DARUNAVIR 800 mg Film-Coated Tablet

Prospect: information for the user

Darunavir Kern Pharma 800 mg film-coated tablets EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor, pharmacist or nurse.

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this prospect. See section 4.

1.What is Darunavir Kern Pharma and for what it is used

2.What you need to know before starting to take Darunavir Kern Pharma

3.How to take Darunavir Kern Pharma

4.Possible adverse effects

5.Storage of Darunavir Kern Pharma

6.Contents of the package and additional information

What is Darunavir Kern Pharma?

Darunavir Kern Pharma contains the active ingredient darunavir. Darunavir is an antiretroviral medication used in the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of medications called protease inhibitors. Darunavir reduces the amount of HIV present in the body. This will improve the immune system and decrease the risk of developing diseases associated with HIV infection.

What is it used for?

Darunavir is used to treat adults and children aged 3 years or older, weighing at least 40 kilograms, infected with HIV and:

-who have not used antiretroviral medications before.

-in certain patients who have used antiretroviral medications before (this will be determined by your doctor).

Darunavir should be taken with a low dose of cobicistat or ritonavir and other HIV medications. Your doctor will explain the most suitable combination of medications for you.

Do not take Darunavir Kern Pharma

-if you areallergicto darunavir, to any of the other components of this medication (listed in section 6), or to cobicistat or ritonavir.

-if you havesevere liver problems. Ask your doctor if you are unsure of the severity of your liver disease. You may need to have some additional tests done.

Inform your doctor ofallthe medications you are taking, including those taken orally, inhaled, injected, or applied to the skin.

Do not combine Darunavir Kern Pharma with any of the following medications

If you are taking any of these medications, consult your doctor to change to another medication.

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting darunavir.

Darunavir does not cure HIV infection. While taking this medication, you may still transmit HIV to others, although effective antiviral treatment reduces the risk. Consult your doctor about what precautions are necessary to avoid infecting others.

People taking darunavir may develop other infections or diseases associated with HIV infection. You should maintain regular contact with your doctor.

People taking darunavir may develop skin rash. It is not common for the rash to be severe or potentially life-threatening. Please consult your doctor if you develop a rash.

Patients taking darunavir and raltegravir (for HIV infection) may experience exanthems (usually mild or moderate) more frequently than patients taking either medication separately.

Inform your doctor about your situation BEFORE and DURING treatment

Make sure to check the following points and inform your doctor if any of them apply to you.

-Inform your doctor if you have had anyliver disease, including hepatitis B or C infection. Your doctor will assess the severity of liver disease before deciding if you can take Darunavir Kern Pharma.

-Inform your doctor if you havediabetes. Darunavir may cause an increase in blood sugar levels.

-Inform your doctor immediately if you notice anysymptoms of infection(e.g. swollen lymph nodes and fever). In some patients with advanced HIV infection and a history of opportunistic infections, signs and symptoms of inflammation due to previous infections may appear shortly after starting HIV treatment. It is believed that these symptoms are due to an improvement in the body's immune response, which allows the body to fight off infections that were present without apparent symptoms.

-Additionally, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may appear after you have started taking medications for HIV treatment.

Autoimmune disorders may appear many months after treatment initiation. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and ascending to the trunk of the body, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive necessary treatment.

-Inform your doctor if you havehemophilia. Darunavir may increase the risk of bleeding.

-Inform your doctor if you areallergic to sulfonamides(e.g. used to treat certain infections).

-Inform your doctor if you notice anybone or muscle problems. Some patients taking combined antiretroviral therapy may develop a condition called osteonecrosis (death of bone tissue due to lack of blood supply to the bone). Some of the many risk factors for developing this disease, among others, are the duration of combined antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immunosuppression, and a higher body mass index. The signs of osteonecrosis are pain and stiffness of the joints (especially the hips, knees, and shoulders) and difficulty moving. If you notice any of these symptoms, please consult your doctor.

Geriatric population

Darunavir has only been used in a limited number of patients aged 65 or older. If you belong to this age group, please consult your doctor to see if you can take darunavir.

Children and adolescents

The Darunavir Kern Pharma 800 mg tablet should not be used in children under 3 years of age or with a weight less than 40 kg.

Taking Darunavir Kern Pharma with other medications

Inform your doctor or pharmacist if you are taking or have recently taken any other medication.

Some medicationsshould not be combinedwith darunavir. The list can be found in the section “Do not combine Darunavir Kern Pharma with any of the following medications:”

In most cases, darunavir can be combined with HIV medications that belong to other classes [e.g. ITINs (nucleoside reverse transcriptase inhibitors), ITINNs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists, and Ifs (fusion inhibitors)]. Darunavir has not been tested with cobicistat or ritonavir with all protease inhibitors (PIs) and should not be used with other protease inhibitors. In some cases, the dose of other medications may need to be adjusted. Therefore, if you are taking other HIV medications, inform your doctor and carefully follow their instructions on which medications can be combined.

The following products may reduce the effectiveness of darunavir. Inform your doctor if you are taking:

-Phenobarbital, diphenylhydantoin(to prevent seizures).

-Dexamethasone(corticosteroid).

-Efavirenz(for HIV infection).

-Rifapentine, rifabutin(medications to treat certain infections such as tuberculosis).

-Saquinavir(for HIV infection).

Darunavir may also affect the effects of other medications, and your doctor may want to perform additional blood tests. Inform your doctor if you are taking:

-Amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, lidocaine, metoprolol, mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil(for heart problems) because the therapeutic or adverse effects of these medications may be increased.

-Apixaban, dabigatran etexilate, edoxaban, rivaroxaban, warfarin, clopidogrel(to reduce blood coagulation) because the therapeutic or adverse effects of these medications may be altered.

-Estrogen-based contraceptives and hormone replacement therapy.

Darunavir may reduce their effectiveness. For birth control, alternative non-hormonal methods are recommended.

-Ethinylestradiol/drospirenone. Darunavir Kern Pharma may increase the risk of elevated potassium levels due to drospirenone.

-Atorvastatin, pravastatin, rosuvastatin(to reduce blood cholesterol). There may be a higher risk of muscle damage. Your doctor will determine which cholesterol-lowering treatment is best for you based on your individual circumstances.

-Clarithromycin(antibiotic).

-Ciclosporin, everolimus, tacrolimus, sirolimus(to inhibit the immune system) because the therapeutic or adverse effects of these medications may be increased.

-Corticosteroids, including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone. These medications are used to treat allergies, asthma, inflammatory bowel disease, skin, eye, joint, and muscle disorders, and other inflammatory conditions. These medications are usually taken orally, inhaled, injected, or applied to the skin. If alternatives cannot be used, their use should only be made after a clinical evaluation and with close monitoring by your doctor to assess the adverse effects of corticosteroids.

-Buprenorphine/naloxone(medications for opioid dependence treatment).

-Salmeterol(asthma medication).

-Artemether/lumefantrine(a combination of medications to treat malaria).

-Dasatinib, everolimus, irinotecan, nilotinib, vinblastine, vincristine(to treat cancer).

-Sildenafil, tadalafil, vardenafil(to treat erectile dysfunction or to treat a heart and lung disorder called pulmonary hypertension).

-Glecaprevir/pibrentasvir(to treat hepatitis C infection).

-Fentanyl, oxycodone, tramadol(to treat pain).

-Fesoterodine, solifenacin(to treat urinary disorders).

It is possible that your doctor will want to perform additional blood tests, and in some cases, the dose of some medications may need to be adjusted as they may affect the therapeutic or adverse effects of these medications or darunavir.

Inform your doctor if you are taking:

-Dabigatran etexilate, edoxaban, warfarin(to reduce blood coagulation)

-Alfentanil(a strong and short-acting analgesic used in surgical procedures).

-Digoxin(to treat certain heart problems).

-Clarithromycin(antibiotic).

-Itraconazole, isavuconazole, fluconazole, posaconazole, clotrimazole(to treat fungal infections). Voriconazole can only be administered after a medical evaluation.

-Rifabutin(to treat bacterial infections).

-Sildenafil, vardenafil, tadalafil(to treat erectile dysfunction or pulmonary hypertension).

-Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone(to treat depression and anxiety).

-Maraviroc(to treat HIV infection).

-Methadone(to treat opioid dependence).

-Carbamazepine, clonazepam(to prevent seizures or to treat certain types of neuropathic pain).

-Colchicine(to treat gout or familial Mediterranean fever).

-Bosentan(to treat pulmonary hypertension).

-Buspirone, chlorazepate, diazepam, estazolam, flurazepam, midazolam when administered by injection, zolpidem(sedatives).

-Perphenazine, risperidone, thioridazine(to treat psychiatric conditions).

-Metformin(to treat type 2 diabetes).

Thisis not a complete list of medications. Inform your doctor aboutallthe medications you are taking.

Taking Darunavir Kern Pharma with food and drink

See section 3 “How to take Darunavir Kern Pharma”.

Pregnancy and breastfeeding

Inform your doctor immediately if you are pregnant, planning to become pregnant. Pregnant women should not take darunavir with ritonavir unless their doctor specifically indicates it. Women should not take Darunavir Kern Pharma with cobicistat.Pregnant women should not take Darunavir Kern Pharma with cobicistat.

Due to the possibility of adverse effects in infants, women should not breastfeed their babies while taking darunavir.

It is not recommended that women living with HIV breastfeed because HIV infection can be transmitted to the baby through breast milk. If you are breastfeeding or plan to breastfeed, you should consult your doctor as soon as possible.

Driving and operating machinery

Do not operate tools or machines or drive if you experience dizziness after taking darunavir.

Darunavir Kern Pharma 800 mg contains lactose

If your doctor has told you that you are intolerant to certain sugars, consult with them before taking this medication.

Darunavir Kern Pharma 800 mg contains propylene glycol (E1520)

This medication contains 111.1 mg of propylene glycol (E1520) in each film-coated tablet. If the baby is less than 4 weeks old, consult your doctor, especially if the baby has been given other medications containing propylene glycol or alcohol.

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. In case of doubts, ask your doctor, pharmacist, or nurse.

Do not stop taking darunavir or cobicistat or ritonavir without consulting your doctor, even if you feel better.

After starting treatment, do not change the dose or form of the dose or interrupt treatment without your doctor's instructions.

Darunavir 800 mg tablets are used only once a day.

Dose for children aged 3 years and older with ritonavir, and 12 years and older with cobicistat, weighing more than 40 kg who have not taken antiretroviral medications before (your child's doctor will determine the dose)

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

Dose for children aged 3 years and older with ritonavir, and 12 years and older with cobicistat, weighing more than 40 kg who have taken antiretroviral medications before (your child's doctor will determine the dose)

The dose is:

-800 mg of darunavir (2 tablets containing 400 mg of darunavir or 1 tablet containing 800 mg of darunavir) once a day, taken with 100 mg of ritonavir or 150 mg of cobicistat.

or

-600 mg of darunavir taken twice a day with 100 mg of ritonavir.

Please talk to your doctor about what dose is correct for your child.

Instructions for children aged 3 years and older with ritonavir, and 12 years and older with cobicistat, weighing more than 40 kg

-Take 800 mg of darunavir (2 tablets containing 400 mg of darunavir or 1 tablet containing 800 mg of darunavir) at the same time, once a day, every day.

-Take darunavir always with 100 mg of ritonavir or 150 mg of cobicistat.

-Take darunavir with food.

-Swallow the tablets with a liquid such as water or milk.

-Take the other medications used in combination with darunavir and ritonavir or cobicistat as your doctor has recommended.

Dose for adults who have not taken antiretroviral medications before (will be determined by your doctor)

The recommended dose of darunavir is 800 mg (2 tablets containing 400 mg of darunavir or 1 tablet containing 800 mg of darunavir) once a day.

You must take darunavir every day and always in combination with 150 mg of cobicistat or 100 mg of ritonavir and with food. Darunavir does not work properly without cobicistat or ritonavir and food. Before taking darunavir and cobicistat or ritonavir, you must eat food 30 minutes beforehand. The type of food is not important. Do not stop treatment with darunavir or with cobicistat or ritonavir without consulting your doctor, even if you feel better.

Dose for adults who have taken antiretroviral medications before (will be determined by your doctor)

The dose is:

-800 mg of darunavir (2 tablets containing 400 mg of darunavir or 1 tablet containing 800 mg of darunavir) once a day, taken with 150 mg of cobicistat or 100 mg of ritonavir.

or

-600 mg of darunavir taken twice a day with 100 mg of ritonavir.

Please talk to your doctor about what dose is correct for you.

Instructions for adults

-Take 2 tablets of 400 mg or 1 tablet of 800 mg at the same time, once a day, every day.

-Take darunavir always with 150 mg of cobicistat or 100 mg of ritonavir.

-Take darunavir with food.

-Swallow the tablet with a drink, which can be water or milk.

-Take the other medications for HIV used in combination with darunavir and cobicistat or ritonavir as your doctor has recommended.

-The oral solution of darunavir may be available for use in children, but in some cases it may also be used in adults.

Removing the child-resistant cap

The plastic bottle has a child-resistant cap and opens as follows:

• Push the plastic cap down, turning it at the same time in a counterclockwise direction.

• Squeeze the cap out.

If you take more Darunavir Kern Pharma than you should

Inform your doctor, pharmacist, or nurse immediately.

If you forget to take Darunavir Kern Pharma

If you realize within12 hours, take the tablets immediately. Always take the dose with cobicistat or ritonavir and with food. If you realizeafter 12 hours, omit that dose and take the next one as usual. Do not take a double dose to make up for the missed doses.

If you vomit after taking Darunavir Kern Pharma and cobicistat or ritonavir

If you vomit within4 hoursof taking the medication, you should take another dose of darunavir and cobicistat or ritonavir with food as soon as possible. If you vomitmore than 4 hoursafter taking the medication, you do not need to take another dose of darunavir and cobicistat or ritonavir until the next scheduled time.

Consult your doctorif you are unsurewhat to do if you miss a dose or vomit.

Do not stop taking darunavir without talking to your doctor

Antiretroviral medications can make you feel better. Even if you feel better, do not stop taking darunavir. Consult your doctor first.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

During HIV treatment, there may be an increase in weight and levels of glucose and lipids in the blood. This may be partly related to health recovery and lifestyle, and in the case of blood lipids, sometimes to the HIV medications themselves. Your doctor will monitor these changes.

Like all medications, this medication may produce side effects, although not all people will experience them.

Inform your doctor if you develop any of the following side effects.

Cases of liver problems have been reported, which may occasionally be severe. Your doctor will perform a blood test before starting treatment with darunavir. If you have a chronic infection caused by hepatitis B or C, your doctor will frequently check your blood test results, as there is a higher probability of developing liver problems. Talk to your doctor about the signs and symptoms of liver problems. These may include yellowing of the skin and the white of the eyes, darkening (tea color) of the urine, pale stools (intestinal movements), nausea, vomiting, loss of appetite, or pain, feeling of pain or discomfort in the right side below your ribs.

Skin rash (more frequent when used in combination with raltegravir), itching. The skin rash is usually mild to moderate. A skin rash can also be a symptom of a rare and severe condition. Therefore, it is essential to talk to your doctor if you develop a rash. Your doctor will advise you on how to control the symptoms or if you should discontinue darunavir.

Other severe side effects were diabetes (frequent) and pancreatitis (infrequent).

Very frequent side effects(may affect more than 1 in 10 people)

• diarrhea.

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

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

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

• chest pain, changes in the electrocardiogram, rapid heart movements.
• decreased or abnormal sensitivity in the skin, paresthesia, attention disorder, memory loss, difficulty maintaining balance.
• difficulty breathing, cough, nasal bleeding, throat irritation.
• inflammation of the stomach or mouth, heartburn, nausea, dry mouth, abdominal discomfort, constipation, belching.
• renal insufficiency, kidney stones, difficulty urinating, excessive or frequent urination, sometimes at night.
• urticaria, severe skin swelling and other tissues (especially the lips or eyes), eczema, excessive sweating, night sweats, alopecia, acne, scaly skin, nail discoloration.
• muscle pain, muscle cramps, or weakness, joint pain, osteoporosis.
• reduced thyroid function. This can be seen in a blood test.
• hypertension (increased blood pressure), flushing.
• red or dry eyes.
• fever, swelling of the lower extremities due to fluid retention, discomfort, irritability, pain.
• symptoms of infection, herpes simplex.
• erectile dysfunction, breast enlargement.
• difficulty falling asleep, drowsiness, depression, anxiety, abnormal dreams, decreased libido.

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

• a reaction called DRESS [severe rash, which may be accompanied by fever, fatigue, facial swelling or lymph node enlargement, increased eosinophils (a type of white blood cell), liver, kidney, or lung damage].
• myocardial infarction, slow heart movements, palpitations.
• visual disturbance.
• chills, strange sensation.
• a feeling of confusion or disorientation, altered mood, agitation.
• syncope, seizure, changes or loss of taste.
• mouth ulcers, vomiting blood, inflammation of the lips, dry lips, tongue with plaque.
• nasal secretion.
• skin lesions, dry skin.
• muscle stiffness or joint stiffness, joint pain with or without inflammation.
• changes in some blood cell or biochemical values. These changes can be seen in blood and/or urine tests. Your doctor will explain them. For example: increased levels of some white blood cells.
• darunavir crystals in the kidney that cause kidney disease.

Some side effects are typical of HIV medications that belong to the same family as darunavir. These are:

• muscle pain, sensitivity, or weakness. In rare cases, these muscle disorders can be severe.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need.By doing so, you will help protect the environment.

Composition of Darunavir Kern Pharma

-The active ingredient is darunavir. Each film-coated tablet contains 800 mg of darunavir (as darunavir propylpiperazine).

-The other components are:

Inner phase:lactose monohydrate, microcrystalline cellulose, povidone K30, crospovidone, anhydrous colloidal silica.

Outer phase:magnesium stearate.

Coating (red):polyvinyl alcohol, macrogol, iron oxide red (E172), talc, and titanium dioxide (E171).

Appearance of the product and contents of the package

Oval-shaped red-brown tablet, marked with “800” on one side and dimensions: length: 21.4 ± 0.2 mm, width: 10.8 ± 0.2 mm, and thickness: 8.0 ± 0.4 mm.

This medicine is supplied in a carton box containing a white, opaque high-density polyethylene bottle with a child-resistant polypropylene (PP) cap and induction seal, along with a leaflet.

Package sizes:

1 or 3 bottles of 30 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer responsible:

Pharmathen International, S.A.

Sapes Industrial Park, Block Nº 5

69300 Rodopi

Greece

or

Pharmathen, S.A.

6, Dervenakion Street

153 51 Pallini, Attiki

Greece

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola, PLA 3000

Malta

or

Hormosan Pharma GmbH

Hanauer Landstraße 139-143

60314 Frankfurt am Main

Germany

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Denmark:DAVARINO

Germany:Davarino Hormosan 800mg Filmtabletten

United Kingdom:Darunavir 800mg film-coated tablets

(Northern Ireland)

Poland:Darunavir Synoptis

Greece:DAVARINO

Cyprus:DAVARINO

Romania:Darunavir Flomi 800mg comprimate filmate

Austria:Darunavir Accord 800mg Filmtabletten

Czech Republic: Darunavir Accord

Slovenia:Darunavir Accord 800mg Filmsko obložene tablete

Netherlands:Darunavir Accord 800mg filmonhulde tabletten

Norway:Darunavir Accord 800mg Tablett filmdrasjert

Italy:Darunavir Accord 800mg compresse rivestite con film

Ireland:Darunavir Accord 800mg Film-coated tablets

Bulgaria:Darunavir Accord 800mg?????????????????

Finland:Darunavir Accord 800mg kalvopäällysteiset tabletit

Croatia:Darunavir Accord 800mg filmom obložene tablete

Sweden:Darunavir Accord 800mg filmdragerade tabletter

Portugal:Darunavir Accord 800mg Comprimidos revestidos por película

France:Darunavir Accord 800mg comprimé pelliculé

Last review date of this leaflet:February 2024

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/