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. It works by reducing the amount of virus in your body.

What Darunavir Accord is used for

Darunavir Accord is used to treat adults and children from 3 years of age and at least 40 kg in weight who are infected with HIV. Your doctor will prescribe Darunavir Accord together with other antiretroviral medicines to treat your HIV infection.

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 (a medicine used to boost the action of darunavir), or to any of the other ingredients of the ritonavir capsules or tablets.
• if you have severe liver disease.

Warnings and precautions

Before you start treatment with Darunavir Accord, your doctor will assess whether you have any liver problems. If you have severe liver disease, you should not take Darunavir Accord.

Tell your doctor if you have had any liver problems in the past. Your doctor may need to check your liver function while you are taking Darunavir Accord.

Some people taking Darunavir Accord can develop a skin rash. The risk of getting a skin rash is higher when Darunavir Accord is taken with raltegravir. The rash is usually mild to moderate.

However, in rare cases, it can be severe and require treatment in hospital.

It is important to tell your doctor if you develop any rash while you are taking Darunavir Accord.

Other medicines and Darunavir Accord

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

Some medicines can interact with Darunavir Accord, which may cause side effects or affect the way Darunavir Accord works.

Do not take Darunavir Accord with any of the following medicines:

Do not take Darunavir Accord with products containing St. John's Wort (Hypericum perforatum) as this may decrease the effectiveness of Darunavir Accord.

Other medicines that can interact with Darunavir Accord

Tell your doctor if you are taking any of the following medicines:

• phenobarbital, phenytoin (for epilepsy),
• dexamethasone (a corticosteroid),
• efavirenz (for HIV infection),
• rifapentine, rifabutin (for tuberculosis),
• saquinavir (for HIV infection).

Taking Darunavir Accord with these medicines may require a change in the dose of either Darunavir Accord or the other medicine.

Tell your doctor if you are taking any of the following medicines:

• amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, lidocaine, metoprolol, mexiletine, nifedipine, nicardipine, propafenone, timolol, and verapamil (for heart problems), as the levels of these medicines in your blood may increase or decrease.
• apixaban, edoxaban, rivaroxaban, and warfarin (for blood clots), as the levels of these medicines in your blood may increase or decrease.
• hormonal contraceptives, such as the pill, patch, or other forms of hormonal contraception, as the levels of these medicines in your blood may decrease. If you are using a hormonal contraceptive, you should use an additional barrier method of contraception, such as a condom.
• ethinyl estradiol with drospirenone, as the levels of drospirenone in your blood may increase.
• atorvastatin, pravastatin, and rosuvastatin (for high cholesterol), as the levels of these medicines in your blood may increase or decrease.
• clarithromycin (an antibiotic),
• cyclosporine, everolimus, tacrolimus, and sirolimus (to prevent rejection of organ transplants), as the levels of these medicines in your blood may increase or decrease.
• buprenorphine/naloxone (for opioid addiction),
• salmeterol (for asthma),
• artemether/lumefantrine (for malaria),
• dasatinib, everolimus, irinotecan, nilotinib, vinblastine, and vincristine (for cancer),
• sildenafil, tadalafil, and vardenafil (for erectile dysfunction or pulmonary arterial hypertension),
• glecaprevir/pibrentasvir (for hepatitis C),
• fentanyl, oxycodone, and tramadol (painkillers),
• fezoterodine and solifenacin (for urinary problems).

Tell your doctor if you are taking any of the following medicines:

• dabigatran, edoxaban, and warfarin (for blood clots),
• alfentanil (an anesthetic),
• digoxin (for heart problems),
• clarithromycin (an antibiotic),
• itraconazole, isavuconazole, fluconazole, posaconazole, and clotrimazole (for fungal infections),
• rifabutin (for tuberculosis),
• sildenafil, vardenafil, and tadalafil (for erectile dysfunction or pulmonary arterial hypertension),
• amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, and trazodone (for depression or anxiety),
• maraviroc (for HIV infection),
• methadone (for opioid addiction),
• carbamazepine and clonazepam (for epilepsy or anxiety),
• colchicine (for gout),
• bosentan (for pulmonary arterial hypertension),
• buspirone, clorazepate, diazepam, estazolam, flurazepam, midazolam (given by injection), and zolpidem (for anxiety or insomnia),
• perphenazine, risperidone, and thioridazine (for psychosis),
• metformin (for diabetes).

This is not a complete list of medicines that can interact with Darunavir Accord.

Darunavir Accord with food and drink

See section 3, "How to take Darunavir Accord".

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Women who are pregnant should not take Darunavir Accord with ritonavir without consulting their doctor.

Women who are pregnant should not take Darunavir Accord with cobicistat.

Mothers taking Darunavir Accord should not breast-feed their babies.

It is recommended that HIV-infected women do not breast-feed their babies to avoid transmitting the virus.

Driving and using machines

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

Darunavir Accord 400 mg film-coated tablets contain sunset yellow FCF (E110)

This may cause allergic reactions.

Darunavir Accord 400 mg film-coated tablets contain lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Darunavir Accord 400 mg film-coated tablets contain propylene glycol

This medicine contains 55.55 mg of propylene glycol in each film-coated tablet.

Darunavir Accord 800 mg film-coated tablets contain lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Darunavir Accord 800 mg film-coated tablets contain propylene glycol

This medicine contains 111.1 mg of propylene glycol in each film-coated tablet.

3. How to take Darunavir Accord

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Do not stop taking Darunavir Accord without consulting your doctor.

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

Take Darunavir Accord with food and with ritonavir 100 mg or cobicistat 150 mg once daily.

Swallow the tablets with a glass of water.

Take Darunavir Accord at about the same time every day.

Children from 3 years of age and at least 40 kg in weight

The dose is 800 mg (two 400 mg tablets or one 800 mg tablet) once daily with ritonavir 100 mg or cobicistat 150 mg.

If you take more Darunavir Accord than you should

Contact your doctor or pharmacist immediately.

If you forget to take Darunavir Accord

If you notice that you have missed a dose within 12 hours of the time you usually take it, take the missed dose as soon as possible with ritonavir and food.

If you notice that you have missed a dose by more than 12 hours, skip the missed dose and take the next dose at the usual time.

If you vomit after taking Darunavir Accord

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

If you vomit more than 4 hours after taking Darunavir Accord, do not take another dose until your next regular dose.

Do not stop taking Darunavir Accord without consulting your doctor

Even if you feel better, do not stop taking Darunavir Accord without consulting your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects are serious, and you should tell your doctor immediately if you get any of the following:

• severe skin reactions, including Stevens-Johnson syndrome and erythema multiforme,
• liver problems, including yellowing of the skin or eyes, dark urine, pale stools, nausea, vomiting, loss of appetite, or pain in the abdomen,
• allergic reactions, including hives, itching, swelling, or difficulty breathing,
• changes in blood tests, including increases in liver enzymes or bilirubin.

Common side effects (may affect up to 1 in 10 people) include:

• diarrhea,
• nausea, vomiting, abdominal pain, or discomfort,
• headache, fatigue, dizziness, or sleepiness.

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

• abdominal distension, flatulence, or constipation,
• pruritus, or rash,
• myalgia, or arthralgia,
• neutropenia, or thrombocytopenia.

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

• severe skin reactions, including DRESS syndrome,
• myocardial infarction, or arrhythmia,
• visual disturbances, or blurred vision,
• chills, or malaise,
• confusion, or disorientation,
• seizures, or tremors.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

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. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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.

The pack contains 60 film-coated tablets.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.

Manufacturer

Pharmadox Healthcare Ltd.

Further information

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

Date of revision of the text

March 2025