Darunavir Sinoptis

Leaflet accompanying the packaging: information for the user

Darunavir Synoptis, 75 mg, film-coated tablets

Darunavir Synoptis, 150 mg, film-coated tablets

Darunavir Synoptis, 300 mg, film-coated tablets

Darunavir Synoptis, 600 mg, film-coated tablets

Darunavir

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for this person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Darunavir Synoptis and what is it used for
• 2. Important information before taking Darunavir Synoptis
• 3. How to take Darunavir Synoptis
• 4. Possible side effects
• 5. How to store Darunavir Synoptis
• 6. Package contents and other information

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

What is Darunavir Synoptis?

Darunavir Synoptis contains the active substance darunavir. Darunavir Synoptis is an antiretroviral medicine used to treat HIV infection. The medicine belongs to a group of protease inhibitors. The action of Darunavir Synoptis is to reduce the amount of HIV virus in the body. This helps the immune system and reduces the risk of developing diseases related to HIV infection.

What is it used for?

Darunavir Synoptis is used to treat adults and children over 3 years of age and weighing at least 15 kg who are infected with the HIV virus and have already been treated with other antiretroviral medicines. Darunavir Synoptis should be taken in combination with a small dose of ritonavir and other HIV medicines. The best combination of medicines for the patient is determined by the doctor.

2. Important information before taking Darunavir Synoptis

When not to take Darunavir Synoptis

• if the patient is allergic to darunavir or any of the other ingredients of this medicine (listed in section 6) or ritonavir,
• if the patient has severe liver problems. In case of doubts about liver problems and their nature, consult a doctor. It may be necessary to perform certain additional tests.

Do not take Darunavir Synoptis with the following medicines

In case of taking any of the medicines listed below, consult a doctor about changing the treatment.

During therapy with Darunavir Synoptis, do not take products containing St. John's Wort (Hypericum perforatum).

Warnings and precautions

Before starting treatment with Darunavir Synoptis, discuss it with your doctor, pharmacist, or nurse. Darunavir Synoptis will not cure HIV infection. The patient can still transmit the HIV virus while taking this medicine, despite effective antiretroviral therapy reducing this risk. The patient should discuss with their doctor the precautions necessary to avoid infecting others. People taking Darunavir Synoptis are still at risk of developing infections or other diseases related to the presence of the HIV virus, so they should maintain regular contact with their doctor. In patients taking Darunavir Synoptis, a skin rash may occur. Rarely, it can be severe or life-threatening. If a rash occurs, consult a doctor. Rash (usually mild or moderate) may occur more frequently in patients taking Darunavir Synoptis and raltegravir than in patients taking either medicine separately.

When to inform your doctor about your health status BEFORE and DURING treatment

After reading the following points, the patient should inform their doctor if any of them apply to them.

• Tell your doctor if you have had liver disease in the past, including hepatitis B or C infection. The doctor will assess how severe the disease was before deciding whether it is possible to take Darunavir Synoptis.
• Tell your doctor if you have diabetes. Darunavir Synoptis may increase blood sugar levels.
• Immediately inform your doctor if you notice signs of infection (e.g. swollen lymph nodes, fever). In some patients with advanced HIV infection and a history of opportunistic infections, subjective and objective symptoms of inflammation related to previous infections may appear immediately after starting antiretroviral therapy. It is believed that the appearance of such symptoms is related to the strengthening of the immune response, which allows the body to fight existing asymptomatic infections. In addition to opportunistic infections, autoimmune diseases (diseases that occur when the immune system attacks healthy tissues) may also occur after starting antiretroviral therapy. Autoimmune diseases can occur many months after starting treatment. If you notice signs of infection or other symptoms such as muscle weakness, weakness starting from the hands and feet and progressing towards the torso, heart palpitations, tremors, or hyperactivity, consult your doctor as soon as possible to start necessary treatment.
• Tell your doctor if you have hemophilia. Darunavir Synoptis may increase the risk of bleeding.
• Tell your doctor if you are allergic to sulfonamides (used, for example, to treat certain infections).
• Tell your doctor if you have musculoskeletal disorders. In some patients taking combination antiretroviral therapy, a bone disease called osteonecrosis (bone death due to insufficient blood supply) may develop. Risk factors for developing this disease include: long-term use of combination antiretroviral therapy, taking corticosteroids, drinking alcohol, severe immunosuppression, increased body mass index, and others. Symptoms of osteonecrosis include: pain and stiffness in the joints (especially hips, knees, or shoulders) and difficulty moving. Inform your doctor if you experience any of these symptoms.

Elderly

Darunavir Synoptis has been used in only a small number of patients aged 65 or older. If you belong to this age group, you should consult your doctor to discuss the possibility of taking this medicine.

Children

Do not give Darunavir Synoptis to children under 3 years of age or weighing less than 15 kg.

Darunavir Synoptis and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken. Some medicines must not be taken with Darunavir Synoptis. Their list is provided in the section "Do not take Darunavir Synoptis with the following medicines". In most cases, Darunavir Synoptis can be taken with HIV medicines from another group [e.g. NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists, and fusion inhibitors]. However, no studies have been conducted on the simultaneous use of Darunavir Synoptis and ritonavir with all PIs (protease inhibitors), and it cannot be used in combination with other protease inhibitors. In some cases, it may be necessary to change the dosage of other medicines. Therefore, in each case, inform your doctor about the use of other HIV medicines and strictly follow the doctor's recommendations regarding the simultaneous use of other medicines. The effectiveness of Darunavir Synoptis may be reduced when taken with one of the following products. Inform your doctor about taking:

• phenobarbital, phenytoin(antiepileptic drugs);
• dexamethasone(corticosteroid);
• efavirenz(HIV-1 infection);
• boceprevir(hepatitis C virus infection);
• rifapentine, rifabutin(antituberculosis drugs);
• saquinavir(HIV-1 infection).

Taking Darunavir Synoptis may affect the effectiveness of other medicines. Inform your doctor about taking:

• amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, lidocaine, metoprolol, mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil(heart medicines), due to the possibility of increased therapeutic effect and side effects of these medicines;
• apixaban, edoxaban, rivaroxaban, warfarin(anticoagulant), due to the possibility of increased therapeutic effect and side effects of these medicines; blood tests may be necessary;
• hormonal contraceptives and hormone replacement therapy containing estrogens; Darunavir Synoptis may reduce their effectiveness; to avoid pregnancy, it is recommended to use other, non-hormonal methods of birth control;
• ethinyl estradiol with drospirenone. Darunavir Synoptis may increase the risk of hyperkalemia associated with drospirenone;
• atorvastatin, pravastatin, rosuvastatin(cholesterol-lowering medicines); there is an increased risk of muscle damage. The doctor will assess which cholesterol-lowering medicine is suitable for the patient in this situation;
• clarithromycin(antibiotic);
• cyclosporine, everolimus, tacrolimus, sirolimus(immunosuppressants), due to the possibility of increased therapeutic effect and side effects of these medicines - the doctor may recommend additional tests;
• corticosteroids, including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone. These medicines are used to treat allergies, asthma, inflammatory bowel disease, eye inflammation, joint and muscle inflammation, and other inflammatory conditions. If there are no alternative medicines, their use is possible only after the doctor's assessment and under the doctor's close supervision of corticosteroid side effects;
• buprenorphine/naloxone(medicines used to treat opioid dependence);
• salmeterol(medicine used to treat asthma);
• artemether/lumefantrine(combined medicine used to treat malaria);
• dasatinib, everolimus, irinotecan, nilotinib, vinblastine, vincristine(medicines used to treat cancer);
• sildenafil, tadalafil, vardenafil(medicines used to treat erectile dysfunction or pulmonary arterial hypertension);
• glecaprevir/pibrentasvir, simeprevir(used to treat hepatitis C virus infection);

fentanyl, oxycodone, tramadol (painkillers);

• fezoterodine, solifenacin (used to treat urological disorders).

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

Darunavir Synoptis with food and drink

See section 3 "How to take Darunavir Synoptis".

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. Pregnant or breastfeeding women should not take Darunavir Synoptis with ritonavir without special recommendation from their doctor. Pregnant or breastfeeding women should not take Darunavir Synoptis with cobicistat. HIV-infected women should not breastfeed, as the virus can be transmitted to the child through breast milk, and the effects of the medicine on the child are unknown.

Driving and using machines

Do not drive or operate machines if taking Darunavir Synoptis causes dizziness.

Darunavir Synoptis contains lactose

This medicine contains lactose. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

Darunavir Synoptis, 75 mg, film-coated tablets contain propylene glycol (E1520).

This medicine contains 10.42 mg of propylene glycol (E1520) in each film-coated tablet. If the treated child is less than 4 weeks old, consult the doctor or pharmacist before giving this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.

Darunavir Synoptis, 150 mg, film-coated tablets contain propylene glycol (E1520).

This medicine contains 20.84 mg of propylene glycol (E1520) in each film-coated tablet. If the treated child is less than 4 weeks old, consult the doctor or pharmacist before giving this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.

Darunavir Synoptis, 300 mg, film-coated tablets contain propylene glycol (E1520).

This medicine contains 41.66 mg of propylene glycol (E1520) in each film-coated tablet. If the treated child is less than 4 weeks old, consult the doctor or pharmacist before giving this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol. Darunavir Synoptis, 300 mg, film-coated tablets also contain orange yellow S (E 110), which may cause allergic reactions.

Darunavir Synoptis, 600 mg, film-coated tablets contain propylene glycol (E1520).

This medicine contains 83.33 mg of propylene glycol (E1520) in each film-coated tablet. If the child is less than 4 weeks old, consult the doctor or pharmacist before giving this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol. Darunavir Synoptis, 600 mg, film-coated tablets also contain orange yellow S (E 110), which may cause allergic reactions.

3. How to take Darunavir Synoptis

Take this medicine always as described in the patient information leaflet or as directed by your doctor, pharmacist, or nurse. In case of doubts, consult your doctor, pharmacist, or nurse. Even if there is a noticeable improvement, do not stop taking Darunavir Synoptis with ritonavir without consulting your doctor.

Dosage for children over 3 years of age, weighing at least 15 kg, who have not previously taken antiretroviral medicines (determined by the doctor)

The doctor will determine the appropriate dose based on the child's body weight (see the table below). The dose should not exceed the recommended dose for adults, which is 800 mg of Darunavir Synoptis and 100 mg of ritonavir once a day. The doctor will inform you how much darunavir and ritonavir (in capsules, tablets, or solution) the child should take. Tablets of different strengths are available, and the doctor may prescribe a combination of tablets to achieve the desired dosage. Darunavir is also available as an oral suspension. The doctor will assess whether the child should take darunavir tablets or oral suspension.

Dosage for children over 3 years of age, weighing at least 15 kg, who have previously taken antiretroviral medicines (determined by the doctor)

The doctor will determine the appropriate dose based on the child's body weight (see the table below). The doctor will assess whether the child should take the medicine once or twice a day. The dose should not exceed the recommended dose for adults, which is 600 mg of darunavir and 100 mg of ritonavir twice a day, or 800 mg of Darunavir Synoptis and 100 mg of ritonavir once a day. The doctor will inform you how much darunavir and ritonavir (in capsules, tablets, or solution) the child should take. Tablets of different strengths are available, and the doctor may prescribe a combination of tablets to achieve the desired dosage. Darunavir is also available as an oral suspension. The doctor will assess whether the child should take darunavir tablets or oral suspension. Twice-daily dosing Once-daily dosing Instructions for taking Darunavir Synoptis in children:

• The child must take Darunavir Synoptis in combination with ritonavir. Darunavir Synoptis does not work properly without ritonavir.
• The child must take the appropriate dose of Darunavir Synoptis and ritonavir twice a day or once a day. If Darunavir Synoptis is taken twice a day, the child should take one dose in the morning and the second dose in the evening. Each dose should be taken with ritonavir and food. The doctor will determine the appropriate dosing schedule for the child.
• The child must take Darunavir Synoptis with food. Darunavir Synoptis does not work properly when taken without food. The type of food is not important.
• The child should swallow the tablets with water or milk.

Dosage for adults who have not previously taken antiretroviral medicines (determined by the doctor)

The patient requires a different dose of Darunavir Synoptis, which cannot be administered using these tablets. Other strengths of Darunavir Synoptis are available.

Dosage for adults who have previously taken antiretroviral medicines (determined by the doctor)

The dose is:

• 600 mg of darunavir with 100 mg of ritonavir twice a day. OR
• 800 mg of Darunavir Synoptis (2 tablets of 400 mg or 1 tablet of 800 mg) with 100 mg of ritonavir once a day. To use the 800 mg scheme, only 400 mg or 800 mg Darunavir Synoptis tablets should be used.

mg once a day. To use the 800 mg scheme, only 400 mg or 800 mg Darunavir Synoptis tablets should be used. Consult your doctor to determine which dose is suitable for you. Recommendations for adults

• Take Darunavir Synoptis always in combination with ritonavir. Darunavir Synoptis does not work properly without ritonavir.
• Take 600 mg of darunavir in the morning with 100 mg of ritonavir.
• Take 600 mg of darunavir in the evening with 100 mg of ritonavir.
• Take Darunavir Synoptis with food. Darunavir Synoptis does not work properly when taken without food. The type of food is not important.
• Swallow the tablets with water or milk.
• Darunavir tablets of different strengths are intended for use in children, but in some cases, they may also be used in adults. An oral suspension is also available.

Opening the child-resistant cap

The plastic bottle is equipped with a child-resistant cap. To open it, follow these steps:

• press the plastic cap and turn it counterclockwise;
• remove the opened cap.

Taking a higher dose of Darunavir Synoptis than recommended

Immediately consult a doctor, pharmacist, or nurse.

Missing a dose of Darunavir Synoptis

If a dose is missed within 6 hours, take the missed tablets as soon as possible. Each dose should be taken with ritonavir and food. If a dose is missed after 6 hours, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Do not stop taking Darunavir Synoptis without consulting your doctor

Antiretroviral medicines can make you feel better, but even if you feel better, do not stop taking Darunavir Synoptis with ritonavir without consulting your doctor. If you have any further doubts about taking this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

During HIV treatment, weight gain and increased blood lipid and glucose levels may occur. This is partly related to improved health and lifestyle, and in the case of blood lipid levels, sometimes to the use of antiretroviral medicines themselves. The doctor will order tests to check these changes. Like all medicines, Darunavir Synoptis can cause side effects, although not everybody gets them.

If you experience any of the following side effects, tell your doctor.

Liver problems have been reported, which have rarely been severe. The doctor will order blood tests before starting Darunavir Synoptis. If you have chronic hepatitis B or C, the doctor should order blood tests more frequently, as there is an increased risk of liver problems. Discuss with your doctor the symptoms of liver disorders. These may include: yellowing of the skin or eyes, dark urine (tea-colored), pale stools, nausea, vomiting, loss of appetite, or pain or discomfort in the area below the ribs on the right side. Skin rash (more common when taken with raltegravir), itching. The rash is usually mild to moderate. However, it can also be a sign of a rare but severe condition. If you notice this symptom, discuss it with your doctor. Other serious side effects have included: diabetes (often) and pancreatitis (not very often). Very common side effects(may affect more than 1 in 10 people)

• diarrhea.

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

• vomiting, nausea, abdominal pain, bloating, indigestion, gas;
• headache, fatigue, dizziness, drowsiness, numbness, tingling, or pain in the hands or feet, weakness, difficulty sleeping.

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

• chest pain, changes in ECG, rapid heart rate;
• disorders or numbness of skin sensation, tingling, concentration disorders, memory loss, balance disorders;
• breathing difficulties, cough, nosebleeds, throat irritation;
• stomach or mouth inflammation, heartburn, belching, bad taste, dry mouth, abdominal discomfort, constipation, bloating;
• kidney failure, kidney stones, difficulty urinating, frequent or excessive urination, sometimes at night;
• hives, severe skin and tissue swelling (usually around the eyes or lips), rash, excessive sweating, night sweats, hair loss, acne, dry skin;
• muscle pain, muscle cramps, or muscle weakness, joint pain with or without inflammation;
• slowed thyroid function, which can be detected by blood tests;
• high blood pressure, sudden flushing of the skin;
• redness or dryness of the eyes;
• fever, swelling of the lower limbs due to fluid retention, feeling unwell, pain;
• infection symptoms, herpes;
• erectile dysfunction, breast enlargement in men;
• sleep disorders, drowsiness, depression, anxiety, strange dreams, decreased libido.

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

• DRESS syndrome [severe rash, which may be accompanied by fever, fatigue, swelling of the face or lymph nodes, increased eosinophil count (a type of white blood cell), liver, kidney, or lung symptoms];
• heart attack, slow heart rate, palpitations;
• vision disorders;
• chills, malaise;
• feeling disoriented or lost, mood changes, restlessness;
• fainting, seizures, changes or loss of taste;
• mouth pain, bloody vomiting, mouth inflammation, dry mouth, unpleasant sensations in the abdominal cavity, constipation, bloating;
• cough;
• diseased skin, dry skin;
• muscle stiffness or joint stiffness, joint pain with or without inflammation;
• blood cell count and biochemical test result disorders. Changes can be observed in blood or urine test results. The doctor will provide more detailed explanations. For example, an increase in the number of a certain type of white blood cell.

Side effects typical of HIV medicines in the same group as Darunavir Synoptis include:

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

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Darunavir Synoptis

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton after "Expiry date" and on the bottle after "EXP". The expiry date refers to the last day of the month stated. There are no special precautions for storing Darunavir Synoptis. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What does Darunavir Synoptis contain?

• The active substance of the medicine is darunavir. Each film-coated tablet of Darunavir Synoptis, 75 mg, contains 75 mg of darunavir (in the form of darunavir with propylene glycol).

Each film-coated tablet of Darunavir Synoptis, 150 mg, contains 150 mg of darunavir (in the form of darunavir with propylene glycol). Each film-coated tablet of Darunavir Synoptis, 300 mg, contains 300 mg of darunavir (in the form of darunavir with propylene glycol). Each film-coated tablet of Darunavir Synoptis, 600 mg, contains 600 mg of darunavir (in the form of darunavir with propylene glycol).

• Other ingredients are: Darunavir Synoptis, 75 mg, film-coated tablets
• microcelac 100 consisting of: lactose monohydrate, microcrystalline cellulose
• povidone K30
• crosprovidone
• silica colloidal anhydrous
• magnesium stearate Coating (White): polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc

Darunavir Synoptis, 150 mg, film-coated tablets

• microcelac 100 consisting of: lactose monohydrate, microcrystalline cellulose
• povidone K30
• crosprovidone
• silica colloidal anhydrous
• magnesium stearate Coating (White): polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc

Darunavir Synoptis, 300 mg, film-coated tablets

• microcelac 100 consisting of: lactose monohydrate, microcrystalline cellulose
• povidone K30
• crosprovidone
• silica colloidal anhydrous
• magnesium stearate Coating (Orange-1): polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, orange yellow S (E 110)

Darunavir Synoptis, 600 mg, film-coated tablets

• microcelac 100 consisting of: lactose monohydrate, microcrystalline cellulose
• povidone K30
• crosprovidone
• silica colloidal anhydrous
• magnesium stearate Coating (Orange-1): polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, orange yellow S (E 110)

What does Darunavir Synoptis look like and what does the pack contain?

Darunavir Synoptis, 75 mg, film-coated tablets White, capsule-shaped tablets with the imprint "75" on one side, measuring: length 9.4 ± 0.2 mm, width 4.5 ± 0.2 mm, and thickness 3.4 ± 0.3 mm. Darunavir Synoptis, 150 mg, film-coated tablets White, oval tablets with the imprint "150" on one side, measuring: length 13.8 ± 0.2 mm, width 7.0 ± 0.2 mm, and thickness 3.6 ± 0.3 mm. Darunavir Synoptis, 300 mg, film-coated tablets Orange, oval tablets with the imprint "300" on one side, measuring: length 16.1 ± 0.2 mm, width 8.1 ± 0.2 mm, and thickness 5.2 ± 0.3 mm. Darunavir Synoptis, 600 mg, film-coated tablets Orange, oval tablets with the imprint "600" on one side, measuring: length 20.2 ± 0.2 mm, width 10.2 ± 0.2 mm, and thickness 6.8 ± 0.4 mm. Carton containing a bottle with HDPE and a PP cap, with a child-resistant closure and a seal. Package sizes: Darunavir Synoptis, 75 mg, film-coated tablets One bottle containing 480 tablets Darunavir Synoptis, 150 mg, film-coated tablets One bottle containing 240 tablets Darunavir Synoptis, 300 mg, film-coated tablets One bottle containing 120 tablets Darunavir Synoptis, 600 mg, film-coated tablets One bottle containing 60 tablets

Marketing authorization holder and manufacturer:

Marketing authorization holder

Synoptis Pharma Sp. z o.o. ul. Krakowiaków 65 02-255 Warsaw

Manufacturer:

Pharmathen S.A. Dervenakion 6 15351 Pallini Attiki Greece Pharmathen International S.A. Industrial Park Sapes Rodopi Prefecture, Block No 5 69300 Rodopi Greece Pharmadox Healthcare Ltd. KW20A Kordin Industrial Park Paola, PLA 3000 Malta Hormosan Pharma GmbH Hanauer Landstraße 139-143 60314 Frankfurt am Main Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Denmark DAVARINO Germany Darunavir Hormosan 75 mg/150 mg/300 mg/400 mg/600 mg/800 mg film-coated tablets Spain Darunavir Kern Pharma 75/150/300/600 mg film-coated tablets United Kingdom Darunavir 600mg/800mg film-coated tablets Poland Darunavir Synoptis Greece DAVARINO Cyprus DAVARINO Romania Darunavir Flomi 400 mg/600 mg/800 mg film-coated tablets Austria Darunavir Accord 75mg/150mg/400mg/600mg/800mg film-coated tablets Czech Republic Darunavir Accord Slovenia Darunavir Accord 75mg/150mg/300mg/400mg/600mg/800mg film-coated tablets Netherlands Darunavir Accord 75mg/150mg/300mg/400mg/600mg/800mg film-coated tablets Norway Darunavir Accord 600mg/800mg film-coated tablets Italy Darunavir Accord 600mg/800mg film-coated tablets Ireland Malta Darunavir Accord 600mg/800mg film-coated tablets Darunavir Accord 600mg film-coated tablets Bulgaria Darunavir Accord 800mg film-coated tablets Croatia Darunavir Accord 800mg film-coated tablets Finland Darunavir Accord 400mg/600mg/800mg film-coated tablets Sweden Darunavir Accord 400mg/600mg/800mg film-coated tablets Portugal Darunavir Accord 400mg/600mg/800mg film-coated tablets France Darunavir Accord 75mg/150mg/300mg/400mg/600mg/800mg film-coated tablets

Date of last revision of the leaflet: 04/2020