Viracept - patient leaflet, side effects, dosage

What Viracept is used for

Viracept is used with other ‘anti-retroviral’ medicines to:

• Work against the Human Immunodeficiency Virus (HIV). It helps to reduce the number of HIV particles in your blood.
• Increase the number of some cells in your blood that help fight infection. These are called CD4 white blood cells. They are particularly reduced in numbers when you have HIV infection. This can lead to an increased risk of many types of infections.

IV infection. You may continue to get infections or other illnesses due to your HIV. Treatment with Viracept does not stop you giving HIV to others through contact with blood or sexual contact. Therefore you must keep taking appropriate precautions to avoid giving the virus to others when you are taking Viracept.

ORE YOU TAKE VIRACEPT

Do not take Viracept if:

• You are allergic to nelfinavir or to any of the other ingredients (listed in Section 6 ‘Further information’).
• You are taking any of the medicines listed in the first part of 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

Check with your doctor or pharmacist before taking Viracept if:

• You have kidney problems.
• You have high blood sugar (diabetes).
• You have a rare blood problem which runs in families called ‘haemophilia’.
• You have liver disease caused by hepatitis B or C. Your doctor may wish to carry out regular

blood tests.

If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Viracept.

Patients with liver disease

Patients with chronic hepatitis B or C and treated with anti-retroviral agents are at increased risk for severe and potentially fatal liver adverse events and may require blood tests for control of liver function. Speak with your doctor if you have a history of liver disease.

Body fat

Combination anti-retroviral therapy may cause changes in body shape due to ch distribution. 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 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 from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately.

Bone disease (osteonecrosis)

Some patients taking combination anti-retroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination anti-retroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor immediately.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Viracept can affect the way some other medicines work. Also some other medicines can affect the way Viracept works.

Omeprazole (for ulcers in your stomach or gut) Alfuzosin (for benign prostatic hyperplasia (BPH)) Sildenafil (for pulmonary arterial hypertension (PAH)) Simvastatin or lovastatin (for lowering blood cholesterol)

Do not take Viracept and tell your doctor or pharmacist if any of these apply to you. If you are not sure, talk to your doctor or pharmacist before taking Viracept.

Tell your doctor or pharmacist if you are taking any of the following medicines:

• Any other medicines for HIV infection such as ritonavir, indinavir, saquinavir and delavirdine, amprenavir, efavirenz or nevirapine
• Oral contraceptives (the pill). Viracept can stop the pill from working, so you shou

contraception methods (such as condoms) while you are taking Viracept. Calcium channel blockers such as bepridil (for heart problems) Immunosuppressant medicines such as tacrolimus or ciclosporin Medicines that lower stomach acid such as lansoprazole Fluticasone (for hay fever) Phenytoin (for fits or epilepsy) Methadone (for drug dependence) Sildenafil (for getting or keeping an erection) Tadalafil (for pulmonary arterial hypertension (PAH), or for ge Vardenafil (for pulmonary arterial hypertension (PAH), or Ketoconazole, itraconazole or fluconazole (for fungal infec Rifabutin, erythromycin or clarithromycin (for bacterial infections) Midazolam given by injection or diazepam (for anxiety or to help you sleep)

Fluoxetine, paroxetine, imipramine, amitriptyline

Atorvastatinor other statins(for lowering blood cholesterol)

Salmeterol (for asthma or chronic obstructive pulmonary disease (COPD))

Warfarin (for lowering the chance of blood clots in your body)

Colchicine (for gout-flares or Median fever)

Bosentan (for pulmonary arterialension (PAH)

Taking Viracept with food and drink

Take Viracept with a meal. This helps your body to get the full benefit from your medicine.

Pregnancy, contraception and breast-feeding

• Talk to your doctor before you take Viracept if you are pregnant or planning to become pregnant.
• Do not breast-feed while taking Viracept because HIV may be passed to the baby.
• Viracept can stop oral contraceptives (the pill) from working, so you should use other contraception methods (such as condoms) while you are taking Viracept.
• Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Viracept is not likely to affect you being able to drive or use any tools or machines.

Important information about some of the ingredients of Viracept

• This medicine contains sucrose, which is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine. Each dose contains up to 5.9 milligrams of sucrose, which should be taken into account in patients with diabetes mellitus.
• This medicine contains aspartame, which is a source of phenylalanine. This may be harmful for people with phenylketonuria.
• This medicine is essentially ‘potassium-free’ as it contains less than 1 mmol (39 milligrams) of potassium per dose.

If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Viracept.

3. HOW TO TAKE VIRACEPT

Other possible side effects, where you should talk to your doctor

If you get any of the side effects on this list, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Very common (affect more than 1 in 10 people):

• Diarrhoea.

Common (affect less than 1 in 10 people): Rash.

Wind.

Feeling sick.

Low numbers of a type of white blood cell that fights infections (neutrophils).

Abnormal results from blood tests that measure how well your liver or muscles are wor

Uncommon (affect less than 1 in 100 people):

• Being sick.
• Pancreatitis. The signs include severe pains in your stomach that spread t k.
• Combination anti-retroviral therapy may cause changes in body shape duhanges in fat distribution. 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.

Rare (affect less than 1 in 1000 people):

• Yellow skin or eyes. This could be a sign of a liver prob

• A severe form of rash (erythema multiforme).

Swelling of your belly (abdomen).

High blood sugar (diabetes) or diabetes get worse.

There have been rare reports of muscle pain, tenderness or weakness, particularly with combination anti-retroviral therapy including protease inhibitors and nucleoside analogues. On

rare occasions these muscle probl (rhabdomyolysis).

Other side effects which have also been reported:

• Combination anti-retroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipaemia (increased fats in the blood) and resistance to insulin.
• Low numbers of red blood cells (anaemia).
• Lung disease (pneumonia).
• Cases of diabetes mellitus or increased blood sugar levels have been reported in patients

receiving this treatment or another protease inhibitor.

hildren

ildren (aged from 0 to 13 years) received Viracept in clinical trials. The side effects seen are similar to those seen in adults. The most commonly reported side effect in children is ea. The side effects only rarely resulted into having to stop taking Viracept.

5. HOW TO STORE VIRACEPT

• Keep out of the reach and sight of children.
• Do not use after the expiry date stated on the label and carton.
• Do not store above 30°C.
• Store in the original container.
• The mixed solution can be stored for up to 6 hours in a refrigerator.
• The active substance in Viracept is nelfinavir. Each gram of oral powder contains an amount of nelfinavir mesilate that makes 50 mg of nelfinavir.
• The other ingredients are microcrystalline cellulose, maltodextrin, dibasic potassium phosphate, crospovidone, hydroxypropyl methylcellulose, aspartame (E951), sucrose palmitate, and natural and artificial flavour.

What Viracept looks like and contents of the pack

Viracept 50 mg/g oral powder is a white to off-white powder. It is supplied in plastic bottles with plastic child resistant lids. Each bottle contains 144 grams of powder and is supplied with a 1 gra scoop (white) and a 5 gram scoop (blue).

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Detailed information on this medicine is available on the European Medicines Agency web site:. There are also links to other websites about rare diseases and treatments.