PREZISTA is an antiretroviral medicine. It belongs to a group called protease inhibitors. PREZISTA works by reducing the amount of human immunodeficiency virus (HIV) in your body. PREZISTA is used in combination with ritonavir and other antiretroviral medicines to treat adults and children 6 years of age and above who are infected with HIV and who have developed resistance to other antiretroviral medicines. Your doctor will discuss with you which combination of medicines is best for you.
1. What PREZISTA is and what it is used for.
2. What you need to know before you take/use PREZISTA.
Do not take PREZISTA:
- If you are allergic (hypersensitive) to darunavir, other ingredients of PREZISTA or to ritonavir.
- If your child is under the age of 3 years.
Do not combine PREZISTA with any of the following medicines:
- Medicines to treat convulsions (carbamazepine, phenobarbital or phenytoin);
- Medicines to treat tuberculosis (rifampicin);
- Medicines to treat high blood pressure in the lungs (sildenafil);
- Medicines to treat prostate problems (alfuzosin);
- Medicines to treat migraine and headaches (dihydroergotamine, ergonovine, ergotamine, methylergonovine);
- Herbal products containing St John’s wort;
- Medicines to treat high cholesterol (lovastatin and simvastatin);
- Medicines to treat psychiatric conditions (pimozide);
- Medicines to treat trouble with sleeping and/or anxiety (midazolam or triazolam);
- Medicines to treat fungal infections (ketoconazole, itraconazole and voriconazole);
- Medicines to treat narcotic dependence (buprenorphine/naloxone).
If you are taking any of these, ask your doctor about switching to another medicine, before you take PREZISTA.
Take special care with PREZISTA
PREZISTA must be taken together with ritonavir and food. PREZISTA is not a cure for HIV infection. PREZISTA does not reduce the risk of passing HIV to others through sexual contact or blood contaminations. Therefore, you must continue to use appropriate precautions. People taking PREZISTA may still develop infections or other illnesses associated with HIV infection. You must keep in regular contact with your doctor.
PREZISTA should not be administered to children younger than 6 years of age nor to children and adolescents younger than 18 years of age who have never used antiretroviral medicines before.
3. How to take/use PREZISTA.
Always take PREZISTA exactly as your doctor has told you. You must check with your doctor or pharmacist if you are unsure.
Do not share medicines prescribed for you with any other person. Make sure that you always have enough PREZISTA and ritonavir tablets available so that you do not run out, for example, in case you cannot return home, need to travel or stay in a hospital.
The usual dose is: Children 6 years of age and older, weighing at least 20 kg, who have taken any anti-HIV medicines before (your child’s doctor will determine this). The doctor will work out the right dose based on the weight of the child. The doctor will inform you exactly on how many PREZISTA tablets and how much ritonavir (capsules or solution) your child should take. If your child feels better, do not stop administering PREZISTA without talking to the child’s doctor.
Instructions
- Your child should always take PREZISTA together with ritonavir.
- Your child should take PREZISTA with food.
- Your child should swallow the tablets with a drink such as water, milk, or any other nutritional drink.
- The other HIV medicines used in combination with PREZISTA and ritonavir should be taken as recommended by the doctor.
In case your child does not tolerate ritonavir oral solution, ask advice from your child’s doctor.
Removing the child-resistant cap
The plastic bottle comes with a child resistant cap and should be opened as follows:
- Push the plastic screw cap down while turning it counter clockwise.
- Remove the unscrewed cap.
Your doctor will tell you how long your treatment with PREZISTA will last. If you have the impression that the effect of PREZISTA is too strong or too weak, tell your doctor or pharmacist.
If you or your child takes more PREZISTA than should be taken: In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison centre.
If you forget to take PREZISTA: If you notice within 6 hours, you must take your tablet immediately. Always take with ritonavir and food. If you notice after 6 hours, then take the next dose as usual. Do not take a double dose to make up for a forgotten dose.
4. Possible side effects.
PREZISTA can cause side effects. Not all side effects reported for PREZISTA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking PREZISTA, please consult your healthcare provider for advice.
The most common side effects are:
- Nausea, vomiting;
- headache;
- stomach pain, diarrhoea, constipation, flatulence, rash and itchiness;
- tiredness, loss of strength and energy, enlargement of breasts.
PREZISTA may change some values of your blood chemistry. These can be seen in the results of blood tests. Your doctor will explain these to you.
In some patients, PREZISTA has been reported to cause a severe or life-threatening rash. In patients taking PREZISTA and raltegravir, rashes (generally mild or moderate) may occur more frequently than in patients taking either medicine separately. Contact your doctor if you develop a rash. Your doctor will advise you whether your symptoms can be managed on therapy or whether PREZISTA should be stopped.
Liver problems that may occasionally be severe have been reported. Your doctor should do blood tests prior to initiating PREZISTA. If you have chronic hepatitis B or C infection, your doctor should check your blood tests more often because you have an increased chance of developing liver problems. Talk to your doctor about the signs and symptoms of liver problems. These may include yellowing of your skin or whites of your eyes, dark (tea colored) urine, pale-coloured stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching, or sensitivity on your right side below your ribs.
Some side effects are typical for anti-HIV medicines in the same family as PREZISTA.
These are:
- Raised blood sugar and worsening of diabetes;
- muscle pain, tenderness or weakness;
- changes in body shape due to fat redistribution. These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck (buffalo hump).
The cause and long-term health effects of these conditions are not known at this time.
5. How to store PREZISTA.
PREZISTA should be stored at or below 30 °C (in a lockable cupboard). Keep in original packaging until required for use. Do not store in a bathroom. Keep the bottle tightly closed. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). STORE ALL MEDICINES OUT OF REACH OF CHILDREN.