Prezista 600 mg Film-Coated Tablets

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. This will improve your immune system and reduce the risk of developing illnesses linked to HIV infection.

PREZISTA is used in combination with ritonavir and other antiretroviral medicines to treat adults 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.

Do not take PREZISTA:

• if you are allergic (hypersensitive) to darunavir, other ingredients of PREZISTA or to ritonavir.

Do not take PREZISTA with any of the following medicines:

• medicines to treat convulsions (epilepsy) (carbamazepine, phenobarbital or phenytoin).
• medicines to treat allergy symptoms (astemizole).
• medicines to treat tuberculosis (rifampicin).
• medicines to treat high blood pressure as a result of problems with your 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 (e.g. for depression).
• medicines to treat high cholesterol (lovastatin or simvastatin).
• medicines to treat psychiatric conditions such as schizophrenia (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, discuss it with your doctor.

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, such as condoms.

People taking PREZISTA may still develop infections or other illnesses associated with HIV infection. You must keep in regular contact with your doctor.

Contact your doctor immediately if the following is experienced:

• severe rash.
• sulphonamide (antimicrobial used to treat certain infections) allergy.

Make sure that you check the following points and tell your doctor if any of these apply to you:

• Tell your doctor if you have had problems with your liver before. Your doctor may evaluate how severe your liver disease is before deciding if you can take PREZISTA.
• Tell your doctor if you have diabetes. Anti-HIV medicines such as PREZISTA may increase sugar levels in the blood.
• Tell your doctor immediately if you notice any symptoms of infection.
• In some patients with advanced HIV and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
• Tell your doctor if you notice changes in body fat. Redistribution, accumulation or loss of body fat may occur in patients receiving a combination of antiretroviral medicines.
• Tell your doctor if you have haemophilia (bleeding disease). Anti-HIV medicines, such as PREZISTA, may increase the risk of bleeding.
• Tell your doctor if you are allergic to sulpha medicines.

Do not share medicines prescribed for you with any other person. Always take PREZISTA exactly as your doctor has told you. You must check with your doctor or pharmacist if you are not sure.

The usual dose of PREZISTA is one tablet twice daily. This is one tablet (600 milligram) in the morning and one tablet (600 milligram) in the evening. You must take PREZISTA every day and always in combination with 100 milligram of ritonavir and with food in the morning and in the evening, at approximately the same time of day. PREZISTA cannot work properly without ritonavir and food. You must eat a meal or a snack 30 minutes before you take your PREZISTA and ritonavir. The type of food is not important.

Swallow the tablet with a drink such as water, milk or any other nutritional drink. Even if you feel better, do not stop taking PREZISTA without talking to your doctor. 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.

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.

In some patients, PREZISTA has been reported to cause a severe or life-threatening rash. 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. PREZISTA should not be taken if you suffer from liver problems.

Other side effects include:

• raised blood sugar and worsening of diabetes.
• muscle pain, tenderness or weakness. On rare occasions, these muscle disorders have been serious.
• 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.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

PREZISTA should be stored at or below 30 °C (in a lockable cupboard). Do not store in a bathroom. Protect from light. Keep in original packaging until required for use.

Keep the bottle tightly closed. Do not use PREZISTA after the expiry date, which is stated on the box and on the bottle after the letters EXP. The expiry date refers to the last day of the month.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN.