VIRACEPT 250 mg film-coated tablets

What Viracept is

Viracept contains a medicine called nelfinavir, which is a ?protease inhibitor?. This belongs to a group of medicines called ?anti-retrovirals?.

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.

Viracept is not a cure for HIV 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.

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 changes 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. 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 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.

Do not take Viracept and tell your doctor or pharmacist if you are taking any of the following medicines:

• Medicines made from ergot such as 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 or TB).
• Terfenadine or astemizole (for allergy).
• Pimozide (used for mental health problems).
• Amiodarone or quinidine (for an uneven heart beat).
• Phenobarbital or carbamazepine (for fits or epilepsy).
• Triazolam or oral midazolam taken by mouth (for anxiety or to help you sleep).
• Cisapride (for heart burn or problems with your digestive system).
• vOmeprazole (for ulcers in your stomach or gut). 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 should use other 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 errection)
• Ketoconazole, itraconazole or fluconazole (for fungal infections)
• Rifabutin, erythromycin or clarithromycin (for bacterial infections)
• Midazolam given by injection or diazepam (for anxiety or to help you sleep)
• Fluoxetine, paroxetine, imipramine, amitriptyline or trazodone (for depression).
• Simvastatin, lovastatin, atorvastatin or rosuvastatin (for lowering blood cholesterol) If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Viracept.

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.

Always take Viracept exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure. The usual doses are described below. Follow the instructions carefully to get the most benefit from Viracept.

The Viracept tablets must be taken by mouth. They should be swallowed whole and should be taken with a meal. For adults or children unable to take tablets, Viracept 50 mg/g oral powder may be taken instead. If you want to take the powder instead please see the Package Leaflet for Viracept 50 mg/g oral powder).

Taking this medicine

• Take Viracept with a meal. This helps your body to get the full benefit from your medicine.
• Take all your doses at the right time each day. This helps make your medicine work as well as it can.
• Do not stop taking this medicine without talking to your doctor first.

How much to take

Adults and children older than 13 years

Viracept tablets can be taken either two or three times a day with a meal. Table 1 below shows the usual doses.

Table 1

Dose to be taken by adults and children older than 13 years

Number of tablets How often you take it 5 How much you take each time in milligrams 1250 mg Two times a day

750 mg Three times a 3 day

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. You will either give the medicine to your child two or three times a day with a meal The different ways are shown in separate tables below.

• Table 2: if you give the medicine two times a day, you will give 50-55 mg nelfinavir each time for each kg of body weight.
• Table 3: if you give the medicine three times a day, you will give 25-30 mg nelfinavir each time for each kg of body weight.

Table 2

Dose to be given two times a day to children aged 3 to 13 years Number of tablets Body Weight of your child 18 to 22 kg 4 over 22 kg 5

Table 3

Dose to be given three times a day to children aged 3 to 13 *

Body Weight of your
child
18 to 22 kg
over 22 kg

Number of tablets
2
3
*see Package Leaflet for Viracept oral powder for children less than 18 kg body weight.

If you take more Viracept than you should

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

If you forget to take Viracept

If you forget to take a dose, take it as soon as you remember it.

• However if it is nearly time for your next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking Viracept

Do not stop taking this medicine without talking to your doctor first.Take all your doses at the right time each day. This helps make your medicine work as well as it can.

Like all medicines, Viracept can have side effects, although not everybody gets them. The following side effects may happen with this medicine.

Contact your doctor straight away if you notice any of the following side effects:

• Allergic reactions. The signs may include difficulty in breathing, fever, itching, swelling of the face and skin rashes that can sometimes form blisters.
• Increased bleeding if you have haemophilia. If you have haemophilia type A or B, in rare cases your bleeding may increase.
• Bone disease (osteonecrosis). Thesigns may include joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. 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).
• Infection. 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 of the above, contact your doctor straight away.

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 working.

Uncommon (affect less than 1 in 100 people):

• Being sick.
• Pancreatitis. The signs include severe pains in your stomach that spread to your back.
• Combination anti-retroviral therapy may cause changes in body shape due to changes 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 problem such as hepatitis or jaundice.
• 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 problems have been serious causing muscle degeneration (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.

Side effects in children

About 400 children (aged from 0 to 13 years) received Viracept in clinical trials. The side effects seen in children are similar to those seen in adults. The most commonly reported side effect in children is diarrhoea. The side effects only rarely resulted into having to stop taking 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.

What Viracept contains

• The active substance in Viracept is nelfinavir. Each tablet contains 250 mg of nelfinavir.
• The other ingredients are calcium silicate, crospovidone, magnesium stearate, indigo carmine (E132), as powder, hypromellose and glycerol triacetate.

What Viracept looks like and contents of the pack

Viracept film-coated tablets is supplied in plastic bottles with plastic child resistant lid. Each bottle contains either 270 or 300 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Manufacturer

Roche Pharma AG
Emil-Barell-Str. 1
D-79639 Grenzach-Wyhlen
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

LuxembourgLuxemburg Voirsiehe BelgiqueBelgien BelgiëBelgiqueBelgien N.V. Roche S.A. TélTel 32 0 2 525 82 11

359 2 818 44 44 Magyarország Roche Magyarország Kft. Tel 36 - 23 446 800

Malta See United Kingdom eská republika Roche s. r. o. Tel 420 - 2 20382111

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Eesti Roche Eesti OÜ Tel 372 - 6 177 380 Österreich Roche Austria GmbH Tel 43 0 1 27739

Roche Hellas A.E. 30 210 61 66 100 Polska Roche Polska Sp.z o.o. Tel 48 - 22 345 18 88

España Roche Farma S.A. Tel 34 - 91 324 81 00 Portugal Roche Farmacêutica Química, Lda Tel 351 - 21 425 70 00

France Roche Tél 33 0 1 46 40 50 00 România Roche România S.R.L. Tel 40 21 206 47 01

Ireland Roche Products Ireland Ltd. Tel 353 0 1 469 0700 Slovenija Roche farmacevtska druba d.o.o. Tel 386 - 1 360 26 00

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K .. . 357 - 22 76 62 76 Sverige Roche AB Tel 46 0 8 726 1200

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