Viracept oral powder 50 mg. / g. 144 g.

WHAT VIRACEPT IS AND WHAT IT IS USED FOR?

What is Viracept?
Viracept contains a medicine called nelfinavir, which is a "protease inhibitor." It belongs to a group of medicines called "antiretroviral".

What is Viracept used for?
Viracept is used together with other "antiretroviral" medicines to:
• Fighting the Human Immunodeficiency Virus (HIV). It helps reduce the number of HIV particles in the blood.
• Increase the number of cells in the blood that help fight the infection. They are called CD4 white blood cells. Their number is particularly low when you have HIV infection. This can lead to an increased risk of many types of infections.
Viracept is not a treatment for HIV infection. You may continue to receive infections or other illnesses that are due to HIV. Treatment with Viracept does not stop the transmission of HIV to others via blood or sexual contact. Therefore, when taking Viracept, you must continue to take appropriate precautions to avoid transmitting the virus to others.

2. BEFORE YOU TAKE VIRACEPT
Do not take Viracept if:
• are allergic to nelfinavir or any of the other ingredients (listed in section 6 "Further information").
• you are taking some of the medicines listed in section 2 "Taking other medicines," "Do not take Viracept":
Do not take Viracept if any of the above apply to you.

Take special care with Viracept:
Ask your doctor or pharmacist before taking Viracept if:
• You have kidney problems.
• If you have high blood sugar (diabetes).
• If you have a rare family history of blood clotting, called "haemophilia".
• If you have liver disease caused by the hepatitis B or C virus. Your doctor may wish to do regular blood tests.
If any of these apply to you or if you are not sure talk to your doctor or pharmacist before taking Viracept.

Patients with liver disease:
Patients with chronic hepatitis B or C treated with antiretroviral agents are at an increased risk of severe and potentially fatal hepatic adverse events, and blood may need to be tested to control hepatic function. Consult your doctor if you have had liver disease in the past.

Body fat
Combination antiretroviral therapy may cause changes in body shape due to fat distribution. These may include loss of fat from the legs, hands and face, increased fat deposition in the abdomen and other internal organs, breast enlargement and formation of fatty lumps on the neck ("buffalo hump") The cause and the late effects these health conditions are not known yet Contact your doctor if you notice changes in body fat.

Signs of previous infections
In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation of previous infections may occur shortly after initiation of HIV treatment. These symptoms are believed to be due to an improvement in the immune response of the body, which allows it to fight infections that may have no apparent symptoms. If you notice symptoms of infection, please tell your doctor immediately.

Bone disease (osteonecrosis)
Some patients treated with combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by a lack of blood supply to the bone). The duration of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, and higher body mass index may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, pain (especially in the thigh, knees and shoulder) and difficulty in movement. If you notice any of these symptoms, please tell your doctor immediately.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you bought without a prescription and herbal medicines. This is because Viracept may affect the way some other medicines work. Some other medicines can also affect the effect of Viracept.
Do not take Viracept and tell your doctor or pharmacist if you are taking any of the following medicines:
• Medicines containing ergo-alkaloids, e.g. cabergoline, ergotamine or lisuride (for Parkinson's disease or migraine)
• Herbal preparations containing St John's wort (for depression or improving your mood)
• Rifampicin (for tuberculosis (TB))
Terfenadine or astemizole (for allergy) Pimozide (used in mental health problems) Amiodarone or quinidine
Oral contraceptives ("the pill") Viracept may prevent the "pill", so you should use other birth control methods (eg condoms) while taking Viracept Calcium antagonists, eg. bepridil (for heart problems) Immune system suppressants, e.g. tacrolimus or ciclosporin Medicines that reduce stomach acidity, e.g. (for seizures or epilepsy) Methadone (for drug dependence) Sildenafil (for erection or retention of erections)
Tadalafil (for pulmonary arterial hypertension (PAH) or for obtaining or maintaining an erection)
Vardenafil (for pulmonary arterial hypertension (PAH) or for obtaining or retaining an erection)
Ketoconazole, itraconazole or fluconazole (for fungal infections) Rifabutin, erythromycin or clarithromycin (for bacterial infections) Midazolam injected or diazepam (for anxiety or to help you fall asleep)
Fluoxetine, paroxetine, imipramine, amitriptyline or trazodone (for depression) Simvastatin, lovastatin, atorvastatin or rosuvastatin (to lower blood cholesterol)
Salmeterol (for asthma and chronic obstructive pulmonary disease (COPD)) Warfarin (to reduce the likelihood of blood clots in your body)
Colchicine (for gout attacks or Mediterranean fever) Bosentan (for pulmonary arterial hypertension (PAH)) If any of the above applies to you or if you are not sure talk to your doctor or pharmacist before taking Viracept.

Taking Viracept with food and drink:
Take Viracept with food. This will help your body take full advantage of your medicine.

Pregnancy, contraception and breastfeeding
• Talk to your doctor before taking Viracept if you are pregnant or are planning a pregnancy.
• Do not breast-feed while taking Viracept because HIV can be transmitted to the baby.
• Viracept may prevent oral contraceptives ("the pill"), so you should use other birth control methods (such as condoms) while taking Viracept.
• Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Viracept is unlikely to affect your ability to drive or use tools or machines.

3. HOW TO TAKE VIRACEPT
Always take Viracept exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The usual doses are described below. Follow these instructions carefully to get the most out of Viracept.
Viracept tablets should be taken orally. They should be swallowed whole and taken during meals.
Adults or children who can not take tablets, Viracept tablets may be put in water and taken as follows:
• Put the tablets in half a glass of water and mix with a spoon.
• After the tablet dissolves, the cloudy bluish fluid is mixed well and is taken immediately.
• Rinse the glass with half a glass of water and drink it to make sure the whole dose is taken.
It is not recommended that acidic food or juice (eg orange juice, apple juice or apple puree) be taken with VIRACEPT, because together they may have a bitter taste.
Alternatively, Viracept 50 mg / g powder for oral use may be used instead. If you want to take powder instead of tablets, please see the Viracept 50 mg / g powder for oral use.

Taking this medicine
• Take Viracept with food. This will help your body take full advantage of your medicine.
• Take the entire dose at the right time every day. This will help your medicine act as well as possible.
• Do not stop taking this medicine without talking to your doctor before.

How much to take
Adults and children over 13 years of age
Viracept tablets may be taken two or three times a day with food. Table 1 below shows the usual doses.

Table 1
Dose to be taken by adults and children over 13 years of age

How often

to be accepted

Number of tablets
How much to take each time (in milligrams)
Twice a day
5 1250 mg
Three times a day, 3 750 mg
Children aged 3 to 13 years

For children aged 3 to 13 years, the recommended dose of Viracept tablets is based on their body weight. Carefully track the weight gain of your child to ensure that the appropriate total daily dose is taken.

• When your baby weighs 18 kg or more, you can give the tablets two or three times a day.

• When your baby weighs 18 kg or less, you should give the tablets three times a day.

The different ways are shown in separate tables below.

Table 2: If you are taking the medicine twice daily (for children weighing 18 kg or more), you will give 50-55 mg of nelfinavir every time for each kg of body weight. Table 3: If you are given the medicine three times a day, you will give 25-35 mg
Children with this weight during the day will be given a different number of tablets. Your doctor will monitor the number of HIV virus particles and number of your child's CD4 white blood cells to make sure they are responding to therapy.
It is important to take the exact number of tablets for each dose. You should monitor your child when taking the tablets to make sure it is taking the recommended number of tablets with food for the body.

If you take more Viracept than you should:
If you take more Viracept than you should, talk to a doctor, pharmacist, or go straight to a hospital. Take the medicine pack with you. Among other things, many large doses of Viracept may cause heart rhythm problems.

If you forget to take Viracept:
If you forget to take a dose, take it as soon as you remember.
• If it is time for your next dose, skip the missed dose.
• Do not take a double dose to make up for the missed dose.

If you stop taking Viracept:
Do not stop taking this medicine without first talking to your doctor. Take all doses at the right time every day. This will help your medicine act as well as possible.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Viracept can have side effects, although not everybody gets them. The following side effects may occur with this medicine.
Contact your doctor immediately if you notice any of the following side effects:
• Allergic reactions. Signs may include difficulty in breathing, fever, itching, swelling of the face and skin rashes that may occasionally cause blisters.
• Increased bleeding if you have haemophilia. If you have type A or B hemophilia, bleeding may rarely increase.
• Disease of bone (osteonecrosis). Signs may include joint stiffness, pain (especially thigh, knee and shoulder) and difficulty in movement. Some patients taking combination antiretroviral therapy may develop bone disease called osteonecrosis (death of bone tissue caused by lack of blood supply to the bone).
• Infection. In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation of previous infections may occur shortly after initiation of HIV treatment. These symptoms are believed to be due to an improvement in the immune response of the body, which allows it to fight infections that may have no apparent symptoms.
If you notice any of the above, please contact your doctor immediately.
Other possible side effects you should talk to with your doctor
If you get any side effects from this list or if you notice any side effects not listed in this leaflet, please tell your doctor.
Very common (affects more than 1 user in 10):
• diarrhea.
Common (affects less than 1 in 10 people):
• Rash.
• Separation of gases.
• Nausea.
• Low numbers of certain types of white blood cells that fight infections (neutrophils).
• Deviations in blood test results that show how well the liver or muscles work.
Uncommon (affects less than 1 in 100 people):
• Vomiting.
• Pancreatitis. Signs include severe stomach pain that spreads to the back.
• Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution. These may include loss of fat from the legs, arms and face, increased tissue deposition in the abdomen (abdomen) and other internal organs, chest enlargement and fat deposits in the neck ("buffalo hump"). this condition and its late effects on health are not yet known.
Rare (affects less than 1 in 1,000 people):
• Yellow skin or eyes. This may be a sign of a liver problem, such as hepatitis or jaundice.
• Severe rash (erythema multiforme).
• Swelling of the abdomen.
• High blood sugar (diabetes) or worsening of diabetes.
• There have been rare reports of muscle pain, increased sensitivity or weakness, especially in combination antiretroviral therapy including protease inhibitors and nucleoside analogues. In rare cases, these muscular disorders were serious, causing muscle degeneration (rhabdomyolysis).
Other side effects that are also reported:
• Combination antiretroviral therapy may also cause increases in lactic acid and sugar in the blood, hyperlipaemia (increase in fat in the blood) and insulin resistance.
• Low red blood cells (anemia).
• Pulmonary disease (pneumonia).
• Cases of diabetes mellitus or elevated blood glucose have been reported in patients receiving this treatment or another protease inhibitor
Adverse reactions in children
Nearly 400 children
HOW TO STORE VIRACEPT
Keep out of the reach and sight of children.
Do not use after the expiry date which is stated on the label and the carton.
Do not store above 30 ° C.
Store in the original package.

6. ADDITIONAL INFORMATION

What does Viracept contain?
• The active substance in Viracept is nelfinavir. Each tablet contains nelfinavir
• The other ingredients are: calcium silicate, crospovidone, magnesium stearate, indigo carmine (E 132) as a powder, hypromellose and glycerol triacetate.

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