Darunavir Zentiva

Package Leaflet: Information for the User

Darunavir Zentiva, 800 mg, Film-Coated Tablets

Darunavir

Read All of This Leaflet Carefully Before You Start Taking This Medicine.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack and Other Information

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

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

What Darunavir Zentiva is

Darunavir Zentiva contains the active substance darunavir. Darunavir Zentiva is an antiretroviral medicine used to treat HIV infection in adults and children from the age of 3 years and at least 40 kg body weight. It works by reducing the amount of virus in the blood.

What Darunavir Zentiva is used for

Darunavir Zentiva is used to treat adults and children from the age of 3 years and at least 40 kg body weight who are infected with HIV. Your doctor will prescribe Darunavir Zentiva together with other antiretroviral medicines to treat your HIV infection.

2. Before you take Darunavir Zentiva

Do not take Darunavir Zentiva

• If you are allergic to darunavir or any of the other ingredients of this medicine.
• If you have severe liver problems.

Do not take Darunavir Zentiva with any of the following medicines

Some medicines may interact with Darunavir Zentiva. You must not take Darunavir Zentiva with these medicines. Your doctor will discuss with you the medicines that you are currently taking before you start treatment with Darunavir Zentiva.

• Aprepitant (used to treat nausea and vomiting).
• Astemizole or terfenadine (used to treat allergy symptoms).
• Triazolam and oral midazolam (used to help you sleep or for anxiety).
• Cisapride (used to treat certain stomach problems).
• Colchicine (used to treat gout or familial Mediterranean fever, especially if you have kidney or liver problems).
• Lurasidone, pimozide, quetiapine or sertindole (used to treat psychiatric problems).
• Ergot alkaloids (e.g. ergotamine, dihydroergotamine, ergometrine, methylergonovine) (used to treat migraine headaches).
• Amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine (used to treat certain heart problems).
• Lovastatin, simvastatin and lomitapide (used to lower cholesterol).
• Rifampicin (used to treat some infections, including tuberculosis).
• A combination product containing lopinavir and ritonavir (used to treat HIV infection).
• Elbasvir/grazoprevir (used to treat hepatitis C).
• Alfuzosin (used to treat enlarged prostate).
• Sildenafil (used to treat high blood pressure in the pulmonary arteries).
• Dabigatran, ticagrelor (used to prevent blood clots).
• Naloxegol (used to treat constipation caused by opioid medicines).
• Dapoxetine (used to treat premature ejaculation).
• Domperidone (used to treat nausea and vomiting).

Do not take Darunavir Zentiva with products containing St. John’s Wort (Hypericum perforatum) as this may decrease the effectiveness of Darunavir Zentiva.

Warnings and precautions

Before you take Darunavir Zentiva, tell your doctor if:

• You have had liver problems, including hepatitis B or C.
• You have diabetes.
• You have symptoms of infection or inflammation.
• You have haemophilia.
• You are allergic to sulphonamides.
• You have problems with your bones or muscles.

Older people

Darunavir has only been used in a small number of patients aged 65 years or older. If you are over 65, you doctor will decide if you can take Darunavir Zentiva.

Children and adolescents

Do not give Darunavir Zentiva 800 mg tablets to children under 3 years of age or less than 40 kg body weight.

Other medicines and Darunavir Zentiva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

• Fenobarbital, phenytoin (used to treat epilepsy),
• Dexamethasone (a corticosteroid),
• Efavirenz (used to treat HIV infection),
• Rifapentine, rifabutin (used to treat some infections, including tuberculosis),
• Saquinavir (used to treat HIV infection).

Tell your doctor or pharmacist if you are taking any of the following medicines:

• Amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, lidocaine, metoprolol, mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil (used to treat heart problems).
• Apixaban, edoxaban, rivaroxaban, warfarin, clopidogrel (used to prevent blood clots).
• Hormonal contraceptives and hormone replacement therapy. Darunavir Zentiva may reduce their effectiveness. If used for contraception, an additional, non-hormonal method of contraception should be used.
• Ethinyl estradiol/drospirenone. Darunavir Zentiva may increase the risk of high potassium levels in the blood through drospirenone.
• Atorvastatin, pravastatin, rosuvastatin (used to lower cholesterol). The risk of muscle damage may be increased. Your doctor will decide which cholesterol-lowering medicine is suitable for you.
• Clarithromycin (an antibiotic).
• Cyclosporine, everolimus, tacrolimus, sirolimus (used to suppress the immune system). Your doctor may need to perform additional blood tests.
• Corticosteroids, including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone. These are used to treat allergies, asthma, inflammatory bowel diseases, skin conditions, eye and ear infections, and other inflammatory conditions. They can be taken orally, inhaled, injected or applied on the skin. If alternatives are not available, they can only be used after consulting your doctor and under close monitoring for corticosteroid side effects.
• Buprenorphine/naloxone (used to treat opioid addiction).
• Salmeterol (used to treat asthma).
• Artemether/lumefantrine (used to treat malaria).
• Dasatinib, everolimus, irinotecan, nilotinib, vinblastine, vincristine (used to treat cancer).
• Sildenafil, tadalafil, vardenafil (used to treat erectile dysfunction or pulmonary arterial hypertension).
• Glecaprevir/pibrentasvir (used to treat hepatitis C).
• Fentanyl, oxycodone, tramadol (used to treat pain).
• Fesoterodine, solifenacin (used to treat urinary incontinence).

This is not a complete list of medicines. Tell your doctor about all the medicines you are taking.

Taking Darunavir Zentiva with food and drink

See section 3, “How to take Darunavir Zentiva”.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Do not drive or operate machines if you feel dizzy after taking Darunavir Zentiva.

Darunavir Zentiva contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

Darunavir Zentiva 800 mg contains Sunset Yellow FCF (E 110)

May cause allergic reactions.

3. How to take Darunavir Zentiva

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• Take Darunavir Zentiva once daily with food.
• Swallow the tablets with a glass of water.

If you take more Darunavir Zentiva than you should

Contact your doctor or pharmacist immediately.

If you forget to take Darunavir Zentiva

If you notice you have missed a dose within 12 hours of the time you usually take Darunavir Zentiva, take the missed dose as soon as possible with a meal. Then take the next dose at its regular time. If you notice you have missed a dose by more than 12 hours, skip the missed dose and take the next dose at its regular time. Do not take a double dose to make up for a forgotten dose.

If you vomit after taking Darunavir Zentiva

If you vomit within 4 hours after taking Darunavir Zentiva, take another dose as soon as possible with a meal. If you vomit more than 4 hours after taking Darunavir Zentiva, do not take another dose until your next regular dose.

If you are unsure what to do or have any other questions, contact your doctor.

Do not stop taking Darunavir Zentiva without your doctor’s advice

Even if you feel better, do not stop taking Darunavir Zentiva without your doctor’s advice. Stopping treatment with Darunavir Zentiva may lead to a worsening of your HIV infection.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects with Darunavir Zentiva

Some side effects are serious and require medical attention. If you experience any of the following side effects, tell your doctor immediately:

• Severe skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis), characterised by skin rash, fever, and blisters or peeling skin.
• Liver problems, which may be severe. Your doctor will perform blood tests by taking a sample of your blood to check for any signs of liver problems.

Other possible side effects of Darunavir Zentiva:

• Diarrhoea.
• Nausea, vomiting, abdominal pain, abdominal distension, flatulence, bloating.
• Headache, fatigue, dizziness, somnolence, paraesthesia, peripheral neuropathy, weakness, insomnia.

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

• Chest pain, changes in the electrocardiogram, palpitations.
• Abnormal sensations such as tingling or numbness, tremor, memory problems, confusion, disorientation, seizures, loss of taste.

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

• Myocardial infarction, abnormal heart rhythm, slow heart rate.
• Visual disturbances.
• Chills, malaise.
• Feeling disoriented or confused, mood changes, restlessness.

How to report side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. How to store Darunavir Zentiva

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Darunavir Zentiva contains

• The active substance is darunavir. Each tablet contains 800 mg of darunavir.
• The other ingredients are: Avicel DG (cellulose microcrystalline and calcium hydrogen phosphate anhydrous), croscarmellose sodium, cellulose microcrystalline, silicon dioxide, magnesium stearate, Opadry II Brown 85F265048 (polyvinyl alcohol, partially hydrolysed, titanium dioxide (E 171), macrogol 3350, talc, Sunset Yellow FCF (E 110), iron oxide red (E 172) and iron oxide yellow (E 172)).

What Darunavir Zentiva looks like and contents of the pack

Darunavir Zentiva 800 mg tablets are oval, biconvex, dark red film-coated tablets, debossed with “800” on one side.

30 film-coated tablets in HDPE bottles with child-resistant closures.

Marketing Authorisation Holder

Zentiva k.s., U kabelovny 130, Dolni Mecholupy, 102 37 Prague 10, Czech Republic

Manufacturer

Zentiva k.s., U kabelovny 130, Dolni Mecholupy, 102 37 Prague 10, Czech Republic

For any information about this medicine, please contact

Zentiva Polska Sp. z o.o., ul. Bonifraterska 17, 00-203 Warsaw, Poland

Date of last revision: September 2022