Darunavir Accord

Package Leaflet: Information for the User

Darunavir Accord, 400 mg, Film-Coated Tablets

Darunavir Accord, 800 mg, Film-Coated Tablets

Darunavir

Read All of This Leaflet Carefully Before You Start Taking This Medicine.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack and Other Information

• 1. What Darunavir Accord is and what it is used for
• 2. What you need to know before you take 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 HIV infection in adults and children from 3 years of age and at least 40 kg in weight.

What Darunavir Accord is used for

Darunavir Accord is used to treat HIV infection in adults and children from 3 years of age and at least 40 kg in weight. It is always used with other antiretroviral medicines.

2. What you need to know before you take Darunavir Accord

Do not take Darunavir Accord

• if you are allergic to darunavir or any of the other ingredients of this medicine (listed in section 6), or to ritonavir.
• if you have severe liver problems.

Do not take Darunavir Accord with any of the following medicines

Tell your doctor if you are taking any of these medicines:

Do not take Darunavir Accord with St. John's Wort (Hypericum perforatum).

Warnings and precautions

Tell your doctor or pharmacist before taking Darunavir Accord:

• if you have had liver problems in the past, including hepatitis B or C.
• if you have diabetes.
• if you notice any symptoms of infection (e.g., enlarged lymph nodes, fever).
• if you have hemophilia.
• if you are allergic to sulfa medicines.
• if you have muscle problems.

Older people

Darunavir Accord has only been studied in a small number of patients over the age of 65.

Children

Darunavir Accord is not recommended for children under 3 years of age or weighing less than 40 kg.

Other medicines and Darunavir Accord

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Darunavir Accord with food and drink

See section 3 "How to take Darunavir Accord".

Pregnancy and breast-feeding

Do not take Darunavir Accord during pregnancy unless your doctor has told you to do so.

Driving and using machines

Do not drive or operate machinery if you feel dizzy after taking Darunavir Accord.

Darunavir Accord contains

Darunavir Accord 400 mg tablets contain sunset yellow FCF (E110), which may cause allergic reactions.

3. How to take Darunavir Accord

Always take Darunavir Accord exactly as your doctor has told you.

Adult patients who have not taken antiretroviral medicines before

The usual dose is 800 mg (two 400 mg tablets or one 800 mg tablet) once daily.

Adult patients who have taken antiretroviral medicines before

The dose is 800 mg (two 400 mg tablets or one 800 mg tablet) once daily, or 600 mg twice daily.

Children from 3 years of age and at least 40 kg in weight who have not taken antiretroviral medicines before

The dose is 800 mg (two 400 mg tablets or one 800 mg tablet) once daily.

Children from 3 years of age and at least 40 kg in weight who have taken antiretroviral medicines before

The dose is 800 mg (two 400 mg tablets or one 800 mg tablet) once daily, or 600 mg twice daily.

What to do if you forget to take Darunavir Accord

If you forget to take a dose within 12 hours of the time you usually take it, take it as soon as you can.

What to do if you vomit after taking Darunavir Accord

If you vomit within 4 hours of taking Darunavir Accord, take another dose as soon as possible.

4. Possible side effects

Like all medicines, Darunavir Accord can cause side effects, although not everybody gets them.

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, indigestion, bloating.
• Headache, fatigue, dizziness, somnolence, numbness, tingling, or pain in hands or feet.

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

• Chest pain, changes in ECG, fast heart rate.
• Abnormal sensations (e.g., tingling, numbness), tremor, concentration problems, memory problems.
• Difficulty breathing, cough, nosebleed, throat irritation.
• Stomach inflammation or mouth ulcers, acid reflux, dry mouth, abdominal discomfort, constipation.
• Kidney problems, kidney stones, difficulty urinating, frequent or excessive urination.
• Rash, itching, excessive sweating, hair loss, acne, skin discoloration.
• Muscle pain, muscle spasms, or muscle weakness, joint pain with or without inflammation.
• Changes in blood test results.

Rare side effects (may affect up to 1 in 1,000 people)

• Severe skin reactions (e.g., DRESS syndrome), heart attack, slow heart rate, palpitations.
• Visual disturbances, chills, malaise.
• Confusion, mood changes, restlessness.
• Fainting, seizures, changes in taste or smell.
• Oral ulcers, bleeding gums, dry mouth, mouth inflammation, tongue discoloration.
• Respiratory problems (e.g., bronchitis), skin problems (e.g., dry skin, skin discoloration).
• Joint or muscle pain, joint inflammation, muscle spasms.
• Changes in blood test results.

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 which is stated on the carton and blister after EXP.

Do not throw away any medicines via wastewater or household waste.

6. Contents of the pack and other information

What Darunavir Accord contains

The active substance is darunavir.

What Darunavir Accord looks like and contents of the pack

Darunavir Accord 400 mg film-coated tablets are orange, oval tablets with "400" engraved on one side.

Darunavir Accord 800 mg film-coated tablets are red, oval tablets with "800" engraved on one side.

Marketing Authorisation Holder

Accord Healthcare Polska Sp. z o.o.

Manufacturer

Pharmadox Healthcare Ltd.

This medicinal product is authorised in the Member States of the EEA under the following names:

Date of last revision of the leaflet

March 2025