.

Darunavir Viatris with food and drink
See section 3 “How to take Darunavir Viatris”.

Pregnancy and breastfeeding
Tell your doctor immediately if you are pregnant or planning a pregnancy.
Pregnant women should not take darunavir with ritonavir, unless they receive
specific instructions from their doctor. Pregnant women should not take darunavir with
cobicistat.
Given the possibility of adverse effects in infants, women should not breastfeed if they are receiving
Darunavir Viatris.
Breastfeeding is not recommended for women with HIV infection as the infection may be
transmitted to the baby in breast milk. If you are breastfeeding or plan to breastfeed, talk to your doctor
as soon as possible.

Driving and using machines
Do not use machines or drive if you feel dizzy after taking darunavir.

Darunavir Viatris contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, therefore it is essentially
“sodium-free”.

3. How to take Darunavir Viatris

Take this medicine exactly as your doctor, pharmacist or
nurse has told you. If you have any doubts, ask your doctor, pharmacist or nurse.
Even if you feel better, do not stop taking Darunavir Viatris and ritonavir without talking to
your doctor.
After starting therapy, you should not change the dose, dosage form or stop the
therapy without your doctor's instructions.

Dose for children aged 3 years or older and weighing at least 15
kilograms who have not previously taken antiretroviral medicines (your child's
doctor will determine this condition).
The doctor will calculate the correct daily dose each time based on the child's body weight
(see the following table). This dose should not exceed the recommended dose for adults, which is
800 milligrams of darunavir together with 100 milligrams of ritonavir once a day.
The doctor will tell you how many Darunavir Viatris tablets and how much ritonavir (capsules,
tablets or solution) the child should take.

Dose for children aged 3 years or older and weighing at least 15 kg
(kilograms) who have previously taken antiretroviral medicines (your child's
doctor will determine this condition)
The doctor will calculate the appropriate dose based on the child's weight (see the table below). The
doctor will decide whether a once-daily or twice-daily dose is appropriate for the child. This dose should not exceed that recommended for adults, which corresponds to 600

milligrams of darunavir together with 100 milligrams of ritonavir twice a day or 800
milligrams of darunavir together with 100 milligrams of ritonavir once a day.
The doctor will tell you how many Darunavir Viatris tablets and how much ritonavir (capsules,
tablets or solution) the child should take. The tablets are available in other strengths and the
doctor may prescribe a combination of tablets to achieve the appropriate dosage
regimen.
Other formulations of this medicine may be more appropriate for children: ask your
doctor or pharmacist.
Twice-daily dose
Once-daily dose

Instructions for children

• The child must always take darunavir together with ritonavir. Darunavir cannot work effectively without ritonavir.
• The child must take the appropriate doses of darunavir and ritonavir twice a day or once a day. If darunavir is prescribed twice a day, the child should take one dose in the morning and one dose in the evening. The doctor will determine which regimen is most appropriate for the child.
• The child must take darunavir with food. Darunavir cannot work effectively without food. The type of food taken is not important.
• The child should swallow the tablets with a drink such as water or milk.

Dose for adults who have never taken antiretroviral medicines (this will be established by the doctor)
Different dosages of darunavir may be needed that cannot be administered with these
150 mg tablets. Other strengths of Darunavir Viatris are available.

Dose for adults who have previously taken antiretroviral medicines (this will be established by the
doctor)
The doses are:

• 600 milligrams of darunavir (2 tablets containing 300 milligrams of darunavir, or one tablet containing 600 milligrams of darunavir) together with 100 milligrams of ritonavir, twice a day. OR
• 800 milligrams of darunavir (2 tablets containing 400 milligrams of darunavir, or one tablet containing 800 milligrams of darunavir) together with 100 milligrams of ritonavir, twice a day. Darunavir Viatris 400 milligram and 800 milligram tablets should only be used to build the 800 milligram once-daily regimen.

Discuss with your doctor which dose is most correct.

Instructions for adults

• Always take darunavir with ritonavir. Darunavir cannot work effectively without ritonavir.
• In the morning, take 600 milligrams of darunavir together with 100 milligrams of ritonavir.
• In the evening, take 600 milligrams of darunavir together with 100 milligrams of ritonavir.
• Take darunavir with food. Darunavir cannot work effectively without food. The type of food taken is not important.
• Swallow the tablets with a drink such as water or milk.
• Darunavir Viatris 75 milligram and 150 milligram tablets have been developed for use in children, but they may also be used in some cases in adults.

If you take more Darunavir Viatris than you should
Tell your doctor, pharmacist or nurse immediately.

If you forget to take Darunavir Viatris
If you realise within 6 hours, you should take the tablets immediately. Always take the tablets
together with ritonavir and food. If you realise after 6 hours, skip the dose and take the next dose,
as usual. Do not take a double dose to make up for a missed dose.

In case of vomiting after taking Darunavir Viatris and ritonavir
If you vomit within 4 hoursof taking the medicine, you should take another dose of
Darunavir Viatris and ritonavir with food as soon as possible. If vomiting occurs more than 4 hours
after taking the medicine, you do not need to take another dose of Darunavir Viatris and
ritonavir until the time usually scheduled for the next dose.
Contact your doctor if you have any doubtsabout what to do if you forget a dose or vomit.

Do not stop treatment with Darunavir Viatris without first consulting your doctor
Anti-HIV medicines can make you feel better. Do not stop taking darunavir, even if
you feel better. Consult your doctor first.
If you have any questions about using this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

During therapy for HIV, an increase in weight and levels of lipids and glucose in the blood may occur.
This is partly related to the restoration of health and lifestyle, and in the case of blood lipids, sometimes to the HIV medications themselves. The doctor will check these
changes.
Like all medicines, this medicine can cause side effects, although not everyone
will experience them.

Tell your doctor if you develop any of the following side effects
Liver problems have been reported that can occasionally be serious. The doctor will need to
perform blood tests before starting darunavir. If you have chronic hepatitis B or C, your doctor
should check your blood tests more frequently because you are more likely to
develop liver problems. Talk to your doctor about the signs and symptoms of liver problems. These
may include yellowing of the skin or whites of the eyes, dark urine (tea-colored), pale stools (bowel movements), nausea, vomiting, loss of appetite, or pain, tenderness or soreness and
discomfort on the right side under the ribs.
Skin rashes (more frequent when used in combination with raltegravir), itching. These rashes
are usually mild to moderate in severity. A rash can also be a symptom of a
more serious and rare condition. It is therefore important that you consult your doctor if you develop a
rash. Your doctor will advise you on how to treat the symptoms or whether darunavir should be stopped.
Other serious side effects were diabetes (common) and inflammation of the pancreas (uncommon).
Very common side effects (may affect more than 1 in 10 people)

• Diarrhea.

Common side effects (may affect up to 1 in 10 people)

• vomiting, nausea, abdominal pain or distension, dyspepsia (indigestion), flatulence
• headache, fatigue, dizziness, drowsiness, numbness, tingling or pain in the hands or feet, loss of strength, difficulty falling asleep.

Uncommon side effects (may affect up to 1 in 100 people)

• chest pain, changes in electrocardiogram, rapid heartbeat
• decreased or abnormal skin sensation, tingling sensation, attention disorders, memory loss, balance problems
• difficulty breathing, cough, nosebleeds, sore throat
• inflammation of the stomach or mouth, heartburn, retching, dry mouth, abdominal discomfort, constipation, belching
• kidney failure, kidney stones, difficulty urinating, frequent or excessive urination, sometimes at night
• hives, severe swelling of the skin and other tissues (especially lips and eyes), eczema, excessive sweating, night sweats, hair loss, acne, scaly skin, nail pigmentation
• muscle pain, muscle cramps or weakness, pain in the extremities, osteoporosis
• slowed thyroid function. This can be demonstrated through a blood test.
• high blood pressure, hot flashes
• red or dry eyes
• fever, leg swelling due to fluid retention, malaise, chills, abnormal sensations, irritability, pain
• infection symptoms, herpes simplex
• erectile dysfunction (problems with erection), breast enlargement
• sleep disorders, drowsiness, depression, anxiety, altered dreams, decreased sexual desire

Rare side effects (may affect up to 1 in 1,000 people)

• a reaction called DRESS [severe rash that may be accompanied by fever, fatigue, swelling of the face or lymph nodes, increased eosinophils (a type of white blood cells), effects on the liver, kidneys or lungs]
• heart attack, slow heartbeat, palpitations
• vision disturbances
• chills, feeling unwell
• a feeling of confusion or disorientation, altered mood, restlessness
• fainting, seizures, change or loss of taste
• mouth ulcers, vomiting blood, inflammation of the lips, dry lips, coated tongue
• runny nose
• skin lesions, dry skin
• stiffness of muscles or joints, joint pain with or without inflammation
• changes in some blood cell or chemical values. These can be seen in blood and/or urine tests. Your doctor will explain these results to you. Examples include: increased white blood cells
• deposition of darunavir crystals in the kidney with resulting kidney disease.

Some side effects are typical of anti-HIV medicines in the same family as darunavir. These are the
following:

• muscle pain, fragility or weakness. In rare cases, these muscle disorders have been serious.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the reporting system indicated in Annex V. By reporting side effects you can
contribute to providing more information on the safety of this medicine.

5. How to store Darunavir Viatris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, blister and
bottle after Exp. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
For bottles: once opened, use within 100 days.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Darunavir Viatris contains

• The active ingredient is darunavir. Each tablet contains 150 milligrams of darunavir.
• The other ingredients are: anhydrous colloidal silicon dioxide, microcrystalline cellulose, crospovidone, sodium starch glycolate, hypromellose, magnesium stearate. The coating contains partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol and talc.

Description of the appearance of Darunavir Viatris and package contents
Darunavir Viatris 150 mg tablets are film-coated, from white to off-white in color, capsule-shaped with two curved sides, with M imprinted on one side and DV2 on the other.
Darunavir Viatris 150 mg film-coated tablets are available in blisters containing 240
tablets and in plastic bottles containing 60 and 240 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder
Viatris Limited
Damastown Industrial Park,
Mulhuddart,
Dublin 15,
DUBLIN,
Ireland

Manufacturers
Mylan Hungary Kft
H-2900 Komárom, Mylan utca 1 Hungary
McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorization holder:

België/Belgique/Belgien
Viatris
Tél/Tel: + 32 (0)2 658 61 00

Lietuva
Viatris UAB
Tel: +370 5 205 1288

България
Майлан ЕООД
Тел.: +359 2 44 55 400

Luxembourg/Luxemburg
Viatris
Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika
Viatris CZ.s.r.o.
Tel: 420 222 004 400

Magyarország
Viatris Healthcare Kft.
Tel.: + 36 1 465 2100

Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Malta
V.J. Salomone Pharma Ltd
Tel: + 356 21 22 01 74

Deutschland
Viatris Healthcare GmbH
Tel: +49 800 0700 800

Nederland
Mylan BV
Tel: + 31 (0)20 426 3300

Eesti
Viatris OÜ
Tel: +372 6363 052

Norge
Viatris AS
Tlf: + 47 66 75 33 00

Ελλάδα
Viatris Hellas Ltd
Τηλ: +30 2100 100 002

Österreich
Viatris Austria GmbH
Tel: +43 1 86390

España
Viatris Pharmaceuticals, S.L.
Tel: + 34 900 102 712

Polska
Viatris Healthcare Sp. z o.o.
Tel.: + 48 22 546 64 00

France
Viatris Santé
Tél: +33 4 37 25 75 00

Portugal
Mylan, Lda.
Tel: + 351 214 127 200

Hrvatska
Viatris Hrvatska
Tel: +385 1 23 50 599

România
BGP Products SRL
Tel: +40 372 579 000

Ireland
Viatris Limited
Tel: +353 1 8711600

Slovenija
Viatris d.o.o.
Tel: + 386 1 23 63 180

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Viatris Italia S.r.l
Tel: + 39 (0) 2 612 46921

Suomi/Finland
Viatris Oy
Puh/Tel: +358 20 720 9555

Κύπρος
GPA Pharmaceuticals Ltd
Τηλ: + 357 22863100

Sverige
Viatris AB
Tel: +46 (0)8 630 19 00

Latvija
Viatris SIASIA
Tel: +371 676 055 80

United Kingdom (Northern Ireland)
Mylan IRE Healthcare Limited
Tel: +353 18711600

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu .

Darunavir Viatris 300 mg film-coated tablets

darunavir

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Darunavir Viatris is and what it is used for
• 2. What you need to know before you take Darunavir Viatris
• 3. How to take Darunavir Viatris
• 4. Possible side effects
• 5. How to store Darunavir Viatris
• 6. Contents of the pack and other information

1. What is Darunavir Viatris and what is it used for

What is Darunavir Viatris
Darunavir Viatris contains the active substance darunavir. Darunavir is an antiretroviral medicine,
used in the treatment of human immunodeficiency virus (HIV) infection. It belongs to
a group of medicines called protease inhibitors. Darunavir works by reducing the amount of
HIV in the body, improving the immune system and reducing the risk of developing
diseases related to HIV infection.

What it is used for
Darunavir is used in the treatment of adults and children aged 3 years or older and of
a body weight of at least 15 kg (kilograms) who have HIV infection and have already used other
antiretroviral medicines.
Darunavir must be taken in combination with a low dose of ritonavir and other anti-
HIV medicines. Your doctor will discuss with you the best combination of medicines for you.

2. What you need to know before taking Darunavir Viatris

Do not take Darunavir Viatris

• If you are allergicto darunavir or to any of the other ingredients of this medicine (listed in section 6) or to ritonavir.
• If you have severe liver (hepatic) problems. Ask your doctor for advice if you are not sure about the severity of your liver disease. Further tests may be needed.

Do not take Darunavir Viatris with any of the following medicines
If you are taking any of these medicines, ask your doctor how to switch to another medicine.

Do not combine darunavir with products containing St John's Wort (Hypericum perforatum).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Darunavir Viatris.
Darunavir is not a cure for HIV infection.
People taking darunavir may also develop infections or other diseases associated
with HIV infection. You should stay in regular contact with your doctor.
Patients taking darunavir may develop a rash. Rarely the rash
may become severe or potentially life-threatening. Contact your doctor every time you
develop a rash.
In patients taking darunavir and raltegravir (for HIV infection), rashes
(usually mild or moderate) may occur more frequently than in patients taking
each medicine separately.

Tell your doctor about your condition BEFORE and DURING treatment
Make sure you check the following points and tell your doctor if any of these apply to you. Tell your doctor if you have suffered from liver disorders, including hepatitis B or C.

• Your doctor may assess the severity of your liver disease before deciding whether to give you darunavir.
• Tell your doctor if you have diabetes. Darunavir may increase blood sugar levels.
• Tell your doctor immediately if you notice any symptoms of infection(e.g. swollen lymph nodes and fever). In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur shortly after starting anti-HIV treatment. These symptoms are believed to be due to an improvement in the body's immune response, which allows the body to fight infections that may have been present without causing noticeable symptoms.
• In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy tissue in the body) may also occur after you have started taking medicines to treat HIV infection. Autoimmune disorders can occur many months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, initial weakness in hands and feet that rises towards the trunk of the body, palpitations, tremors or hyperactivity, tell your doctor immediately for necessary treatment.
• Tell your doctor if you have hemophilia. Darunavir may increase the risk of bleeding.
• Tell your doctor if you are allergic to sulfonamides(used to treat some infections).
• Tell your doctor if you notice any musculoskeletal problems. Some patients taking a combination of antiretroviral medicines may develop a bone disease called osteonecrosis (bone tissue death caused by lack of blood supply to the bone). Some of the many risk factors for developing this disease may be the duration of use of antiretrovirals in combination, the use of corticosteroids, alcohol consumption, severe immunodeficiency, a high body mass index. Signs of osteonecrosis are joint stiffness, pain and aches (especially in the hip, knee and shoulder) and difficulty moving. If you notice any of these symptoms, tell your doctor immediately.

Elderly
Darunavir has been given to a limited number of patients aged 65 years or older. If
you belong to this age group, consult your doctor before taking Darunavir Viatris.

Children
Darunavir is not indicated for use in children under 3 years of age or weighing less than 15 kg
(kilograms).

Other medicines and Darunavir Viatris
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines.
There are some medicines that must not be takenwith darunavir. These have been listed previously
under the heading “ Do not take Darunavir Viatris with any of the following medicines”.
In most cases, darunavir can be combined with anti-HIV medicines that belong to
another class [e.g. NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs
(non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists and FIs (fusion inhibitors). Darunavir in combination with ritonavir has not been studied with all PIs (protease inhibitors) and should not be used with other HIV PIs. In some cases, the dose of other medicines may need to be adjusted. Therefore, always tell your doctor if you are taking other
anti-HIV medicines and carefully follow your doctor's instructions on which medicines you can take.
The effects of darunavir may be reduced if you take any of the following medicines. Tell your
doctor if you take:

• Phenobarbital, phenytoin(to prevent seizures)
• Dexamethasone(a corticosteroid)
• Efavirenz(to treat HIV infection)
• Rifapentine, rifabutin(medicines to treat some infections such as tuberculosis)
• Saquinavir(to treat HIV infection).

The effects of other medicines may be affected by taking darunavir and your doctor
may require further blood tests. Tell your doctor if you take:

• Amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, lidocaine, metoprolol,mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil(for heart disease), as the therapeutic effect or side effects of these medicines may be altered.
• Apixaban, dabigatran etexilate, edoxaban, rivaroxaban, warfarin, clopidogrel(to reduce blood clotting), because both the therapeutic effect and side effects may be altered.
• Hormonal contraceptives containing estrogen or hormone replacement therapy. Darunavir may reduce their effectiveness. When hormone therapy is used for contraceptive purposes, the use of other contraceptive methods other than hormone therapy is recommended.
• Ethinylestradiol/drospirenone. Darunavir may increase the risk of an increase in potassium levels due to drospirenone.
• Atorvastatin, pravastatin, rosuvastatin(to lower cholesterol levels). It may increase the risk of muscle damage. Your doctor will assess which medicine to lower cholesterol is most suitable for you.
• Clarithromycin(antibiotic).
• Cyclosporine, everolimus, tacrolimus, sirolimus(to reduce the activity of the immune system), as the therapeutic effect or side effects of these medicines may be increased.
• Corticosteroids, including betamethasone, budesonide, fluticasone, mometasone, prednisone,triamcinolone. These medicines are used in the treatment of allergies, asthma, inflammatory bowel disease, skin, eye, joint and muscle diseases and other types of inflammatory diseases. These medicines are generally taken orally, by inhalation, injection or applied to the skin. If alternative treatments cannot be used, these medicines can only be taken after assessment by your doctor and under close monitoring by your doctor for side effects due to corticosteroids.
• Buprenorphine/naloxone(to treat opioid dependence).
• Salmeterol(for the treatment of asthma).
• Artemether/lumefantrine(a combination of medicines for the treatment of malaria).
• Dasatinib, everolimus, irinotecan, nilotinib, vinblastine, vincristine(to treat cancer).
• Sildenafil, tadalafil, vardenafil(for erectile dysfunction or for the treatment of a heart or lung disorder called pulmonary arterial hypertension).
• Glecaprevir/pibrentasvir(for the treatment of hepatitis C infection).
• Fentanyl, oxycodone, tramadol(for the treatment of pain). Fesoterodine, solifenacin(to treat urological disorders).

Your doctor may require further blood tests and the dosage of other medicines may
be modified because the therapeutic effect and side effects of these medicines or of
darunavir may be affected if taken together.
Tell your doctor if you are taking:

• Dabigatran etexilate, edoxaban, warfarin(to reduce blood clotting).
• Alfentanil(strong short-acting injectable pain reliever used for surgery).
• Digoxin(for the treatment of some heart disorders).
• Clarithromycin(antibiotic).
• Itraconazole, isavuconazole, fluconazole, posaconazole, clotrimazole(to treat fungal infections). Voriconazole can only be taken after assessment by your doctor.
• Rifabutin(against bacterial infections).
• Sildenafil, vardenafil, tadalafil(for erectile dysfunction or for high blood pressure in the pulmonary circulation).
• Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone(for the treatment of depression and anxiety).
• Maraviroc(to treat HIV infection).
• Methadone(to treat opioid dependence).
• Carbamazepine, clonazepam(to prevent seizures or to treat some types of neuropathic pain).
• Colchicine(for the treatment of gout or Familial Mediterranean fever).
• Bosentan(for the treatment of high blood pressure in the pulmonary circulation).
• Buspirone, clorazepate, diazepam, estazolam, flurazepam, midazolam when used in the formof injection, zolpidem(sedatives).
• Perphenazine, risperidone, thioridazine(to treat psychiatric conditions).

This is nota complete list of medicines. Tell your doctor about allthe medicines you are
taking.

Darunavir Viatris with food and drink
See section 3 “How to take Darunavir Viatris”.

Pregnancy and breastfeeding
Tell your doctor immediately if you are pregnant or planning a pregnancy.
Pregnant women should not take darunavir with ritonavir unless specifically instructed by their doctor. Pregnant women should not take darunavir with
cobicistat.
Because of the possibility of adverse effects in infants, women should not breastfeed while taking
Darunavir Viatris.
Breastfeeding is not recommended in women with HIV infection as the infection can be
transmitted to the baby in breast milk. If you are breastfeeding or are thinking about breastfeeding, talk to your doctor as
soon as possible.

Driving and using machines
Do not use machines or drive if you feel dizzy after taking darunavir.

Darunavir Viatris contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, therefore it is essentially
“sodium-free”.

3. How to take Darunavir Viatris

Take this medicine always exactly as your doctor, pharmacist or
nurse has told you. If you have doubts, ask your doctor, pharmacist or nurse.
Even if you feel better, do not stop taking darunavir and ritonavir without talking to your
doctor.
After starting therapy, you must not change the dose, dosage form or stop the
therapy without your doctor's instructions.

Dose for adults who have never taken antiretroviral medicines (your doctor will determine this)
Different dosages of darunavir may be needed that cannot be administered with these
300 mg tablets. Other dosages of Darunavir Viatris are available.

Dose for adults who have previously taken antiretroviral medicines (your doctor will determine this)
The doses are:

• 600 milligrams of darunavir (2 tablets containing 300 milligrams of darunavir, or one tablet containing 600 milligrams of darunavir) together with 100 milligrams of ritonavir, twice a day. OR
• 800 milligrams of darunavir (2 tablets containing 400 milligrams of darunavir, or one tablet containing 800 milligrams of darunavir) together with 100 milligrams of ritonavir, twice a day. Darunavir Viatris 400 milligram and 800 milligram tablets must only be used to build the 800 milligram once-daily regimen.

Discuss with your doctor which is the correct dose.

Instructions for adults

• Always take darunavir with ritonavir. Darunavir cannot work effectively without ritonavir.
• In the morning, take two 300 milligram tablets of darunavir together with 100 milligrams of ritonavir.
• In the evening, take two 300 milligram tablets of darunavir together with 100 milligrams of ritonavir.
• Take darunavir with food. Darunavir cannot work effectively without food. The type of food taken is not important.
• Swallow the tablets with a drink such as water or milk.
• Darunavir Viatris 75 milligram and 150 milligram tablets have been developed for use in children, but they can also be used in some cases in adults.

Dose for children aged 3 years or older and weighing at least 15
kilograms who have never taken antiretroviral medicines (the child's doctor will determine this)
The doctor will calculate the correct daily dose each time based on the child's body weight
(see table below). This dose must not exceed the recommended dose for adults, which is
800 milligrams of darunavir together with 100 milligrams of ritonavir once a day.
The doctor will tell you how many darunavir tablets and how much ritonavir (capsules, tablets or
solution) the child must take.
ritonavir oral solution: 80 milligrams per millilitre

Dose for children aged 3 years or older and weighing at least 15 kg
(kilograms) who have previously taken antiretroviral medicines (the child's doctor will determine this)
The doctor will calculate the appropriate dose based on the child's weight (see the table below). The
doctor will decide whether the once-daily or twice-daily dose is appropriate for the child. This dose must not exceed that recommended for adults, which corresponds to
600 milligrams of darunavir together with 100 milligrams of ritonavir twice a day or
800 milligrams of darunavir together with 100 milligrams of ritonavir once a day. The doctor will tell you
how many darunavir tablets and how much ritonavir (capsules, tablets or solution) the child must
take. Lower dosage tablets are available and your doctor may have prescribed a specific combination of tablets to achieve the appropriate dosing schedule.
Other formulations of this medicine may be more appropriate for children: ask your
doctor or pharmacist.
Twice-daily dose

Once-daily dose

Instructions for children

• The child must always take darunavir together with ritonavir. Darunavir cannot work effectively without ritonavir.
• The child must take the appropriate doses of darunavir and ritonavir twice a day or once a day. If darunavir is prescribed twice a day, the child must take one dose in the morning and one dose in the evening. The doctor will determine which regimen is most appropriate for the child.
• The child must take darunavir with food. Darunavir cannot work effectively without food. The type of food is not important.
• The child must swallow the tablets with a drink such as water or milk.

If you take more Darunavir Viatris than you should
Tell your doctor, pharmacist or nurse immediately.

If you forget to take Darunavir Viatris
If you remember within 6 hours, you should take the tablets immediately. Always take the
tablets with ritonavir and food. If you remember after 6 hours, skip the dose and take the
next dose as usual. Do not take a double dose to make up for a missed dose.

If you vomit after taking Darunavir Viatris and ritonavir
If you vomit within 4 hoursof taking the medicine, you should take another dose of
Darunavir Viatris and ritonavir with food as soon as possible. If vomiting occurs more than 4 hours
after taking the medicine, you do not need to take another dose of Darunavir Viatris and
ritonavir until the time usually scheduled for the next dose.
Contact your doctor if you are unsureabout what to do if you forget a dose or vomit.

Do not stop treatment with Darunavir Viatris without first consulting your doctor
Anti-HIV medicines can make you feel better. Do not stop taking darunavir, even if
you feel better. Ask your doctor first.
If you have any questions about using this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

During HIV therapy, an increase in weight and levels of lipids and glucose in the blood may occur.
This is partly related to the restoration of health and lifestyle and, in the case of blood lipids, sometimes to the HIV medications themselves. The doctor will check these changes.
Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Tell your doctor if you develop any of the following side effects
Liver problems have been reported that can occasionally be serious. The doctor will need to perform blood tests before starting darunavir. If you have chronic hepatitis B or C, your doctor should check your blood tests more frequently because you are more likely to develop liver problems. Talk to your doctor about the signs and symptoms of liver problems. These

may include yellowing of the skin or whites of the eyes, dark urine (tea-colored), pale stools (bowel movements), nausea, vomiting, loss of appetite, or pain, tenderness or soreness and discomfort on the right side under the ribs.
Skin rashes (more frequent when used in combination with raltegravir), itching. These rashes are usually mild to moderate in severity. A rash may also be a symptom of a more serious and rare condition. It is therefore important that you consult your doctor if you develop a rash. Your doctor will advise you on how to treat the symptoms or whether darunavir should be discontinued.
Other serious side effects were diabetes (common) and inflammation of the pancreas (uncommon).
Very common side effects (may affect more than 1 in 10 people)

• diarrhea

Common side effects (may affect up to 1 in 10 people)

• vomiting, nausea, abdominal pain or distension, dyspepsia (indigestion), flatulence
• headache, fatigue, dizziness, drowsiness, numbness, tingling or pain in the hands or feet, loss of strength, difficulty falling asleep

Uncommon side effects (may affect up to 1 in 100 people)

• chest pain, changes in electrocardiogram, rapid heartbeat
• decreased or abnormal skin sensation, tingling sensation, attention disorders, memory loss, balance problems
• difficulty breathing, cough, nosebleed, sore throat
• inflammation of the stomach or mouth, heartburn, retching, dry mouth, abdominal discomfort, constipation, belching
• kidney failure, kidney stones, difficulty urinating, frequent or excessive urination, sometimes at night
• urticaria, severe swelling of the skin and other tissues (especially lips and eyes), eczema, excessive sweating, night sweats, hair loss, acne, scaly skin, nail pigmentation
• muscle pain, muscle cramps or weakness, pain in the extremities, osteoporosis
• slowing of thyroid function. This can be demonstrated through a blood test.
• high blood pressure, hot flashes
• red or dry eyes
• fever, swelling of the legs due to fluid retention, malaise, chills, abnormal sensations, irritability, pain
• infection symptoms, herpes simplex
• erectile dysfunction (problems with erection), breast enlargement
• sleep disorders, drowsiness, depression, anxiety, altered dreams, decreased sexual desire

Rare side effects (may affect up to 1 in 1,000 people)

• a reaction called DRESS [severe rash that may be accompanied by fever, fatigue, facial or lymph node swelling, increased eosinophils (a type of white blood cell), effects on the liver, kidneys or lungs]
• heart attack, slow heartbeat, palpitations
• vision disturbances
• chills, feeling unwell
• a feeling of confusion or disorientation, altered mood, restlessness
• fainting, seizures, change or loss of taste
• mouth ulcers, vomiting blood, inflammation of the lips, dry lips, coated tongue
• runny nose
• skin lesions, dry skin
• stiffness of muscles or joints, joint pain with or without inflammation
• changes in some blood cell or chemical values. These can be seen in blood and/or urine tests. Your doctor will explain these results to you. Examples are: increased numbers of certain white blood cells
• darunavir crystal deposition in the kidney leading to kidney disease.

Some side effects are typical of HIV medicines from the same family as darunavir. These are:

• muscle pain, fragility or weakness. In rare cases, these muscle disorders have been severe.

Reporting of side effects
If you get any side effect, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the reporting system indicated in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Darunavir Viatris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, blister and
bottle after Exp. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
For bottles: once opened, use within 100 days.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Darunavir Viatris contains

• The active ingredient is darunavir. Each tablet contains 300 milligrams of darunavir.
• The other ingredients are: colloidal anhydrous silica, microcrystalline cellulose, crospovidone (Type A), sodium starch glycolate, hypromellose, magnesium stearate. The coating contains partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol and talc.

Description of the appearance of Darunavir Viatris and contents of the pack
Darunavir Viatris 300 mg tablets are film-coated, from white to off-white in color,
oval with two curved sides, with M imprinted on one side and DV3 on the other.
Darunavir Viatris 300 mg film-coated tablets are available in blisters containing 30, 60
and 120 tablets and in plastic bottles containing 30 and 120 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park,
Mulhuddart,
Dublin 15,
DUBLIN,
Ireland

Manufacturer
Mylan Hungary Kft
H-2900 Komárom, Mylan utca 1
Hungary
McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Viatris
Tél/Tel: + 32 (0)2 658 61 00

Lietuva
Viatris UAB
Tel: +370 5 205 1288

България
Майлан ЕООД
Тел.: +359 2 44 55 400

Luxembourg/Luxemburg
Viatris
Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika
Viatris CZ.s.r.o.
Tel: 420 222 004 400

Magyarország
Viatris Healthcare Kft.
Tel.: + 36 1 465 2100

Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Malta
V.J. Salomone Pharma Ltd
Tel: + 356 21 22 01 74

Deutschland
Viatris Healthcare GmbH
Tel: +49 800 0700 800

Nederland
Mylan BV
Tel: + 31 (0)20 426 3300

Eesti
Viatris OÜ
Tel: +372 6363 052

Norge
Viatris AS
Tlf: + 47 66 75 33 00

Ελλάδα
Viatris Hellas Ltd
Τηλ: +30 2100 100 002

Österreich
Viatris Austria GmbH
Tel: +43 1 86390

España
Viatris Pharmaceuticals, S.L.
Tel: + 34 900 102 712

Polska
Viatris Healthcare Sp. z o.o.
Tel.: + 48 22 546 64 00

France
Viatris Santé
Tél: +33 4 37 25 75 00

Portugal
Mylan, Lda.
Tel: + 351 214 127 200

Hrvatska
Viatris Hrvatska
Tel: +385 1 23 50 599

România
BGP Products SRL
Tel: +40 372 579 000

Ireland
Viatris Limited
Tel: +353 1 8711600

Slovenija
Viatris d.o.o.
Tel: + 386 1 23 63 180

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Viatris Italia S.r.l
Tel: + 39 (0) 2 612 46921

Suomi/Finland
Viatris Oy
Puh/Tel: +358 20 720 9555

Κύπρος
GPA Pharmaceuticals Ltd
Τηλ: + 357 22863100

Sverige
Viatris AB
Tel: +46 (0)8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

United Kingdom (Northern Ireland)
Mylan IRE Healthcare Limited
Tel: +353 18711600

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu .

Darunavir Viatris 400 mg film-coated tablets

darunavir

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Darunavir Viatris is and what it is used for
• 2. What you need to know before you take Darunavir Viatris
• 3. How to take Darunavir Viatris
• 4. Possible side effects
• 5. How to store Darunavir Viatris
• 6. Contents of the pack and other information

1. What is Darunavir Viatris and what it is used for

What is Darunavir Viatris
Darunavir Viatris contains the active substance darunavir. Darunavir is an antiretroviral medicine,
used in the treatment of human immunodeficiency virus (HIV) infection. It belongs to
a group of medicines called protease inhibitors. Darunavir works by reducing the amount of
HIV in the body, improving the immune system and reducing the risk of developing
diseases related to HIV infection.

What it is used for
Darunavir is used for the treatment of adult and children patients aged 3 years or older and
with a minimum weight of 40 kg (kilograms) with HIV infection and

• who have not previously used other antiretroviral medicines.
• in some patients who have already used antiretroviral medicines previously (the doctor will determine who to administer it to).

Darunavir must be taken in combination with a low dose of cobicistat or ritonavir and other
anti-HIV medicines. The doctor will discuss with you the best combination of medicines for you.

2. What you need to know before taking Darunavir Viatris

Do not take Darunavir Viatris

• If you are allergicto darunavir, or to any of the other ingredients of this medicine (listed in section 6) or to cobicistat or ritonavir.
• If you have severe liver problems (hepatic). Ask your doctor for advice if you are not sure about the severity of your liver disease. Further tests may be needed.

Do not combine Darunavir Viatris with any of the following medicines
If you are taking any of these medicines, ask your doctor how to switch to another medicine.

Do not combine darunavir with products containing St. John's Wort (Hypericum perforatum).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Darunavir Viatris.
Darunavir is not a cure for HIV infection.
People taking darunavir may also develop infections or other illnesses associated
with HIV infection. You should stay in regular contact with your doctor.
Patients taking darunavir may develop a rash. Rarely, the rash
may become severe or potentially life-threatening. Contact your doctor whenever you
develop a rash.
In patients taking darunavir and raltegravir (for HIV infection), rashes
(usually mild or moderate) may occur more frequently than in patients taking
each medicine separately.

Tell your doctor about your condition BEFORE and DURING therapy
Make sure you check the following points and tell your doctor if any of these apply to you.

• Tell your doctor if you have suffered from liver problems, including hepatitis B or C. Your doctor may assess the severity of your liver disease before deciding whether to give you darunavir.
• Tell your doctor if you have diabetes. Darunavir may increase blood sugar levels.
• Tell your doctor immediately if you notice any signs of infection(e.g. swollen lymph nodes and fever). In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur shortly after starting anti-HIV treatment. These symptoms are thought to be due to an improvement in the body's immune response,

which allows the body to fight infections that may have been present without
causing noticeable symptoms.

• In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy tissue in the body) may also occur after you have started taking medicines to treat HIV infection. Autoimmune disorders can occur many months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, initial weakness in the hands and feet that rises towards the trunk of the body, palpitations, tremors or hyperactivity, tell your doctor immediately for the necessary treatment.
• Tell your doctor if you have hemophilia. Darunavir may increase the risk of bleeding.
• Tell your doctor if you are allergic to sulfonamides(used to treat some infections).
• Tell your doctor if you notice any musculoskeletal problems. Some patients taking a combination of antiretroviral medicines may develop a bone disease called osteonecrosis (death of bone tissue caused by a lack of blood supply to the bone). Some of the many risk factors for developing this disease may be the duration of use of antiretrovirals in combination, the use of corticosteroids, alcohol consumption, severe immunodeficiency, a high body mass index. Signs of osteonecrosis are joint swelling, pain and aches (especially in the hip, knee and shoulder) and difficulty moving. If you notice any of these symptoms, tell your doctor immediately.

Elderly
Darunavir has been given to a limited number of patients aged 65 years or older. If
you belong to this age group, consult your doctor before taking Darunavir Viatris.

Children and adolescents
Darunavir should not be used in children under 3 years of age or weighing less than
15 kilograms.

Other medicines and Darunavir Viatris
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines.
There are some medicines that must not be combinedwith darunavir. These have been listed previously
under the heading “Do not combine Darunavir Viatris with any of the following medicines”.
In most cases, darunavir can be combined with anti-HIV medicines that belong to
another class [e.g. NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs
(non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists and FIs (fusion
inhibitors)]. Darunavir in combination with cobicistat or ritonavir has not been studied with all PIs
(protease inhibitors) and should not be used with other HIV PIs. In some cases, the dose of other medicines may need to be adjusted. Therefore, always tell your doctor if you are taking
other anti-HIV medicines and carefully follow your doctor's instructions on which medicines you can
take.
The effects of darunavir may be reduced if you take any of the following medicines. Tell your
doctor if you take:

• Phenobarbital, phenytoin(to prevent seizures)
• Dexamethasone(a corticosteroid)
• Efavirenz(to treat HIV infection)
• Rifapentine, rifabutin(medicines to treat some infections such as tuberculosis)
• Saquinavir(to treat HIV infection).

The effects of other medicines may be affected by taking darunavir and your doctor
may require further blood tests. Tell your doctor if you take:

• Amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, lidocaine, metoprolol,mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil(for heart disease), as the therapeutic effect or side effects of these medicines may be altered.
• Apixaban, dabigatran etexilate, edoxaban, rivaroxaban, warfarin, clopidogrel(to reduce blood clotting), because both the therapeutic effect and side effects may be altered.
• Hormonal contraceptives containing estrogens or hormone replacement therapy. Darunavir may reduce their effectiveness. When hormone therapy is used for contraceptive purposes, the use of other methods of contraception is recommended.
• Ethinylestradiol/drospirenone. Darunavir may increase the risk of an increase in potassium levels due to drospirenone.
• Atorvastatin, pravastatin, rosuvastatin(to lower cholesterol levels). It may increase the risk of muscle damage. Your doctor will assess which medicine to lower cholesterol is most suitable for you.
• Clarithromycin(antibiotic).
• Cyclosporine, everolimus, tacrolimus, sirolimus(to reduce the activity of the immune system), as the therapeutic effect or side effects of these medicines may be increased.
• Corticosteroids, including betamethasone, budesonide, fluticasone, mometasone, prednisone,triamcinolone.These medicines are used in the treatment of allergies, asthma, inflammatory bowel disease, inflammatory skin, eye, joint and muscle conditions and other types of inflammatory conditions. These medicines are generally taken orally, by inhalation, injection or applied to the skin. If alternative treatments cannot be used, these medicines may only be taken after assessment by your doctor and under close monitoring by your doctor for side effects due to corticosteroids.
• Buprenorphine/naloxone(to treat opioid dependence)
• Salmeterol(for the treatment of asthma)
• Artemether/lumefantrine(a combination of medicines for the treatment of malaria).
• Dasatinib, everolimus, irinotecan, nilotinib, vinblastine, vincristine(to treat cancer)
• Sildenafil, tadalafil, vardenafil(for erectile dysfunction or for the treatment of a heart or lung condition called pulmonary arterial hypertension)
• Glecaprevir/pibrentasvir(for the treatment of hepatitis C infection)
• Fentanyl, oxycodone, tramadol(for the treatment of pain)
• Fesoterodine, solifenacin(to treat urological disorders).

This is nota complete list of medicines. Tell your doctor about allthe medicines you are
taking.

Darunavir Viatris with food and drink
See section 3 “How to take Darunavir Viatris”.

Pregnancy and breastfeeding
Tell your doctor immediately if you are pregnant or planning a pregnancy.
Pregnant women should not take darunavir with ritonavir, unless they receive
specific instructions from their doctor. Pregnant women should not take darunavir with
cobicistat.
Given the possibility of adverse effects in infants, women should not breastfeed if they are receiving
Darunavir Viatris.
Breastfeeding is not recommended in women with HIV infection as the infection can
be transmitted to the baby in breast milk. If you are breastfeeding or think you might be, talk to your doctor
as soon as possible.

Driving and using machines
Do not use machines or drive if you feel dizzy after taking darunavir.

Darunavir Viatris contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, therefore it is essentially
“sodium-free”.

3. How to take Darunavir Viatris

Take this medicine exactly as your doctor, pharmacist or
nurse has told you. If you have any doubts, ask your doctor, pharmacist or nurse.
Even if you feel better, do not stop taking darunavir and cobicistat or ritonavir without
talking to your doctor.
After therapy has started, the dose or dosage form must not be changed or the
therapy must not be interrupted without instructions from your doctor.
The 400 milligram tablets of darunavir must only be used to build the 800
milligram once-daily regimen.

Dose for adults who have not previously taken antiretroviral drugs (your doctor
will assess this)
The usual dose of darunavir is 800 milligrams (2 tablets containing 400 milligrams of
Darunavir Viatris or 1 tablet containing 800 milligrams of Darunavir Viatris) once daily.
You must take darunavir every day and always together with 150 milligrams of cobicistat or
100 milligrams of ritonavir and with food. Darunavir may not work as well without cobicistat or
ritonavir and without food. You should have a meal or snack within 30 minutes before taking
darunavir and cobicistat or ritonavir. The type of food is irrelevant. Even if you feel better, do not stop
taking darunavir and cobicistat or ritonavir before talking to your doctor.

Instructions for adults

• Take two 400 milligram tablets at the same time, once a day, every day.
• Always take darunavir with 150 milligrams of cobicistat or 100 milligrams of ritonavir.
• Take darunavir with food.
• Swallow the tablets with a drink such as water or milk.
• Take the other medicines for HIV used in combination with darunavir and cobicistat or ritonavir following your doctor’s instructions

Dose for adults who have previously taken antiretroviral drugs (your doctor will assess this)

• 800 milligrams of darunavir (2 tablets containing 400 milligrams of darunavir or 1 tablet containing 800 milligrams of darunavir) together with 150 milligrams of cobicistat or 100 milligrams of ritonavir once daily. OR
• 600 milligrams of darunavir (2 tablets containing 300 milligrams of darunavir or one tablet containing 600 milligrams of darunavir) together with 100 milligrams of ritonavir twice daily.

Discuss with your doctor what the correct dose is.

Dose with ritonavir for children aged 3 years and over and with cobicistat for adolescents
aged 12 years and over and weighing at least 40 kilograms who have not
previously taken antiretroviral medicines (the child’s doctor will determine
this condition)

• The usual dose of darunavir is 800 milligrams once daily (2 tablets containing 400 milligrams of darunavir or 1 tablet containing 800 milligrams of darunavir) together with 100 mg of ritonavir or 150 mg of cobicistat once daily.

Dose with ritonavir for children aged 3 years and over and with cobicistat for adolescents
aged 12 years and over and weighing at least 40 kilograms who have
previously taken antiretroviral medicines (the child’s doctor will determine this
condition)

• 800 milligrams of darunavir (2 tablets containing 400 milligrams of darunavir or 1 tablet containing 800 milligrams of darunavir) together with 100 milligrams of ritonavir or 150 milligrams of cobicistat once daily. OR
• 600 milligrams of darunavir (2 tablets containing 300 milligrams of darunavir or 1 tablet containing 600 milligrams of darunavir) together with 100 milligrams of ritonavir twice daily.

Discuss with your doctor what the correct dose is.

Instructions for the dose with ritonavir for children aged 3 years and over and with cobicistat
for adolescents aged 12 years and over and weighing more than 40 kilograms

• Take 800 milligrams of darunavir (2 tablets containing 400 milligrams of darunavir or 1 tablet containing 800 milligrams of darunavir) at the same time, once a day, every day.
• Always take darunavir together with 100 milligrams of ritonavir or 150 milligrams of cobicistat.
• Take darunavir with food.
• Swallow the tablets with a drink such as water or milk.
• Take the other medicines for HIV used in combination with darunavir and ritonavir or cobicistat as recommended by your doctor.

If you take more Darunavir Viatris than you should
Tell your doctor, pharmacist or nurse immediately.

If you forget to take Darunavir Viatris
If you remember within 12 hours, you should take the tablets immediately. Always take the
tablets together with cobicistat or ritonavir and with food. If you remember after 12 hours, skip the dose and
take the next dose as usual. Do not take a double dose to make up for a missed dose.

In case of vomiting after taking Darunavir Viatris and ritonavir
If you vomit within 4 hoursof taking the medicine, you should take another dose of
Darunavir Viatris and ritonavir with food as soon as possible. If vomiting occurs more than 4 hours
after taking the medicine, you do not need to take another dose of Darunavir Viatris and
ritonavir until the time of your next scheduled dose.
Contact your doctor if you are unsureabout what to do if you forget a dose or vomit.

Do not stop treatment with Darunavir Viatris without first talking to your doctor
HIV medicines can make you feel better. Do not stop taking Darunavir Viatris, even
if you feel better. Talk to your doctor first.
If you have any questions about using this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

During HIV therapy, an increase in weight and levels of lipids and glucose in the blood may occur.
This is partly related to the restoration of health and lifestyle, and in the case of blood lipids, sometimes to the
HIV medications themselves. The doctor will check these changes.
Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Tell your doctor if you develop any of the following side effects
Liver problems have been reported that can occasionally be serious. The doctor will need to perform blood tests
before starting darunavir. If you have chronic hepatitis B or C, your doctor should check your blood tests more
frequently because you are more likely to develop liver problems. Talk to your doctor about the signs and symptoms
of liver problems. These may include yellowing of the skin or the whites of the eyes, dark urine (tea-colored), pale
stools (bowel movements), nausea, vomiting, loss of appetite, or pain, tenderness or soreness and discomfort on
the right side under the ribs.
Skin rashes (more frequent when used in combination with raltegravir), itching. These rashes are usually mild to
moderate in severity. A rash can also be a symptom of a more serious and rare condition. It is therefore important
that you consult your doctor if you develop a rash. Your doctor will advise you on how to treat the symptoms or
whether darunavir should be discontinued.
Other serious side effects were diabetes (common) and inflammation of the pancreas (uncommon).
Very common side effects (may affect more than 1 in 10 people)

• diarrhea

Common side effects (may affect up to 1 in 10 people)

• vomiting, nausea, abdominal pain or distension, dyspepsia (indigestion), flatulence
• headache, fatigue, dizziness, drowsiness, numbness, tingling or pain in the hands or feet, loss of strength, difficulty falling asleep.

Uncommon side effects (may affect up to 1 in 100 people)

• chest pain, changes in electrocardiogram, rapid heartbeat
• decreased or abnormal skin sensation, tingling sensation, attention disorders, memory loss, difficulty with balance
• difficulty breathing, cough, nosebleeds, sore throat
• inflammation of the stomach or mouth, heartburn, retching, dry mouth, abdominal discomfort, constipation, belching
• kidney failure, kidney stones, difficulty urinating, frequent or excessive urination, sometimes at night
• hives, severe swelling of the skin and other tissues (especially lips and eyes), eczema, excessive sweating, night sweats, hair loss, acne, scaling skin, nail pigmentation
• muscle pain, muscle cramps or weakness, pain in the extremities, osteoporosis
• slowed thyroid function. This can be demonstrated through a blood test.
• high blood pressure, hot flushes
• red or dry eyes
• fever, leg swelling due to fluid retention, malaise, chills, abnormal sensations, irritability, pain
• infection symptoms, herpes simplex
• erectile dysfunction (problems with erection), breast enlargement
• sleep disorders, drowsiness, depression, anxiety, altered dreams, decreased sexual desire

Rare side effects (may affect up to 1 in 1,000 people)

• a reaction called DRESS [severe rash that may be accompanied by fever, fatigue, swelling of the face or lymph nodes, increased eosinophils (a type of white blood cells), effects on the liver, kidneys or lungs]
• heart attack, slow heartbeat, palpitations
• vision disturbances
• chills, feeling unwell
• a feeling of confusion or disorientation, altered mood, restlessness
• fainting, seizures, change or loss of taste
• mouth ulcers, vomiting blood, inflammation of the lips, dry lips, coated tongue
• runny nose
• skin lesions, dry skin
• stiffness of muscles or joints, joint pain with or without inflammation
• changes in some blood cell or chemical values. These can be seen in blood and/or urine tests. Your doctor will explain these results. Examples include: increased levels of certain white blood cells
• deposition of darunavir crystals in the kidney with resulting kidney disease.

Some side effects are typical of anti-HIV medicines in the same class as darunavir. These are the
following:

• muscle pain, fragility or weakness. In rare cases, these muscle disorders have been severe.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can
also report side effects directly through the reporting system indicated in Annex V. By reporting side effects you can
help provide more information on the safety of this medicine.

5. How to store Darunavir Viatris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, blister and
bottle after Exp. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
For the bottles: once opened, use within 100 days.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Darunavir Viatris contains

• The active ingredient is darunavir. Each tablet contains 400 milligrams of darunavir ethanolate.
• The other ingredients are: anhydrous colloidal silica, microcrystalline cellulose, crospovidone, sodium starch glycolate, hypromellose, magnesium stearate. The coating contains partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol and talc.

Description of the appearance of Darunavir Viatris and package contents
Darunavir Viatris 400 mg tablets are film-coated, from white to off-white in colour,
oval with two curved sides, with M imprinted on one side and DV4 on the other.
Darunavir Viatris 400 mg film-coated tablets are available in blisters containing 30 and 60
tablets and in HDPE bottles containing 60 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park,
Mulhuddart,
Dublin 15,
DUBLIN,
Ireland

Manufacturer
Mylan Hungary Kft
H-2900 Komárom, Mylan utca 1 Hungary
McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352
Germany
For further information on this medicine, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Viatris
Tél/Tel: + 32 (0)2 658 61 00

Lietuva
Viatris UAB
Tel: +370 5 205 1288

България
Майлан ЕООД
Тел.: +359 2 44 55 400

Luxembourg/Luxemburg
Viatris
Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika
Viatris CZ.s.r.o.
Tel: 420 222 004 400

Magyarország
Viatris HealthcareTel.: + 36 1 465 2100

Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Malta
V.J. Salomone Pharma Ltd
Tel: + 356 21 22 01 74

Deutschland
Viatris Healthcare GmbH
Tel: +49 800 0700 800

Nederland
Mylan BV
Tel: + 31 (0)20 426 3300

Eesti
Viatris OÜTel: +372 6363 052

Norge
Viatris AS
Tlf: + 47 66 75 33 00

Ελλάδα
Viatris Hellas Ltd Τηλ: +30 2100 100 002

Österreich
Viatris Austria GmbH
Tel: +43 1 86390

España
Viatris Pharmaceuticals, S.L.Tel: + 34 900
102 712

Polska
Viatris Healthcare Sp. z o.o.
Tel.: + 48 22 546 64 00

France
Viatris Santé
Tél: +33 4 37 25 75 00

Portugal
Mylan, Lda.
Tel: + 351 214 127 200

Hrvatska
Viatris Hrvatska
Tel: +385 1 23 50 599

România
BGP Products SRL
Tel: +40 372 579 000

Ireland
Viatris Limited
Tel: +353 1 8711600

Slovenija
Viatris d.o.o.
Tel: + 386 1 23 63 180

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Viatris Italia S.r.l Tel: + 39 (0) 2 612 46921

Suomi/Finland
Viatris Oy
Puh/Tel: +358 20 720 9555

Κύπρος
GPA PharmaceuticalsΤηλ: + 357 22863100

Sverige
Viatris AB
Tel: +46 (0)8 630 19 00

Latvija
Viatris SIATel: +371 676 055 80

United Kingdom (Northern Ireland)
Mylan IRE Healthcare Limited
Tel: +353 18711600

Other sources of information
More detailed information on this medicine is available on the website of the European
Medicines Agency, http://www.ema.europa.eu .

Darunavir Viatris 600 mg film-coated tablets

darunavir

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Darunavir Viatris is and what it is used for
• 2. What you need to know before you take Darunavir Viatris
• 3. How to take Darunavir Viatris
• 4. Possible side effects
• 5. How to store Darunavir Viatris
• 6. Contents of the pack and other information

1. What is Darunavir Viatris and what is it used for

What is Darunavir Viatris
Darunavir Viatris contains the active ingredient darunavir. Darunavir is an antiretroviral medicine,
used in the treatment of human immunodeficiency virus (HIV) infection. It belongs to
a group of medicines called protease inhibitors. Darunavir works by reducing the amount of
HIV in the body, improving the immune system and reducing the risk of developing
diseases related to HIV infection.

What is it used for
Darunavir is used in the treatment of adults and children aged 3 years or older and
weighing at least 15 kg (kilograms) with HIV infection who have already used other
antiretroviral medicines.
Darunavir must be taken in combination with a low dose of ritonavir and other anti-
HIV medicines. Your doctor will discuss with you the best combination of medicines for you.

2. What you need to know before you take Darunavir Viatris

Do not take Darunavir Viatris

• If you are allergicto darunavir, or to any of the other ingredients of this medicine (listed in section 6) or to ritonavir.
• If you have severe liver problems (hepatic). Ask your doctor for advice if you are not sure about the severity of your liver disease. Further tests may be necessary.

Do not combine Darunavir Viatris with any of the following medicines
If you are taking any of these medicines, ask your doctor how to switch to another medicine.

Do not combine darunavir with products containing St John's Wort (Hypericum perforatum).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Darunavir Viatris.
Darunavir is not a cure for HIV infection.
People taking darunavir may also develop infections or other illnesses associated
with HIV infection. You should stay in regular contact with your doctor.
Patients taking darunavir may develop a rash. Rarely the rash
may become severe or potentially life-threatening. Contact your doctor whenever you
develop a rash.
In patients taking darunavir and raltegravir (for HIV infection), rashes
(usually mild or moderate) may occur more frequently than in patients taking
each medicine separately.

Tell your doctor about your condition BEFORE and DURING treatment
Make sure you check the following points and tell your doctor if any of these apply to you.

• Tell your doctor if you have suffered from liver problems, including hepatitis B or C. Your doctor may assess the severity of your liver disease before deciding whether to give you darunavir.
• Tell your doctor if you have diabetes. Darunavir may increase blood sugar levels.
• Immediately tell your doctor if you notice any signs of infection(e.g. swollen lymph nodes and fever). In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur shortly after starting anti-HIV treatment. These symptoms are thought to be due to an improvement in the body's immune response, allowing the body to fight infections that may have been present without causing obvious symptoms.
• In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy tissue in the body) may also occur after you have started taking medicines to treat HIV infection. Autoimmune disorders can occur many months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, initial weakness in hands and feet that rises towards the body trunk, palpitations, tremors or hyperactivity, tell your doctor immediately to request the necessary treatment.
• Tell your doctor if you have hemophilia. Darunavir may increase the risk of bleeding.
• Tell your doctor if you are allergic to sulfonamides(used to treat some infections).
• Tell your doctor if you notice any musculoskeletal problems. Some patients taking a combination of antiretroviral medicines may develop a bone disease called osteonecrosis (death of bone tissue caused by a lack of blood supply to the bone). Some of the many risk factors for developing this disease may be the duration of use of antiretrovirals in combination, the use of corticosteroids, alcohol consumption, severe immunodeficiency, a high body mass index. Signs of osteonecrosis are joint swelling, pain and aches (especially in the hip, knee and shoulders) and difficulty moving. If you notice any of these symptoms, tell your doctor immediately.

Elderly
Darunavir has been given to a limited number of patients aged 65 years or older. If
you belong to this age group, consult your doctor before taking Darunavir Viatris.

Children
Darunavir should not be used in children under 3 years of age or weighing less than
15 kilograms.

Other medicines and Darunavir Viatris
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines.
There are some medicines that must not be combinedwith darunavir. These have been listed previously
under the heading “ Do not combine Darunavir Viatris with any of the following medicines”.
In most cases, darunavir can be combined with anti-HIV medicines that belong to
another class [e.g. NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs
(non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists and FIs (fusion
inhibitors)]. Darunavir in combination with cobicistat or ritonavir has not been studied with all PIs
(protease inhibitors) and should not be used with other HIV PIs. In some cases, the dose of other medicines may need to be adjusted. Therefore, always tell your doctor if you are taking
other anti-HIV medicines and carefully follow your doctor's instructions on which medicines you can
take.
The effects of darunavir may be reduced if you take any of the following medicines. Tell
your doctor if you take:

• Phenobarbital, phenytoin(to prevent seizures)
• Dexamethasone(a corticosteroid)
• Efavirenz(to treat HIV infection)
• Rifapentine, rifabutin(medicines to treat some infections such as tuberculosis)
• Saquinavir(to treat HIV infection).

The effects of other medicines may be affected by taking darunavir and your doctor
may require further blood tests. Tell your doctor if you take:

• Amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, lidocaine, metoprolol,mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil(for heart disease), as the therapeutic effect or side effects of these medicines may be altered.
• Apixaban, dabigatran etexilate, edoxaban, rivaroxaban, warfarin, clopidogrel(to reduce blood clotting), because both the therapeutic effect and side effects may be altered.
• Hormonal contraceptives based on estrogens or hormone replacement therapy. The effectiveness of darunavir may be reduced. When hormone therapy is used for contraceptive purposes, the use of other methods of contraception is recommended in addition to hormone therapy.
• Ethinylestradiol/drospirenone. Darunavir may increase the risk of an increase in potassium levels due to drospirenone.
• Atorvastatin, pravastatin, rosuvastatin(to lower cholesterol levels). It may increase the risk of muscle damage. Your doctor will assess which medicine to reduce your cholesterol level is most suitable for you.
• Clarithromycin(antibiotic)
• Cyclosporine, everolimus, tacrolimus, sirolimus(to reduce the activity of the immune system), as the therapeutic effect or side effects of these medicines may be increased.
• Corticosteroids, including betamethasone, budesonide, fluticasone, mometasone, prednisone,triamcinolone.These medicines are used in the treatment of allergies, asthma, inflammatory bowel disease, inflammatory skin, eye, joint and muscle conditions and other types of inflammatory diseases. These medicines are generally taken orally, by inhalation, injection or applied to the skin. If alternative treatments cannot be used, these medicines may only be taken after assessment by your doctor and under close monitoring by your doctor for side effects due to corticosteroids.
• Buprenorphine/naloxone(to treat opioid dependence).
• Salmeterol(for the treatment of asthma).
• Artemether/lumefantrine(a combination of medicines for the treatment of malaria).
• Dasatinib, everolimus, irinotecan, nilotinib, vinblastine, vincristine(to treat cancer).
• Sildenafil, tadalafil, vardenafil(for erectile dysfunction or for the treatment of a heart or lung condition called pulmonary arterial hypertension).
• Glecaprevir/pibrentasvir(for the treatment of hepatitis C infection).
• Fentanyl, oxycodone, tramadol(for the treatment of pain).
• Fesoterodine, solifenacin(to treat urological disorders).

Your doctor may require further blood tests and the dosage of other medicines may
be changed because the therapeutic effect and side effects of these medicines or of
darunavir may be affected if taken together.
Tell your doctor if you take:

• Dabigatran etexilate, edoxaban, warfarin(to reduce blood clotting)
• Alfentanil(a strong short-acting injectable pain reliever used for surgery)
• Digoxin(for the treatment of some heart disorders)
• Clarithromycin(antibiotic)
• Itraconazole, isavuconazole, fluconazole, posaconazole, clotrimazole(to treat fungal infections). Voriconazole can only be taken after assessment by your doctor.
• Rifabutin(against bacterial infections)
• Sildenafil, vardenafil, tadalafil(for erectile dysfunction or for high blood pressure in the pulmonary circulation)
• Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone(for the treatment of depression and anxiety)
• Maraviroc(to treat HIV infection)
• Methadone(to treat opioid dependence)
• Carbamazepine, clonazepam(to prevent seizures or to treat some types of neuropathic pain)
• Colchicine(to treat gout or Familial Mediterranean fever)
• Bosentan(to treat high blood pressure in the pulmonary circulation).
• Buspirone, clorazepate, diazepam, estazolam, flurazepam, midazolam when used in the formof injection, zolpidem(sedatives)
• Perphenazine, risperidone, thioridazine(to treat psychiatric conditions)

This is nota complete list of medicines. Tell your doctor about allthe medicines you are
taking.

Darunavir Viatris with food and drink
See section 3 “How to take Darunavir Viatris”.

Pregnancy and breastfeeding
Tell your doctor immediately if you are pregnant or planning a pregnancy.
Pregnant women should not take darunavir with ritonavir unless specifically instructed
by their doctor. Pregnant women should not take darunavir with
cobicistat.
Because of the possibility of adverse effects in infants, women should not breastfeed if they are receiving
Darunavir Viatris.
Breastfeeding is not recommended in women with HIV infection as the infection may
be transmitted to the baby in breast milk. If you are breastfeeding or plan to breastfeed, talk to your doctor
as soon as possible.

Driving and using machines
Do not use machines or drive if you feel dizzy after taking Darunavir Viatris.

Darunavir Viatris contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, therefore it is essentially
“sodium-free”.

3. How to take Darunavir Viatris

Take this medicine always exactly as your doctor, pharmacist or
nurse has told you. If you have doubts, ask your doctor, pharmacist or nurse.
Even if you feel better, do not stop taking Darunavir Viatris and cobicistat or ritonavir
without talking to your doctor.
After therapy has been started, the dose or dosage form must not be changed or the
therapy must not be interrupted without instructions from the doctor.

Dose for adults who have never taken antiretroviral medicines (this will be established by the doctor)
Different dosages of darunavir may be needed that cannot be administered with these
600 mg tablets. Other dosages of Darunavir Viatris are available.

Dose for adults who have previously taken antiretroviral medicines (this will be established by the
doctor)
The doses are:

• 600 milligrams of darunavir (2 tablets containing 300 milligrams of darunavir, or one tablet containing 600 milligrams of darunavir) together with 100 milligrams of ritonavir, twice a day. OR
• 800 milligrams of darunavir (2 tablets containing 400 milligrams of darunavir, or one tablet containing 800 milligrams of darunavir) together with 100 milligrams of ritonavir, twice a day. Darunavir Viatris 400 milligram and 800 milligram tablets must only be used to build the 800 milligram regimen once a day.

Discuss with your doctor which is the most correct dose.

Instructions for adults

• Take darunavir always with ritonavir. Darunavir cannot act effectively without ritonavir.
• In the morning, take one 600 milligram tablet of darunavir together with 100 milligrams of ritonavir.
• In the evening, take one 600 milligram tablet of darunavir together with 100 milligrams of ritonavir.
• Take darunavir with food. Darunavir cannot act effectively without food. The type of food taken is not important. Swallow the tablets with a drink such as water or milk.
• Darunavir Viatris 75 milligram and 150 milligram tablets have been developed for use in children, but may also be used in some cases in adults.

Dose for children aged 3 years or older and weighing at least 15
kilograms who have never taken antiretroviral medicines (the child’s doctor will determine this condition).
The doctor will calculate the correct daily dose each time based on the child’s body weight
(see table below). This dose must not exceed the recommended dose for adults, which is
800 milligrams of darunavir together with 100 milligrams of ritonavir once a day.
The doctor will inform you how many Darunavir Viatris tablets and how much ritonavir (capsules,
tablets or solution) the child must take.

Dose for children aged 3 years or older and weighing at least 15 kg
(kilograms) who have previously taken antiretroviral medicines (the child’s doctor will determine this condition)
The doctor will calculate the appropriate dose based on the child’s weight (see the table below). The
doctor will determine whether the once-a-day or twice-a-day dose is appropriate for the child. This dose must not exceed that recommended for adults, which corresponds to
600 milligrams of darunavir together with 100 milligrams of ritonavir twice a day or 800
milligrams of darunavir together with 100 milligrams of ritonavir once a day.
The doctor will inform you how many Darunavir Viatris tablets and how much ritonavir (capsules,
tablets or solution) the child must take. Other tablet formulations are available to
achieve the appropriate dosing regimen.
Other formulations of this medicine may be more appropriate for children: ask your
doctor or pharmacist.
Twice-a-day dose

Once-a-day dose

Instructions for children

• The child must always take darunavir together with ritonavir. Darunavir cannot act effectively without ritonavir.
• The child must take the appropriate doses of darunavir and ritonavir twice a day or once a day. If darunavir is prescribed twice a day, the child must take one dose in the morning and one dose in the evening. The doctor will determine which regimen is most appropriate for the child.
• The child must take darunavir with food. Darunavir cannot act effectively without food. The type of food taken is not important.
• The child must swallow the tablets with a drink such as water or milk.
• Darunavir Viatris 75 milligram and 150 milligram tablets have been developed for use in children weighing less than 40 kilograms, but may also be used in some cases in adults.

If you take more Darunavir Viatris than you should
Tell your doctor, pharmacist or nurse immediately.

If you forget to take Darunavir Viatris
If you realize it within 6 hours, you should take the forgotten dose immediately. Always take the
tablets together with ritonavir and food. If you realize it after 6 hours, skip the dose
and take the next dose as usual. Do not take a double dose to make up for the forgotten dose.

In case of vomiting after taking Darunavir Viatris and ritonavir
In case of vomiting within 4 hoursof taking the medicine, you should take another dose of
Darunavir Viatris and ritonavir with food as soon as possible. If vomiting occurs more than 4 hours
after taking the medicine, you do not need to take another dose of Darunavir Viatris and
ritonavir until the time usually scheduled for the next dose.
Contact your doctor if you have any doubtsabout what to do if you forget a dose or vomit.

Do not stop treatment with Darunavir Viatris without first consulting your doctor
HIV medicines can make you feel better. Do not stop taking Darunavir Viatris, even
if you feel better. Consult your doctor first.
If you have any questions about using this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

During therapy for HIV, an increase in weight and levels of lipids and glucose in the blood may occur.
This is partly related to the restoration of health and lifestyle, and in the case of blood lipids, sometimes to the
HIV medications themselves. The doctor will check these changes.
Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Tell your doctor if you develop any of the following side effects
Liver problems have been reported that can rarely be serious. The doctor will need to perform blood tests
before starting darunavir. If you have chronic hepatitis B or C, the doctor should check your blood tests
more often, as you are more likely to develop liver problems. Talk to your doctor about the signs and symptoms
of liver problems. These can include yellowing of the skin or whites of the eyes, dark urine (tea-colored), pale
stools (bowel movements), nausea, vomiting, loss of appetite, or pain, tenderness or soreness and
discomfort on the right side under the ribs.
Skin rashes (more frequent when used in combination with raltegravir), itching. These skin rashes are usually
mild or moderate. A skin rash can also be a symptom of a rare serious condition. It is therefore important
that you consult your doctor if you develop a skin rash. The doctor will advise you on how to treat the symptoms
or whether darunavir should be discontinued.
Other serious side effects were diabetes (common) and inflammation of the pancreas (uncommon).
Very common side effects (may affect more than 1 in 10 people)

• diarrhea.

Common side effects (may affect up to 1 in 10 people)

• vomiting, nausea, abdominal pain or distension, dyspepsia (indigestion), flatulence
• headache, fatigue, dizziness, drowsiness, numbness, tingling or pain in the hands or feet, loss of strength, difficulty falling asleep.

Uncommon side effects (may affect up to 1 in 100 people)

• chest pain, changes in electrocardiogram, rapid heartbeat
• decreased or abnormal skin sensitivity, tingling sensation, attention disorders, memory loss, difficulty with balance
• difficulty breathing, cough, nosebleeds, sore throat
• inflammation of the stomach or mouth, heartburn, retching, dry mouth, abdominal discomfort, constipation, belching
• kidney failure, kidney stones, difficulty urinating, frequent or excessive urination, sometimes at night
• urticaria, severe swelling of the skin and other tissues (especially lips and eyes), eczema, excessive sweating, night sweats, hair loss, acne, scaly skin, nail pigmentation
• muscle pain, muscle cramps or weakness, pain in the extremities, osteoporosis
• slowed thyroid function. This can be demonstrated through a blood test.
• high blood pressure, hot flashes
• red or dry eyes
• fever, leg swelling due to fluid retention, malaise, irritability, pain
• infection symptoms, herpes simplex
• erectile dysfunction (problems with erection), breast enlargement
• sleep disorders, drowsiness, depression, anxiety, altered dreams, decreased sexual desire

Rare side effects (may affect up to 1 in 1,000 patients)

• a reaction called DRESS [severe rash that may be accompanied by fever, fatigue, swelling of the face or lymph nodes, increased eosinophils (a type of white blood cell), effects on liver, kidneys or lungs]
• heart attack, slow heartbeat, palpitations
• vision disturbances
• chills, feeling unwell
• a feeling of confusion or disorientation, altered mood, restlessness
• fainting, seizures, change or loss of taste
• mouth ulcers, vomiting blood, inflammation of the lips, dry lips, coated tongue
• runny nose
• skin lesions, dry skin
• stiffness of muscles or joints, joint pain with or without inflammation
• changes in some blood cell or chemical values. These can be seen in blood and/or urine tests. The doctor will explain these results to you. Examples are: increased white blood cells
• darunavir crystal deposition in the kidney with resulting kidney disease.

Some side effects are typical of anti-HIV medicines from the same family as darunavir. These are:

• muscle pain, fragility or weakness. In rare cases, these muscle disorders have been severe.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through the national reporting system listed in Annex V. By reporting side effects
you can help provide more information on the safety of this medicine.

5. How to store Darunavir Viatris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the box, blister and
bottle after Exp. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
For bottles: once opened, use within 100 days.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Darunavir Viatris contains

• The active ingredient is darunavir. Each tablet contains 600 milligrams of darunavir.
• The other ingredients are anhydrous colloidal silica, microcrystalline cellulose, crospovidone, sodium starch glycolate, hypromellose, magnesium stearate. The film coating contains polyvinyl alcohol, partially hydrolysed, titanium dioxide (E171), macrogol and talc.

Description of the appearance of Darunavir Viatris and contents of the pack
Darunavir Viatris 600 mg tablets are film-coated, from white to off-white in colour,
oval with two curved sides, with M imprinted on one side and DV5 on the other.
Darunavir Viatris 600 mg film-coated tablets are available in blisters containing 30 and 60
tablets and in plastic bottles containing 30, 60 and 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park,
Mulhuddart,
Dublin 15,
DUBLIN,
Ireland

Manufacturers
Mylan Hungary Kft
H-2900 Komárom, Mylan utca 1 Hungary
McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Viatris
Tél/Tel: + 32 (0)2 658 61 00

Lietuva
Viatris UAB
Tel: +370 5 205 1288

България
Майлан ЕООД
Тел.: +359 2 44 55 400

Luxembourg/Luxemburg
Viatris
Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika
Viatris CZ.s.r.o.
Tel: 420 222 004 400

Magyarország
Viatris Healthcare Kft.
Tel.: + 36 1 465 2100

Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Malta
V.J. Salomone Pharma Ltd
Tel: + 356 21 22 01 74

Deutschland
Viatris Healthcare GmbH
Tel: +49 800 0700 800

Nederland
Mylan BV
Tel: + 31 (0)20 426 3300

Eesti
Viatris OÜTel: +372 6363 052

Norge
Viatris AS
Tlf: + 47 66 75 33 00

Ελλάδα
Viatris Hellas Ltd
Τηλ: +30 2100 100 002

Österreich
Viatris Austria GmbH
Tel: +43 1 86390

España
Viatris Pharmaceuticals, S.L.
Tel: + 34 900 102 712

Polska
Viatris Healthcare Sp. z o.o.
Tel.: + 48 22 546 64 00

France
Viatris Santé
Tél: +33 4 37 25 75 00

Portugal
Mylan, Lda.
Tel: + 351 214 127 200

Hrvatska
Viatris Hrvatska
Tel: +385 1 23 50 599

România
BGP Products SRL
Tel: +40 372 579 000

Ireland
Viatris Limited
Tel: +353 1 8711600

Slovenija
Viatris d.o.o.
Tel: + 386 1 23 63 180

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Viatris Italia S.r.l
Tel: + 39 (0) 2 612 46921

Suomi/Finland
Viatris Oy
Puh/Tel: +358 20 720 9555

Κύπρος
GPA Pharmaceuticals Ltd
Τηλ: + 357 22863100

Sverige
Viatris AB
Tel: +46 (0)8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

United Kingdom (Northern Ireland)
Mylan IRE Healthcare Limited
Tel: +353 18711600

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu .

Darunavir Viatris 800 mg film-coated tablets

darunavir

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Darunavir Viatris is and what it is used for
• 2. What you need to know before you take Darunavir Viatris
• 3. How to take Darunavir Viatris
• 4. Possible side effects
• 5. How to store Darunavir Viatris
• 6. Contents of the pack and other information

1. What is Darunavir Viatris and what is it used for

What is Darunavir Viatris
Darunavir Viatris contains the active substance darunavir. Darunavir is an antiretroviral medicine,
used in the treatment of human immunodeficiency virus (HIV) infection. It belongs to
a group of medicines called protease inhibitors. Darunavir works by reducing the amount of
HIV in the body, improving the immune system and reducing the risk of developing
diseases related to HIV infection.

What is it used for
Darunavir is used for the treatment of adult and children patients (with age equal to or greater than 3 years and
with minimum weight of 40 kilograms) with HIV infection and

• who have not already used other antiretroviral medicines.
• in some patients who have already used other antiretroviral medicines (this will be established by the doctor).

Darunavir must be taken in combination with a low dose of cobicistat or ritonavir and other
anti-HIV medicines. The doctor will discuss with you the best combination of medicines for you.

2. What you need to know before you take Darunavir Viatris

Do not take Darunavir Viatris:

• if you are allergicto darunavir or to any of the other ingredients of this medicine (listed in section 6) or to cobicistat or to ritonavir.
• If you have serious liver(hepatic) problems. Ask your doctor for advice if you are not sure about the severity of your liver disease. Further tests may be necessary.

Do not combine Darunavir Viatris with any of the following medicines
If you are taking any of these medicines, ask your doctor how to switch to another medicine.

Do not combine darunavir with products containing St John's Wort (Hypericum perforatum).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Darunavir Viatris.
Darunavir is not a cure for HIV infection.
People taking darunavir may also develop infections or other diseases associated
with HIV infection. You should be in regular contact with your doctor.
Patients taking darunavir may develop a rash. Rarely the rash
may become severe or potentially life-threatening. Contact your doctor whenever you
develop a rash.
In patients taking darunavir and raltegravir (for HIV infection), rashes
(usually mild or moderate) may occur more frequently than in patients taking
each medicine separately

Tell your doctor about your condition BEFORE and DURING treatment
Make sure you check the following points and tell your doctor if any of these apply to you.

• Tell your doctor if you have suffered from liver disorders, including hepatitis B or C. Your doctor may assess the severity of your liver disease before deciding whether to give you darunavir.
• Tell your doctor if you have diabetes. Darunavir may increase blood sugar levels.
• Immediately tell your doctor if you notice any signs of infection(e.g. swollen lymph nodes and fever). In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur shortly after starting anti-HIV treatment. These symptoms are believed to be due to an improvement in the body's immune response, which allows the body to fight infections that may have been present without causing obvious symptoms.
• In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy tissue in the body) may also occur after you have started taking medicines to treat HIV infection. Autoimmune disorders can occur many months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, initial weakness in hands and feet that rises towards the trunk of the body, palpitations, tremor or hyperactivity, tell your doctor immediately for necessary treatment.
• Tell your doctor if you have hemophilia. Darunavir may increase the risk of bleeding.
• Tell your doctor if you are allergic to sulfonamides(used to treat some infections).
• Tell your doctor if you notice any musculoskeletal problems. Some patients taking a combination of antiretroviral medicines may develop a bone disease called osteonecrosis (bone tissue death caused by insufficient blood supply to the bone). Some of the many risk factors for developing this disease may be the duration of use of antiretrovirals in combination, the use of corticosteroids, alcohol consumption, severe immunodeficiency, a high body mass index. Signs of osteonecrosis are joint swelling, pain and aches (especially in the hip, knee and shoulder) and difficulty of movement. If you notice any of these symptoms, tell your doctor immediately.

Elderly
Darunavir has been given to a limited number of patients aged 65 years or older. If
you belong to this age group, consult your doctor before taking Darunavir Viatris.

Children and adolescents
Darunavir Viatris 800 milligrams should not be used in children under the age of 3 years or
weighing less than 40 kilograms.

Other medicines and Darunavir Viatris
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines.
There are some medicines that must not be combinedwith darunavir. These have been listed previously
under the heading “Do not combine Darunavir Viatris with any of the following medicines”.
In most cases, darunavir can be combined with anti-HIV medicines that belong to
another class [e.g. NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs
(non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists and FIs (fusion
inhibitors)]. Darunavir in combination with cobicistat or ritonavir has not been studied with all PIs
(protease inhibitors) and should not be used with other HIV PIs. In some cases, the dose of other medicines may need to be adjusted. Therefore, always tell your doctor if you are taking
other anti-HIV medicines and carefully follow your doctor's instructions on which medicines you can
take.
The effects of darunavir may be reduced if you take any of the following medicines. Tell
your doctor if you take:

• Phenobarbital, phenytoin(to prevent seizures).
• Dexamethasone(a corticosteroid).
• Efavirenz(to treat HIV infection).
• Rifapentine, rifabutin(medicines to treat some infections such as tuberculosis).
• Saquinavir(to treat HIV infection).

The effects of other medicines may be affected by taking darunavir and your doctor
may require further blood tests. Tell your doctor if you take:

• Amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, lidocaine, metoprolol,mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil(for heart disease), as the therapeutic effect or side effects of these medicines may be altered.
• Apixaban, dabigatran etexilate, edoxaban, rivaroxaban, warfarin, clopidogrel(to reduce blood clotting), because both the therapeutic effect and side effects may be altered.
• Hormonal contraceptives based on estrogens or hormone replacement therapy. Darunavir may reduce their effectiveness. When hormone therapy is used for contraceptive purposes, the use of other methods of contraception is recommended.
• Ethinylestradiol/drospirenone. Darunavir may increase the risk of an increase in potassium levels due to drospirenone.
• Atorvastatin, pravastatin, rosuvastatin(to lower cholesterol levels). It may increase the risk of muscle damage. Your doctor will assess which medicine to lower cholesterol is most suitable for you.
• Clarithromycin(antibiotic).
• Cyclosporine, everolimus, tacrolimus, sirolimus(to reduce the activity of the immune system), as the therapeutic effect or side effects of these medicines may be increased.
• Corticosteroids, including betamethasone, budesonide, fluticasone, mometasone, prednisone,triamcinolone.These medicines are used in the treatment of allergies, asthma, inflammatory bowel diseases, inflammatory skin, eye, joint and muscle diseases and other types of inflammatory diseases. These medicines are generally taken orally, by inhalation, injection or applied to the skin. If alternative treatments cannot be used, these medicines can only be taken after evaluation by the doctor and under close monitoring by the doctor for side effects due to corticosteroids.
• Buprenorphine/naloxone(to treat opioid dependence).
• Salmeterol(for the treatment of asthma).
• Artemether/lumefantrine(a combination of medicines for the treatment of malaria).
• Dasatinib, everolimus, irinotecan, nilotinib, vinblastine, vincristine(to treat cancer)
• Sildenafil, tadalafil, vardenafil(for erectile dysfunction or for the treatment of a heart or lung disorder called pulmonary arterial hypertension).
• Glecaprevir/pibrentasvir(for the treatment of hepatitis C infection)
• Fentanyl, oxycodone, tramadol(for pain treatment)
• Fesoterodine, solifenacin(to treat urological disorders).

This is nota complete list of medicines. Tell your doctor about allthe medicines you are
taking.

Darunavir Viatris with food and drink
See section 3 “How to take Darunavir Viatris”.

Pregnancy and breastfeeding
Tell your doctor immediately if you are pregnant or planning a pregnancy.
Pregnant women should not take darunavir with ritonavir, unless they receive
specific instructions from their doctor. Pregnant women should not take darunavir with
cobicistat.
Given the possibility of adverse effects in infants, women should not breastfeed if they are receiving
Darunavir Viatris.
Breastfeeding is not recommended in women with HIV infection as the infection may
be transmitted to the baby in breast milk. If you are breastfeeding, or think you might be, talk to your doctor as
soon as possible.

Driving and operating machinery
Do not use machinery or drive if you feel dizzy after taking darunavir.

Darunavir Viatris contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, therefore it is essentially
“sodium-free”.

3. How to take Darunavir Viatris

Take this medicine exactly as your doctor, pharmacist or
nurse has told you. If you have any doubts, ask your doctor, pharmacist or nurse.
Even if you feel better, do not stop taking darunavir and cobicistat or ritonavir without
talking to your doctor.
After therapy has been started, the dose or dosage form must not be changed or the
therapy must not be interrupted without instructions from your doctor.
The 800 milligram tablets of darunavir are intended only for daily use.

Dose for adults who have not previously taken antiretroviral drugs (your doctor
will assess this)
The usual dose of darunavir is 800 milligrams (2 tablets containing 400 milligrams of
darunavir or 1 tablet containing 800 milligrams of darunavir) once a day.
You must take darunavir every day and always together with 150 milligrams of cobicistat or
100 milligrams of ritonavir and with food. Darunavir may not work as well without cobicistat or
ritonavir and without food. You should have a meal or snack within 30 minutes before taking
darunavir and cobicistat or ritonavir. The type of food is irrelevant. Even if you feel better, do not stop
taking darunavir and cobicistat or ritonavir before talking to your doctor.

Instructions for adults

• Take one 800 milligram tablet at the same time, once a day, every day.
• Take darunavir always with 150 milligrams of cobicistat or 100 milligrams of ritonavir.
• Take darunavir with food.
• Swallow the tablet with a drink such as water or milk.
• Take the other medicines for HIV used in combination with darunavir and cobicistat or ritonavir following your doctor’s instructions.

Dose for adults who have previously taken antiretrovirals (your doctor will assess this)

• 800 milligrams of darunavir (2 tablets containing 400 milligrams of darunavir or 1 tablet containing 800 milligrams of darunavir) together with 150 milligrams of cobicistat or 100 milligrams of ritonavir once a day. OR
• 600 milligrams of darunavir (2 tablets containing 300 milligrams of darunavir or one tablet containing 600 milligrams of darunavir) together with 100 milligrams of ritonavir twice a day.

Discuss with your doctor what the correct dose is.

Dose with ritonavir for children aged 3 years and over and with cobicistat for adolescents
aged 12 years and over and weighing at least 40 kilograms who have not
previously taken antiretroviral medicines (the child’s doctor will determine
this condition)

• The usual dose of darunavir is 800 milligrams once a day (2 tablets containing 400 milligrams of darunavir or 1 tablet containing 800 milligrams of darunavir) together with 100 mg of ritonavir or 150 mg of cobicistat once a day.

Dose with ritonavir for children aged 3 years and over and with cobicistat for adolescents
aged 12 years and over and weighing at least 40 kilograms who have
previously taken antiretroviral medicines (the child’s doctor will determine this
condition)

• 800 milligrams of darunavir (2 tablets containing 400 milligrams of darunavir or 1 tablet containing 800 milligrams of darunavir) together with 100 milligrams of ritonavir or 150 milligrams of cobicistat once a day. OR
• 600 milligrams of darunavir (2 tablets containing 300 milligrams of darunavir or 1 tablet containing 600 milligrams of darunavir) together with 100 milligrams of ritonavir twice a day.

Discuss with your doctor what the correct dose is.

Instructions for dose with ritonavir for children aged 3 years and over and with cobicistat
for adolescents aged 12 years and over and weighing at least 40
kilograms

• Take 800 milligrams of darunavir (2 tablets containing 400 milligrams of darunavir or 1 tablet containing 800 milligrams of Darunavir Viatris) at the same time, once a day, every day.
• Take darunavir always together with 100 milligrams of ritonavir or 150 milligrams of cobicistat.
• Take darunavir with food.
• Swallow the tablets with a drink such as water or milk.
• Take the other medicines for HIV used in combination with darunavir and ritonavir or cobicistat as recommended by your doctor.

If you take more Darunavir Viatris than you should
Tell your doctor, pharmacist or nurse immediately.

If you forget to take Darunavir Viatris
If you remember within 12 hours, you should take the tablets immediately. Always take the
tablets together with cobicistat or ritonavir and with food. If you remember after 12 hours, skip the dose and
take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

In case of vomiting after taking Darunavir Viatris and ritonavir
If you vomit within 4 hoursof taking the medicine, you should take another dose of
Darunavir Viatris and ritonavir with food as soon as possible. If vomiting occurs more than 4 hours
after taking the medicine, you do not need to take another dose of Darunavir Viatris and
ritonavir until the time of your next scheduled dose.
Contact your doctor if you have any doubtsabout what to do if you forget a dose or vomit.

Do not stop treatment with Darunavir Viatris without first consulting your doctor
HIV medicines can make you feel better. Do not stop taking darunavir, even if
you feel better. Consult your doctor first.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

During therapy for HIV, an increase in weight and levels of lipids and glucose in the blood may occur.
This is partly related to the restoration of health and lifestyle and, in the case of blood lipids, sometimes to the HIV medications themselves. The doctor will check these changes.
Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Tell your doctor if you develop any of the following side effects
Liver problems have been reported that can occasionally be serious. The doctor will need to perform blood tests before starting darunavir. If you have chronic hepatitis B or C, the doctor should check your blood tests more frequently because you are more likely to develop liver problems. Talk to your doctor about the signs and symptoms of liver problems. These can include yellowing of the skin or whites of the eyes, dark urine (tea-colored), pale stools (bowel movements), nausea, vomiting, loss of appetite, or pain, tenderness or soreness and discomfort on the right side under the ribs.
Skin rashes (more frequent when used in combination with raltegravir), itching. These rashes are usually mild to moderate in severity. A rash can also be a symptom of a more serious and rare condition. It is therefore important that you consult your doctor if you develop a rash. The doctor will advise you on how to treat the symptoms or whether darunavir should be discontinued.
Other serious side effects were diabetes (common) and inflammation of the pancreas (uncommon).
Very common side effects (may affect more than 1 in 10 people)

• Diarrhea.

Common side effects (may affect up to 1 in 10 people)

• vomiting, nausea, abdominal pain or distension, dyspepsia (indigestion), flatulence
• headache, fatigue, dizziness, drowsiness, numbness, tingling or pain in the hands or feet, loss of strength, difficulty falling asleep.

Uncommon side effects (may affect up to 1 in 100 people)

• chest pain, changes in electrocardiogram, rapid heartbeat
• decreased or abnormal skin sensation, tingling sensation, attention disorders, memory loss, difficulty with balance
• difficulty breathing, cough, nosebleeds, sore throat
• inflammation of the stomach or mouth, heartburn, retching, dry mouth, abdominal discomfort, constipation, belching
• kidney failure, kidney stones, difficulty urinating, frequent or excessive urination, sometimes at night
• urticaria, severe swelling of the skin and other tissues (especially lips and eyes), eczema, excessive sweating, night sweats, hair loss, acne, scaly skin, nail pigmentation
• muscle pain, muscle cramps or weakness, pain in the extremities, osteoporosis
• slowing of thyroid function. This can be demonstrated through a blood test.
• high blood pressure, hot flashes
• red or dry eyes
• fever, leg swelling due to fluid retention, malaise, chills, abnormal sensations, irritability, pain
• infection symptoms, herpes simplex
• erectile dysfunction (problems with erection), breast enlargement
• sleep disorders, drowsiness, depression, anxiety, altered dreams, decreased sexual desire

Rare side effects (may affect up to 1 in 1,000 people)

• a reaction called DRESS [severe rash that may be accompanied by fever, fatigue, swelling of the face or lymph nodes, increased eosinophils (a type of white blood cell), effects on the liver, kidneys or lungs]
• heart attack, slow heartbeat, palpitations
• vision disturbances
• chills, feeling unwell
• a feeling of confusion or disorientation, altered mood, restlessness
• fainting, seizures, change or loss of taste
• mouth ulcers, vomiting blood, inflammation of the lips, dry lips, coated tongue
• runny nose
• skin lesions, dry skin
• stiffness of muscles or joints, joint pain with or without inflammation
• changes in some blood cell or chemical values. These can be seen in blood and/or urine tests. The doctor will explain these results to you. Examples include: increased numbers of certain white blood cells
• deposition of darunavir crystals in the kidney with resulting kidney disease.

Some side effects are typical of anti-HIV medicines in the same family as darunavir. These are the
following:

• muscle pain, fragility or weakness. In rare cases, these muscle disorders have been severe.

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the reporting system indicated in Annex V. By reporting side effects you can help to provide more information on the safety of this medicine.

5. How to store Darunavir Viatris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack, blister and
bottle after Exp. The expiry date refers to the last day of that month.
For blisters with one side plastic and one side aluminium: Do not store at temperatures above
25°C.
For blisters with both sides aluminium: This medicine does not require special storage
conditions.
For bottles: once opened, use within 90 days. This medicine does not require special storage
conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Darunavir Viatris contains

• The active ingredient is darunavir. Each tablet contains 800 milligrams of darunavir ethanolate.
• The other ingredients are: anhydrous colloidal silicon dioxide, microcrystalline cellulose, crospovidone, sodium starch glycolate, hypromellose, magnesium stearate. The coating contains partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol and talc.

Description of the appearance of Darunavir Viatris and package contents
Darunavir Viatris 800 mg tablets are film-coated, from white to off-white in colour,
oval shaped with two curved sides, with M imprinted on one side and DV8 on the other.
Darunavir Viatris 800 mg film-coated tablets are available in blisters containing 30
tablets and in plastic bottles containing 30, 60 and 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park,
Mulhuddart,
Dublin 15,
DUBLIN,
Ireland

Manufacturers
Mylan Hungary Kft
H-2900 Komárom, Mylan utca 1 Hungary
McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352
Germany
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Viatris
Tél/Tel: + 32 (0)2 658 61 00

Lietuva
Viatris UAB
Tel: +370 5 205 1288

България
Майлан ЕООД
Тел.: +359 2 44 55 400

Luxembourg/Luxemburg
Viatris
Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika
Viatris CZ.s.r.o.
Tel: 420 222 004 400

Magyarország
Viatris Healthcare Kft.
Tel.: + 36 1 465 2100

Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Malta
V.J. Salomone Pharma Ltd
Tel: + 356 21 22 01 74

Deutschland
Viatris Healthcare GmbH
Tel: +49 800 0700 800

Nederland
Mylan BV
Tel: + 31 (0)20 426 3300

Eesti
Viatris OÜ
Tel: +372 6363 052

Norge
Viatris AS
Tlf: + 47 66 75 33 00

Ελλάδα
Viatris Hellas Ltd
Τηλ: +30 2100 100 002

Österreich
Viatris Austria GmbH
Tel: +43 1 86390

España
Viatris Pharmaceuticals, S.L.
Tel: + 34 900 102 712

Polska
Viatris Healthcare Sp. z o.o.
Tel.: + 48 22 546 64 00

France
Viatris Santé
Tél: +33 4 37 25 75 00

Portugal
Mylan, Lda.
Tel: + 351 214 127 200

Hrvatska
Viatris Hrvatska
Tel: +385 1 23 50 599

România
BGP Products SRL
Tel: +40 372 579 000

Ireland
Viatris Limited
Tel: +353 1 8711600

Slovenija
Viatris d.o.o.
Tel: + 386 1 23 63 180

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Viatris Italia S.r.l
Tel: + 39 (0) 2 612 46921

Suomi/Finland
Viatris Oy
Puh/Tel: +358 20 720 9555

Κύπρος
GPA Pharmaceuticals Ltd
Τηλ: + 357 22863100

Sverige
Viatris AB
Tel: +46 (0)8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

United Kingdom (Northern Ireland)
Mylan IRE Healthcare Limited
Tel: +353 18711600

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu .