Darunavir Sinoptis

Package Leaflet: Information for the User

Darunavir Synoptis, 400 mg, Film-Coated Tablets

Darunavir Synoptis, 800 mg, Film-Coated Tablets

Darunavir

Read all of this leaflet carefully before taking this medicine.

• 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 experience any side effects, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of the Pack

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

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

What Darunavir Synoptis is

Darunavir Synoptis contains the active substance darunavir. Darunavir Synoptis is an antiretroviral medicine used to treat HIV infection.

What Darunavir Synoptis is used for

Darunavir Synoptis 400 mg and 800 mg film-coated tablets are used to treat adults and children from 3 years of age and at least 40 kg body weight who are infected with HIV.

• who have not taken any antiretroviral medicines before,
• and for some patients who have taken other antiretroviral medicines in the past (as determined by their doctor).

Darunavir Synoptis should be taken in combination with other HIV medicines and a small dose of cobicistat or ritonavir.

2. Important information before taking Darunavir Synoptis

When not to take Darunavir Synoptis

• if you are allergic to darunavir or any of the other ingredients of this medicine,
• if you have severe liver problems.

Do not take Darunavir Synoptis with the following medicines

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

During treatment with Darunavir Synoptis, you must not take any of the following medicines:

Warnings and precautions

Before taking Darunavir Synoptis, tell your doctor if:

• you have ever had liver problems,
• you have diabetes,
• you notice any signs of infection (e.g., swollen lymph nodes, fever),
• you have hemophilia,
• you are allergic to sulfonamides,
• you have musculoskeletal disorders.

Elderly patients

Darunavir Synoptis has only been used in a small number of patients aged 65 and over.

Children and adolescents

Darunavir Synoptis 400 mg and 800 mg film-coated tablets are not intended for children below 3 years of age or weighing less than 40 kg.

Interactions with other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken.

Darunavir Synoptis with food and drink

See section 3 "How to take Darunavir Synoptis".

Pregnancy and breastfeeding

Do not take Darunavir Synoptis with ritonavir during pregnancy or while breastfeeding without consulting your doctor.

Driving and using machines

Do not drive or operate machines if you experience dizziness while taking Darunavir Synoptis.

Darunavir Synoptis contains lactose

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

Darunavir Synoptis 400 mg film-coated tablets contain sunset yellow FCF (E 110)

This may cause allergic reactions.

3. How to take Darunavir Synoptis

Always take this medicine exactly as your doctor or pharmacist has told you.

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

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

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

The dose is:

• 800 mg Darunavir Synoptis (two 400 mg tablets or one 800 mg tablet) once daily with 100 mg ritonavir, or
• 600 mg darunavir with 100 mg ritonavir twice daily.

Discuss with your doctor which dose is right for you.

Dosing in adults who have not taken antiretroviral medicines before

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

Dosing in adults who have taken antiretroviral medicines before

The dose is:

• 800 mg Darunavir Synoptis (two 400 mg tablets or one 800 mg tablet) once daily with 150 mg cobicistat or 100 mg ritonavir, or
• 600 mg darunavir with 100 mg ritonavir twice daily.

Discuss with your doctor which dose is right for you.

How to take Darunavir Synoptis

• Take the dose at the same time every day.
• Take Darunavir Synoptis with food.
• Swallow the tablets with water or milk.

Opening the child-resistant cap

The plastic bottle has a child-resistant cap. To open it, press the plastic cap while turning it counterclockwise.

If you take more Darunavir Synoptis than you should

Contact your doctor or pharmacist immediately.

If you forget to take Darunavir Synoptis

If you notice you have missed a dose within 12 hours, take the missed dose as soon as possible. If you notice you have missed a dose after 12 hours, skip the missed dose and take the next dose at the usual time.

Do not stop taking Darunavir Synoptis without talking to your doctor

Even if you feel better, do not stop taking Darunavir Synoptis without talking to your doctor.

4. Possible side effects

During HIV treatment, weight and levels of blood fats and sugar may increase.

Common side effects

• Diarrhea.

Uncommon side effects

• Nausea, vomiting, abdominal pain, indigestion, bloating.

Rare side effects

• Severe skin reactions, including DRESS syndrome.

5. How to store Darunavir Synoptis

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

What Darunavir Synoptis contains

• The active substance is darunavir.

Each film-coated tablet contains 400 mg or 800 mg of darunavir.

What Darunavir Synoptis looks like and contents of the pack

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

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

The pack contains a bottle with a child-resistant cap and a desiccant.

Marketing authorization holder and manufacturer

Marketing authorization holder: Synoptis Pharma Sp. z o.o.

Manufacturer: Pharmathen S.A.

Revision date of the leaflet

04/2020