ATAZANAVIR 150 mg Hard Capsule

Зміст інструкції

1. Atazanavir Viatris 150mg hard capsules, 200 mg hard capsules, 300 mg hard capsules
   1. What is Atazanavir Viatris and what it is used for
   2. What you need to know before taking Atazanavir Viatris
   3. How to take Atazanavir Viatris
   4. Possible side effects
   5. How to store Atazanavir Viatris
   6. Contents of the pack and other information

Atazanavir Viatris 150mg hard capsules, 200 mg hard capsules, 300 mg hard capsules

atazanavir

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

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

Atazanavir Viatris is an antiviral (or antiretroviral) medicine.It belongs to a group
called protease inhibitors. These medicines control the human immunodeficiency virus (HIV) infection by blocking a protein that HIV needs to replicate.
These medicines work by reducing the amount of HIV virus in the body, and this leads to a
strengthening of the immune system. In this way, Atazanavir Viatris reduces the risk of
developing diseases associated with HIV infection.
Atazanavir Viatris capsules can be used by both adults and children aged 6 years or older.
Your doctor has prescribed Atazanavir Viatris because you are affected by the HIV virus that causes
Acquired Immunodeficiency Syndrome (AIDS). It is usually used in combination with other
anti-HIV medicines. Your doctor will discuss with you which combinations of these medicines with Atazanavir
Viatris are best.

2. What you need to know before taking Atazanavir Viatris

Do not take Atazanavir Viatris

• if you are allergicto atazanavir or to any of the other ingredients of this medicine (listed in section 6).
• if you have moderate to severe liver problems.Your doctor will assess the severity of your liver problems before deciding if you can take Atazanavir Viatris.
• if you are taking any of these medicines:see also Other medicines and Atazanavir Viatris
• rifampicin, an antibiotic for the treatment of tuberculosis
• astemizole or terfenadine (commonly used to treat allergy symptoms, these medicines may be available without a prescription); cisapride (used to treat heartburn, sometimes called acid indigestion); pimozide (used to treat schizophrenia); quinidine or bepridil (used to correct heart rhythm); ergotamine, dihydroergotamine, ergonovine, methylergonovine (used to treat headaches); alfuzosin (used to treat enlarged prostate).
• quetiapine (used to treat schizophrenia, bipolar disorder and major depressive disorder)
• lurasidone (used to treat schizophrenia).
• medicines containing St John's Wort (Hypericum perforatum, a herbal medicinal product )
• triazolam and oral midazolam (taken by mouth) (used to help you sleep and/or reduce anxiety).
• lomitapide, simvastatin and lovastatin (used to lower cholesterol levels in the blood).
• medicines that contain grazoprevir, including the fixed-dose combination of elbasvir/grazoprevir and the fixed-dose combination of glecaprevir/pibrentasvir (used to treat chronic hepatitis C infection)
• apalutamide (used to treat prostate cancer)

Do not take sildenafil with Atazanavir Viatris when sildenafil is used for the treatment
of pulmonary arterial hypertension. Sildenafil is also used for the treatment of erectile
dysfunction. Tell your doctor if you are using sildenafil for the treatment of erectile dysfunction.
Talk to your doctor immediately if you are in any of these conditions.

Warnings and precautions
Atazanavir Viatris is not a cure for HIV infection.You may continue to develop infections or
other diseases associated with HIV infection.
Some people may require special attention before or during taking Atazanavir
Viatris. Talk to your doctor or pharmacist before taking Atazanavir Viatris, and make sure your
doctor knows:

• if you suffer from hepatitis B or C
• if you develop signs or symptoms of gallstones (pain in the upper right side of the stomach)
• if you suffer from haemophilia A or B
• if you are on haemodialysis

Atazanavir can affect kidney function.
Kidney stones have been reported in patients taking Atazanavir Viatris. If you develop signs or
symptoms of kidney stones (pain in the side, blood in the urine, pain when urinating), tell your
doctor immediately.
In some patients with advanced HIV infection (AIDS) and with a history of opportunistic infection,
inflammatory signs and symptoms of 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 occurred without clear symptoms. If you notice
any symptoms of infection, please inform your doctor immediately. In addition to opportunistic
infections, autoimmune diseases (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 diseases 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, tremor or hyperactivity, tell your doctor
immediately for necessary treatment.
Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis
(bone tissue death caused by a lack of blood supply to the bone). The duration of combination
antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immunosuppression,
a higher body mass index, among others, may be some of the numerous risk factors for the
development of this disease. Signs of osteonecrosis are joint stiffness, discomfort and pain
(especially in the hips, knees and shoulders) and difficulty moving. See your doctor if you notice the
appearance of any of these symptoms.
Hyperbilirubinemia (an increase in the level of bilirubin in the blood) has occurred in patients taking
Atazanavir Viatris. The signs may be a slight yellowing of the skin and eyes. See your doctor if you
notice the appearance of any of these symptoms.
Severe skin rash, including Stevens-Johnson syndrome, has been reported in patients taking Atazanavir
Viatris. If you should develop a rash, tell your doctor immediately.
See your doctor if you notice a change in your heartbeat (changes in heart rhythm).
Children receiving Atazanavir Viatris may need cardiac monitoring and this will be established by the
paediatrician.

Children
Do not give this medicine to childrenunder 3 months of age and weighing less than 5 kg. The use of
atazanavir in children under 3 months of age and weighing less than 5 kg has not been studied due to
the risk of serious complications.

Other medicines and Atazanavir Viatris
You must not take Atazanavir Viatris with some medicines. These medicines are listed in the
section Do not take Atazanavir Viatris, at the beginning of Section 2.
There are other medicines that you must not take with Atazanavir Viatris. Tell your doctor or pharmacist
if you are taking, have recently taken or might take any other medicines.
In particular, it is important to mention the following:

• other medicines for the treatment of HIV infection (e.g. indinavir, nevirapine and efavirenz)
• sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C)
• sildenafil, vardenafil or tadalafil (used by men to treat impotence (erectile dysfunction))
• if you are taking oral contraceptives ("the pill") with Atazanavir Viatris to prevent pregnancy, be sure to
  take them exactly as directed by your doctor and do not miss any dose
• any medicine used to treat acid-related disorders (e.g.: antacids to be taken one hour before taking
  Atazanavir Viatris or 2 hours after taking Atazanavir Viatris, histamine H receptor blockers such as
  famotidine and proton pump inhibitors such as omeprazole)
• medicines to lower blood pressure, decrease heart rate or correct heart rhythm (amiodarone, diltiazem,
  systemic lidocaine, verapamil)
• atorvastatin, pravastatin and fluvastatin (used to lower cholesterol levels in the blood)
• salmeterol (used to treat asthma)
• cyclosporine, tacrolimus and sirolimus (medicines to lower the activity of the immune system)
• some antibiotics (rifabutin, clarithromycin)
• ketoconazole, itraconazole and voriconazole (antifungals)
• apixaban, dabigatran, edoxaban, rivaroxaban, warfarin, clopidogrel, prasugrel and ticagrelor (used to
  reduce blood clot formation)
• carbamazepine, phenytoin, phenobarbital and lamotrigine (antiepileptics)
• encorafenib, ivosidenib and irinotecan (used in cancer treatment)
• elagolix (gonadotropin-releasing hormone receptor antagonists, used to treat severe endometriosis pain)
• fostamatinib (used to treat chronic immune thrombocytopenia)
• sedatives (e.g., injectable midazolam)
• buprenorphine (used to treat opioid dependence and pain)
• corticosteroids (all routes of administration; including dexamethasone).

Some medicines can interact with ritonavir, a medicine that is taken with Atazanavir
Viatris. It is important that you tell your doctor if you are taking a corticosteroid administered by
inhalation or nasal (in the nose), including fluticasone or budesonide (administered for the treatment of
allergic symptoms or asthma).

Atazanavir Viatris with food and drink
It is important that you take Atazanavir Viatris with food (a meal or a substantial snack) as
this helps the absorption of the medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Atazanavir, the active ingredient of Atazanavir Viatris, is excreted in breast milk. Patients should
not breastfeed while taking Atazanavir Viatris.
Breastfeeding is not recommendedfor HIV-positive women as HIV infection can be
transmitted to the baby through breast milk.
If you are breastfeeding or thinking about breastfeeding you should talk to your doctor as soon as possible.

Driving and using machines
If you feel dizzy or lightheaded, do not drive or use machines and contact your
doctor immediately.

Atazanavir Viatris contains lactose.
If you have been told by your doctor that you have an intolerance to some sugars (e.g., lactose),
contact them before taking this medicine.

3. How to take Atazanavir Viatris

Take this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor or pharmacist. This way, you can be sure that the medicine will be fully effective and will reduce the risk of the virus developing resistance to treatment.

The recommended dose of Atazanavir Viatris capsules for adults is 300 mg once a day with 100 mg of ritonavir, once a day, taken with food,in combination with other anti-HIV medicines. Your doctor may adjust the dose of Atazanavir Viatris based on your anti-HIV therapy.

For children (from 6 years to less than 18 years of age), the pediatrician will determine the correct dose based on the child's weight.The dose of Atazanavir Viatris capsules in children is calculated based on body weight and is taken once a day with food and 100 mg of ritonavir, as indicated below: Atazanavir is also available in other formulations for use in children who are at least 3 months old and weigh at least 5 kg. It is suggested to switch from the other formulation of atazanavir to atazanavir capsules as soon as patients are able to swallow capsules regularly. A change in dosage may occur when switching from oral powder to capsules. The doctor will decide the correct dose based on the child's weight.

There are no recommended dosages of Atazanavir Viatris for pediatric patients under 3 months of age.

Take Atazanavir Viatris capsules with food(a meal or a substantial snack). Swallow the capsules whole. Do not open the capsules.

If you take more Atazanavir Viatris than you should
If you or the child takes too high a dose of Atazanavir Viatris, yellowing of the skin and/or eyes (jaundice) and irregular heartbeat (QTc prolongation) may occur. If you accidentally take more Atazanavir Viatris capsules than prescribed by your doctor, contact your doctor or the nearest hospital immediately for advice.

If you forget to take Atazanavir Viatris
If you forget to take a dose, take the forgotten dose as soon as possible with food and then take the next dose at the scheduled time. However, if the time of the next dose is near, do not take the forgotten dose. Wait and take only the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.

If you stop taking Atazanavir Viatris
Do not stop taking Atazanavir Viatris before talking to your doctor. If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
When you are being treated for HIV infection it is not always easy to tell which side effects are caused by atazanavir, by other medicines you are taking, or by the HIV infection itself.
Tell your doctor if you notice anything unusual about your health.
During HIV therapy, you may experience an increase in weight and in levels of lipids and glucose
in the blood. This is partly related to the improvement of your health and lifestyle and, in the case of
blood lipids, sometimes to the HIV medicines themselves. Your doctor will check these
changes.
Tell your doctor immediately if you develop any of the following serious side effects:

• Skin redness and itching have been reported, which can occasionally be severe. The redness usually disappears within 2 weeks without any change to Atazanavir Viatris treatment. Severe redness can develop in association with other symptoms which may be serious. Stop taking Atazanavir Viatris and tell your doctor immediately if you develop severe redness or redness with flu-like symptoms, blisters, fever, mouth sores, muscle or joint pain, facial swelling, eye inflammation causing redness (conjunctivitis), painful, warm or red lumps (nodules).
• Yellowing of the skin or the white part of the eyes has been commonly reported, caused by high levels of bilirubin in the blood. This side effect is usually not dangerous in adults and infants over 3 months of age; but it can be a symptom of a serious problem. Tell your doctor immediately if your skin or the white part of your eyes become yellow.
• Changes in the way your heart beats (changes in heart rhythm) can occur occasionally. Tell your doctor immediately if you feel dizzy, lightheaded or faint. These may be symptoms of a serious heart problem.
• Liver problems can occur infrequently. Your doctor should perform blood tests before and during treatment with this medicine. If you have liver problems, including hepatitis B or C infection, you may experience a worsening of your liver problems.

Tell your doctor immediately if you notice dark urine (tea-colored), itching, yellowing
of the skin or the white part of the eyes, pain around the stomach, pale stools or nausea.

• Gallbladder problems, such as gallstones, occur infrequently in people taking Atazanavir Viatris. Symptoms of gallstones may include pain in the upper right or middle of the stomach, nausea, vomiting, fever or yellowing of the skin or the white part of the eyes.
• Atazanavir can affect kidney function.
• Kidney stones occur infrequently in people taking Atazanavir Viatris. Tell your doctor immediately if you notice symptoms of kidney stones which include pain in your lower back or stomach, blood in your urine or pain when urinating.

Other side effects reported for patients treated with Atazanavir Viatris are the following:
Common (may affect up to 1 in 10 people)

• headache
• vomiting, diarrhea, abdominal pain (stomach discomfort), nausea, dyspepsia (indigestion)
• fatigue (extreme tiredness)

Uncommon (may affect up to 1 in 100 people)

• peripheral neuropathy (numbness, weakness, tingling or pain in the arms and legs)
• hypersensitivity (allergic reaction)
• asthenia (unusual tiredness or weakness)
• decreased weight, increased weight, anorexia (loss of appetite), increased appetite
• depression, anxiety, sleep disorders
• disorientation, amnesia (loss of memory), dizziness, drowsiness, abnormal dreams
• syncope (fainting), hypertension (high blood pressure)
• dyspnea (shortness of breath)
• pancreatitis (inflammation of the pancreas), gastritis (inflammation of the stomach), aphthous stomatitis (mouth ulcers and inflammation of the oral cavity), dysgeusia (altered taste), flatulence (gas), dry mouth, abdominal distension
• angioedema (severe swelling of the skin and other tissues, most frequently lips and eyes)
• alopecia (unusual hair loss or thinning), itching
• muscle atrophy (reduction of muscle mass), arthralgia (joint pain), myalgia (muscle pain)
• interstitial nephritis (kidney inflammation), hematuria (blood in the urine), proteinuria (excess protein in the urine), pollakiuria (increased frequency of urination)
• gynecomastia (breast enlargement in men)
• chest pain, malaise (feeling unwell), fever
• insomnia (difficulty sleeping)

Rare (may affect up to 1 in 1,000)

• gait disturbance (abnormal way of walking)
• edema (swelling)
• hepato-splenomegaly (enlargement of the liver and spleen)
• myopathy (muscle pain, muscle weakness from fatigue not caused by exercise)
• kidney pain

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. 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 Atazanavir 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 label, the carton or the
blister. The expiry date refers to the last day of that month.
Store at a temperature below 25°C. Store in the original packaging to protect the
medicine from moisture.
For bottles: once opened, use within 90 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 Atazanavir Viatris contains
Atazanavir Viatris 150 mg hard capsules

• The active ingredient is atazanavir. Each capsule contains 150 mg of atazanavir (as sulfate).
• The other ingredients are lactose monohydrate (see section 2, 'Atazanavir Viatris contains lactose'), crospovidone, magnesium stearate. The capsule shell and printing ink contain red iron oxide (E172), titanium dioxide (E171), Patent Blue V (E131), gelatin, shellac, propylene glycol, concentrated ammonia solution, black iron oxide (E172), potassium hydroxide.

Atazanavir Viatris 200 mg hard capsules

• The active ingredient is atazanavir. Each capsule contains 200 mg of atazanavir (as sulfate).
• The other ingredients are lactose monohydrate (see section 2, 'Atazanavir Viatris contains lactose'), crospovidone, magnesium stearate. The capsule shell and printing ink contain titanium dioxide (E171), indigo carmine (E132), red iron oxide (E172), Patent Blue V (E131), gelatin, shellac, propylene glycol, concentrated ammonia solution, black iron oxide (E172), potassium hydroxide.

Atazanavir Viatris 300 mg hard capsules

• The active ingredient is atazanavir. Each capsule contains 300 mg of atazanavir (as sulfate).
• The other ingredients are lactose monohydrate, crospovidone, magnesium stearate. The capsule shell and printing ink contain yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171), Patent Blue V (E131), gelatin, shellac, propylene glycol, concentrated ammonia solution, black iron oxide (E172), potassium hydroxide.

Description of the appearance of Atazanavir Viatris and contents of the pack
Atazanavir Viatris 150 mg hard capsules are opaque, aquamarine and blue coloured capsules, with the
writing "MYLAN" above "AR150" in black ink on the cap and body.
Atazanavir Viatris 200 mg hard capsules are opaque, blue and aquamarine coloured capsules, with the
writing "MYLAN" above "AR200" in black ink on the cap and body.
Atazanavir Viatris 300 mg hard capsules are opaque, red and aquamarine coloured capsules, with the
writing "MYLAN" above "AR300" in black ink on the cap and body.
Atazanavir Viatris 150 mg hard capsules
This medicinal product is supplied in blisters containing 60 or 60 x 1 (unit dose) capsules or in bottles
containing 60 hard capsules.
Atazanavir Viatris 200 mg hard capsules
This medicinal product is supplied in blisters containing 30, 60 or 60 x 1 (unit dose) capsules or in bottles
containing 60 hard capsules.
Atazanavir Viatris 300 mg hard capsules
This medicinal product is supplied in blisters containing 30 or 30 x 1 (unit dose) capsules or in bottles
containing 30 or 90 hard capsules.
Not all pack sizes may be marketed.

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

Manufacturer
McDermott Laboratories trading as Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland
Mylan Hungary Kft, Mylan utca 1, Komárom, H-2900 Hungary
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, please 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 B.V.
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 22 564 64 00

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

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

Hrvatska
Viatris Hrvatska d.o.o.
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 1 236 31 80

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 02 612 46921

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

Κύπρος
GPA Pharmaceuticals LtdΤηλ: + 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
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu .