Darunavir Sandoz

Package Leaflet: Information for the Patient

Darunavir Sandoz, 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 or pharmacist.
• 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Darunavir Sandoz and What is it Used For
• 2. Important Information Before You Take Darunavir Sandoz
• 3. How to Take Darunavir Sandoz
• 4. Possible Side Effects
• 5. How to Store Darunavir Sandoz
• 6. Contents of the Pack and Other Information

1. What is Darunavir Sandoz and What is it Used For

What is Darunavir Sandoz

Darunavir Sandoz contains the active substance darunavir. Darunavir Sandoz is an antiretroviral medicine used to treat HIV infection in adults and children from the age of 3 years and at least 15 kg body weight. It belongs to a group of medicines called protease inhibitors, which are used to treat HIV infection.

What is Darunavir Sandoz Used For

Darunavir Sandoz is used to treat adults and children from the age of 3 years and weighing at least 15 kg who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).

Darunavir Sandoz should be taken in combination with other HIV medicines.

2. Important Information Before You Take Darunavir Sandoz

When Not to Take Darunavir Sandoz

Do not take Darunavir Sandoz:

• if you are allergic (hypersensitive) to darunavir or any of the other ingredients of Darunavir Sandoz
• if you have severe liver problems

Tell your doctor if you have any of the following conditions:

• liver problems (such as hepatitis B or C)
• diabetes

Warnings and Precautions

Before you start taking Darunavir Sandoz, your doctor will explain the benefits and risks of taking it.

Darunavir Sandoz does not cure HIV infection. You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.

People taking Darunavir Sandoz may still develop infections or other illnesses associated with HIV infection.

It is essential to keep in regular contact with your doctor and to monitor your health while taking Darunavir Sandoz.

Tell Your Doctor Before and During Treatment

Before you start treatment, tell your doctor:

• if you have had liver disease, including chronic hepatitis B or C
• if you have diabetes

3. How to Take Darunavir Sandoz

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

Do not stop taking Darunavir Sandoz without your doctor's advice.

The recommended dose of Darunavir Sandoz for adults is 800 mg once daily.

Special Warnings and Precautions for Use

Do not take Darunavir Sandoz if you have any of the following conditions:

• severe liver problems

Interaction with Other Medicines

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

Some medicines may interact with Darunavir Sandoz.

Pregnancy and Breast-Feeding

Do not take Darunavir Sandoz if you are pregnant or breast-feeding.

Driving and Using Machines

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

4. Possible Side Effects

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

The most common side effects of Darunavir Sandoz are:

• diarrhea
• nausea
• abdominal pain

How to Store Darunavir Sandoz

Keep this medicine out of the sight and reach of children.

Do not use Darunavir Sandoz after the expiry date which is stated on the carton.

6. Contents of the Pack and Other Information

What Darunavir Sandoz Contains

The active substance is darunavir.

What Darunavir Sandoz Looks Like and Contents of the Pack

Darunavir Sandoz is a dark red, oval, film-coated tablet.

The pack contains 30 film-coated tablets.

Marketing Authorisation Holder

Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria

Manufacturer

Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia

For Further Information

Sandoz Polska Sp. z o.o., ul. Domaniewska 50 C, 02-672 Warszawa, Poland