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 this leaflet carefully before using this medicine, as it contains important
information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

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. Darunavir Synoptis works by reducing the amount of HIV in the body. This helps support 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 aged over 3 years and weighing more than 15 kg who have previously been treated with other antiretroviral medicines.
Darunavir Synoptis must be taken in combination with a low dose of ritonavir and other anti-HIV medicines. Your treating doctor will determine the most appropriate combination of medicines for you.

2. 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 uncertainty regarding liver-related conditions and their nature, a physician should be consulted. Additional tests may be required.

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.

During treatment with Darunavir Synoptis, medicinal products containing
St. John's wort (Hypericum perforatum) must not be used.
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 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, it may become severe or potentially life-threatening. If a rash occurs, contact your doctor immediately.
Skin rash (usually mild or moderate) may occur more frequently in patients taking Darunavir Synoptis and raltegravir (for HIV 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, patients should inform their doctor if any of them apply.

• 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 of inflammation related to past infections may appear soon after initiating 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 HIV treatment. Autoimmune disorders may manifest months after treatment initiation. If symptoms such as muscle weakness, ascending weakness starting in hands and feet, palpitations, tremor, or hyperactivity are observed, contact your doctor immediately 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 disease called osteonecrosis (bone death due to impaired blood supply). Risk factors include prolonged use 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. If you belong to this age group, consult your doctor to discuss the possibility of using this medicine.
Children
Darunavir Synoptis must not be used in children under 3 years of age or weighing less than 15 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 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 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 and ritonavir 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 medical advice regarding concomitant use of other medicines.
The effectiveness of Darunavir Synoptis may be reduced when taken simultaneously 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);
• saxagliptin (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; blood tests may be necessary;
• hormonal contraceptives and hormone replacement therapies containing estrogens; Darunavir Synoptis may reduce their effectiveness; to prevent 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 medicines). There is an increased risk of muscle damage. Your doctor will determine which cholesterol-lowering medicine is appropriate in this situation;
• clarithromycin (antibiotic);
• cyclosporine, everolimus, tacrolimus, sirolimus (immunosuppressants), due to the possibility of increased therapeutic effects and adverse reactions – 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, their use may only be considered after medical evaluation 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 heart and lung disorders, so-called pulmonary arterial hypertension);
• glecaprevir/pibrentasvir, simeprevir (used in the treatment of viral hepatitis

type C);

• fentanyl, oxycodone, tramadol (analgesics);
• fesoterodine, solifenacin (in the treatment of urological disorders).

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, 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 medicines). Voriconazole may be used only after consultation with your 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 preventing seizures or used in treating certain types of neuropathic pain);
• colchicine (in the treatment of gout or familial Mediterranean fever);
• bosentan (medicine used in the treatment of pulmonary hypertension);
• buspirone, chlordiazepoxide, diazepam, estazolam, flurazepam, midazolam administered by injection, zolpidem (sedatives);
• perphenazine, risperidone, thioridazine (antipsychotics).

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, suspect you may be pregnant, or plan to become pregnant, consult your 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 with HIV infection 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. If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this 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 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 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 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 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 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 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 treating 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 you have any doubts, consult your doctor, pharmacist, or nurse. Even if you notice a clear improvement, do not stop taking Darunavir Synoptis together with ritonavir without first discussing it with your doctor.

Once treatment has been started, do not change the dose, dosage form, 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 adult dose of 800 mg Darunavir Synoptis and 100 mg ritonavir once daily.

Your 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 allow for a specific 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.

Dosage for children aged over 3 years weighing at least 15 kg who have previously received antiretroviral medicines (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 of Darunavir Synoptis and 100 mg ritonavir once daily.
The physician will advise how many tablets of darunavir and how much ritonavir (in capsules, tablets, or oral solution) the child should take. Darunavir tablets of different strengths are available, and the treating physician may have prescribed a suitable combination to achieve the correct dosage. 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 regimen

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 during a meal. 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 received antiretroviral treatment
(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 received antiretroviral treatment
(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 follow 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. It should be opened 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 a meal. If the 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 consulting 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 HIV treatment, 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 use of antiretroviral drugs themselves. Your doctor will order 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 a blood test 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 the symptoms of liver dysfunction.

These may include: yellowing of the skin or eyes, dark-coloured urine (tea-coloured), pale stools (faeces), nausea, vomiting, loss of appetite, or pain 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 symptom 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 treatment with 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, somnolence, numbness, tingling or pain in hands or feet, weakness, difficulty falling asleep.

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

• Chest pain, changes in ECG recording, rapid heartbeat;
• Sensory disturbances or loss of skin sensation, tingling, difficulty concentrating, memory loss, balance disorders;
• Breathing difficulties, cough, nosebleeds, sore throat;
• Inflammation of the stomach or oral cavity, heartburn, retching (without vomiting), dry mouth, discomfort in the abdominal cavity, constipation, belching;
• Kidney failure, kidney stones, difficulty passing urine, excessive or frequent 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 nails;
• Muscle pain, muscle cramps or decreased muscle strength, limb pain, osteoporosis;
• Slowing of thyroid activity, which may be detected from blood test results;
• Hypertension, sudden flushing of the skin of the face;
• 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, enlargement of breast glands in men;
• Sleep disorders, drowsiness, depression, anxiety, strange dreams, decreased libido.

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

• DRESS syndrome [severe rash, which may be accompanied by fever, fatigue, facial swelling or swollen lymph nodes, increased eosinophil count (a type of white blood cell), liver, kidney or lung symptoms];
• 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;
• Nasal congestion;
• 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 of such a disorder is an increase in a certain type of white blood cells.

Adverse reactions typical for antiretroviral drugs belonging to 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 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 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 precautions for storage of Darunavir Synoptis.
Medicines must not be disposed of via the wastewater system 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 Pack 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.

Cardboard 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 Warszawa
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 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 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