Darunavir Accord

Leaflet accompanying the packaging: information for the user

Darunavir Accord, 75 mg, film-coated tablets

Darunavir Accord, 150 mg, film-coated tablets

Darunavir Accord, 300 mg, film-coated tablets

Darunavir Accord, 600 mg, film-coated tablets

Darunavir

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Darunavir Accord and what is it used for
• 2. Important information before taking Darunavir Accord
• 3. How to take Darunavir Accord
• 4. Possible side effects
• 5. How to store Darunavir Accord
• 6. Package contents and other information

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

What is Darunavir Accord?

Darunavir Accord contains the active substance darunavir. Darunavir Accord is an antiretroviral medicine used to treat HIV infections. The medicine belongs to a group of protease inhibitors. The action of Darunavir Accord is to reduce the amount of HIV virus in the body. This helps the immune system and reduces the risk of developing HIV-related diseases.

What is it used for?

Darunavir Accord is used to treat adults and children aged 3 years and older and weighing at least 15 kg with HIV infection who have already been treated with other antiretroviral medicines. Darunavir Accord should be taken in combination with a small dose of ritonavir and other HIV medicines. The best combination of medicines for the patient is determined by the doctor.

2. Important information before taking Darunavir Accord

When not to take Darunavir Accord

• if the patient is allergicto darunavir or any of the other ingredients of this medicine (listed in section 6) or to ritonavir,
• if the patient has severe liver problems. In case of doubts about liver problems and their nature, consult a doctor. It may be necessary to perform some additional tests.

Inform your doctor about allmedicines you are taking, including those taken orally, inhaled, injected, or applied to the skin.

Do not take Darunavir Accord with the following medicines

If you are taking any of the following medicines, consult your doctor about changing your treatment.

During treatment with Darunavir Accord, do not take products containing St. John's Wort (Hypericum perforatum).

Warnings and precautions

Before starting treatment with Darunavir Accord, discuss it with your doctor, pharmacist, or nurse. Darunavir Accord will not cure HIV infection. People taking Darunavir Accord are still at risk of developing infections or other diseases related to the presence of HIV, so they should maintain regular contact with their doctor. In patients taking Darunavir Accord, a skin rash may appear. Rarely, it can be severe or life-threatening. If a rash occurs, consult a doctor. Rash (usually mild or moderate) may occur more frequently in patients taking Darunavir Accord and raltegravir than in patients taking either medicine separately.

When to inform your doctor about your health status BEFORE and DURING treatment

After reading the following points, the patient should inform their doctor if any of them apply to them.

• Inform your doctor if you have had liver diseasein the past, including hepatitis B or C virus infection. The doctor will assess how severe the disease was before deciding whether it is possible to take Darunavir Accord.
• Inform your doctor if you have diabetes. Darunavir Accord may increase blood sugar levels.
• Inform your doctor immediately if you notice infection symptoms(e.g., swollen lymph nodes, fever). In some patients with advanced HIV infection and a history of opportunistic infections, subjective and objective symptoms of inflammation related to previous infections may appear immediately after starting antiretroviral therapy. It is believed that the appearance of such symptoms is related to the strengthening of the body's immune response, which allows the body to fight existing asymptomatic infections.
• Inform your doctor if you have hemophilia. Darunavir Accord may increase the risk of bleeding.
• Inform your doctor if you are allergic to sulfonamides(used, for example, to treat certain infections).
• Inform your doctor if you have musculoskeletal disorders. In some patients taking combined antiretroviral therapy, a bone disease called osteonecrosis (bone death due to insufficient blood supply) may develop. Risk factors for developing this disease include: long duration of combined antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, increased body mass index, and others. Symptoms of osteonecrosis include: joint pain and stiffness (especially in the hips, knees, or shoulders) and difficulty moving. Inform your doctor if you experience any of these symptoms.

Elderly patients

Darunavir Accord has been used in only a small number of patients aged 65 or older. If you belong to this age group, you should consult your doctor to discuss the possibility of taking this medicine.

Children

Do not use Darunavir Accord in children under 3 years of age or weighing less than 15 kilograms.

Darunavir Accord and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken. Some medicines must not be takenwith Darunavir Accord. A list of these medicines is provided in the section "Do not take Darunavir Accord with the following medicines". In most cases, Darunavir Accord can be combined with HIV medicines from another group [e.g., NRTI (nucleoside reverse transcriptase inhibitors), NNRTI (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists, and fusion inhibitors]. However, studies have not been conducted on the simultaneous use of Darunavir Accord and ritonavir with all protease inhibitors (PI), and it cannot be used in combination with other protease inhibitors. In some cases, it may be necessary to change the dosage of other medicines. Therefore, in each case, inform your doctor about the use of other HIV medicines and strictly follow the doctor's recommendations regarding the simultaneous use of other medicines. The effectiveness of Darunavir Accord may be reduced when taken with one of the following products. Inform your doctor if you are taking:

• phenobarbital, phenytoin(antiepileptic drugs);
• dexamethasone(corticosteroid);
• efavirenz(HIV-1 infection);
• rifapentine, rifabutin(antituberculosis drugs);
• saquinavir(HIV-1 infection).

Taking Darunavir Accord may affect the effectiveness of other medicines, and your doctor may order additional blood tests. Inform your doctor if you are taking:

• amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, lidocaine, metoprolol, mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil(heart medicines), due to the possibility of increased therapeutic effects and side effects of these medicines;
• apixaban, edoxaban, rivaroxaban, warfarin, clopidogrel(anticoagulant medicine), due to the possibility of increased therapeutic effects and side effects of these medicines;
• hormonal contraceptives and hormone replacement therapy containing estrogens; Darunavir Accord may reduce their effectiveness; to avoid pregnancy, it is recommended to use other, non-hormonal methods of birth control;
• ethinyl estradiol with drospirenone. Darunavir Accord may increase the risk of hyperkalemia associated with drospirenone;
• atorvastatin, pravastatin, rosuvastatin(cholesterol-lowering medicines). There is an increased risk of muscle damage. The doctor will assess which cholesterol-lowering medicine is suitable for the patient in this situation;
• clarithromycin(antibiotic);
• cyclosporine, everolimus, tacrolimus, sirolimus(immunosuppressive medicines), due to the possibility of increased therapeutic effects and side effects of these medicines;
• corticosteroids, including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone. These medicines are used to treat allergies, asthma, inflammatory bowel diseases, skin, eye, joint, and muscle inflammation, and other inflammatory conditions. They are usually taken orally, inhaled, injected, or applied to the skin. If there are no alternative medicines, their use is possible only after the doctor's assessment and under the close monitoring of corticosteroid side effects by the attending doctor;
• buprenorphine/naloxone(medicines used to treat opioid addiction);
• salmeterol(medicine used to treat asthma);
• artemether/lumefantrine(combined medicine used to treat malaria);
• dasatinib, everolimus, irinotecan, nilotinib, vinblastine, vincristine(medicines used to treat cancer);
• sildenafil, tadalafil, vardenafil(medicines used to treat erectile dysfunction or pulmonary arterial hypertension);
• glecaprevir/pibrentasvir(used to treat hepatitis C virus infection);
• fentanyl, oxycodone, tramadol(pain relievers);
• fezoterodine, solifenacin(used to treat urological disorders).

Concomitant use of other medicines with Darunavir Accord may affect their therapeutic effects and side effects. Therefore, the attending doctor may order additional blood tests, and the dosage of other medicines may need to be changed. Inform your doctor if you are taking:

• dabigatran etexilate, edoxaban, warfarin (medicines that affect blood clotting);
• alfentanil(injection, a strong and short-acting pain reliever used in surgical procedures);
• digoxin(medicine used to treat certain heart diseases);
• clarithromycin(antibiotic);
• itraconazole, isavuconazole, fluconazole, posaconazole, clotrimazole(antifungal medicines). Voriconazolecan only be taken after consulting a doctor;
• rifabutin(medicine used to treat bacterial infections);
• sildenafil, vardenafil, tadalafil(medicines used to treat erectile dysfunction or pulmonary arterial hypertension);
• amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone(antidepressant and anxiolytic medicines);
• maraviroc(medicine used to treat HIV infection);
• methadone(medicine used to treat opioid addiction);
• carbamazepine, clonazepam(medicine used to prevent seizures or treat certain types of nerve pain);
• colchicine(used to treat gout or familial Mediterranean fever);
• bosentan(medicine used to treat pulmonary arterial hypertension);
• buspirone, clorazepate, diazepam, estazolam, flurazepam, midazolam(injection), zolpidem(sedative medicines);
• perphenazine, risperidone, thioridazine(antipsychotic medicines).

This is not a complete list of medicines. Inform your doctor about allmedicines you are taking.

Darunavir Accord with food and drink

See section 3 "How to take Darunavir Accord".

Pregnancy and breastfeeding

Inform your doctor immediately if you are pregnant or planning to become pregnant. Pregnant women should not take Darunavir Accord with ritonavir without special recommendation from their doctor. Pregnant women should not take Darunavir Accord with cobicistat. Due to the possibility of side effects in breastfed children, women should not breastfeed while taking Darunavir Accord. It is not recommended for HIV-infected women to breastfeed, as HIV can be transmitted to the child through breast milk. If you are breastfeeding or considering breastfeeding, consult your doctor as soon as possible.

Driving and using machines

Do not drive or operate machines if taking Darunavir Accord causes dizziness.

Darunavir Accord, 75 mg, film-coated tablets contain lactose

This medicine contains lactose. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

Darunavir Accord, 75 mg, film-coated tablets contain propylene glycol

This medicine contains 10.42 mg of propylene glycol in each film-coated tablet. If the treated child is less than 4 weeks old, consult the attending doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.

Darunavir Accord, 150 mg, film-coated tablets contain lactose

This medicine contains lactose. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

Darunavir Accord, 150 mg, film-coated tablets contain propylene glycol

This medicine contains 20.84 mg of propylene glycol in each film-coated tablet. If the treated child is less than 4 weeks old, consult the attending doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.

Darunavir Accord, 300 mg, film-coated tablets contain lactose

This medicine contains lactose. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

Darunavir Accord, 300 mg, film-coated tablets contain propylene glycol

This medicine contains 41.66 mg of propylene glycol in each film-coated tablet. If the treated child is less than 4 weeks old, consult the attending doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol. Darunavir Accord, 300 mg, film-coated tablets contain orange yellow S (E110), which may cause allergic reactions.

Darunavir Accord, 600 mg, film-coated tablets contain lactose

This medicine contains lactose. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

Darunavir Accord, 600 mg, film-coated tablets contain propylene glycol

This medicine contains 83.33 mg of propylene glycol in each film-coated tablet. If the child is less than 4 weeks old, consult the attending doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol. Darunavir Accord, 600 mg, film-coated tablets contain orange yellow S (E110), which may cause allergic reactions.

3. How to take Darunavir Accord

Take this medicine always as described in the patient information leaflet or as directed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse. If you notice significant improvement, do not stop taking Darunavir Accord with ritonavir without consulting your doctor. Do not change the dose, form of the medicine, or stop treatment without your doctor's advice.

Dosing for children aged 3 years and older, weighing at least 15 kg, who have not taken antiretroviral medicines before (determined by the attending doctor)

The doctor will determine the appropriate dose to be taken once daily based on the child's weight (see the table below). This dose should not exceed the recommended dose for adults, which is 800 mg of Darunavir Accord and 100 mg of ritonavir once daily. The doctor will inform you about the amount of darunavir and ritonavir (in capsules, tablets, or solution) the child should take.

Dosing for children aged 3 years and older, weighing at least 15 kg, who have taken antiretroviral medicines before (determined by the attending doctor)

The doctor will determine the appropriate dose based on the child's weight (see the table below). The doctor will assess whether once-daily or twice-daily dosing is suitable for the child. The dose should not exceed the recommended dose for adults, which is 600 mg of darunavir and 100 mg of ritonavir twice daily, or 800 mg of Darunavir Accord and 100 mg of ritonavir once daily. The doctor will inform you about the amount of darunavir tablets and ritonavir (capsules, tablets, or solution) the child should take.

Darunavir Accord is available in other strengths and the attending doctor may have prescribed a suitable combination to achieve the correct dosing. Darunavir is also available as an oral suspension. The attending doctor will assess whether darunavir tablets or oral suspension are suitable for the child. Twice-daily dosing: The child must take the appropriate dose of Darunavir Accord and ritonavir twice daily. If Darunavir Accord is prescribed twice daily, the child should take one dose in the morning and the second dose in the evening. The doctor will determine the correct dosing schedule for the child.

Instructions for taking Darunavir Accord in children:

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

Dosing for adults who have not taken antiretroviral medicines before (determined by the attending doctor)

The patient requires a different dose of Darunavir Accord that cannot be administered using these tablets. Other strengths of Darunavir Accord are available.

Dosing for adults who have taken antiretroviral medicines before (determined by the attending doctor)

The dose is:

• 600 mg of Darunavir Accord and 100 mg of ritonavir taken together twice daily. OR
• 800 mg of Darunavir Accord (2 tablets of 400 mg or 1 tablet of 800 mg) and 100 mg of ritonavir taken together once daily. To use the 800 mg once-daily regimen, only 400 mg or 800 mg Darunavir Accord tablets should be used.

Discuss with your doctor which dose is suitable for you. Recommendations for adults

• Take Darunavir Accord always in combination with ritonavir. Darunavir Accord does not work properly without ritonavir.
• Take 600 mg of darunavir in the morning and 100 mg of ritonavir.
• Take 600 mg of darunavir in the evening and 100 mg of ritonavir.

• Take Darunavir Accord with food. Darunavir Accord does not work properly when taken without food. The type of food is not important.
• Swallow the tablets with water or milk.
• Darunavir Accord 75 mg and 150 mg tablets are intended for use in children, but in some cases, they may also be used in adults.

Opening the child-resistant cap

The plastic bottle has a child-resistant cap. To open it, follow these steps:

• Press the plastic cap while turning it counterclockwise.
• Remove the opened cap.

Overdose of Darunavir Accord

Immediately consult your doctor, pharmacist, or nurse.

Missing a dose of Darunavir Accord

If a dose is missed within 6 hours, take the missed tablets as soon as possible. Each dose should be taken with ritonavir and food. If a dose is missed 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 the missed dose.

Vomiting after taking Darunavir Accord and ritonavir

If vomiting occurs within 4 hoursof taking the medicine, take another dose of darunavir and ritonavir as soon as possible with food. If vomiting occurs more than 4 hoursafter taking the medicine, do not take another dose of Darunavir Accord and ritonavir until the next scheduled dose. If in doubtabout what to do in case of a missed dose or vomiting, consult your doctor.

Do not stop taking Darunavir Accord without consulting your doctor

Antiretroviral medicines can make you feel better, but even if you feel better, do not stop taking the medicine without consulting your doctor. If you have any further doubts about taking this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

During HIV treatment, weight gain and increased 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 medicines themselves. Your doctor will order tests to monitor these changes. As with any medicine, Darunavir Accord can cause side effects, although not everybody gets them.

If you experience any of the following side effects, tell your doctor.

Liver problems have been reported, which in rare cases were severe. Your doctor will order blood tests before starting Darunavir Accord. If you have chronic hepatitis B or C virus infection, your doctor should order more frequent blood tests, as there is an increased risk of liver problems. Discuss with your doctor the symptoms of liver problems, which may include: yellowing of the skin or eyes, dark urine (tea-colored), pale stools, nausea, vomiting, loss of appetite, or pain or discomfort in the area below the ribs on the right side. Skin rash (occurring more frequently when taking raltegravir), itching. The rash is usually mild to moderate. The rash can also be a symptom of a rare but severe condition. If you experience this symptom, discuss it with your doctor. The doctor will recommend appropriate treatment for the symptoms or decide to stop taking Darunavir Accord. Other serious side effects included: diabetes (often) and pancreatitis (not very often). 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, somnolence, numbness, tingling, or pain in the hands or feet, weakness, insomnia.

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

• chest pain, changes in ECG, rapid heart rate;
• disorders or decreased skin sensation, numbness, tingling, concentration disorders, memory loss, balance disorders;
• breathing difficulties, cough, nosebleeds, throat irritation;
• gastritis, oral thrush, gastroesophageal reflux, bad taste, dry mouth, abdominal discomfort, constipation, belching;
• kidney failure, kidney stones, difficulty urinating, frequent or excessive urination, sometimes at night;
• hives, severe skin and tissue swelling (usually around the mouth or eyes), rash, excessive sweating, night sweats, hair loss, acne, flaky skin;
• muscle pain, muscle cramps, or decreased muscle strength, joint pain with or without inflammation;
• hypothyroidism, which can be detected by blood tests;
• high blood pressure, sudden flushing of the face;
• redness or dryness of the eyes;
• fever, swelling of the lower limbs due to fluid retention, feeling unwell, pain;
• infection symptoms, herpes;
• erectile dysfunction, breast enlargement in men;
• sleep disorders, drowsiness, depression, anxiety, strange dreams, decreased libido.

Rare side effects(may affect up to 1 in 1000 people):

• DRESS syndrome [severe rash, which may be accompanied by fever, fatigue, swelling of the face or lymph nodes, increased eosinophil count (a type of white blood cell), liver, kidney, or lung symptoms];
• heart attack, slow heart rate, palpitations;
• vision disorders;
• chills, malaise;
• feeling disoriented or lost, mood changes, restlessness;
• fainting, seizures, changes or loss of taste;
• mouth pain, bloody vomiting, oral thrush, dry mouth, abdominal discomfort;
• common cold;
• skin diseases, dry skin;
• muscle stiffness or joint pain with or without inflammation;
• blood cell count and biochemical test abnormalities. Changes can be observed in blood or urine test results. Your doctor will provide more information on this. For example, an abnormality may be an increased count of a certain type of white blood cell;
• darunavir crystals in the kidneys, causing kidney disease.

Side effects typical of HIV medicines in the same group as Darunavir Accord include:

• muscle pain, tenderness, or weakness. In rare cases, these disorders can be severe.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Darunavir Accord

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and bottle after "EXP". The expiry date refers to the last day of the month. There are no special storage instructions for Darunavir Accord. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Darunavir Accord contains

• The active substance is darunavir. Each film-coated tablet of Darunavir Accord, 75 mg, contains 75 mg of darunavir (in the form of darunavir with propylene glycol).

Each film-coated tablet of Darunavir Accord, 150 mg, contains 150 mg of darunavir (in the form of darunavir with propylene glycol). Each film-coated tablet of Darunavir Accord, 300 mg, contains 300 mg of darunavir (in the form of darunavir with propylene glycol). Each film-coated tablet of Darunavir Accord, 600 mg, contains 600 mg of darunavir (in the form of darunavir with propylene glycol).

• Other ingredients are: Darunavir Accord, 75 mg, film-coated tablets

Lactose monohydrate, microcrystalline cellulose, povidone K30, crospovidone, colloidal anhydrous silica, magnesium stearate. Coating (white): polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b). Darunavir Accord, 150 mg, film-coated tablets Lactose monohydrate, microcrystalline cellulose, povidone K30, crospovidone, colloidal anhydrous silica, magnesium stearate. Coating (white): polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b). Darunavir Accord, 300 mg, film-coated tablets Lactose monohydrate, microcrystalline cellulose, povidone K30, crospovidone, colloidal anhydrous silica, magnesium stearate. Coating (orange-1): polyvinyl alcohol (E1203), macrogol 3350 (E1521), titanium dioxide (E171), talc (E553b), orange yellow S, aluminum lake (E110). Darunavir Accord, 600 mg, film-coated tablets Lactose monohydrate, microcrystalline cellulose, povidone K30, crospovidone, colloidal anhydrous silica, magnesium stearate. Coating (orange-1): polyvinyl alcohol (E1203), macrogol 3350 (E1521), titanium dioxide (E171), talc (E553b), orange yellow S, aluminum lake (E110).

What Darunavir Accord looks like and contents of the pack

Darunavir Accord, 75 mg, film-coated tablets White, capsule-shaped tablets with the imprint "75" on one side, measuring: length 9.4 ± 0.2 mm, width 4.5 ± 0.2 mm, and thickness 3.4 ± 0.3 mm. Darunavir Accord, 150 mg, film-coated tablets White, oval tablets with the imprint "150" on one side, measuring: length 13.8 ± 0.2 mm, width 7.0 ± 0.2 mm, and thickness 3.6 ± 0.3 mm. Darunavir Accord, 300 mg, film-coated tablets Orange, oval tablets with the imprint "300" on one side, measuring: length 16.1 ± 0.2 mm, width 8.1 ± 0.2 mm, and thickness 5.2 ± 0.3 mm. Darunavir Accord, 600 mg, film-coated tablets Orange, oval tablets with the imprint "600" on one side, measuring: length 20.2 ± 0.2 mm, width 10.2 ± 0.2 mm, and thickness 6.8 ± 0.4 mm. A cardboard box containing a white, non-transparent bottle made of high-density polyethylene (HDPE) with a polypropylene child-resistant cap and a seal, and a patient information leaflet. Pack sizes: Darunavir Accord, 75 mg, film-coated tablets Pack containing 480 film-coated tablets (one bottle containing 480 film-coated tablets). Darunavir Accord, 150 mg, film-coated tablets Pack containing 240 film-coated tablets (one bottle containing 240 film-coated tablets). Darunavir Accord, 300 mg, film-coated tablets Pack containing 120 film-coated tablets (one bottle containing 120 film-coated tablets). Pack containing 30 film-coated tablets (one bottle containing 30 film-coated tablets). Darunavir Accord, 600 mg, film-coated tablets Pack containing 60 film-coated tablets (one bottle containing 60 film-coated tablets). Pack containing 180 film-coated tablets (three bottles containing 60 film-coated tablets each).

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o. ul. Taśmowa 7 02-677 Warsaw Tel: +48 22 577 28 00

Manufacturer / Importer

Pharmadox Healthcare Ltd. KW20A Kordin Industrial Park Paola, PLA3000 Malta Pharmathen International S.A. 6, Dervenakion street Pallini, Attiki, 153 51 Greece Pharmathen International S.A. Industrial Park Sapes Rodopi Prefecture, Block No 5 Rodopi, 69300 Greece LABORATORI FUNDACIÓ DAU C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona, 08040 Spain

This medicinal product is authorized in the Member States of the European

Economic Area under the following names:

Date of the last update of the leaflet: March 2025