Darunavir accord

Package leaflet: 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
Darunavirum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as 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 someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What Darunavir Accord is and what it is used for
2. What you need to know before taking Darunavir Accord
3. How to take Darunavir Accord
4. Possible side effects
5. How to store Darunavir Accord
6. Contents of the pack and other information

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

What Darunavir Accord is
Darunavir Accord contains the active substance darunavir. Darunavir Accord is an antiretroviral medicine used to treat human immunodeficiency virus (HIV) infection.
It belongs to a group of medicines called protease inhibitors. Darunavir Accord 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 it is used for
Darunavir Accord is used to treat HIV-infected adults and children aged 3 years and older with a body weight above 15 kg who have been previously treated with other antiretroviral medicines.
Darunavir Accord 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. What you need to know before taking Darunavir Accord

Do not take Darunavir Accord

• if you are allergic to darunavir, or to any of the other ingredients of this medicine (listed in section 6), or to ritonavir,
• if you have severe liver problems. If you are unsure about liver-related conditions or their nature, consult your doctor. Additional tests may be required.

You must inform your doctor about all medicines you are taking, including those taken orally, by inhalation, by injection or applied to the skin.
Do not take Darunavir Accord with the following medicines
If you are taking any of the medicines listed below, talk to your doctor about changing your treatment.

Products containing St John's wort (Hypericum perforatum) must not be used during treatment with Darunavir Accord.
Warnings and precautions
Before starting treatment with Darunavir Accord, discuss this with your doctor, pharmacist, or nurse.
Darunavir Accord will not cure HIV infection.
Patients taking Darunavir Accord remain at risk of developing infections or other illnesses associated with HIV, so regular medical follow-up is essential.
Skin rash may occur in patients taking Darunavir Accord. Rarely, this rash may become severe or potentially life-threatening. If a rash develops, contact your doctor.
Skin rash (usually mild or moderate) may occur more frequently in patients taking Darunavir Accord and raltegravir together (for treatment of HIV infection) than in patients taking either drug alone.
When to inform your doctor about your health status BEFORE and DURING treatment
After reviewing the points below, the patient should inform the 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 Accord can be taken.
• Inform your doctor if you have diabetes. Darunavir Accord may increase blood glucose levels.
• Inform your doctor immediately if you notice signs of infection (e.g. swollen lymph nodes, fever). In some patients with advanced HIV infection and a history of opportunistic infections, symptoms and signs of inflammation from prior infections may appear soon after starting antiretroviral therapy. These symptoms are believed to result from an enhanced immune response, enabling the body to fight previously asymptomatic infections.
• In addition to opportunistic infections, autoimmune diseases (conditions in which the immune system attacks healthy body tissues) may also occur after starting HIV treatment. Autoimmune disorders may appear many months after treatment initiation. If you experience symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and progressing toward the trunk, palpitations, tremors, or hyperactivity, contact your doctor immediately to begin necessary treatment.
• Inform your doctor if you have haemophilia. Darunavir Accord may increase the risk of bleeding.
• Inform your doctor if you are allergic to sulfonamides (used, for example, in treating certain infections).
• Inform your doctor if you have 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 condition include: long duration of combination antiretroviral therapy, corticosteroid use, alcohol consumption, profound immunosuppression, increased body mass index, and others. Symptoms of osteonecrosis include: joint pain and stiffness (especially in hips, knees, or shoulders) and difficulty moving. Inform your doctor if any of these symptoms occur.

Elderly patients
Darunavir Accord has been used in only a small number of patients aged 65 years or older.
If you belong to this age group, you should consult your doctor to discuss the possibility of taking this medicine.
Children
Darunavir Accord must not be used in children under 3 years of age or weighing less than 15 kg.
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 combined with Darunavir Accord. A list of these medicines is provided in the section “Do not use Darunavir Accord with the following medicines”.
In most cases, Darunavir Accord can be used together with HIV medicines from other classes [e.g. NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists, and FIs (fusion inhibitors)]. Studies have not been conducted on the concomitant use of Darunavir Accord 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 the use of other HIV medicines and strictly follow your doctor’s instructions regarding concomitant use of other medicines.
The effectiveness of Darunavir Accord may be reduced when taken together with any of the following products. Inform your doctor if you are taking:

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

Taking Darunavir Accord may affect the effectiveness of other medicines. Your treating 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 (cardiovascular medicines), due to the potential for increased therapeutic effects and adverse reactions of these drugs;
• apixaban, dabigatran etexilate, edoxaban, rivaroxaban, warfarin, clopidogrel (anticoagulants), due to the potential for increased therapeutic effects and adverse reactions of these drugs;
• hormonal contraceptives and hormone replacement therapies containing estrogens; Darunavir Accord may reduce their effectiveness; to avoid unintended pregnancy, use of alternative non-hormonal methods of birth control is recommended;
• ethinylestradiol with drospirenone. Darunavir Accord may increase the risk of elevated potassium levels associated with drospirenone;
• atorvastatin, pravastatin, rosuvastatin (cholesterol-lowering medicines). There is an increased risk of muscle damage. Your doctor will assess which cholesterol-lowering medicine is appropriate for you in this situation;
• clarithromycin (antibiotic);
• cyclosporine, everolimus, tacrolimus, sirolimus (immunosuppressants), due to the potential for increased therapeutic effects and adverse reactions of these drugs;
• 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. These medicines are usually taken orally, by inhalation, by injection, or applied to the skin. If no alternative medicines are available, use of these drugs is possible only after evaluation by a doctor 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 in erectile dysfunction or in heart and lung disorders, so-called pulmonary arterial hypertension);
• glecaprevir/pibrentasvir (used in the treatment of hepatitis C virus infection);
• fentanyl, oxycodone, tramadol (analgesics);
• fesoterodine, solifenacin (in the treatment of urological disorders).

Concomitant administration of other medicines with Darunavir Accord may affect their therapeutic effects and adverse reactions. Therefore, your treating doctor may order additional blood tests, and dosage adjustments of other medicines may be required.
Inform your doctor if you are taking:

• dabigatran etexilate, edoxaban, warfarin (medicines affecting blood coagulation);
• alfentanil (injection, a 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 (antifungals). Voriconazole may be taken only after consultation with a doctor;
• rifabutin (medicine for bacterial infections);
• sildenafil, vardenafil, tadalafil (medicines for erectile dysfunction or pulmonary hypertension);
• amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (antidepressants and anxiolytics);
• maraviroc (medicine used in HIV infection);
• methadone (medicine used in opioid dependence treatment);
• carbamazepine, clonazepam (medicines 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 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 specific medical advice.
Pregnant women should not take Darunavir Accord with cobicistat.
Due to the potential for adverse effects in breastfed infants, women should not breastfeed while taking Darunavir Accord.
Breastfeeding is not recommended for women with HIV infection, 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 machinery if taking Darunavir Synoptis causes dizziness.
Darunavir Accord 75 mg film-coated tablets contain lactose
This medicine contains lactose. If you have previously been diagnosed with intolerance to certain sugars, you should contact your doctor before taking this 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 child being treated is less than 4 weeks old, talk to your doctor or pharmacist before giving this medicine, especially if the child is receiving other medicines containing propylene glycol or alcohol.
Darunavir Accord 150 mg film-coated tablets contain lactose
This medicine contains lactose. If you have previously been diagnosed with intolerance to certain sugars, you should contact your doctor before taking this 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 child being treated is less than 4 weeks old, talk to your doctor or pharmacist before giving this medicine, especially if the child is receiving other medicines containing propylene glycol or alcohol.
Darunavir Accord 300 mg film-coated tablets contain lactose
This medicine contains lactose. If you have previously been diagnosed with intolerance to certain sugars, you should contact your doctor before taking this 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 child being treated is less than 4 weeks old, talk to your doctor or pharmacist before giving this medicine, especially if the child is receiving other medicines containing propylene glycol or alcohol.
Darunavir Accord 300 mg film-coated tablets contain sunset yellow FCF (E110), which may cause allergic reactions.
Darunavir Accord 600 mg film-coated tablets contain lactose
This medicine contains lactose. If you have previously been diagnosed with intolerance to certain sugars, you should contact your doctor before taking this 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, talk to your doctor or pharmacist before giving this medicine, especially if the child is receiving other medicines containing propylene glycol or alcohol.
Darunavir Accord 600 mg film-coated tablets contain sunset yellow FCF (E110), which may cause allergic reactions.

3. How to take Darunavir Accord

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. Even if you notice a clear improvement, do not stop taking Darunavir Accord together with ritonavir without first consulting your treating doctor.

Do not change the dose, formulation, or discontinue treatment after starting therapy without medical advice from your doctor.

Dosage for children aged 3 years and older, weighing at least 15 kg, who have not previously received antiretroviral therapy (to be determined by the treating doctor)

Your 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 Accord and 100 mg of ritonavir once daily.

Your doctor will inform you how much darunavir and how much ritonavir (in capsules, tablets, or oral solution) the child should take.

Dosing for children aged 3 years and older, weighing at least 15 kg, who have previously received
antiretroviral therapy (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 of darunavir and 100 mg of ritonavir twice daily, or 800 mg of Darunavir Accord and 100 mg of ritonavir once daily.
The physician will advise how many darunavir tablets and how much ritonavir (in capsules, tablets, or solution) the child should take. Darunavir 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 determine whether darunavir tablets or the oral suspension is more suitable for the child.
Twice-daily dosing

Once-daily dosing

Instructions for using Darunavir Accord in children:

• The child must always take Darunavir Accord in combination with ritonavir. Darunavir Accord does not work properly without ritonavir.
• The child must take the appropriate dose of Darunavir Accord and ritonavir twice daily or once daily. If twice-daily dosing is prescribed, the child must take one dose in the morning and one 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 must swallow the tablets with water or milk.

Dosing in adults who have not previously taken antiretroviral medicines
(to be determined by the treating physician)
The patient requires a dose of Darunavir Accord that cannot be achieved with these tablets.
Other strengths of Darunavir Accord are available.

Dosing in adults who have previously taken antiretroviral medicines (to be determined by the
treating physician)
The dose is:

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

Please discuss with your doctor which dose is appropriate for the patient.

Recommendations for adults

• Always take Darunavir Accord together with ritonavir. Darunavir Accord does not work properly without ritonavir.
• Take 600 mg of darunavir in the morning together with 100 mg of ritonavir.
• Take 600 mg of darunavir in the evening together with 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.
• The 75 mg and 150 mg tablets of Darunavir Accord are intended for use in children, but in certain cases may also be used in adults.

How to open the child-resistant cap
The plastic bottle is equipped with a child-resistant cap. Open it as follows:

• press down on the plastic cap while turning it counterclockwise;

• remove the loosened cap.

Taking more Darunavir Accord than recommended
Contact your doctor, pharmacist, or nurse immediately.

Missing a dose of Darunavir Accord
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.

If vomiting occurs after taking Darunavir Accord and ritonavir
If vomiting occurs within 4 hours of taking the medicine, take another dose of darunavir and ritonavir as soon as possible, together with food. If vomiting occurs more than 4 hours after taking the medicine, do not take another dose of Darunavir Accord and ritonavir—wait until the next regularly scheduled dose.

If in doubt about what to do when a dose is missed or vomiting occurs, contact your doctor.

Do not stop taking Darunavir Accord 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, contact your doctor, pharmacist, or nurse.

4. Possible adverse reactions

During treatment for HIV infection, increases in body weight and blood levels of lipids and glucose 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 will get them.
If any of the adverse reactions described below occur, you should inform your doctor.

Hepatic complications have been reported, which very rarely became severe. Your doctor will order a blood test before starting treatment with Darunavir Accord. 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 talk to your doctor about symptoms of liver dysfunction, which 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 common when used concomitantly with raltegravir), itching. Skin rash is usually mild to moderate in severity. However, skin rash may also be a sign of a rare but serious condition. Therefore, if this symptom occurs, you should consult your doctor. Your doctor will decide on appropriate symptomatic treatment or whether to discontinue Darunavir Accord.

Other serious adverse reactions included: diabetes (common) and pancreatitis (uncommon).

Very common adverse reactions (may occur in more than 1 in 10 patients):

• diarrhoea.

Common adverse reactions (may occur in up to 1 in 10 patients):

• vomiting, nausea, abdominal pain or bloating, indigestion, flatulence;
• headache, fatigue, dizziness, drowsiness, numbness, tingling or pain in hands or feet, weakness, difficulty falling asleep.

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• chest pain, changes in ECG recording, rapid heartbeat;
• sensory disturbances or loss of skin sensation, tingling, difficulty concentrating, memory loss, balance disorders;
• difficulty breathing, cough, nosebleed, throat irritation;
• inflammation of the stomach or mouth, heartburn, retching (without vomiting), dry mouth, abdominal discomfort, constipation, belching;
• kidney failure, kidney stones, difficulty passing urine, frequent or excessive urination, sometimes at night;
• urticaria, severe swelling of the skin and other tissues (most commonly lips or eyes), rash, excessive sweating, night sweats, hair loss, acne, scaly skin, pigment deposition in nails;
• muscle pain, muscle cramps or reduced muscle strength, limb pain, osteoporosis;
• reduced thyroid activity, which may be detected from blood test results;
• hypertension, sudden flushing of the facial skin;
• redness or dryness of the eyeballs;
• fever, swelling of the lower limbs due to fluid retention, malaise, irritability, pain;
• signs of infection, herpes;
• erectile dysfunction, gynaecomastia (enlargement of breast glands in men);
• sleep disorders, somnolence, depression, anxiety, strange dreams, decreased libido.

Rare adverse reactions (may occur in up to 1 in 1000 patients):

• 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, feeling unwell;
• confusion or disorientation, 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;
• muscle or joint stiffness, joint pain with or without inflammation;
• blood count and biochemical test abnormalities. Changes may be observed in blood or urine tests. Your doctor will provide detailed explanations on this matter. An example is an increase in a certain type of white blood cells;
• darunavir crystals in the kidneys causing kidney disease.

Adverse reactions typical of antiretroviral drugs in the same class as Darunavir Accord 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 or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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
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 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 stated month.
There are no special requirements for the storage conditions of Darunavir Accord.
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 pack and other information

What Darunavir Accord contains

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

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

• Other ingredients are:
  Darunavir Accord, 75 mg, coated tablets
  Monohydrate lactose, microcrystalline cellulose, povidone K30, crospovidone, anhydrous colloidal silicon dioxide, magnesium stearate.
  Coating Coating (white): polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b).

Darunavir Accord, 150 mg, coated tablets
Monohydrate lactose, microcrystalline cellulose, povidone K30, crospovidone, anhydrous colloidal silicon dioxide, magnesium stearate.
Coating Coating (white): polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b).

Darunavir Accord, 300 mg, coated tablets
Monohydrate lactose, microcrystalline cellulose, povidone K30, crospovidone, anhydrous colloidal silicon dioxide, magnesium stearate.
Coating Coating (orange-1): polyvinyl alcohol (E1203), macrogol 3350 (E1521), titanium dioxide (E171), talc (E553b), sunset yellow FCF, aluminium lake (E110).

Darunavir Accord, 600 mg, coated tablets
Monohydrate lactose, microcrystalline cellulose, povidone K30, crospovidone, anhydrous colloidal silicon dioxide, magnesium stearate.
Coating Coating (orange-1): polyvinyl alcohol (E1203), macrogol 3350 (E1521), titanium dioxide (E171), talc (E553b), sunset yellow FCF, aluminium lake (E110).

What Darunavir Accord looks like and contents of the pack
Darunavir Accord, 75 mg, 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 Accord, 150 mg, 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 Accord, 300 mg, 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 Accord, 600 mg, 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 a white, opaque high-density polyethylene (HDPE) bottle with a child-resistant polypropylene cap and seal, and a package leaflet.

Pack sizes:
Darunavir Accord, 75 mg, coated tablets
Pack containing 480 coated tablets (One bottle containing 480 coated tablets).

Darunavir Accord, 150 mg, coated tablets
Pack containing 240 coated tablets (One bottle containing 240 coated tablets).

Darunavir Accord, 300 mg, coated tablets
Pack containing 120 coated tablets (One bottle containing 120 coated tablets).
Pack containing 30 coated tablets (One bottle containing 30 coated tablets).

Darunavir Accord, 600 mg, coated tablets
Pack containing 60 coated tablets (One bottle containing 60 coated tablets).
Pack containing 180 coated tablets (Three bottles each containing 60 coated tablets).

Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa 7 Street
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 authorised for marketing in the European Economic Area countries under the following names: