Darunavir synoptis

Package leaflet: 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
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 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 leaflet

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 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.
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 is it used for?
Darunavir Synoptis is used to treat HIV-infected adults and children above 3 years of age and weighing more than 15 kg, who have been previously treated with other antiretroviral medicines.
Darunavir Synoptis must be taken in combination with a low dose of ritonavir and other anti-HIV medicines. Your 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 ritonavir,
• if the patient has severe liver function disorders. In case of doubt regarding liver-related conditions and their nature, consult a doctor. 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 doctor 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. Patients may still transmit HIV virus while taking this medicine, although effective antiretroviral therapy reduces this risk. Patients should discuss with their doctor the precautions necessary to avoid infecting others.
Patients taking Darunavir Synoptis remain at risk of developing infections or other HIV-related diseases; therefore, regular contact with a doctor is necessary.
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.
Skin rash (usually mild or moderately severe) may occur more frequently in patients taking Darunavir Synoptis and raltegravir (for treatment of HIV infection) together than in patients taking either drug alone.
When to inform the doctor about health status BEFORE and DURING treatment
After reviewing the following points, the patient should inform the 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 disease before deciding whether Darunavir Synoptis can be taken.
• Inform the doctor if the patient has diabetes. Darunavir Synoptis may increase blood sugar 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.
• In addition to 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 several months after starting treatment. If signs of infection or other symptoms such as muscle weakness, weakness starting in hands and feet and progressing toward the trunk, palpitations, tremor, or hyperactivity are observed, contact the 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. In some patients receiving combination antiretroviral therapy, bone disease called osteonecrosis (bone tissue death due to impaired blood supply) may develop. 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. Inform the 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. If the patient belongs to this age group, they should consult their doctor to discuss the possibility of taking this medicine.
Children
Do not use Darunavir Synoptis in children under 3 years of age or weighing less than 15 kilograms.
Darunavir Synoptis and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken by the patient.
Some medicines must not be combined with Darunavir Synoptis. A list is provided in the section "Do not use Darunavir Synoptis with the following medicines".
In most cases, Darunavir Synoptis can be combined with antiretroviral drugs 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 and ritonavir with all PIs (protease inhibitors) have not been conducted, and it must not be used in combination with other protease inhibitors. In some cases, dosage adjustment of other medicines may be necessary. Therefore, always inform the doctor about the use of other antiretroviral drugs 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 drugs);
• saxagliptin (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 (cardiac medications), due to the possibility of increased therapeutic effect and adverse reactions of these drugs;

• apixaban, edoxaban, rivaroxaban, warfarin (anticoagulant), due to the possibility of increased therapeutic effect 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 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 drugs). There is an increased risk of muscle damage. The doctor will evaluate which cholesterol-lowering drug is appropriate for the patient in this situation;

• clarithromycin (antibiotic);

• cyclosporine, everolimus, tacrolimus, sirolimus (immunosuppressive drugs), due to the possibility of increased therapeutic effect and adverse reactions of these drugs – the doctor may recommend additional tests;

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

• buprenorphine/naloxone (medicines used in opioid addiction 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 in erectile dysfunction or in treating heart and lung disorders, so-called pulmonary arterial hypertension);

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

• fentanyl, oxycodone, tramadol (painkillers);

• fesoterodine, solifenacin (in urological disorders treatment).

Concomitant administration of other medicines with Darunavir Synoptis may affect their therapeutic effect and adverse reactions. Therefore, dosage of other medicines may require adjustment.
Inform the doctor if taking:

• alfentanil (injections, strong and short-acting painkiller used in surgical procedures);
• digoxin (medicine used in therapy of certain heart diseases);
• clarithromycin (antibiotic);
• itraconazole, isavuconazole, fluconazole, posaconazole, clotrimazole (antifungal medicines). Voriconazole may be taken only after consultation with the doctor;
• rifabutin (medicine against 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 addiction treatment);
• carbamazepine, clonazepam (medicines preventing seizures or used in treating certain types of neuralgia);
• colchicine (in gout or familial Mediterranean fever treatment);
• bosentan (medicine used in pulmonary hypertension treatment);
• buspirone, chlordiazepoxide, diazepam, estazolam, flurazepam, midazolam administered by injection, zolpidem (sedatives);
• perphenazine, risperidone, thioridazine (antipsychotics).

This is not a complete list of medicines. Inform the doctor about all medicines the patient is 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 have a child, she should consult her doctor or pharmacist before using 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 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. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the 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, talk to the attending doctor or pharmacist before administering this medicine, especially if the child is receiving 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, talk to the attending doctor or pharmacist before administering this medicine, especially if the child is receiving 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, talk to the attending doctor or pharmacist before administering this medicine, especially if the child is receiving other medicines containing propylene glycol or alcohol.
Darunavir Synoptis 300 mg film-coated tablets contain sunset yellow (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, talk to the attending doctor or pharmacist before administering this medicine, especially if the child is receiving other medicines containing propylene glycol or alcohol.
Darunavir Synoptis 600 mg film-coated tablets contain sunset yellow (E 110), which may cause allergic reactions.

3. How to take Darunavir Synoptis

This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse. If a noticeable improvement occurs, do not stop taking Darunavir Synoptis in combination with ritonavir without consulting your treating doctor.

Once treatment has started, do not change the dose, formulation, or stop treatment without your doctor's advice.

Dosage for children above 3 years of age weighing at least 15 kg who have not previously received antiretroviral therapy (to be determined by the treating doctor)
The doctor will determine the appropriate once-daily dose based on the child's body weight (see table below). This dose must not exceed the recommended dose for adult patients, which is 800 mg of Darunavir Synoptis and 100 mg of ritonavir once daily.

The doctor will inform you how much darunavir and how much ritonavir (in capsules, tablets, or solution) the child should take. Tablets of different strengths are available, and the doctor may recommend a combination of tablets to achieve the required dosing regimen. Darunavir may also be available as an oral suspension.

The doctor will decide whether darunavir tablets or oral suspension are suitable for the child.

Dosing in children above 3 years of age weighing at least 15 kg who have
previously received antiretroviral medicinal products (to be determined by the treating physician)
The physician will determine the appropriate dose based on body weight (see table below). The physician will assess whether once-daily or twice-daily dosing is suitable for the child. This dose must not exceed the recommended dose for adult patients, which is 600 mg darunavir and 100 mg ritonavir twice daily, or 800 mg Darunavir Synoptis and 100 mg ritonavir once daily.
The physician will inform you how many tablets of darunavir and how much ritonavir (capsules, tablets, or oral solution) the child must take. Tablets of different strengths are available, and the treating physician may have prescribed an appropriate combination to achieve the correct dose. An oral suspension formulation of darunavir is also available. The treating physician will assess whether darunavir tablets or the oral suspension is appropriate for the child.
Twice-daily dosing

Once-daily dosing

Instructions for using Darunavir Synoptis in children:

• The child must always 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 daily or once daily. If Darunavir Synoptis has been prescribed twice daily, the child must take one dose in the morning and one in the evening. The doctor will determine the appropriate dosing schedule for the child.
• The child must take Darunavir Synoptis with food. Darunavir Synoptis does not work properly when taken without food. The type of food is not important.
• The child must swallow the tablets with water or milk.

Dosage in adults who have not previously taken antiretroviral medicines
(this will be determined by the treating physician)
The patient requires a dose of Darunavir Synoptis that cannot be administered using
these tablets. Other strengths of Darunavir Synoptis are available.
Dosage in adults who have previously taken antiretroviral medicines
(this will be determined by the treating physician)
The dose is:

• 600 mg darunavir taken simultaneously with 100 mg ritonavir twice daily. OR
• 800 mg of Darunavir Synoptis (2 tablets of Darunavir Synoptis 400 mg or 1 tablet of 800 mg) taken simultaneously with 100 mg ritonavir once daily. To use the 800 mg once-daily regimen, only Darunavir Synoptis tablets of 400 mg or 800 mg strength should be used.
  The appropriate dose for the patient should be discussed with the doctor.

Recommendations for adults

• Always take Darunavir Synoptis with ritonavir. Darunavir Synoptis does not work properly without ritonavir.
• Take 600 mg darunavir in the morning simultaneously with 100 mg ritonavir.
• Take 600 mg darunavir in the evening simultaneously with 100 mg ritonavir.
• Take Darunavir Synoptis with food. Darunavir Synoptis does not work properly when taken without food. The type of food is not important.
• Swallow the tablets with water or milk.
• Darunavir tablets of other strengths are intended for use in children, but in certain cases 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. 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 6 hours, take the missed tablets immediately. Each dose must be taken with ritonavir and food. If a missed dose is noticed after 6 hours, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
Do not stop taking Darunavir Synoptis without consulting your doctor
HIV medicines may make you feel better, but even if you feel improved, do not stop taking the medicine without first talking to 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, as well as blood lipid and glucose levels, may occur. This is partly related to improved health and lifestyle, and in the case of blood lipid levels, sometimes to the antiretroviral therapy itself. Your doctor will order blood tests to monitor these changes.

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

Hepatic complications have been reported, which in rare cases may be severe. Your doctor will order blood tests before starting treatment with Darunavir Synoptis. If you have chronic viral 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 symptoms of liver dysfunction.

These may include: yellowing of the skin or eyes, dark urine (tea-colored), pale stools (faeces), nausea, vomiting, loss of appetite, or pain or discomfort under the ribs on the right side.

Skin rash (more commonly occurring when raltegravir is taken concomitantly), 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, if this symptom occurs, you should consult your doctor. Your doctor will recommend appropriate symptomatic treatment or decide whether to discontinue Darunavir Synoptis.

Other serious adverse reactions include: diabetes (frequent) and pancreatitis (uncommon).

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

• Diarrhea

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 hands or feet, weakness, difficulty sleeping.

Uncommon adverse reactions (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, 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, pigmentation of the nails;
• Muscle pain, muscle cramps or reduced muscle strength, limb pain, osteoporosis;
• Slowed thyroid activity, which may be detected from blood test results;
• Hypertension, sudden flushing of the face;
• Redness or dryness of the eyeballs;
• Fever, swelling of the lower limbs due to fluid retention, malaise, pain;
• Symptoms of infection, herpes;
• Erectile dysfunction, breast enlargement in men;
• Sleep disturbances, drowsiness, depression, anxiety, strange dreams, reduced libido.

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

• DRESS syndrome [severe rash accompanied by fever, fatigue, facial swelling or swollen lymph nodes, increased eosinophil count (a type of white blood cell), and liver, kidney, or lung involvement];
• Heart attack, slow heartbeat, palpitations;
• Visual disturbances;
• Chills, malaise;
• Feeling confused or disoriented, 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;
• Stiffness of muscles or joints, joint pain with or without inflammation;
• Blood cell count and biochemical test abnormalities. Changes may be observed in blood or urine test results. Your doctor will provide detailed explanations on this matter. An example 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 have been 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 for Monitoring Adverse Reactions of Medicinal Products, 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
Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps provide more information on the safety of the 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 carton after "Expiry date (EXP)" and on the bottle after "EXP". The expiry date refers to the last day of the stated month.
There are no special storage precautions for Darunavir Synoptis.
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. Contents of the packaging and other information

What Darunavir Synoptis contains

• The active substance is darunavir. Each Darunavir Synoptis, 75 mg, film-coated tablet contains 75 mg of darunavir (as darunavir propylene glycol solvate).

Each Darunavir Synoptis, 150 mg, film-coated tablet contains 150 mg of darunavir (as darunavir propylene glycol solvate).
Each Darunavir Synoptis, 300 mg, film-coated tablet contains 300 mg of darunavir (as darunavir propylene glycol solvate).
Each Darunavir Synoptis, 600 mg, film-coated tablet contains 600 mg of darunavir (as darunavir propylene glycol solvate).

• Other ingredients are:
  Darunavir Synoptis, 75 mg, film-coated tablets
• Microcelac 100 composed of: monohydrate lactose, microcrystalline cellulose
• povidone K30
• crospovidone
• colloidal anhydrous silica
• magnesium stearate
  Coating (White): polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc

Darunavir Synoptis, 150 mg, film-coated tablets

• Microcelac 100 composed of: monohydrate lactose, microcrystalline cellulose
• povidone K30
• crospovidone
• colloidal anhydrous silica
• magnesium stearate
  Coating (White): polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc

Darunavir Synoptis, 300 mg, film-coated tablets

• Microcelac 100 composed of: monohydrate lactose, microcrystalline cellulose
• povidone K30
• crospovidone
• colloidal anhydrous silica
• magnesium stearate
  Coating (Orange-1): polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, sunset yellow FCF (E 110)

Darunavir Synoptis, 600 mg, film-coated tablets

• Microcelac 100 composed of: monohydrate lactose, microcrystalline cellulose
• povidone K30
• crospovidone
• colloidal anhydrous silica
• magnesium stearate
  Coating (Orange-1): polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, sunset yellow FCF (E 110)

What Darunavir Synoptis looks like and contents of the pack
Darunavir Synoptis, 75 mg, film-coated tablets
White, capsule-shaped tablets with the engraved mark "75" on one side, dimensions:
length 9.4 ± 0.2 mm, width 4.5 ± 0.2 mm, thickness 3.4 ± 0.3 mm.

Darunavir Synoptis, 150 mg, film-coated tablets
White, oval tablets with the engraved mark "150" on one side, dimensions:
length 13.8 ± 0.2 mm, width 7.0 ± 0.2 mm, thickness 3.6 ± 0.3 mm.

Darunavir Synoptis, 300 mg, film-coated tablets
Orange, oval tablets with the engraved mark "300" on one side, dimensions:
length 16.1 ± 0.2 mm, width 8.1 ± 0.2 mm, thickness 5.2 ± 0.3 mm.

Darunavir Synoptis, 600 mg, film-coated tablets
Orange, oval tablets with the engraved mark "600" on one side, dimensions:
length 20.2 ± 0.2 mm, width 10.2 ± 0.2 mm, thickness 6.8 ± 0.4 mm.

Carton box containing an HDPE bottle with PP screw cap, child-resistant closure, and sealing.

Pack 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 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-coated tablets
Spain Darunavir Kern Pharma 75/150/300/600 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