JASUPA contains two active ingredients that are used to treat HIV infection: dolutegravir plus rilpivirine. Dolutegravir belongs to a group of anti-retroviral medicines called integrase inhibitors (INIs). Rilpivirine belongs to a group of anti-retroviral medicines called non-nucleoside analogue reverse transcriptase inhibitors (NNRTIs).
1. WHAT JASUPA IS AND WHAT IT IS USED FOR :
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE JASUPA :
Do not take JASUPA:
- if you are hypersensitive (allergic) to dolutegravir or rilpivirine or to any of the other ingredients of JASUPA (listed in section 6)
- if you are taking any of the following medicines:
- dofetilide or pilsicainide (to treat heart conditions)
- carbamazepine, oxcarbazepine, phenobarbitone or phenytoin (also known as anticonvulsants used to treat epilepsy and prevent seizures)
- fampridine (also known as dalfampridine; used in multiple sclerosis)
- rifampicin or rifapentine (to treat some bacterial infections such as tuberculosis)
- omeprazole, esomeprazole, lansoprazole, pantoprazole or rabeprazole (proton pump inhibitors that are medicines to prevent and treat stomach ulcers, heartburn, or acid reflux disease)
- dexamethasone (a corticosteroid used in a variety of conditions such as inflammation and allergic reactions)
- products that contain St John’s wort (Hypericum perforatum) (a herbal product used to treat depression).
- Do not take JASUPA with any of these medicines. Tell your doctor immediately.
- if you have severe liver disease
- if you want to fall pregnant and, in the time, just before/during/after conception (peri and post-conception) and are in the first trimester of your pregnancy
- if you are breastfeeding.
Warnings and precautions:
Take special care with JASUPA: If you develop a rash you must contact your doctor immediately. If any of the following occur, you must tell your doctor as soon as possible:
3. HOW TO TAKE JASUPA:
Do not share medicines prescribed for you with any other person. Always take JASUPA exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
The usual dose of JASUPA is one tablet once a day with a meal. Swallow the tablet with some water. You will need regular blood tests. For as long as you are taking JASUPA, your doctor will arrange regular blood tests to check for side effects.
If you take more JASUPA than you should: In the event of overdosage, consult your doctor or pharmacist. If neither are available, contact the nearest hospital or poison centre.
If you forget to take JASUPA: If you miss a dose, take it as soon as you remember. JASUPA must be taken with a meal. If your next dose is due within 12 hours, skip the dose you missed and take the next dose at the usual time. Then continue your treatment as before. Do not take a double dose to make up for a missed dose.
Effects when treatment is stopped: JASUPA helps to control your condition, but it is not a cure for HIV infection. You need to keep taking it every day to stop your illness from getting worse. Because JASUPA does not cure HIV infection, you may still develop other infections and illnesses linked to HIV infection.
• Keep in touch with your doctor and don’t stop taking JASUPA without your doctor’s advice.
4. POSSIBLE SIDE EFFECTS:
JASUPA can have side effects. Not all side effects reported for JASUPA are included in this leaflet. Should your general health worsen or of you experience any untoward effects while taking JASUPA, please consult your doctor, pharmacist or other healthcare professional for advice.
It is very important to talk to your doctor about any changes in your health. Some side effects may only be seen in your blood tests and may not appear immediately after you start taking JASUPA. If you get any of these effects and if they are severe, your doctor may advise you to stop taking JASUPA.
Conditions you need to look out for:
Allergic reactions: If any of the following happens, stop taking JASUPA and tell your doctor immediately or go to the casualty department of your nearest hospital:
- skin rash
- a high temperature (fever)
- lack of energy (fatigue)
- swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
- muscle or joint aches.
These are all very serious side effects. If you have them, you may have had a serious allergic reaction to JASUPA. You may need urgent medical attention or hospitalisation. Contact your doctor immediately. Your doctor may decide to carry out tests on your liver, kidneys or blood.
5. HOW TO STORE JASUPA :
Store at or below 30 ºC. Store in the original package to protect from moisture. Keep the bottle tightly closed. Do not remove the desiccant. Store all medicines out of reach of children. Return all unused medicines to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems.