PACKAGE LEAFLET: INFORMATION FOR THE USER this medicine (listed in section 6) or to ritonavir. People taking darunavir may develop a widespread rash with tissue caused by loss of blood supply to the bone). The length as the therapeutic effect or side effects of these medicines may clotrimazole (to treat fungal infections). Voriconazole should 3. HOW TO TAKE DARUNAVIR • 600 mg darunavir (1 tablet of darunavir containing 600 mg If you forget to take darunavir your doctor about the signs and symptoms of liver problems. Rare side effects (may affect up to 1 in 1,000 people): phosphate), croscarmellose sodium, microcrystalline cellulose, • if you have severe liver problems. Ask your doctor if you are blisters and peeling skin, particularly around the mouth, nose, of combination antiretroviral therapy, corticosteroid use, alcohol be increased. only be taken after medical evaluation. darunavir) together with 100 mg ritonavir twice daily. If you notice within 12 hours, you must take the tablets immediately. These may include yellowing of your skin or whites of your • Heart attack, slow heart beating, palpitations. colloidal anhydrous silica, magnesium stearate, Opadry II Orange Darunavir 400 mg film-coated tablets unsure about the severity of your liver disease. Some additional eyes and genitals (Stevens-Johnson syndrome) or a more consumption, severe immunosuppression, higher body mass • Apixaban, edoxaban, rivaroxaban, warfarin, clopidogrel (to reduce • Rifabutin (against bacterial infections). Always take this medicine exactly as your doctor or pharmacist has Please discuss with your doctor which dose is right for you. Always take with ritonavir and food. If you notice after 12 hours, eyes, dark (tea coloured) urine, pale coloured stools (bowel • Visual disturbance. 85F23836 [mixture of poly(vinyl alcohol) – partially hydrolysed, Darunavir 800 mg film-coated tablets tests might be necessary. severe form of rash causing skin peeling in more than 30% of index, among others, may be some of the many risk factors for clotting of the blood) as their therapeutic effect or side effects • Sildenal, vardenal, tadalal (for erectile dysfunction or high told you. Check with your doctor or pharmacist if you are not sure. then skip the intake and take the next doses as usual. Do not take movements), nausea, vomiting, loss of appetite, or pain, • Chills, feeling abnormal. titanium dioxide (E171), macrogol 3350, talc and sunset yellow the body surface (toxic epidermal necrolysis). Infrequently a rash may be altered; your doctor may have to check your blood. Even if you feel better, do not stop taking darunavir and ritonavir Dose for children of 3 years of age and above with ritonavir, a double dose to make up for a forgotten dose. aching, and discomfort on your right side below your ribs. Do not combine darunavir with any of the following developing this disease. Signs of osteonecrosis are joint blood pressure in the pulmonary circulation). and 12 years of age and above with cobicistat, weighing • A feeling of confusion or disorientation, altered mood, restlessness. FCF aluminium lake (E110)]. medicines may become severe or potentially life-threatening. Please contact stiffness, aches and pains (especially of the hip, knee and • Oestrogen-based hormonal contraceptives and hormonal • Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, without talking to your doctor. • Skin rash (more often when used in combination with Read all of this leaflet carefully before you start taking this more than 40 kg who have not taken antiretroviral medicines If you vomit after taking darunavir and cobicistat or ritonavir • Fainting, epileptic ts, changes or loss of taste. Darunavir 800 mg lm-coated tablets: medicine because it contains important information for you. If you are taking any of these, ask your doctor about switching to your doctor whenever you develop a rash. shoulder) and difculty in movement. If you notice any of these replacement therapy. Darunavir might reduce its effectiveness. sertraline, trazodone (to treat depression and anxiety). After therapy has been initiated, the dose or dosage form must raltegravir), itching. The rash is usually mild to moderate. A skin before (your child’s doctor will determine this) If you vomit within 4 hours of taking the medicine, another dose of • Mouth sores, vomiting blood, in ammation of the lips, dry lips, The other ingredients are: dry granulation agent (mixture of • Keep this lea et. You may need to read it again. another medicine. In patients taking darunavir and raltegravir (for HIV infection), symptoms please inform your doctor. When used for birth control, alternative methods of • Maraviroc (to treat HIV infection). not be changed or therapy must not be stopped without darunavir and cobicistat or ritonavir should be taken with food as rash might also be a symptom of a rare severe situation. It is coated tongue. instruction of the doctor. • The usual dose of darunavir is 800 mg (2 tablets of darunavir microcrystalline cellulose and anhydrous calcium phosphate), • If you have any further questions, ask your doctor or • Avanal (to treat erectile dysfunction). rashes (generally mild or moderate) may occur more frequently Elderly non-hormonal contraception are recommended. • Methadone (to treat opiate dependence). soon as possible. If you vomit more than 4 hours after taking the therefore important to contact your doctor if you develop a • Running nose. • Astemizole or terfenadine (to treat allergy symptoms). than in patients taking either medicine separately. • Ethinylestradiol/drospirenone. Darunavir might increase the risk • Carbamazepine, clonazepam (to prevent seizures or to treat Darunavir 400 mg lm-coated tablets: containing 400 mg darunavir or 1 tablet of darunavir containing medicine, then you do not need to take another dose of darunavir rash. Your doctor will advise you how to deal with your croscarmellose sodium, microcrystalline cellulose, colloidal pharmacist Darunavir has only been used in limited numbers of patients 65 800 mg darunavir) together 100 mg ritonavir or 150 mg of • Skin lesions, dry skin. • This medicine has been prescribed for you only. Do not pass it • Triazolam and oral (taken by mouth) midazolam (to help you for elevated potassium levels by drospirenone. certain types of nerve pain). Darunavir 400 mg is only to be used to construct the once daily and cobicistat or ritonavir until the next regularly scheduled time. symptoms or whether darunavir must be stopped. anhydrous silica, magnesium stearate, Opadry II Brown 85F265048 Tell your doctor about your situation BEFORE and DURING years or older. If you belong to this age group, please discuss • Atorvastatin, pravastatin, rosuvastatin (to lower cholesterol cobicistat once daily. • Stiffness of muscles or joints, joint pain with or without in ammation. on to others. It may harm them, even if their signs of illness are sleep and/or relieve anxiety). your treatment with your doctor if you can use darunavir. • Colchicine (to treat gout or familial Mediterranean fever). 800 mg regimen. Contact your doctor if you are uncertain about what to do if you • Other severe side effects were diabetes (common) and [mixture of poly(vinyl alcohol) – partially hydrolysed, titanium levels). The risk of muscle damage might be increased. Your Darunavir 800 mg lm-coated tablets: • Changes in some values of your blood cells or chemistry. These the same as yours. • Cisapride (to treat some stomach conditions). Make sure that you check the following points and tell your • Bosentan (to treat high blood pressure in the pulmonary circulation). Dose for children 3 years of age and above with ritonavir, and miss a dose or vomit. in ammation of the pancreas (uncommon). Symptoms of can be seen in the results of blood and/or urine tests. Your dioxide (E171), macrogol 3350, talc, Ponceau 4R aluminium lake • Colchicine (if you have kidney and/or liver problems; to treat Children doctor will evaluate which cholesterol lowering regimen is best Darunavir 800 mg is intended for once daily use only. in ammation of the pancreas include severe stomach pain, • If you get any side effects, talk to your doctor or pharmacist. doctor if any of these apply to you. • Buspirone, clorazepate, diazepam, estazolam, urazepam, 12 years of age and above with cobicistat, weighing more Do not stop taking darunavir without talking to your doctor doctor will explain these to you. Examples are: increase in (E124), red iron oxide (E172) and yellow iron oxide (E172)]. gout or familial Mediterranean fever). The darunavir 400mg/800mg tablet is not for use in children for your specic situation. Dose for adults who have not taken antiretroviral medicines which may reach through to your back. This includes any possible side effects not listed in this lea et • Tell your doctor if you have had problems with your liver younger than 3 years of age or weighing less than 40 kg. midazolam when used as an injection zolpidem (sedative agents). than 40 kg who have taken antiretroviral medicines before first some white blood cells. What darunavir looks like and contents of the pack: • Lurasidone, pimozide, quetiapine or sertindole (to treat • Clarithromycin (antibiotic). before (your doctor will determine this) (your child’s doctor will determine this) Very common side effects (may affect more than 1 in 10 people): (see section 4). before, including hepatitis B and C infection. Your doctor may • Ciclosporin, everolimus, tacrolimus, sirolimus (for dampening • Perphenazine, risperidone, thioridazine (to treat psychiatric Anti-HIV medicines may make you feel better. Even when you feel Some side effects are typical for anti-HIV medicines in the same Darunavir 400 mg lm-coated tablets: psychiatric conditions). evaluate how severe your liver disease is before deciding if you Other medicines and darunavir conditions). The usual dose of darunavir is 800 mg (2 tablets of darunavir The dose is: • Diarrhoea. What is in this leaflet: • Ergot alkaloids like ergotamine, dihydroergotamine, Tell your doctor or pharmacist if you are taking, have recently down your immune system) as the therapeutic effect or side better, do not stop taking darunavir. Talk to your doctor rst. family as darunavir. These are: Plain, oval, biconvex, light orange lm-coated tablets of approx. can take darunavir. • Metformin (to treat type 2 diabetes). containing 400 mg darunavir or 1 tablet of darunavir containing • 800 mg darunavir (2 tablets of darunavir containing 400 mg Common side effects (may affect up to 1 in 10 people): 1. What darunavir is and what it is used for ergometrine and methylergonovine (to treat migraine taken or might take any other medicines. effects of these medicines might be increased. Your doctor 800 mg darunavir) once daily. If you have any further questions on the use of this medicine, ask • Muscle pain, tenderness or weakness. On rare occasions, 19 mm length and 10 mm width. 60 lm-coated tablets in HDPE 2. What you need to know before you take darunavir • Tell your doctor if you have diabetes. Darunavir might increase might want to do some additional tests. This is not a complete list of medicines, tell your healthcare darunavir or 1 tablet of darunavir containing 800 mg darunavir) your doctor, pharmacist. • Vomiting, nausea, abdominal pain or distension, dyspepsia, headaches). sugar levels in the blood. There are some medicines that you must not combine with You must take darunavir every day and always in combination with these muscle disorders have been serious. bottle with child-resistant screw cap. 3. How to take darunavir • Amiodarone, bepridil, dronedarone, ivabradine, quinidine, • Corticosteroids including betametasone, budesonide, provider about all medicines that you are taking. with 100 mg ritonavir or 150 mg of cobicistat once daily. atulence. • Tell your doctor immediately if you notice any symptoms of darunavir. These are mentioned above under the heading “Do not uticasone, mometasone, prednisone, triamcinolone. These 150 mg of cobicistat or 100 mg of ritonavir and with food. Darunavir OR 4. POSSIBLE SIDE EFFECTS • Headache, tiredness, dizziness, drowsiness, numbness, tingling Reporting of side effects Darunavir 800 mg lm-coated tablets: 4. Possible side effects ranolazine (to treat certain heart disorders e.g. abnormal heart beat). combine darunavir with any of the following medicines”. Darunavir with food and drink cannot work properly without ritonavir and food. You must eat a If you get any side effects, talk to your doctor or pharmacist. This 5. How to store darunavir infection (for example enlarged lymph nodes and fever). In medicines are used to treat allergies, asthma, in ammatory • 600 mg darunavir (1 tablet of darunavir containing 600 mg During HIV therapy there may be an increase in weight and in levels or pain in hands or feet, loss of strength, difculty falling asleep. Plain, oval, biconvex, dark red lm-coated tablets of approx. 20 mm • Lovastatin, simvastatin or lomitapide (to lower cholesterol levels). some patients with advanced HIV infection and a history of See section 3 “How to take darunavir”. meal or a snack within 30 minutes prior to taking your darunavir and includes any possible side effects not listed in this lea et. You 6. Contents of the pack and other information • Rifampicin (to treat some infections such as tuberculosis). In most cases, darunavir can be combined with anti-HIV bowel diseases, in ammatory conditions of the eyes, joints and darunavir) together with 100 mg ritonavir twice daily. of blood lipids and glucose. This is partly linked to restored health Uncommon side effects (may affect up to 1 in 100 people): length and 10 mm width. opportunistic infection, signs and symptoms of in ammation medicines belonging to another class [e.g. NRTIs (nucleoside muscles and other in ammatory conditions. If alternatives Pregnancy and breast-feeding ritonavir. The type of food is not important. Even if you feel better, do • Chest pain, changes in electrocardiogram, rapid heart beating. can also report side effects directly via the Yellow Card Scheme 30 lm-coated tablets in HDPE bottle with child-resistant screw cap. • The combination product lopinavir/ritonavir (this anti-HIV not stop taking darunavir and ritonavir without talking to your doctor. Please discuss with your doctor which dose is right for you. and life style, and in the case of blood lipids sometimes to the HIV 1. WHAT DARUNAVIR IS AND WHAT IT IS USED FOR from previous infections may occur soon after anti-HIV reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse cannot be used, its use should only take place after medical Tell your doctor immediately if you are pregnant, planning to medicines themselves. Your doctor will test for these changes. • Decreased or abnormal skin sensitivity, pins and needles, attention at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card medicine belongs to the same class as darunavir). become pregnant or if you are breast-feeding. Pregnant or Bundle pack of 2 HDPE bottles with 30 lm-coated tablets in Darunavir contains the active substance darunavir. Darunavir is • Elbasvir/grazoprevir (to treat hepatitis C infection). treatment is started. It is believed that these symptoms are due transcriptase inhibitors), CCR5 antagonists and FIs (fusion evaluation and under close monitoring by your doctor for Instructions for adults Instructions for children 3 years of age and above with disturbance, loss of memory, problems with your balance. in the Google Play or Apple App Store. By reporting side effects to an improvement in the body’s immune response, enabling breast-feeding mothers should not take darunavir with ritonavir Darunavir 400 mg lm-coated tablets: ritonavir, and 12 years of age and above with cobicistat, Like all medicines, this medicine can cause side effects, although each bottle. an antiretroviral medicine used in the treatment of human • Alfuzosin (to treat enlarged prostate). inhibitors)]. Darunavir with ritonavir has not been tested with all corticosteroid side effects. not everybody gets them. • Difculty breathing, cough, nosebleed, throat irritation. you can help provide more information on the safety of this medicine. • Sildenal (to treat high blood pressure in the pulmonary the body to ght infections that may have been present with no PIs (protease inhibitors) and must not be used with other HIV PIs. • Buprenorphine/naloxone (medicines to treat opiate unless specically directed by the doctor. Pregnant or • Take two 400 mg tablets at the same time, once a day, every day. weighing more than 40 kg • In ammation of the stomach or mouth, heartburn, retching, dry Darunavir is also available as 75, 150, 400 and 600 mg immunodeciency virus (HIV) infection. It belongs to a group of obvious symptoms. breast-feeding mothers should not take darunavir with cobicistat. Darunavir 800 mg lm-coated tablets: Tell your doctor if you develop any of the following side effects 5. HOW TO STORE DARUNAVIR lm-coated tablets. medicines called protease inhibitors. Darunavir works by circulation). In some cases dosage of other medicines might need to be dependence). • Take 800 mg darunavir (2 tablets of darunavir containing 400 mg mouth, discomfort of the abdomen, constipation, belching. • Dabigatran, ticagrelor (to help stop the clumping of platelets in • In addition to the opportunistic infections, autoimmune changed. Therefore always tell your doctor if you take other • Salmeterol (medicine to treat asthma). It is recommended that HIV infected women must not • Take one 800 mg tablet at the same time, once a day, every day. darunavir or 1 tablet of darunavir containing 800 mg darunavir) • A reaction called DRESS [severe rash, which may be • Kidney failure, kidney stones, difcult discharge of urine, Keep this medicine out of the sight and reach of children. Not all pack sizes may be marketed. reducing the amount of HIV in your body. This will improve your disorders (a condition that occurs when the immune system breast-feed their infants because of both the possibility of your • Always take darunavir together with 150 mg of cobicistat or accompanied by fever, fatigue, swelling of the face or lymph immune system and reduces the risk of developing illnesses the treatment of patients with a history of a heart attack). anti-HIV medicines and follow your doctor’s instruction carefully • Artemether/lumefantrine (a combination medicine to treat malaria). at the same time, once a day, every day. frequent or excessive passage of urine, sometimes at night. Do not use this medicine after the expiry date which is stated on • Naloxegol (to treat opioid induced constipation). attacks healthy body tissue) may also occur after you start on which medicines can be combined. • Dasatinib, everolimus, irinotecan, nilotinib, vinblastine, baby becoming infected with HIV through your breast milk and 100 mg of ritonavir. • Take darunavir always together with 100 mg of ritonavir or 150 mg glands, increase of eosinophils (type of white blood cells), • Urticaria, severe swelling of the skin and other tissues (most the carton and on the bottle after EXP. The expiry date refers to The Marketing Authorisation Holder is linked to HIV infection. taking medicines for the treatment of your HIV infection. • Take darunavir with food. effects on liver, kidney or lung]. • Dapoxetine (to treat premature ejaculation). The effects of darunavir might be reduced if you take any of vincristine (to treat cancer). because of the unknown effects of the medicine on your baby. of cobicistat. often the lips or the eyes), eczema, excessive sweating, night the last day of that month. Zentiva Pharma UK Limited, The darunavir 400mg/800mg tablet is used to treat adults and Autoimmune disorders may occur many months after the start • Sildenal, tadalal, vardenal (for erectile dysfunction or to treat • Swallow the tablets with a drink such as water or milk. • Severe skin reactions (Stevens Johnsons Syndrome and Toxic children 3 years of age and above, and at least 40 kg body • Domperidone (to treat nausea and vomiting). the following products. Tell your doctor if you take: Driving and using machines • Take darunavir with food. sweats, hair loss, acne, scaly skin, colouration of nails. This medicine does not require any special storage conditions. 12 New Fetter Lane, London, EC4A 1JP, UK of treatment. If you notice any symptoms of infection or other a heart and lung disorder called pulmonary arterial hypertension). Do not operate machines or drive if you feel dizzy after taking • Take your other HIV medicines used in combination with darunavir • Swallow the tablets with a drink such as water or milk. Epidermal Necrolysis), causing u like symptoms, (cough, runny • Muscle pain, muscle cramps or weakness, pain in extremities Do not throw away any medicines via wastewater or household weight, who are infected by HIV and Do not combine darunavir with products that contain St. John’s symptoms such as muscle weakness, weakness beginning in • Phenobarbital, phenytoin (to prevent seizures) and cobicistat or ritonavir as recommended by your doctor. The manufacturer is wort (Hypericum perforatum). • Glecaprevir/pibrentasvir (to treat hepatitis C infection) darunavir. • Take your other HIV medicines used in combination with darunavir nose, fever, decreased appetite and malaise) and skin rashes osteoporosis. waste. Ask your pharmacist how to throw away medicines you • who have not used antiretroviral medicines before. the hands and feet and moving up towards the trunk of the • Dexamethasone (corticosteroid) • Fentanyl, oxycodone, tramadol (to treat pain) • Oral suspension containing darunavir has been developed for which may develop into blisters and peeling skin; a widespread Zentiva, k. s., U kabelovny 130, Dolní M cholupy, • Efavirenz (HIV infection) Darunavir contains sodium. and ritonavir or cobicistat as recommended by your doctor. • Slowing down of the thyroid gland function. This can be seen in no longer use. These measures will help protect the environment. ě • in certain patients who have used antiretroviral medicines Warnings and precautions body, palpitations, tremor or hyperactivity, please inform your • Fesoterodine, solifenacin (to treat urologic disorders). use in children, but in some cases, can also be used in adults. rash with blisters and peeling skin, particularly around the mouth, a blood test. 102 37 Prague, Czech Republic Talk to your doctor or pharmacist before taking darunavir. • Rifapentine, rifabutin (medicines to treat some infections such This medicine contains less than 1 mmol sodium (23 mg) per Removing the child resistant cap before (your doctor will determine this). doctor immediately to seek necessary treatment. The dosage of other medicines might need to be changed since Dose for adults who have taken antiretroviral medicines nose and genitals (Stevens-Johnson syndrome) or a more severe • High blood pressure, ushing. 6. CONTENTS OF THE PACK AND OTHER INFORMATION Darunavir must be taken in combination with a low dose of cobicistat Darunavir is not a cure for HIV infection. You can still pass on • Tell your doctor if you have haemophilia. Darunavir might as tuberculosis) tablet that is to say essentially “sodium free”. before (your doctor will determine this) The plastic bottle comes with a child resistant cap form of rash causing skin peeling in more than 30% of the body Or • Saquinavir (HIV infection). either their own or therapeutic effect of darunavir or side effects and must be opened as follows: • Red or dry eyes. What darunavir contains: or ritonavir and other anti-HIV medicines. Your doctor will discuss HIV when taking this medicine, although the risk is lowered by increase the risk of bleeding. may be in uenced when combined. Tell your doctor if you take: Darunavir 400mg film-coated tablets contains sunset yellow The dose is either: surface. • Fever, swelling of lower limbs due to uids, malaise, irritability, • The active substance is darunavir. Each tablet contains 400mg S.C. Zentiva S.A. with you which combination of medicines is best for you. effective antiretroviral therapy. Discuss with your physician the • Tell your doctor if you are allergic to sulphonamides (e.g. The effects of other medicines might be influenced if you take FCF (E110) • 800 mg darunavir (2 tablets of darunavir containing 400 mg • Push the plastic screw cap down while turning it • Liver problems that may occasionally be severe have been pain. • Alfentanil (injectable strong and short-acting painkiller that is counter clockwise. or 800 mg of darunavir. B-dul Theodor Pallady nr. 50, sector 3 precautions needed to avoid infecting other people. used to treat certain infections). darunavir. Tell your doctor if you take: used for surgical procedures). It may cause allergic reactions darunavir or 1 tablet of darunavir containing 800 mg darunavir) reported. Your doctor should do blood tests before you start • Symptoms of infection, herpes simplex. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DARUNAVIR • Remove the unscrewed cap. Darunavir 400 mg lm-coated tablets: Bucuresti, Cod – 032266 People taking darunavir may still develop infections or other • Tell your doctor if you notice any musculoskeletal problems. • Amlodipine, diltiazem, disopyramide, carvedilol, felodipine, • Digoxin (to treat certain heart disorders). Darunavir 800 mg film-coated tablets contains ponceau 4R together with 150 mg cobicistat or 100 mg ritonavir once daily. darunavir. If you have chronic hepatitis B or C infection, your • Erectile dysfunction, enlargement of breasts. Romania Some patients taking combination antiretroviral therapy may ecainide, lidocaine, metoprolol, mexiletine, nifedipine, If you take more darunavir than you should Do not take darunavir: illnesses associated with HIV infection. You must keep in regular • Clarithromycin (antibiotic). red (E124) OR doctor should check your blood tests more often because you • Sleeping problems, sleepiness, depression, anxiety, abnormal The other ingredients are: dry granulation agent (mixture of • if you are allergic to darunavir or any of the other ingredients of contact with your doctor. develop a bone disease called osteonecrosis (death of bone nicardipine, propafenone, timolol, verapamil (for heart disease) • Itraconazole, isavuconazole, uconazole, posaconazole, It may cause allergic reactions. Contact your doctor, pharmacist or nurse immediately. have an increased chance of developing liver problems. Talk to dreams, decrease in sexual drive. microcrystalline cellulose and anhydrous calcium hydrogen This leaflet was last updated in June 2021 PACKAGE LEAFLET: INFORMATION FOR THE USER this medicine (listed in section 6) or to ritonavir. People taking darunavir may develop a widespread rash with tissue caused by loss of blood supply to the bone). The length as the therapeutic effect or side effects of these medicines may clotrimazole (to treat fungal infections). Voriconazole should 3. HOW TO TAKE DARUNAVIR • 600 mg darunavir (1 tablet of darunavir containing 600 mg If you forget to take darunavir your doctor about the signs and symptoms of liver problems. Rare side effects (may affect up to 1 in 1,000 people): phosphate), croscarmellose sodium, microcrystalline cellulose, • if you have severe liver problems. Ask your doctor if you are blisters and peeling skin, particularly around the mouth, nose, of combination antiretroviral therapy, corticosteroid use, alcohol be increased. only be taken after medical evaluation. darunavir) together with 100 mg ritonavir twice daily. If you notice within 12 hours, you must take the tablets immediately. These may include yellowing of your skin or whites of your • Heart attack, slow heart beating, palpitations. colloidal anhydrous silica, magnesium stearate, Opadry II Orange Darunavir 400 mg film-coated tablets unsure about the severity of your liver disease. Some additional eyes and genitals (Stevens-Johnson syndrome) or a more consumption, severe immunosuppression, higher body mass • Apixaban, edoxaban, rivaroxaban, warfarin, clopidogrel (to reduce • Rifabutin (against bacterial infections). Always take this medicine exactly as your doctor or pharmacist has Please discuss with your doctor which dose is right for you. Always take with ritonavir and food. If you notice after 12 hours, eyes, dark (tea coloured) urine, pale coloured stools (bowel • Visual disturbance. 85F23836 [mixture of poly(vinyl alcohol) – partially hydrolysed, Darunavir 800 mg film-coated tablets tests might be necessary. severe form of rash causing skin peeling in more than 30% of index, among others, may be some of the many risk factors for clotting of the blood) as their therapeutic effect or side effects • Sildenal, vardenal, tadalal (for erectile dysfunction or high told you. Check with your doctor or pharmacist if you are not sure. then skip the intake and take the next doses as usual. Do not take movements), nausea, vomiting, loss of appetite, or pain, • Chills, feeling abnormal. titanium dioxide (E171), macrogol 3350, talc and sunset yellow the body surface (toxic epidermal necrolysis). Infrequently a rash may be altered; your doctor may have to check your blood. Even if you feel better, do not stop taking darunavir and ritonavir Dose for children of 3 years of age and above with ritonavir, a double dose to make up for a forgotten dose. aching, and discomfort on your right side below your ribs. Do not combine darunavir with any of the following developing this disease. Signs of osteonecrosis are joint blood pressure in the pulmonary circulation). and 12 years of age and above with cobicistat, weighing • A feeling of confusion or disorientation, altered mood, restlessness. FCF aluminium lake (E110)]. may become severe or potentially life-threatening. Please contact stiffness, aches and pains (especially of the hip, knee and • Oestrogen-based hormonal contraceptives and hormonal without talking to your doctor. • Skin rash (more often when used in combination with Read all of this leaflet carefully before you start taking this medicines • Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, more than 40 kg who have not taken antiretroviral medicines If you vomit after taking darunavir and cobicistat or ritonavir • Fainting, epileptic ts, changes or loss of taste. Darunavir 800 mg lm-coated tablets: medicine because it contains important information for you. If you are taking any of these, ask your doctor about switching to your doctor whenever you develop a rash. shoulder) and difculty in movement. If you notice any of these replacement therapy. Darunavir might reduce its effectiveness. sertraline, trazodone (to treat depression and anxiety). After therapy has been initiated, the dose or dosage form must If you vomit within 4 hours of taking the medicine, another dose of raltegravir), itching. The rash is usually mild to moderate. A skin • Mouth sores, vomiting blood, in ammation of the lips, dry lips, not be changed or therapy must not be stopped without before (your child’s doctor will determine this) The other ingredients are: dry granulation agent (mixture of • Keep this lea et. You may need to read it again. another medicine. In patients taking darunavir and raltegravir (for HIV infection), symptoms please inform your doctor. When used for birth control, alternative methods of • Maraviroc (to treat HIV infection). darunavir and cobicistat or ritonavir should be taken with food as rash might also be a symptom of a rare severe situation. It is coated tongue. instruction of the doctor. • The usual dose of darunavir is 800 mg (2 tablets of darunavir microcrystalline cellulose and anhydrous calcium phosphate), • If you have any further questions, ask your doctor or • Avanal (to treat erectile dysfunction). rashes (generally mild or moderate) may occur more frequently Elderly non-hormonal contraception are recommended. • Methadone (to treat opiate dependence). soon as possible. If you vomit more than 4 hours after taking the therefore important to contact your doctor if you develop a • Running nose. • Astemizole or terfenadine (to treat allergy symptoms). than in patients taking either medicine separately. • Ethinylestradiol/drospirenone. Darunavir might increase the risk • Carbamazepine, clonazepam (to prevent seizures or to treat Darunavir 400 mg lm-coated tablets: containing 400 mg darunavir or 1 tablet of darunavir containing medicine, then you do not need to take another dose of darunavir rash. Your doctor will advise you how to deal with your croscarmellose sodium, microcrystalline cellulose, colloidal pharmacist Darunavir has only been used in limited numbers of patients 65 800 mg darunavir) together 100 mg ritonavir or 150 mg of • Skin lesions, dry skin. • This medicine has been prescribed for you only. Do not pass it • Triazolam and oral (taken by mouth) midazolam (to help you for elevated potassium levels by drospirenone. certain types of nerve pain). Darunavir 400 mg is only to be used to construct the once daily and cobicistat or ritonavir until the next regularly scheduled time. symptoms or whether darunavir must be stopped. anhydrous silica, magnesium stearate, Opadry II Brown 85F265048 Tell your doctor about your situation BEFORE and DURING years or older. If you belong to this age group, please discuss • Atorvastatin, pravastatin, rosuvastatin (to lower cholesterol cobicistat once daily. • Stiffness of muscles or joints, joint pain with or without in ammation. on to others. It may harm them, even if their signs of illness are sleep and/or relieve anxiety). your treatment with your doctor if you can use darunavir. • Colchicine (to treat gout or familial Mediterranean fever). 800 mg regimen. Contact your doctor if you are uncertain about what to do if you • Other severe side effects were diabetes (common) and [mixture of poly(vinyl alcohol) – partially hydrolysed, titanium levels). The risk of muscle damage might be increased. Your Darunavir 800 mg lm-coated tablets: • Changes in some values of your blood cells or chemistry. These the same as yours. • Cisapride (to treat some stomach conditions). Make sure that you check the following points and tell your • Bosentan (to treat high blood pressure in the pulmonary circulation). Dose for children 3 years of age and above with ritonavir, and miss a dose or vomit. in ammation of the pancreas (uncommon). Symptoms of can be seen in the results of blood and/or urine tests. Your dioxide (E171), macrogol 3350, talc, Ponceau 4R aluminium lake • Colchicine (if you have kidney and/or liver problems; to treat Children doctor will evaluate which cholesterol lowering regimen is best Darunavir 800 mg is intended for once daily use only. in ammation of the pancreas include severe stomach pain, • If you get any side effects, talk to your doctor or pharmacist. doctor if any of these apply to you. • Buspirone, clorazepate, diazepam, estazolam, urazepam, 12 years of age and above with cobicistat, weighing more Do not stop taking darunavir without talking to your doctor doctor will explain these to you. Examples are: increase in (E124), red iron oxide (E172) and yellow iron oxide (E172)]. gout or familial Mediterranean fever). The darunavir 400mg/800mg tablet is not for use in children for your specic situation. Dose for adults who have not taken antiretroviral medicines which may reach through to your back. This includes any possible side effects not listed in this lea et • Tell your doctor if you have had problems with your liver younger than 3 years of age or weighing less than 40 kg. midazolam when used as an injection zolpidem (sedative agents). than 40 kg who have taken antiretroviral medicines before first some white blood cells. What darunavir looks like and contents of the pack: • Lurasidone, pimozide, quetiapine or sertindole (to treat • Clarithromycin (antibiotic). before (your doctor will determine this) (your child’s doctor will determine this) Very common side effects (may affect more than 1 in 10 people): (see section 4). before, including hepatitis B and C infection. Your doctor may • Ciclosporin, everolimus, tacrolimus, sirolimus (for dampening • Perphenazine, risperidone, thioridazine (to treat psychiatric Anti-HIV medicines may make you feel better. Even when you feel Some side effects are typical for anti-HIV medicines in the same Darunavir 400 mg lm-coated tablets: psychiatric conditions). evaluate how severe your liver disease is before deciding if you Other medicines and darunavir conditions). The usual dose of darunavir is 800 mg (2 tablets of darunavir The dose is: • Diarrhoea. What is in this leaflet: • Ergot alkaloids like ergotamine, dihydroergotamine, Tell your doctor or pharmacist if you are taking, have recently down your immune system) as the therapeutic effect or side better, do not stop taking darunavir. Talk to your doctor rst. family as darunavir. These are: Plain, oval, biconvex, light orange lm-coated tablets of approx. can take darunavir. • Metformin (to treat type 2 diabetes). containing 400 mg darunavir or 1 tablet of darunavir containing • 800 mg darunavir (2 tablets of darunavir containing 400 mg Common side effects (may affect up to 1 in 10 people): 1. What darunavir is and what it is used for ergometrine and methylergonovine (to treat migraine taken or might take any other medicines. effects of these medicines might be increased. Your doctor 800 mg darunavir) once daily. If you have any further questions on the use of this medicine, ask • Muscle pain, tenderness or weakness. On rare occasions, 19 mm length and 10 mm width. 60 lm-coated tablets in HDPE 2. What you need to know before you take darunavir • Tell your doctor if you have diabetes. Darunavir might increase might want to do some additional tests. This is not a complete list of medicines, tell your healthcare darunavir or 1 tablet of darunavir containing 800 mg darunavir) your doctor, pharmacist. • Vomiting, nausea, abdominal pain or distension, dyspepsia, headaches). sugar levels in the blood. There are some medicines that you must not combine with You must take darunavir every day and always in combination with these muscle disorders have been serious. bottle with child-resistant screw cap. 3. How to take darunavir • Amiodarone, bepridil, dronedarone, ivabradine, quinidine, • Corticosteroids including betametasone, budesonide, provider about all medicines that you are taking. with 100 mg ritonavir or 150 mg of cobicistat once daily. atulence. • Tell your doctor immediately if you notice any symptoms of darunavir. These are mentioned above under the heading “Do not uticasone, mometasone, prednisone, triamcinolone. These 150 mg of cobicistat or 100 mg of ritonavir and with food. Darunavir OR 4. POSSIBLE SIDE EFFECTS • Headache, tiredness, dizziness, drowsiness, numbness, tingling Reporting of side effects Darunavir 800 mg lm-coated tablets: 4. Possible side effects ranolazine (to treat certain heart disorders e.g. abnormal heart beat). combine darunavir with any of the following medicines”. Darunavir with food and drink cannot work properly without ritonavir and food. You must eat a If you get any side effects, talk to your doctor or pharmacist. This 5. How to store darunavir infection (for example enlarged lymph nodes and fever). In medicines are used to treat allergies, asthma, in ammatory • 600 mg darunavir (1 tablet of darunavir containing 600 mg During HIV therapy there may be an increase in weight and in levels or pain in hands or feet, loss of strength, difculty falling asleep. Plain, oval, biconvex, dark red lm-coated tablets of approx. 20 mm • Lovastatin, simvastatin or lomitapide (to lower cholesterol levels). some patients with advanced HIV infection and a history of See section 3 “How to take darunavir”. meal or a snack within 30 minutes prior to taking your darunavir and includes any possible side effects not listed in this lea et. You 6. Contents of the pack and other information • Rifampicin (to treat some infections such as tuberculosis). In most cases, darunavir can be combined with anti-HIV bowel diseases, in ammatory conditions of the eyes, joints and darunavir) together with 100 mg ritonavir twice daily. of blood lipids and glucose. This is partly linked to restored health Uncommon side effects (may affect up to 1 in 100 people): length and 10 mm width. opportunistic infection, signs and symptoms of in ammation medicines belonging to another class [e.g. NRTIs (nucleoside muscles and other in ammatory conditions. If alternatives Pregnancy and breast-feeding ritonavir. The type of food is not important. Even if you feel better, do and life style, and in the case of blood lipids sometimes to the HIV • Chest pain, changes in electrocardiogram, rapid heart beating. can also report side effects directly via the Yellow Card Scheme 30 lm-coated tablets in HDPE bottle with child-resistant screw cap. • The combination product lopinavir/ritonavir (this anti-HIV from previous infections may occur soon after anti-HIV Tell your doctor immediately if you are pregnant, planning to not stop taking darunavir and ritonavir without talking to your doctor. Please discuss with your doctor which dose is right for you. 1. WHAT DARUNAVIR IS AND WHAT IT IS USED FOR medicine belongs to the same class as darunavir). reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse cannot be used, its use should only take place after medical medicines themselves. Your doctor will test for these changes. • Decreased or abnormal skin sensitivity, pins and needles, attention at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card Bundle pack of 2 HDPE bottles with 30 lm-coated tablets in treatment is started. It is believed that these symptoms are due become pregnant or if you are breast-feeding. Pregnant or Instructions for adults Instructions for children 3 years of age and above with in the Google Play or Apple App Store. By reporting side effects Darunavir contains the active substance darunavir. Darunavir is • Elbasvir/grazoprevir (to treat hepatitis C infection). transcriptase inhibitors), CCR5 antagonists and FIs (fusion evaluation and under close monitoring by your doctor for Like all medicines, this medicine can cause side effects, although disturbance, loss of memory, problems with your balance. each bottle. to an improvement in the body’s immune response, enabling inhibitors)]. Darunavir with ritonavir has not been tested with all corticosteroid side effects. breast-feeding mothers should not take darunavir with ritonavir Darunavir 400 mg lm-coated tablets: ritonavir, and 12 years of age and above with cobicistat, • Difculty breathing, cough, nosebleed, throat irritation. you can help provide more information on the safety of this medicine. an antiretroviral medicine used in the treatment of human • Alfuzosin (to treat enlarged prostate). not everybody gets them. Darunavir is also available as 75, 150, 400 and 600 mg • Sildenal (to treat high blood pressure in the pulmonary the body to ght infections that may have been present with no PIs (protease inhibitors) and must not be used with other HIV PIs. • Buprenorphine/naloxone (medicines to treat opiate unless specically directed by the doctor. Pregnant or • Take two 400 mg tablets at the same time, once a day, every day. weighing more than 40 kg • In ammation of the stomach or mouth, heartburn, retching, dry immunodeciency virus (HIV) infection. It belongs to a group of obvious symptoms. breast-feeding mothers should not take darunavir with cobicistat. Darunavir 800 mg lm-coated tablets: Tell your doctor if you develop any of the following side effects 5. HOW TO STORE DARUNAVIR lm-coated tablets. medicines called protease inhibitors. Darunavir works by circulation). In some cases dosage of other medicines might need to be dependence). • Take 800 mg darunavir (2 tablets of darunavir containing 400 mg mouth, discomfort of the abdomen, constipation, belching. • Dabigatran, ticagrelor (to help stop the clumping of platelets in • In addition to the opportunistic infections, autoimmune changed. Therefore always tell your doctor if you take other • Salmeterol (medicine to treat asthma). It is recommended that HIV infected women must not • Take one 800 mg tablet at the same time, once a day, every day. darunavir or 1 tablet of darunavir containing 800 mg darunavir) • A reaction called DRESS [severe rash, which may be • Kidney failure, kidney stones, difcult discharge of urine, Keep this medicine out of the sight and reach of children. Not all pack sizes may be marketed. reducing the amount of HIV in your body. This will improve your disorders (a condition that occurs when the immune system breast-feed their infants because of both the possibility of your • Always take darunavir together with 150 mg of cobicistat or accompanied by fever, fatigue, swelling of the face or lymph immune system and reduces the risk of developing illnesses the treatment of patients with a history of a heart attack). anti-HIV medicines and follow your doctor’s instruction carefully • Artemether/lumefantrine (a combination medicine to treat malaria). at the same time, once a day, every day. frequent or excessive passage of urine, sometimes at night. Do not use this medicine after the expiry date which is stated on • Naloxegol (to treat opioid induced constipation). attacks healthy body tissue) may also occur after you start on which medicines can be combined. • Dasatinib, everolimus, irinotecan, nilotinib, vinblastine, baby becoming infected with HIV through your breast milk and 100 mg of ritonavir. • Take darunavir always together with 100 mg of ritonavir or 150 mg glands, increase of eosinophils (type of white blood cells), • Urticaria, severe swelling of the skin and other tissues (most the carton and on the bottle after EXP. The expiry date refers to The Marketing Authorisation Holder is linked to HIV infection. taking medicines for the treatment of your HIV infection. • Take darunavir with food. effects on liver, kidney or lung]. • Dapoxetine (to treat premature ejaculation). The effects of darunavir might be reduced if you take any of vincristine (to treat cancer). because of the unknown effects of the medicine on your baby. of cobicistat. often the lips or the eyes), eczema, excessive sweating, night the last day of that month. Zentiva Pharma UK Limited, The darunavir 400mg/800mg tablet is used to treat adults and Autoimmune disorders may occur many months after the start • Sildenal, tadalal, vardenal (for erectile dysfunction or to treat • Swallow the tablets with a drink such as water or milk. • Severe skin reactions (Stevens Johnsons Syndrome and Toxic children 3 years of age and above, and at least 40 kg body • Domperidone (to treat nausea and vomiting). the following products. Tell your doctor if you take: Driving and using machines • Take darunavir with food. sweats, hair loss, acne, scaly skin, colouration of nails. This medicine does not require any special storage conditions. 12 New Fetter Lane, London, EC4A 1JP, UK of treatment. If you notice any symptoms of infection or other a heart and lung disorder called pulmonary arterial hypertension). Do not operate machines or drive if you feel dizzy after taking • Take your other HIV medicines used in combination with darunavir • Swallow the tablets with a drink such as water or milk. Epidermal Necrolysis), causing u like symptoms, (cough, runny • Muscle pain, muscle cramps or weakness, pain in extremities Do not throw away any medicines via wastewater or household weight, who are infected by HIV and Do not combine darunavir with products that contain St. John’s symptoms such as muscle weakness, weakness beginning in • Phenobarbital, phenytoin (to prevent seizures) and cobicistat or ritonavir as recommended by your doctor. The manufacturer is wort (Hypericum perforatum). • Glecaprevir/pibrentasvir (to treat hepatitis C infection) darunavir. • Take your other HIV medicines used in combination with darunavir nose, fever, decreased appetite and malaise) and skin rashes osteoporosis. waste. Ask your pharmacist how to throw away medicines you • who have not used antiretroviral medicines before. the hands and feet and moving up towards the trunk of the • Dexamethasone (corticosteroid) • Fentanyl, oxycodone, tramadol (to treat pain) • Oral suspension containing darunavir has been developed for which may develop into blisters and peeling skin; a widespread Zentiva, k. s., U kabelovny 130, Dolní M cholupy, • Efavirenz (HIV infection) Darunavir contains sodium. and ritonavir or cobicistat as recommended by your doctor. • Slowing down of the thyroid gland function. This can be seen in no longer use. These measures will help protect the environment. ě • in certain patients who have used antiretroviral medicines Warnings and precautions body, palpitations, tremor or hyperactivity, please inform your • Fesoterodine, solifenacin (to treat urologic disorders). use in children, but in some cases, can also be used in adults. rash with blisters and peeling skin, particularly around the mouth, a blood test. 102 37 Prague, Czech Republic before (your doctor will determine this). Talk to your doctor or pharmacist before taking darunavir. doctor immediately to seek necessary treatment. • Rifapentine, rifabutin (medicines to treat some infections such This medicine contains less than 1 mmol sodium (23 mg) per Dose for adults who have taken antiretroviral medicines Removing the child resistant cap nose and genitals (Stevens-Johnson syndrome) or a more severe 6. CONTENTS OF THE PACK AND OTHER INFORMATION as tuberculosis) The dosage of other medicines might need to be changed since The plastic bottle comes with a child resistant cap • High blood pressure, ushing. Darunavir must be taken in combination with a low dose of cobicistat Darunavir is not a cure for HIV infection. You can still pass on • Tell your doctor if you have haemophilia. Darunavir might tablet that is to say essentially “sodium free”. before (your doctor will determine this) form of rash causing skin peeling in more than 30% of the body • Red or dry eyes. Or 799045 • Saquinavir (HIV infection). either their own or therapeutic effect of darunavir or side effects and must be opened as follows: What darunavir contains: 1065023588 or ritonavir and other anti-HIV medicines. Your doctor will discuss HIV when taking this medicine, although the risk is lowered by increase the risk of bleeding. may be in uenced when combined. Tell your doctor if you take: Darunavir 400mg film-coated tablets contains sunset yellow The dose is either: surface. • Fever, swelling of lower limbs due to uids, malaise, irritability, S.C. Zentiva S.A. 170x580 • Push the plastic screw cap down while turning it • The active substance is darunavir. Each tablet contains 400mg 210 with you which combination of medicines is best for you. effective antiretroviral therapy. Discuss with your physician the • Tell your doctor if you are allergic to sulphonamides (e.g. The effects of other medicines might be influenced if you take FCF (E110) • 800 mg darunavir (2 tablets of darunavir containing 400 mg • Liver problems that may occasionally be severe have been pain. B-dul Theodor Pallady nr. 50, sector 3 • Alfentanil (injectable strong and short-acting painkiller that is counter clockwise. or 800 mg of darunavir. precautions needed to avoid infecting other people. used to treat certain infections). darunavir. Tell your doctor if you take: used for surgical procedures). It may cause allergic reactions darunavir or 1 tablet of darunavir containing 800 mg darunavir) reported. Your doctor should do blood tests before you start • Symptoms of infection, herpes simplex. Bucuresti, Cod – 032266 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DARUNAVIR • Remove the unscrewed cap. Darunavir 400 mg lm-coated tablets: People taking darunavir may still develop infections or other • Tell your doctor if you notice any musculoskeletal problems. • Amlodipine, diltiazem, disopyramide, carvedilol, felodipine, • Digoxin (to treat certain heart disorders). Darunavir 800 mg film-coated tablets contains ponceau 4R together with 150 mg cobicistat or 100 mg ritonavir once daily. darunavir. If you have chronic hepatitis B or C infection, your • Erectile dysfunction, enlargement of breasts. Romania Some patients taking combination antiretroviral therapy may ecainide, lidocaine, metoprolol, mexiletine, nifedipine, If you take more darunavir than you should Do not take darunavir: illnesses associated with HIV infection. You must keep in regular • Clarithromycin (antibiotic). red (E124) OR doctor should check your blood tests more often because you • Sleeping problems, sleepiness, depression, anxiety, abnormal The other ingredients are: dry granulation agent (mixture of • if you are allergic to darunavir or any of the other ingredients of contact with your doctor. develop a bone disease called osteonecrosis (death of bone nicardipine, propafenone, timolol, verapamil (for heart disease) • Itraconazole, isavuconazole, uconazole, posaconazole, It may cause allergic reactions. Contact your doctor, pharmacist or nurse immediately. have an increased chance of developing liver problems. Talk to dreams, decrease in sexual drive. microcrystalline cellulose and anhydrous calcium hydrogen This leaflet was last updated in June 2021