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 to a specific 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 HIV 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 dysfunction. In case of doubts about liver disease and its nature, consult a doctor. It may be necessary to perform some additional tests.

Do not take Darunavir Synoptis with the following medicines

If the patient is taking any of the following medicines, they should consult their doctor about changing their 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 HIV to others during treatment with 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 HIV infection, 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 alone.

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 system, 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, you should contact your doctor as soon as possible to start the 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 combined antiretroviral therapy, a bone disease called osteonecrosis (bone death due to insufficient blood supply to the bone tissue) may develop. Risk factors for developing this disease include: long-term use of combined antiretroviral therapy, use of corticosteroids, alcohol consumption, severe immunosuppression, increased body mass index, and others. Symptoms of osteonecrosis include: joint pain and stiffness (especially in the 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 are in this age group, you should consult your doctor to discuss the possibility of taking this medicine.

Children

Darunavir Synoptis should not be used in children under 3 years of age or weighing less than 15 kilograms.

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., NRTI (nucleoside reverse transcriptase inhibitors), NNRTI (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists, and fusion inhibitors]. However, studies have not been conducted on the simultaneous use of Darunavir Synoptis and ritonavir with all protease inhibitors (PI), and it should not 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 if you are 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 if you are taking:

• amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, lidocaine, metoprolol, mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil(heart medicines), as they may increase the therapeutic effect and side effects of these medicines;
• apixaban, edoxaban, rivaroxaban, warfarin(anticoagulant), as it may increase the 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(immunosuppressive medicines), as they may increase the 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, they can be used only after the doctor's assessment and under the doctor's close supervision for 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, simprevir(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. Women who are pregnant or breastfeeding should not take Darunavir Synoptis with ritonavir without special recommendation from their doctor. Women who are pregnant or breastfeeding 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 an 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. Do not stop taking Darunavir Synoptis with ritonavir without consulting your doctor. After starting treatment, do not change the dose, form of the medicine, or stop treatment without the doctor's recommendation.

Dosing in children over 3 years of age, weighing at least 15 kg, who have not taken antiretroviral medicines before (the doctor will determine this)

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 specific combination of tablets to achieve the desired dosing regimen. Darunavir is also available as an oral suspension. The doctor will determine whether the child should take darunavir tablets or oral suspension.

Dosing in children over 3 years of age, weighing at least 15 kg, who have taken antiretroviral medicines before (the doctor will determine this)

The doctor will determine the appropriate dose based on 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 specific combination of tablets to achieve the desired dosing regimen. Darunavir is also available as an oral suspension. The doctor will determine 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.

Dosing in adults who have not taken antiretroviral medicines before (the doctor will determine this)

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

Dosing in adults who have taken antiretroviral medicines before (the doctor will determine this)

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.

Take Darunavir Synoptis always 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 unscrewed 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 can be severe in rare cases. 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 dysfunction, which 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, the skin rash can also be a symptom of a rare but severe condition. If you notice this symptom, discuss it with your doctor. Other serious side effects 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 or bloating, indigestion, bloating;
• 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, gagging, dry mouth, unpleasant abdominal sensations, constipation, belching;
• kidney failure, kidney stones, difficulty urinating, frequent or excessive urination, sometimes at night;
• hives, severe skin and tissue swelling (most often around the lips or eyes), rash, excessive sweating, night sweats, hair loss, acne, scaly skin, nail discoloration;
• muscle pain, muscle cramps, or muscle weakness, limb pain, osteoporosis;
• slowed thyroid function, which can be determined by blood tests;
• high blood pressure, sudden flushing of the face;
• 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, face or lymph node swelling, 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 oral sensations, oral thrush;
• runny nose;
• diseases of the skin, dry skin;
• muscle 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 information on this. 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 can be 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 Adverse Reaction 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 this 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 no longer required. 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
• crospovidone
• 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
• crospovidone
• 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
• crospovidone
• 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
• crospovidone
• 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 inscription "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 inscription "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 inscription "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 inscription "600" on one side, measuring: length 20.2 ± 0.2 mm, width 10.2 ± 0.2 mm, and thickness 6.8 ± 0.4 mm. A cardboard box containing a HDPE bottle with a PP cap, child-resistant and sealed. 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