Darunavir Sinoptis

Package Leaflet: Information for the User

Darunavir Synoptis, 400 mg, Film-Coated Tablets

Darunavir Synoptis, 800 mg, Film-Coated Tablets

Darunavir

Read All of This Leaflet Carefully Before You Start Taking This Medicine.

• 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. Do Not Pass It on to Others. It May Harm Them, Even if Their Symptoms Are the Same as Yours.
• If You Get Any Side Effects, Talk to Your Doctor, Pharmacist, or Nurse. This Includes Any Possible Side Effects Not Listed in This Leaflet. See Section 4.

Contents of the Pack and Other Information

• 1. What Darunavir Synoptis Is and What It Is Used For
• 2. What You Need to Know Before You Take 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 to Treat HIV Infection in Adults and Children from the Age of 3 Years and at Least 40 Kg Body Weight. It Is Used in Combination with Other Antiretroviral Medicines to Treat HIV-1 Infection.

What Darunavir Synoptis Is Used For

Darunavir Synoptis Is Used to Treat Adults and Children from the Age of 3 Years and at Least 40 Kg Body Weight with HIV-1 Infection:

• Who Have Not Taken Any Other Antiretroviral Medicines Before;
• Who Have Taken Other Antiretroviral Medicines Before (as Determined by Their Doctor).

Darunavir Synoptis Should Be Taken in Combination with Ritonavir and Other Antiretroviral Medicines. The Best Combination of Medicines for You Will Be Determined by Your Doctor.

2. What You Need to Know Before You Take Darunavir Synoptis

Do Not Take Darunavir Synoptis

• If You Are Allergic to Darunavir or Any of the Other Ingredients of This Medicine (Listed in Section 6);
• If You Have Severe Liver Problems;

Do Not Take Darunavir Synoptis with Any of the Following Medicines

If You Are Taking Any of These Medicines, Consult Your Doctor to Discuss the Best Course of Action.

During Treatment with Darunavir Synoptis, You Must Not Take Medicines Containing St. John's Wort (Hypericum Perforatum).

Warnings and Precautions

Before You Start Taking Darunavir Synoptis, Talk to Your Doctor, Pharmacist, or Nurse:

Darunavir Synoptis Will Not Cure Your HIV Infection. You Can Still Transmit HIV to Others While Taking This Medicine, Even if You Are Feeling Better. You Must Continue to Take All the Medicines Your Doctor Prescribes to Control Your HIV Infection. Keep in Regular Contact with Your Doctor.

Patients Taking Darunavir Synoptis May Develop Skin Rash. Rarely, This Can Be Severe or Life-Threatening. If You Develop a Rash, Contact Your Doctor.

When to Tell Your Doctor Before and During Treatment

After Reading the Following List, Tell Your Doctor If Any of These Apply to You:

• Tell Your Doctor If You Have Ever Had Liver Problems, Including Hepatitis B or C. Your Doctor Will Assess How Severe Your Liver Disease Is Before Deciding Whether You Can Take Darunavir Synoptis.
• Tell Your Doctor If You Have Diabetes. Darunavir Synoptis May Increase Blood Sugar Levels.
• Tell Your Doctor Right Away If You Notice Any Signs of Infection (such as Enlarged Lymph Nodes, Fever). In Some Patients with Advanced HIV Infection and a History of Opportunistic Infections, Signs, and Symptoms of Inflammation from Previous Infections May Occur Soon After Anti-HIV Treatment Is Started. It Is Believed That These Symptoms Are Due to the Body's Immune Response to the Infection, as a Result of the Antiretroviral Treatment.
• In Addition to Opportunistic Infections, Autoimmune Disorders (a Condition Where the Body's Immune System Attacks Healthy Body Tissue) Can Also Occur After Starting Antiretroviral Treatment. Autoimmune Disorders May Occur Several Months After Starting Treatment. If You Develop Symptoms Such as Muscle Weakness, Tingling, or Numbness in the Hands and Feet, or Problems with Walking, and/or Blurred Vision, or a Rash, Inform Your Doctor Immediately.
• 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 to Treat Certain Infections).
• Tell Your Doctor If You Have Muscle Disorders. In Some Patients Taking Combination Antiretroviral Therapy, Including Darunavir Synoptis, a Condition Called Osteonecrosis (Death of Bone Tissue Due to Lack of Blood Supply) Can Occur. The Risk of Osteonecrosis Is Greater in Patients with Other Risk Factors, Such as Long-Term Use of Antiretroviral Therapy, Use of Corticosteroids, Alcohol Consumption, Severe Immunosuppression, Higher Body Mass Index, and Other Factors. Symptoms of Osteonecrosis Include Joint Pain and Stiffness, Limited Mobility, and Difficulty Walking. Inform Your Doctor If You Experience Any of These Symptoms.

Elderly Patients

Darunavir Synoptis Has Been Used in a Limited Number of Patients Aged 65 and Over. If You Are Older Than 65, Consult Your Doctor to Discuss the Possibility of Taking This Medicine.

Children and Adolescents

Darunavir Synoptis 400 Mg and 800 Mg Film-Coated Tablets Are Not Intended for Children Weighing Less Than 40 Kg or Aged Less Than 3 Years.

Darunavir Synoptis with Other Medicines

Tell Your Doctor or Pharmacist About All the Medicines You Are Taking or Have Recently Taken:

Some Medicines Must Not Be Taken with Darunavir Synoptis. Their Names Are Listed in the Section "Do Not Take Darunavir Synoptis with Any of the Following Medicines".

In Most Cases, Darunavir Synoptis Can Be Taken with Other Antiretroviral Medicines Belonging to Another Class (such as NRTIs, NNRTIs, Entry Inhibitors, and Integrase Inhibitors). However, Studies Have Not Been Conducted with All These Medicines, and Darunavir Synoptis Should Not Be Used with Other Protease Inhibitors.

In Some Cases, Your Doctor May Need to Change the Dose of Other Medicines You Are Taking. Therefore, Always Inform Your Doctor About the Medicines You Are Taking and Follow Their Advice.

The Effectiveness of Darunavir Synoptis May Be Reduced If You Take Any of the Following Medicines:

• Phenobarbital, Phenytoin(Anti-Epileptic Medicines);
• Dexamethasone(Corticosteroid);
• Efavirenz(HIV-1 Infection Treatment);
• Boceprevir(Hepatitis C Virus Infection Treatment);
• Rifapentine, Rifabutin(Anti-Tuberculosis Medicines);
• Saquinavir(HIV-1 Infection Treatment).

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 the Therapeutic Effect and Adverse Reactions of These Medicines May Be Increased;
• Apixaban, Edoxaban, Rivaroxaban, Warfarin(Anticoagulant Medicines), as the Therapeutic Effect and Adverse Reactions of These Medicines May Be Increased; Blood Tests May Be Necessary;
• Hormonal Contraceptives and Hormone Replacement Therapy; Darunavir Synoptis May Reduce Their Effectiveness; to Avoid Pregnancy, Non-Hormonal Methods of Contraception Should Be Used;
• Etonogestrel/Ethinyl Estradiol. Darunavir Synoptis May Increase the Risk of High 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 Suitable for You in This Situation;
• Clarithromycin(Antibiotic);
• Cyclosporine, Everolimus, Tacrolimus, Sirolimus(Immunosuppressants), as the Therapeutic Effect and Adverse Reactions of These Medicines May Be Increased; Your Doctor May Need to Perform Additional Tests;
• Corticosteroids, Including Betamethasone, Budesonide, Fluticasone, Mometasone, Prednisone, and Triamcinolone. These Medicines Are Used to Treat Allergies, Asthma, Inflammatory Bowel Diseases, Eye, Joint, or Muscle Inflammations, and Other Inflammatory Conditions. If There Are No Alternative Medicines, the Use of These Medicines Is Possible Only After Evaluation by Your Doctor and Under Close Monitoring for Corticosteroid Side Effects;
• Buprenorphine/Naloxone(Medicines Used to Treat Opioid Dependence);
• Salmeterol(Asthma Medication);
• Artemether/Lumefantrine(Malaria Treatment);
• Dasatinib, Everolimus, Irinotecan, Nilotinib, Vinblastine, Vincristine(Cancer Medicines);

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, Ask Your Doctor or Pharmacist for Advice Before Taking This Medicine.

Women Who Are HIV-Positive Should Not Breastfeed Their Babies Because the Virus Can Be Passed to the Baby in Breast Milk, and the Safety of Darunavir Synoptis for the Baby Is Not Known.

Driving and Using Machines

Do Not Drive or Operate Machines If You Experience Dizziness After Taking Darunavir Synoptis.

Darunavir Synoptis Contains Lactose

This Medicine Contains Lactose. If You Have Been Told by Your Doctor That You Have an Intolerance to Some Sugars, Contact Your Doctor Before Taking This Medicinal Product.

Darunavir Synoptis 400 Mg Contains Orange 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 to Be Treated Is Less Than 4 Weeks Old, Consult the Doctor or Pharmacist Before Administering This Medicine, Especially If the Child Is Also Taking 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 to Be Treated Is Less Than 4 Weeks Old, Consult the Doctor or Pharmacist Before Administering This Medicine, Especially If the Child Is Also Taking Other Medicines Containing Propylene Glycol or Alcohol.

3. How to Take Darunavir Synoptis

Always Take This Medicine Exactly as Described in This Leaflet or as Your Doctor, Pharmacist, or Nurse Has Told You. Check with Your Doctor, Pharmacist, or Nurse If You Are Not Sure.

Do Not Stop Taking Darunavir Synoptis Without Consulting Your Doctor.

Once You Have Started Taking Darunavir Synoptis, Do Not Change the Dose or Stop Treatment Without Consulting Your Doctor.

Darunavir Synoptis 400 Mg Film-Coated Tablets Are Only for Use in the 800 Mg Once-Daily Dosing Regimen.

Darunavir Synoptis 800 Mg Film-Coated Tablets Are Only for Use in the Once-Daily Dosing Regimen.

Dosing in Children Aged 3 Years and Older and Weighing at Least 40 Kg Who Have Not Taken Any Other Antiretroviral Medicines Before (as Determined by the Doctor)

• The Recommended Dose of Darunavir Synoptis Is 800 Mg (2 Tablets of 400 Mg or 1 Tablet of 800 Mg) in Combination with Ritonavir 100 Mg Once Daily.

Dosing in Children Aged 3 Years and Older and Weighing at Least 40 Kg Who Have Taken Other Antiretroviral Medicines Before (as Determined by the Doctor)

The Dose Is:

• 800 Mg of Darunavir Synoptis (2 Tablets of 400 Mg or 1 Tablet of 800 Mg) in Combination with 100 Mg of Ritonavir Once Daily. Or
• 600 Mg of Darunavir in Combination with 100 Mg of Ritonavir Twice Daily.

Discuss with Your Doctor Which Dose Is Suitable for You.

Recommendations for Children Aged 3 Years and Older and Weighing at Least 40 Kg

• Take a Dose of 800 Mg of Darunavir Synoptis (2 Tablets of 400 Mg or 1 Tablet of 800 Mg) at the Same Time, Once Daily, Every Day.
• Always Take Darunavir Synoptis with 100 Mg of Ritonavir.
• Take Darunavir Synoptis with Food.
• Swallow the Tablets with Water or Milk.
• Take Other Antiretroviral Medicines in Combination with Darunavir Synoptis and Ritonavir as Advised by Your Doctor.

Dosing in Adults Who Have Not Taken Any Other Antiretroviral Medicines Before (as Determined by the Doctor)

The Typical Dose of Darunavir Synoptis Is 800 Mg (2 Tablets of 400 Mg or 1 Tablet of 800 Mg) Once Daily.

Dosing in Adults Who Have Taken Other Antiretroviral Medicines Before (as Determined by the Doctor)

The Dose Is:

• 800 Mg of Darunavir Synoptis (2 Tablets of 400 Mg or 1 Tablet of 800 Mg) in Combination with 150 Mg of Cobicistat or 100 Mg of Ritonavir Once Daily. Or
• 600 Mg of Darunavir in Combination with 100 Mg of Ritonavir Twice Daily.

Discuss with Your Doctor Which Dose Is Suitable for You.

Recommendations for Adults

• Take 2 Tablets of 400 Mg at the Same Time, Once Daily, Every Day.
• Always Take Darunavir Synoptis with 150 Mg of Cobicistat or 100 Mg of Ritonavir.
• Take Darunavir Synoptis with Food.
• Swallow the Tablets with Water or Milk.
• Take Other Antiretroviral Medicines in Combination with Darunavir Synoptis and Cobicistat or Ritonavir as Advised by Your Doctor.
• A Darunavir Suspension Is Also Available for Use in Children and May Be Used in Certain Cases for Adults.

Opening the Child-Resistant Closure

The Plastic Bottle Is Equipped with a Child-Resistant Closure. To Open It, Follow These Steps:

• Press the Plastic Cap While Turning It in the Direction Opposite to the Direction of the Clock Hands;
• Remove the Unscrewed Cap.

What to Do If You Take More Darunavir Synoptis Than You Should

Contact Your Doctor, Pharmacist, or Nurse Immediately.

What to Do If You Forget to Take Darunavir Synoptis

If You Forget to Take a Dose Within 12 Hours, Take the Missed Dose as Soon as Possible. Each Dose Should Be Taken with Cobicistat or Ritonavir and Food. If You Forget to Take a Dose 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 Forgotten Dose.

Do Not Stop Taking Darunavir Synoptis Without Consulting Your Doctor

Antiretroviral Therapy May Improve Your Condition. Even If You Feel Better, Do Not Stop Taking Darunavir Synoptis Without Consulting Your Doctor.

4. Possible Side Effects

During HIV Treatment, Weight Gain and Increases in Blood Lipids and Glucose Levels May Occur. These Changes May Be Due to the Improvement of Your Health and, in the Case of Blood Lipids, to the Antiretroviral Therapy Itself. Your Doctor Will Monitor These Changes.

Like All Medicines, This Medicine Can Cause Side Effects, Although Not Everybody Gets Them.

If You Experience Any of the Following Side Effects, Tell Your Doctor

Severe Liver Problems Have Been Reported, Which in Rare Cases Have Been Fatal. Your Doctor Will Perform Blood Tests Before You Start Taking Darunavir Synoptis and Regularly While You Are Taking It. If You Have Hepatitis B or C, Your Doctor Will Monitor You More Frequently, as There Is a Greater Risk of Liver Problems.

A Skin Rash (More Common When Used with Raltegravir) and Itching May Occur. The Rash Is Usually Mild to Moderate. However, in Rare Cases, It Can Be Severe or Life-Threatening. If You Develop a Rash, Contact Your Doctor.

Other Serious Side Effects Include:

• Diabetes (Frequently) and Pancreatitis (Not Very Commonly).

Very Common Side Effects(May Affect More Than 1 in 10 People)

• Diarrhea.

Common Side Effects(May Affect Up to 1 in 10 People)

• Vomiting, Nausea, Abdominal Pain, Bloating, Indigestion, Flatulence;
• 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 the Electrocardiogram, Rapid Heart Rate;
• Numbness or Reduced Sensation, Tingling, Difficulty Concentrating, 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 Swelling and Other Tissue Swelling (Mostly Around the Eyes or Lips), Rash, Excessive Sweating, Night Sweats, Hair Loss, Acne, Flaky Skin, Nail Discoloration;

Rare Side Effects(May Affect Up to 1 in 1,000 People)

• DRESS Syndrome [Severe Rash, Which Can Be Accompanied by Fever, Fatigue, Swelling of the Face or Lymph Nodes, Increased Number of Eosinophils (a Type of White Blood Cell), Liver, Kidney, or Lung Symptoms];
• Heart Attack, Slow Heart Rate, Palpitations;
• Vision Disorders;
• Chills, Malaise;
• Disorientation or Confusion, Mood Changes, Restlessness;
• Fainting, Seizures, Changes in or Loss of Taste;
• Pain in the Mouth, Bloody Vomiting, Inflammation of the Lips, Dryness of the Lips, Furry Tongue;
• Runny Nose;
• Diseased Skin Conditions, Dry Skin;
• Muscle Stiffness or Joint Pain with or Without Inflammation;
• Abnormal Blood Cell Counts and Biochemical Test Results. These Changes Can Be Seen in Blood or Urine Test Results. Your Doctor Will Explain This in More Detail. An Example of Such a Disorder Is an Increase in the Number of a Certain Type of White Blood Cell.

Side Effects Typical of Medicines Used to Treat HIV Infection in the Same Class as Darunavir Synoptis Include:

• Muscle Pain, Tenderness, or Weakness. In Rare Cases, These Conditions Can Be Severe.

Reporting of Side Effects

If You Experience Any Side Effects, Tell Your Doctor, Pharmacist, or Nurse. Side Effects Can Also Be Reported to the Department of Drug Safety, 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.

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 Which Is Stated on the Carton After "Exp" and on the Bottle After "Exp". The Expiry Date Refers to the Last Day of That Month.

No Special Precautions for Storage Are Necessary for Darunavir Synoptis.

Do Not Throw Away Any Medicines via Wastewater or Household Waste. Ask Your Pharmacist How to Throw Away Medicines You No Longer Use. These Measures Will Help Protect the Environment.

6. Contents of the Pack and Other Information

What Darunavir Synoptis Contains

• The Active Substance Is Darunavir. Each 400 Mg Film-Coated Tablet Contains 400 Mg of Darunavir (as Darunavir Ethanolate).

Each 800 Mg Film-Coated Tablet Contains 800 Mg of Darunavir (as Darunavir Ethanolate).

• The Other Ingredients Are: Darunavir Synoptis 400 Mg Film-Coated Tablets
• Microcelac 100 (Lactose Monohydrate, Microcrystalline Cellulose)
• Povidone K30
• Crospovidone
• Colloidal Silicon Dioxide
• 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 (Lactose Monohydrate, Microcrystalline Cellulose)
• Povidone K30
• Crospovidone
• Colloidal Silicon Dioxide
• 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 "400" Engraved on One Side, Measuring 18.2 ± 0.2 Mm in Length, 9.2 ± 0.2 Mm in Width, and 5.7 ± 0.4 Mm in Thickness.

Darunavir Synoptis 800 Mg Film-Coated Tablets

Dark Red, Oval Tablets with "800" Engraved on One Side, Measuring 21.4 ± 0.2 Mm in Length, 10.8 ± 0.2 Mm in Width, and 8.0 ± 0.4 Mm in Thickness.

Carton Containing a Hdpe Bottle with a PP Cap, Equipped with a Child-Resistant Closure and a Seal.

Available 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 May Be Marketed.

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 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 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