Darunavir synoptis

Package leaflet: Information for the user

Darunavir Synoptis, 400 mg, film-coated tablets
Darunavir Synoptis, 800 mg, film-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 other people, 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 is Darunavir Synoptis?
Darunavir Synoptis contains the active substance darunavir. Darunavir Synoptis is an antiretroviral medicine used in the treatment of human immunodeficiency virus (HIV) infection.
Darunavir Synoptis belongs to a group of medicines called protease inhibitors. The action of Darunavir Synoptis is to reduce the amount of HIV in the body. This helps the immune system and reduces the risk of developing HIV-related illnesses.

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

• who have not previously been treated with any other antiretroviral medicines, or
• in certain patients who have previously been treated with antiretroviral medicines (your doctor will decide).

Darunavir Synoptis must be taken in combination with a low dose of cobicistat or ritonavir and other anti-HIV medicines. Your treating doctor will determine 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 impairment of liver function. In case of doubt regarding liver disorders and their nature, a physician 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, consult a physician about changing the treatment regimen.

Do not use products containing St John's wort (Hypericum perforatum) during treatment with Darunavir Synoptis.
Warnings and precautions
Before starting treatment with Darunavir Synoptis, discuss this with your doctor, pharmacist, or nurse.
Darunavir Synoptis will not cure HIV infection. You may still transmit HIV while taking this medicine, although effective antiretroviral therapy reduces this risk. You should discuss with your doctor the necessary precautions to avoid infecting others.
People taking Darunavir Synoptis remain at risk of developing infections or other illnesses associated with HIV, so regular contact with your doctor is essential.
Skin rash may occur in patients taking Darunavir Synoptis. Rarely, it may become severe or potentially life-threatening. If a rash occurs, contact your doctor.
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 medicine alone.
When to inform the doctor about health status BEFORE and DURING treatment
After reviewing the points below, you should inform your doctor if any of them apply to you.

• Inform your doctor if you have previously had liver disease, including hepatitis B or C virus infection. Your doctor will assess the severity of the condition before deciding whether Darunavir Synoptis can be taken.
• Inform your doctor if you have diabetes. Darunavir Synoptis may increase blood sugar levels.
• Inform your doctor immediately 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, symptoms and signs of inflammation related to prior infections may appear soon after starting antiretroviral therapy. These symptoms are believed to result from an enhanced immune response, enabling the body to fight previously asymptomatic infections.
• In addition to opportunistic infections, autoimmune diseases (conditions arising when the immune system attacks healthy body tissues) may also occur after starting antiretroviral therapy for HIV infection. Autoimmune disorders may appear several months after starting treatment. If you notice symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and progressing toward the trunk, palpitations, tremors, or hyperactivity, contact your doctor as soon as possible to initiate necessary treatment.
• Inform your doctor if you have haemophilia. Darunavir Synoptis may increase the risk of bleeding.
• Inform your doctor about sulphonamide allergy (used, for example, in treating certain infections).
• Inform your doctor about musculoskeletal disorders. Some patients receiving combination antiretroviral therapy may develop a bone condition called osteonecrosis (bone death caused by reduced blood supply to the bone). Risk factors for developing this condition 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. Inform your doctor if any of these symptoms occur.

Elderly patients
Darunavir Synoptis has been used in only 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 and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken.
Some medicines must not be used together with Darunavir Synoptis. A list of these is provided in the section “Do not use Darunavir Synoptis with the following medicines”.
In most cases, Darunavir Synoptis can be used together with anti-HIV medicines from other classes [e.g., NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists, and FIs (fusion inhibitors)].
No studies have been conducted on the concomitant use of Darunavir Synoptis with cobicistat or ritonavir together with all PIs (protease inhibitors), and it must not be used in combination with other protease inhibitors. In some cases, dosage adjustments of other medicines may be necessary. Therefore, always inform your 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 together with any of the following products. Inform your doctor if you are 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 your doctor if you are taking:

• amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, lidocaine, metoprolol, mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil (cardiovascular medicines), due to the possibility of increased therapeutic effects and adverse reactions of these medicines;
• apixaban, edoxaban, rivaroxaban, warfarin (anticoagulants), due to the possibility of increased therapeutic effects and adverse reactions of these medicines; blood tests may be necessary;
• hormonal contraceptives and hormone replacement therapies containing oestrogens; Darunavir Synoptis may reduce their effectiveness; to avoid pregnancy, use of alternative non-hormonal methods of birth control is recommended;
• ethinylestradiol with drospirenone. Darunavir Synoptis may increase the risk of elevated potassium levels associated with drospirenone;
• atorvastatin, pravastatin, rosuvastatin (cholesterol-lowering medicines). There is an increased risk of muscle damage. Your doctor will assess which cholesterol-lowering medicine is appropriate for you in this situation;
• clarithromycin (antibiotic);
• cyclosporine, everolimus, tacrolimus, sirolimus (immunosuppressants), due to the possibility of increased therapeutic effects and adverse reactions of these medicines – your 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 medicines is possible only after evaluation by a doctor and under strict monitoring for corticosteroid 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 for treating 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 your doctor if you are taking:

• alfentanil (injection, a potent and short-acting painkiller used during surgical procedures);
• digoxin (medicine used in the treatment of certain heart conditions);
• clarithromycin (antibiotic);
• itraconazole, isavuconazole, fluconazole, posaconazole, clotrimazole (antifungal medicines). Voriconazole may be taken only after consultation with a doctor;
• rifabutin (medicine for bacterial infections);
• 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 (medicines to prevent seizures or used in treating certain types of neuropathic pain);
• colchicine (for treatment of gout or familial Mediterranean fever);
• bosentan (medicine used in treatment of pulmonary hypertension);
• buspirone, chlordiazepoxide, diazepam, estazolam, flurazepam, midazolam when administered by injection, zolpidem (anxiolytic and hypnotic medicines);
• perphenazine, risperidone, thioridazine (antipsychotics);
• metformin (medicine for type 2 diabetes);

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 are planning to have a baby, consult your doctor or pharmacist before taking this medicine. Pregnant or breastfeeding women should not take Darunavir Synoptis with ritonavir without special 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 child 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 Darunavir Synoptis causes dizziness.
Darunavir Synoptis contains lactose
This medicine contains lactose. Consult your doctor before taking it if you 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, film-coated tablets contain propylene glycol (E1520).
This medicine contains 55.55 mg of propylene glycol in each film-coated tablet. If the child being treated is less than 4 weeks old, talk to 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, film-coated tablets contain propylene glycol (E1520).
This medicine contains 111.1 mg of propylene glycol in each film-coated tablet. If the child being treated is less than 4 weeks old, talk to 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 use Darunavir Synoptis

This medicine should always be used exactly as described in this patient information leaflet or as prescribed by your doctor, pharmacist, or nurse. If in doubt, 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 started.

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

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

The dose is:

• 800 mg Darunavir Synoptis (2 tablets of 400 mg or 1 tablet of 800 mg) taken 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 therapy (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. Eat a meal or snack within 30 minutes before taking Darunavir Synoptis and cobicistat or ritonavir. The type of food does not matter.

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 therapy (to be determined by the treating physician)

The dose is:

• 800 mg Darunavir Synoptis (2 tablets of 400 mg or 1 tablet of 800 mg) taken together with 150 mg cobicistat or 100 mg ritonavir once daily. OR
• 600 mg darunavir taken 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 darunavir suspension is also available, intended for use in children, which in certain cases may also be used in adults.

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 Darunavir Synoptis than recommended

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

Anti-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 side effects

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 use of anti-HIV drugs themselves. Your doctor will order blood tests before starting treatment with this medicine. If you have chronic viral hepatitis B or C, your doctor should perform blood tests more frequently, as there is an increased risk of liver complications. Discuss with your doctor the 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 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 sign of a rare but serious condition. Therefore, contact your doctor if a rash develops. Your doctor will decide on appropriate symptomatic treatment or may discontinue treatment with Darunavir Synoptis.

Other serious side effects include: diabetes (frequent) and pancreatitis (uncommon).

Very common side effects (may affect more than 1 in 10 people)

• Diarrhoea

Common side effects (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 hands or feet, weakness, difficulty sleeping.

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

• Chest pain, changes in ECG recording, rapid heartbeat;

• Sensory disturbances or reduced skin sensation, tingling, difficulty concentrating, memory loss, balance disorders;

• Breathing difficulties, cough, nosebleeds, sore throat;

• Inflammation of the stomach or mouth, heartburn, retching (without vomiting), dry mouth, discomfort in the abdominal cavity, 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, feeling unwell, irritability, pain;

• Symptoms of infection, herpes;

• Erectile dysfunction, breast enlargement in men;

• Sleep disorders, somnolence, depression, anxiety, strange dreams, reduced libido.

Rare side effects (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), liver, kidney or lung involvement];
• Heart attack, slow heartbeat, palpitations;
• Visual disturbances;
• Chills, malaise;
• Feeling confused or disoriented, mood changes, psychomotor agitation;
• Fainting, seizures, changes or loss of taste;
• Mouth pain, vomiting blood, inflammation of lips, dry lips, coated tongue;
• Catarrh;
• Skin disorders, dry skin;
• Muscle or joint stiffness, joint pain with or without inflammation;
• Changes in blood cell composition and biochemical test results. These 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.

Side effects typical for antiviral HIV medicines belonging to the same class as Darunavir Synoptis include:

• Muscle pain, tenderness or weakness. In rare cases, such disorders have been severe.

Reporting of side effects

If any side effects occur, including any side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects 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
Side effects can also be reported to the marketing authorisation holder. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Darunavir Synoptis

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the box after "Expiry date (EXP)" and on the bottle after "EXP". The expiry date refers to the last day of the stated month.
No special precautions regarding storage of Darunavir Synoptis are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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, consisting of: monohydrate lactose, microcrystalline cellulose
• Povidone K30
• Crospovidone
• Colloidal anhydrous silica
• Magnesium stearate
  Coating (Orange-2): polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, sunset yellow FCF (E 110)

Darunavir Synoptis 800 mg film-coated tablets

• Microcelac 100, consisting of: monohydrate lactose, 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 engraved mark "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 engraved mark "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

Manufacturers:
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 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 Tablets
Spain Darunavir Kern Pharma 400/800 mg coated tablets with film 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 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