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 the patient.

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

Table of contents

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 is Darunavir Accord?
Darunavir Accord contains the active substance darunavir. Darunavir Accord is an antiretroviral medicine used in the treatment of human immunodeficiency virus (HIV) infection.
Darunavir Accord 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 is it 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 previously been treated with other antiretroviral medicines.
Darunavir Accord must be taken in combination with a low dose of ritonavir and other anti-HIV medicines. The optimal combination of medicines for the patient will be determined by the treating doctor.

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.

Please 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, please consult your doctor about changing your treatment regimen.

Do not use products containing St. John's wort (Hypericum perforatum) 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 HIV-related illnesses and should maintain regular contact with their doctor.
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.
Rash (usually mild or moderate) may occur more frequently in patients taking Darunavir Accord and raltegravir (for HIV treatment) together 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 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 and signs of inflammation related to prior infections may appear shortly 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 arising when the immune system attacks healthy body tissues) may also occur after starting antiretroviral therapy for HIV infection. Autoimmune disorders may manifest many months after treatment initiation. If you notice 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 initiate necessary treatment.
• Inform your doctor if you have haemophilia. Darunavir Accord 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 caused by impaired blood supply to bone tissue). Risk factors for developing this condition 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 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
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 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 another class [e.g., NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists, and IFs (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 taking 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 one of the following products. Inform your doctor if you are taking:

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

Taking Darunavir Accord may affect the effectiveness of other medicines; 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 (cardiac medicines), due to the potential for increased therapeutic effect and adverse reactions of these medicines;
• apixaban, dabigatran etexilate, edoxaban, rivaroxaban, warfarin, clopidogrel (anticoagulant medicines), due to the potential for increased therapeutic effect and adverse reactions of these medicines;
• hormonal contraceptives and hormone replacement therapy containing estrogens; Darunavir Accord may reduce their effectiveness; to avoid 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 (an antibiotic);
• cyclosporine, everolimus, tacrolimus, sirolimus (immunosuppressive medicines), due to the potential for increased therapeutic effect and adverse reactions 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. These medicines are usually taken orally, inhaled, injected, or applied to the skin. If no alternative medicines are available, use of these medicines is possible only after evaluation by a doctor and under strict monitoring for corticosteroid adverse effects by the treating physician;
• buprenorphine/naloxone (medicines used in opioid dependence treatment);
• salmeterol (a medicine used in asthma treatment);
• artemether/lumefantrine (a 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 in the treatment of heart and lung disorders, so-called pulmonary arterial hypertension);
• glecaprevir/pibrentasvir (used in the treatment of hepatitis C virus infection);
• fentanyl, oxycodone, tramadol (painkillers);
• 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 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 (for injection, a potent and short-acting painkiller used in surgical procedures);
• digoxin (a medicine used in the treatment of certain heart conditions);
• clarithromycin (an antibiotic);
• itraconazole, isavuconazole, fluconazole, posaconazole, clotrimazole (antifungal medicines). Voriconazole may be taken only after consultation with a doctor;
• rifabutin (a medicine for bacterial infections);
• sildenafil, vardenafil, tadalafil (medicines for erectile dysfunction or high blood pressure in the pulmonary circulation);
• amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (antidepressants and anxiolytics);
• maraviroc (a medicine used in HIV infection);
• methadone (a medicine used in opioid dependence treatment);
• carbamazepine, clonazepam (medicines preventing seizures or used in treating certain types of nerve pain);
• colchicine (in the treatment of gout or familial Mediterranean fever);
• bosentan (a medicine used in the treatment of high blood pressure in the pulmonary circulation);
• 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 infected with HIV, as HIV can be transmitted to the child through breast milk. If you are breastfeeding or considering breastfeeding, you should consult your doctor as soon as possible.
Driving and operating machinery
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 been previously 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 been previously 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 been previously 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 (E110), which may cause allergic reactions.
Darunavir Accord 600 mg film-coated tablets contain lactose
This medicine contains lactose. If you have been previously 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 (E110), which may cause allergic reactions.

3. How to take Darunavir Accord

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

After starting treatment, do not change the dose, formulation, or discontinue therapy without medical advice.

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 physician)

The physician 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.

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

Dosing in children aged 3 years and older, weighing at least 15 kg, who have previously received
antiretroviral drugs (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 Accord and 100 mg ritonavir once daily.
The physician will advise how many darunavir tablets and how much ritonavir (capsules, tablets, or oral solution) the child should take. Tablets of different strengths are available, and the treating physician may have prescribed a combination to achieve the correct dose. An oral suspension formulation of darunavir is also available. The treating physician will determine whether darunavir tablets or oral suspension are 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 Darunavir Accord has been prescribed twice daily, 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 simultaneously 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 simultaneously 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 the doctor which dose is appropriate for the patient.
Recommendations for adults

• Always take Darunavir Accord with ritonavir. Darunavir Accord does not work properly without ritonavir.
• Take 600 mg of darunavir in the morning simultaneously with 100 mg of ritonavir.
• Take 600 mg of darunavir in the evening simultaneously 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 Darunavir Accord tablets 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 than the prescribed dose of Darunavir Accord
Contact your doctor, pharmacist, or nurse immediately.

Missed 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 food. 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 scheduled dose.

If in doubt about what to do in case of a missed dose or vomiting, 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 well, 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, as well as blood lipid and glucose levels, may occur. This is partly related to improved health status and lifestyle, and in the case of blood lipid levels, sometimes to the antiretroviral treatment itself. Your doctor will order tests to monitor these changes.

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone. If any of the adverse reactions described below 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 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 discuss with your doctor the 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 commonly occurring 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 Accord.

Other serious adverse reactions included: diabetes (frequent) 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, somnolence, numbness, tingling or pain in hands or feet, loss of strength, difficulty sleeping.

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

• chest pain, changes in ECG recording, rapid heartbeat;
• disturbances or loss of skin sensation, tingling, difficulty concentrating, memory loss, balance disorders;
• difficulty breathing, cough, nosebleeds, throat irritation;
• 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 urinating, too 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 decreased muscle strength, limb pain, osteoporosis;
• slowing of thyroid activity, which may be detected based on blood test results;
• hypertension, sudden flushing of the face;
• redness or dryness of the eyes;
• 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, reduced 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), liver, kidney or lung involvement];
• heart attack, slow heartbeat, palpitations;
• visual disturbances;
• chills, malaise;
• feeling lost 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;
• disturbances in blood cell composition and biochemical test results. Changes may be observed in blood or urine tests. Your doctor will provide detailed explanations on this matter. An example of such a disturbance is an increase in a certain type of white blood cells;
• darunavir crystals in the kidneys causing kidney disease.

Adverse reactions typical for antiretroviral medicines in the same class as Darunavir Accord include:

• muscle pain, tenderness or weakness. In rare cases, such disorders may be 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 may also be reported to the marketing authorization holder.

By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Darunavir Accord

Keep this medicine out of 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 specified 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Darunavir Accord contains

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

Each Darunavir Accord 150 mg coated tablet contains 150 mg of darunavir (as darunavir propylene glycol solvate).
Each Darunavir Accord 300 mg coated tablet contains 300 mg of darunavir (as darunavir propylene glycol solvate).
Each Darunavir Accord 600 mg coated tablet 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 engraved marking “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 engraved marking “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 engraved marking “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 engraved marking “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 sealing, and the 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 in the European Economic Area countries under the following names: