Darunavir Sinoptis

Leaflet attached to 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

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms 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 infections. 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 supports the immune system and reduces the risk of diseases associated with 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 with HIV infection who have already been treated with other antiretroviral medicines. Darunavir Synoptis should be taken in combination with a low dose of ritonavir and other HIV medicines. The most suitable 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 function disorders. In case of doubts about liver disorders and their nature, the patient should 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, the patient should consult a doctor about changing the treatment method.

During therapy with Darunavir Synoptis, products containing St. John's Wort (Hypericum perforatum) must not be used.

Warnings and precautions

Before starting treatment with Darunavir Synoptis, the patient should discuss it with their 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 associated with 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, the patient should contact their 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 the doctor about health status BEFORE and DURING treatment

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

• The patient should inform their doctor if they 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.
• The patient should inform their doctor if they have diabetes. Darunavir Synoptis may increase blood sugar levels.
• The patient should immediately inform their doctor if they 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 body's 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 the patient notices 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, they should contact their doctor as soon as possible to start necessary treatment.
• The patient should inform their doctor if they have hemophilia. Darunavir Synoptis may increase the risk of bleeding.
• The patient should inform their doctor about an allergy to sulfonamides (used, for example, to treat certain infections).
• The patient should inform their doctor about 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 the development of 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: pain and stiffness in the joints (especially hips, knees, or shoulders) and difficulty moving. The patient should inform their doctor if they experience any of these symptoms.

Elderly

Darunavir Synoptis has been used in only a small number of patients aged 65 or older. If the patient belongs to this age group, they should consult their 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 kg.

Darunavir Synoptis and other medicines

The patient should tell their doctor or pharmacist about all medicines they 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 combined with HIV medicines from another group [e.g., NRTI (nucleoside reverse transcriptase inhibitors), NNRTI (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists, and fusion inhibitors]. No studies have been conducted on the simultaneous use of Darunavir Synoptis and ritonavir with all protease inhibitors (PI), 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, the patient should inform their 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. The patient should inform their 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. The patient should inform their 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(immunosuppressive medicines), 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, joint, or 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 infection);

fentanyl, oxycodone, tramadol(painkillers);

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

This is not a complete list of medicines. The patient should inform their doctor about allmedicines they are taking.

Darunavir Synoptis with food and drink

See section 3 "How to take Darunavir Synoptis".

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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

The patient should not drive or operate machines if taking Darunavir Synoptis causes dizziness.

Darunavir Synoptis contains lactose

This medicine contains lactose. If the patient has been diagnosed with intolerance to some sugars, they should consult their 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, the patient should discuss this with their 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, the patient should discuss this with their 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, the patient should discuss this with their 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, the patient should discuss this with their 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

This medicine should always be taken as described in the patient information leaflet or as directed by the doctor, pharmacist, or nurse. In case of doubts, the patient should consult their doctor, pharmacist, or nurse. Even if the patient's condition improves, they should not stop taking Darunavir Synoptis without consulting their doctor. After starting treatment, the patient should 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 previously taken antiretroviral medicines (the doctor will determine this)

The doctor will determine the appropriate dose to be given once a day based on the child's body weight (see the table below). This dose should not exceed the recommended dose for adult patients, which is 800 mg of Darunavir Synoptis and 100 mg of ritonavir once a day. The doctor will inform the patient about 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 to achieve the desired dosing regimen. Darunavir is also available as an oral suspension. The doctor will determine whether darunavir tablets or oral suspension are suitable for the child.

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

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 adult patients, 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 the patient about 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 to achieve the desired dosing regimen. Darunavir is also available as an oral suspension. The doctor will determine whether darunavir tablets or oral suspension are suitable for the child. Dosing twice a day Dosing once a day Instructions for using 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 type of food is not important.
• The child must take Darunavir Synoptis with food. Darunavir Synoptis does not work properly when taken without food.
• The child should swallow the tablets with water or milk.

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

The dose is: 600 mg of darunavir and 100 mg of ritonavir twice a day. OR 800 mg of Darunavir Synoptis (2 tablets of 400 mg or 1 tablet of 800 mg) and 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.

• The patient should take Darunavir Synoptis in combination with ritonavir. Darunavir Synoptis does not work properly without ritonavir.
• The patient should take 600 mg of darunavir in the morning and 100 mg of ritonavir.
• The patient should take 600 mg of darunavir in the evening and 100 mg of ritonavir.
• The patient should take Darunavir Synoptis with food. Darunavir Synoptis does not work properly when taken without food. The type of food is not important.
• The patient should 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

The patient should immediately contact their doctor, pharmacist, or nurse.

Missing a dose of Darunavir Synoptis

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

Do not stop taking Darunavir Synoptis without consulting a doctor

Antiretroviral medicines can make the patient feel better, but even if their condition improves, they should not stop taking Darunavir Synoptis without consulting their doctor. If the patient has any further doubts about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

During HIV treatment, weight gain and increased lipid and glucose levels in the blood may occur. This is partly related to improved health and lifestyle, and in the case of lipid levels in the blood, 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 the patient experiences any of the following side effects, they should inform their doctor.

Liver problems have been reported, which can be severe in rare cases. The doctor will order blood tests before starting Darunavir Synoptis. If the patient has chronic hepatitis B or C, the doctor should order blood tests more frequently, as there is an increased risk of liver problems. The patient should discuss with their doctor the symptoms of liver function 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 (occurring more frequently during simultaneous use of raltegravir), itching. The rash is usually mild to moderate. However, skin rash can also be a symptom of a rare but severe condition. Therefore, if this symptom occurs, the patient should discuss it with their doctor. The doctor will recommend appropriate treatment for the symptoms or decide to stop taking Darunavir Synoptis. Other serious side effects were: 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, insomnia.

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

• chest pain, changes in the 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, vomiting, 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 mouth or eyes), rash, excessive sweating, night sweats, hair loss, acne, scaly skin, nail discoloration;
• muscle pain, muscle spasms or weakness, limb pain, osteoporosis;
• slowed thyroid function, which can be detected 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, 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 lost or disoriented, mood changes, restlessness;
• fainting, seizures, changes or loss of taste;
• mouth pain, bloody vomiting, mouth inflammation, dry mouth, unpleasant oral sensations;
• runny nose;
• diseased skin, dry skin;
• muscle stiffness or joint pain, 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 about this. For example, a disorder may be an increased number of a certain type of white blood cell.

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

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

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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, more information can be collected on the safety of the medicine.

5. How to store Darunavir Synoptis

The medicine should be stored out of 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. The patient should ask their 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 containing: 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 containing: 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 containing: 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 containing: 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 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. Carton containing a bottle with HDPE and a PP cap, with a child-resistant closure and a tamper-evident 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