Darunavir synoptis

Package leaflet: Information for the user

Darunavir Synoptis, 400 mg, coated tablets
Darunavir Synoptis, 800 mg, coated tablets
Darunavir
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

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

Contents of the leaflet

1. What Darunavir Synoptis is and what it is used for
2. What you need to know before taking Darunavir Synoptis
3. How to take Darunavir Synoptis
4. Possible side effects
5. How to store Darunavir Synoptis
6. Contents of the pack and other information

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

What Darunavir Synoptis is
Darunavir Synoptis contains the active substance darunavir. Darunavir Synoptis is an antiretroviral medicine used in the treatment of human immunodeficiency virus (HIV) infection.
It belongs to a group of medicines called protease inhibitors. Darunavir Synoptis works by reducing the amount of HIV in the body. This helps the immune system and reduces the risk of developing HIV-related illnesses.

What it is used for
Darunavir Synoptis 400 mg and 800 mg tablets are used to treat adults and children (aged at least 3 years and weighing at least 40 kg) infected with HIV, who:

• have not previously been treated with any other antiretroviral medicines, or
• in some patients who have previously been treated with antiretroviral medicines (this will be determined by your doctor).

Darunavir Synoptis must be taken in combination with a low dose of cobicistat or ritonavir and other antiretroviral medicines for HIV. Your treating doctor will decide the most appropriate combination of medicines for you.

2. Important information before using Darunavir Synoptis

When not to use Darunavir Synoptis

• if the patient is allergic to darunavir, or to any of the other ingredients of this medicine (listed in section 6), or to cobicistat or ritonavir,
• if the patient has severe liver function disorders. In case of any doubts regarding liver disorders and their nature, a doctor should be consulted. Additional tests may be necessary.

Do not use Darunavir Synoptis with the following medicines
If the patient is taking any of the medicines listed below, please consult a doctor about changing the treatment regimen.

It is forbidden to use products containing St John's wort (Hypericum perforatum) during treatment with Darunavir Synoptis.
Warnings and precautions
Before starting treatment with Darunavir Synoptis, patients should discuss this with their doctor, pharmacist, or nurse.
Darunavir Synoptis will not cure HIV infection. Patients may still transmit HIV while taking this medicine, although effective antiretroviral therapy reduces this risk. Patients should discuss with their doctor the necessary precautions to avoid infecting others.
Patients taking Darunavir Synoptis remain at risk of developing infections or other HIV-related illnesses; therefore, regular contact with a doctor is essential.
Skin rash may occur in patients taking Darunavir Synoptis. Rarely, this rash may become severe or potentially life-threatening. If a rash develops, patients should contact their doctor immediately.
Rash (usually mild or moderate) may occur more frequently in patients taking Darunavir Synoptis and raltegravir (for HIV infection treatment) together than in patients taking either drug alone.
When to inform the doctor about health status BEFORE and DURING treatment
After reviewing the points below, patients should inform their doctor if any of them apply.

• Inform the doctor if the patient has previously had liver disease, including hepatitis B or C virus infection. The doctor will assess the severity of the condition before deciding whether Darunavir Synoptis can be taken.
• Inform the doctor if the patient has diabetes. Darunavir Synoptis may increase blood glucose levels.
• Inform the doctor immediately if the patient notices signs of infection (e.g., swollen lymph nodes, fever). In some patients with advanced HIV infection and a history of opportunistic infections, symptoms and signs of inflammation related to previous infections may appear soon after starting antiretroviral therapy. These symptoms are believed to be due to an enhanced immune response, enabling the body to fight previously asymptomatic infections.
• Besides opportunistic infections, autoimmune disorders (diseases occurring when the immune system attacks healthy body tissues) may also occur after starting antiretroviral therapy for HIV infection. Autoimmune disorders may appear many months after starting treatment. If symptoms of infection or other symptoms such as muscle weakness, weakness starting in hands and feet and progressing toward the trunk, palpitations, tremor, or hyperexcitability occur, patients should contact their doctor immediately to initiate necessary treatment.
• Inform the doctor if the patient has haemophilia. Darunavir Synoptis may increase the risk of bleeding.
• Inform the doctor about sulphonamide allergy (used, for example, in treating certain infections).
• Inform the doctor about musculoskeletal disorders. Some patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (bone tissue death caused by impaired blood supply). Risk factors for developing this disease include: long duration of combination antiretroviral therapy, corticosteroid use, alcohol consumption, profound immunosuppression, increased body mass index, and others. Symptoms of osteonecrosis include: joint pain and stiffness (especially in hips, knees, or shoulders) and difficulty moving. Patients should inform their doctor if any of these symptoms occur.

Elderly patients
Darunavir Synoptis has been used only in a small number of patients aged 65 years or older. Patients in this age group should consult their doctor to discuss the possibility of taking the medicine.
Children and adolescents
Darunavir Synoptis 400 mg, 800 mg tablets are not intended for children under 3 years of age or weighing less than 40 kg.
Darunavir Synoptis with other medicines
Patients should inform their doctor or pharmacist about all medicines currently taken or recently taken.
Some medicines must not be combined with Darunavir Synoptis. A list of these is provided in the section “Do not take Darunavir Synoptis with the following medicines.”
In most cases, Darunavir Synoptis can be combined with anti-HIV medicines belonging to other classes [e.g., NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists, and FIs (fusion inhibitors)].
Studies on the concomitant use of Darunavir Synoptis with cobicistat or ritonavir and all PIs (protease inhibitors) have not been conducted, and Darunavir Synoptis must not be used in combination with other protease inhibitors. In some cases, dosage adjustments of other medicines may be necessary. Therefore, patients must always inform their doctor about taking other anti-HIV medicines and strictly follow the doctor’s instructions regarding concomitant use of other medicines.
The effectiveness of Darunavir Synoptis may be reduced when taken simultaneously with any of the following products. Inform the doctor if taking:

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

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

• amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, lidocaine, metoprolol, mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil (cardiovascular medicines), due to the possibility of enhanced therapeutic effects and adverse reactions of these drugs;

• apixaban, edoxaban, rivaroxaban, warfarin (anticoagulants), due to the possibility of enhanced therapeutic effects and adverse reactions of these drugs; blood tests may be necessary;

• hormonal contraceptives and hormone replacement therapies containing estrogens; Darunavir Synoptis may reduce their effectiveness; to avoid pregnancy, use of alternative non-hormonal birth control methods is recommended;

• ethinylestradiol with drospirenone. Darunavir Synoptis may increase the risk of elevated potassium levels associated with drospirenone;

• atorvastatin, pravastatin, rosuvastatin (cholesterol-lowering agents). There is an increased risk of muscle damage. The doctor will assess which cholesterol-lowering agent is appropriate for the patient in this situation;

• clarithromycin (antibiotic);

• cyclosporine, everolimus, tacrolimus, sirolimus (immunosuppressants), due to the possibility of enhanced therapeutic effects and adverse reactions of these drugs—the doctor may recommend additional monitoring;

• corticosteroids including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone. These medicines are used to treat allergies, asthma, inflammatory bowel diseases, eye, joint, and muscle inflammation, and other inflammatory conditions. If no alternative medicines are available, use of these drugs is possible only after a doctor’s assessment and under strict monitoring for corticosteroid-related adverse effects by the treating physician;

• buprenorphine/naloxone (medicines used in opioid dependence treatment);

• salmeterol (medicine used in asthma treatment);

• artemether/lumefantrine (combination medicine used in malaria treatment);

• dasatinib, everolimus, irinotecan, nilotinib, vinblastine, vincristine (medicines used in cancer treatment);

• sildenafil, tadalafil, vardenafil (medicines used for erectile dysfunction or in the treatment of heart and lung disorders, so-called pulmonary arterial hypertension);

• glecaprevir/pibrentasvir, simeprevir (medicines used in hepatitis C virus infection treatment);

• fentanyl, oxycodone, tramadol (for pain treatment);

• fesoterodine, solifenacin (for urological disorders treatment).

Concomitant administration of other medicines with Darunavir Synoptis may affect their therapeutic effects and adverse reactions. Therefore, dosage adjustments of other medicines may be required.
Inform the doctor if taking:

• alfentanil (injectable, potent and short-acting analgesic used in surgical procedures);
• digoxin (medicine used in the treatment of certain heart conditions);
• clarithromycin (antibiotic);
• itraconazole, isavuconazole, fluconazole, posaconazole, clotrimazole (antifungal agents). Voriconazole may be taken only after consultation with a doctor;
• rifabutin (antibacterial agent);
• sildenafil, vardenafil, tadalafil (medicines for erectile dysfunction or pulmonary hypertension);
• amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (antidepressants and anxiolytics);
• maraviroc (medicine used in HIV infection);
• methadone (medicine used in opioid dependence treatment);
• carbamazepine, clonazepam (anticonvulsant or used in treating certain types of neuropathic pain);
• colchicine (for gout or familial Mediterranean fever);
• bosentan (medicine used in pulmonary hypertension treatment);
• buspirone, chlordiazepoxide, diazepam, estazolam, flurazepam, midazolam administered by injection, zolpidem (anxiolytics and hypnotics);
• perphenazine, risperidone, thioridazine (antipsychotics);
• metformin (antidiabetic for type 2 diabetes);

This is not a complete list of medicines. Patients must inform their doctor about all medicines 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, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine. Pregnant or breastfeeding women should not take Darunavir Synoptis with ritonavir without specific medical advice. Pregnant or breastfeeding women should not take Darunavir Synoptis with cobicistat.
Women infected with HIV should not breastfeed, as the virus may be transmitted to the infant through breast milk, and the effects of the medicine on the infant are unknown.
Driving and operating machinery
Do not drive or operate machinery if taking Darunavir Synoptis causes dizziness.
Darunavir Synoptis contains lactose
This medicine contains lactose. Patients should contact their doctor before taking it if they have previously been diagnosed with intolerance to certain sugars.
Darunavir Synoptis 400 mg contains sunset yellow FCF (E 110), which may cause allergic reactions.
Darunavir Synoptis 400 mg, coated tablets contain propylene glycol (E1520).
This medicine contains 55.55 mg of propylene glycol in each coated tablet. If the child being treated is less than 4 weeks old, discuss with the treating doctor or pharmacist before administering this medicine, especially if the child is receiving other medicines containing propylene glycol or alcohol.
Darunavir Synoptis 800 mg, coated tablets contain propylene glycol (E1520).
This medicine contains 111.1 mg of propylene glycol in each coated tablet. If the child being treated is less than 4 weeks old, discuss with the treating doctor or pharmacist before administering this medicine, especially if the child is receiving other medicines containing propylene glycol or alcohol.

3. How to take Darunavir Synoptis

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor, pharmacist, or nurse. If you are unsure, consult your doctor, pharmacist, or nurse. Do not stop taking Darunavir Synoptis together with cobicistat or ritonavir without first discussing it with your doctor, even if you feel noticeably better.

Do not change the dose, formulation, or stop treatment without your doctor’s advice once treatment has been started.

Darunavir Synoptis 400 mg, film-coated tablets are intended solely for use in creating a dosing regimen of 800 mg once daily.

Darunavir Synoptis 800 mg, film-coated tablets are intended solely for once-daily administration.

Dosing in children aged 3 years and older weighing at least 40 kilograms who have not previously received antiretroviral medicines (to be determined by the treating physician)

• The recommended dose of Darunavir Synoptis is 800 mg (2 tablets of 400 mg or 1 tablet of 800 mg) taken together with ritonavir 100 mg once daily.

Dosing in children aged 3 years and older weighing at least 40 kilograms who have previously received antiretroviral medicines (to be determined by the treating physician)

The dose is:

• 800 mg of Darunavir Synoptis (2 tablets of 400 mg or 1 tablet of 800 mg) together with 100 mg ritonavir once daily. OR
• 600 mg darunavir with 100 mg ritonavir twice daily.

Discuss with your doctor which dose is appropriate for the patient.

Recommendations for children aged over 3 years weighing at least 40 kilograms

• Take 800 mg of Darunavir Synoptis (2 tablets of 400 mg or 1 tablet of 800 mg) at the same time each day.
• Always take Darunavir Synoptis together with 100 mg ritonavir.
• Take Darunavir Synoptis with food.
• Swallow the tablets with water or milk.
• Take other anti-HIV medicines in combination with Darunavir Synoptis and ritonavir as directed by your doctor.

Dosing in adults who have not previously received antiretroviral medicines (to be determined by the treating physician)

The usual dose of Darunavir Synoptis is 800 mg (2 tablets of 400 mg or 1 tablet of 800 mg) once daily.

Take Darunavir Synoptis every day, always together with cobicistat 150 mg or ritonavir 100 mg, and with food. Darunavir Synoptis will not provide the desired therapeutic effect if taken without cobicistat or ritonavir, or without food. A meal or snack should be consumed within 30 minutes before taking Darunavir Synoptis and cobicistat or ritonavir. The type of food is not important.

Even if you feel noticeably better, do not stop taking Darunavir Synoptis with cobicistat or ritonavir without first discussing it with your doctor.

Dosing in adults who have previously received antiretroviral medicines (to be determined by the treating physician)

The dose is:

• 800 mg of Darunavir Synoptis (2 tablets of 400 mg or 1 tablet of 800 mg) together with 150 mg cobicistat or 100 mg ritonavir once daily. OR
• 600 mg darunavir together with 100 mg ritonavir twice daily.

Discuss with your doctor which dose is appropriate for the patient.

Recommendations for adults

• Take two 400 mg tablets at the same time each day (daily).
• Always take Darunavir Synoptis together with 150 mg cobicistat or 100 mg ritonavir.
• Take Darunavir Synoptis with food.
• Swallow the tablets with water or milk.
• Take other anti-HIV medicines in combination with Darunavir Synoptis and cobicistat or ritonavir as directed by your doctor.
• Oral suspension formulation of darunavir is also available for use in children and may, in certain cases, be used in adults as well.

Opening the child-resistant cap

The plastic bottle is equipped with a child-resistant cap. Open it as follows:

• Press down on the plastic cap while turning it counterclockwise;
• Remove the loosened cap.

Taking more than the recommended dose of Darunavir Synoptis

Contact your doctor, pharmacist, or nurse immediately.

Missing a dose of Darunavir Synoptis

If a missed dose is noticed within 12 hours, take the missed tablets immediately. Each dose must be taken with cobicistat or ritonavir and with food. If the missed dose is noticed after 12 hours, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

Do not stop taking Darunavir Synoptis without consulting your doctor

HIV medicines can improve your well-being. However, even if you feel better, do not stop taking this medicine without first discussing it with your doctor.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

During treatment for HIV infection, increases in body weight, blood lipid levels, and blood glucose levels may occur. This is partly related to improved health and lifestyle, and in the case of blood lipid levels, sometimes to the antiretroviral treatment itself. Your doctor will order tests to monitor these changes.

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
If any of the adverse reactions described below occur, you should inform your doctor.

Hepatic complications have been observed, which in rare cases may be severe. Your doctor will order a blood test before starting treatment with this medicine. If you have chronic hepatitis B or C, your doctor should order blood tests more frequently, as there is an increased risk of liver complications. You should discuss with your doctor any symptoms of liver dysfunction.

These may include: yellowing of the skin or eyes, dark urine (tea-coloured), pale stools (faeces), nausea, vomiting, loss of appetite, or pain, tenderness, or pain and discomfort under the ribs on the right side. Skin rash (more common when used concomitantly with raltegravir), itching. Skin rash is usually mild to moderate in severity. However, skin rash may also be a symptom of a rare but serious condition. Therefore, you should contact your doctor if a rash develops. Your doctor will decide on appropriate symptomatic treatment or whether to discontinue Darunavir Synoptis.

Other serious adverse reactions included: diabetes (common) and pancreatitis (uncommon).

Very common adverse reactions (may affect more than 1 in 10 people)

• Diarrhoea

Common adverse reactions (may affect up to 1 in 10 people)

• Vomiting, nausea, abdominal pain or bloating, indigestion, flatulence;
• Headache, fatigue, dizziness, drowsiness, numbness, tingling or pain in the hands or feet, weakness, difficulty sleeping.

Uncommon adverse reactions (may affect up to 1 in 100 people)

• Chest pain, changes in ECG, rapid heartbeat;
• Sensory disturbances or reduced skin sensation, tingling, difficulty concentrating, memory loss, balance disorders;
• Breathing difficulties, cough, nosebleeds, throat irritation;
• Inflammation of the stomach or mouth, heartburn, retching (without vomiting), dry mouth, abdominal discomfort, constipation, belching;
• Kidney failure, kidney stones, difficulty urinating, frequent or excessive urination, sometimes at night;
• Urticaria, severe swelling of the skin and other tissues (most commonly lips or eyes), rash, excessive sweating, night sweats, hair loss, acne, scaly skin, pigment deposition in nails;
• Muscle pain, muscle cramps or reduced muscle strength, limb pain, osteoporosis;
• Slowed thyroid activity, which can be detected from blood test results;
• Hypertension, sudden flushing of the facial skin;
• Redness or dryness of the eyeballs;
• Fever, swelling of the lower limbs due to fluid retention, malaise, irritability, pain;
• Signs of infection, herpes;
• Erectile dysfunction, breast enlargement in men;
• Sleep disorders, somnolence, depression, anxiety, strange dreams, decreased libido.

Rare adverse reactions (may affect up to 1 in 1,000 people)

• DRESS syndrome [severe rash accompanied by fever, fatigue, facial or lymph node swelling, increased eosinophil count (a type of white blood cell), and liver, kidney, or lung symptoms];
• Heart attack, slow heartbeat, palpitations;
• Visual disturbances;
• Chills, malaise;
• Feeling of confusion or disorientation, mood changes, restlessness;
• Fainting, seizures, changes or loss of taste;
• Mouth pain, vomiting blood, inflammation of the lips, dry lips, coated tongue;
• Catarrh;
• Skin disorders, dry skin;
• Muscle or joint stiffness, joint pain with or without inflammation;
• Blood cell count and biochemical test abnormalities. Changes may be observed in blood or urine tests. Your doctor will provide detailed explanations on this matter. An example of such a disorder is an increase in a certain type of white blood cells.

Adverse reactions typical for antiretroviral medicines in the same class as Darunavir Synoptis include:

• Muscle pain, tenderness or weakness. In rare cases, such disorders may be severe.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder. Reporting adverse reactions helps to provide more information on the safety of the 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 (EXP)" and on the bottle after "EXP". The expiry date refers to the last day of the stated month.
No special storage precautions are required for Darunavir Synoptis.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. How to store Darunavir Synoptis

What Darunavir Synoptis contains

• The active substance is darunavir. Each Darunavir Synoptis 400 mg film-coated tablet contains 400 mg of darunavir (as darunavir propylene glycol solvate).

Each Darunavir Synoptis 800 mg film-coated tablet contains 800 mg of darunavir (as darunavir propylene glycol solvate).

• Other ingredients are:
  Darunavir Synoptis, 400 mg, film-coated tablets
• microcelac 100 composed of: lactose monohydrate, microcrystalline cellulose
• povidone K30
• crospovidone
• colloidal anhydrous silica
• magnesium stearate
  Coating (Orange-2): polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, orange-yellow FCF (E 110)

Darunavir Synoptis, 800 mg, film-coated tablets

• microcelac 100 composed of: lactose monohydrate, microcrystalline cellulose
• povidone K30
• crospovidone
• colloidal anhydrous silica
• magnesium stearate
  Coating (Red): polyvinyl alcohol, macrogol 3350, iron oxide red (E 172), talc, titanium dioxide (E 171)

What Darunavir Synoptis looks like and contents of the pack
Darunavir Synoptis, 400 mg, film-coated tablets
Light orange, oval tablets with the imprint "400" on one side,
dimensions: length 18.2 ± 0.2 mm, width 9.2 ± 0.2 mm, thickness 5.7 ± 0.4 mm.
Darunavir Synoptis, 800 mg, film-coated tablets
Dark red, oval tablets with the imprint "800" on one side,
dimensions: length 21.4 ± 0.2 mm, width 10.8 ± 0.2 mm, thickness 8.0 ± 0.4 mm.
Carton box containing an HDPE bottle with PP screw cap, child-resistant closure and seal.
Pack sizes:
Darunavir Synoptis, 400 mg, film-coated tablets
One bottle containing 60 tablets
Darunavir Synoptis, 800 mg, film-coated tablets
One bottle containing 30 tablets
Not all pack sizes and types may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
Poland

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 authorised for supply in the European Economic Area countries 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 400/800 mg film-coated tablets EFG
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 filmsko obložene tablete
Netherlands Darunavir Accord 75mg/150mg/300mg/400mg/600mg/800mg filmomhulde tabletten
Norway Darunavir Accord 600mg/800mg Tablett, filmdrasjert
Italy Darunavir Accord 600mg/800mg compresse rivestite con film
Ireland Darunavir Accord 600mg/800mg Film-coated tablets
Malta Darunavir Accord 600mg Film-coated tablets
Bulgaria Darunavir Accord 800mg Филмирани таблетки
Croatia Darunavir Accord 800mg filmom obložene tablete
Finland Darunavir Accord 400mg/600mg/800mg kalvopäällysteiset tabletit
Sweden Darunavir Accord 400mg/600mg/800mg filmdragerade tabletter
Portugal Darunavir Accord 400mg/600mg/800mg Comprimidos revestidos por película
France Darunavir Accord 75mg/150mg/300mg/400mg/600mg/800mg comprimé pelliculé