Viracept
nelfinavir
Nelfinavir
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
What Viracept is and what it is used for
Before you take Viracept
How to take Viracept
Possible side effects
How to store Viracept
Further information
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Viracept contains a medicine called nelfinavir, which is a ‘protease inhibitor’. This belongs to a group of medicines called ‘anti-retrovirals’.
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.
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.
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 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.
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.
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
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notice any symptoms of infection, please inform your doctor immediately.
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.
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.
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 (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)
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.
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 erection)
Tadalafil (for pulmonary arterial hypertension (PAH), or for getting or keeping an erection)
Vardenafil (for pulmonary arterial hypertension (PAH), or for getting or keeping an erection)
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)
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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 Mediterranean fever)
Bosentan (for pulmonary arterial hypertension (PAH)
)
If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Viracept.
Take Viracept with a meal. This helps your body to get the full benefit from your medicine.
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.
Viracept is not likely to affect you being able to drive or use any tools or machines.
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.
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.
Viracept powder is for people who cannot take tablets. Viracept tablets are generally recommended for adults and older children. For younger children able to take tablets, Viracept tablets may be taken instead of the oral powder. If you want to take the tablets instead please see the Package Leaflet for Viracept 250 mg tablets.
Two measuring scoops are provided in the medicine box:
White 1 gram (1g) scoop.
Blue 5 gram (5g) scoop.
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Measure out a level scoop of powder. You can use the handle of the second scoop to scrape off the extra powder and make your scoop level (see picture below).
You can mix the powder with a small amount of water, milk, baby formula, soy formula, soy milk, dietary liquid supplements or pudding.
If you mix the powder, but do not take it straight away you can store it for up to 6 hours in a refrigerator.
Do not mix the powder with orange juice, apple sauce or other acidic liquids or foods. This may give your medicine a bitter taste.
Do not add liquid to the powder in its original container
Take all the mixture you make each time. This will make sure that you get the right amount of 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.
Viracept powder can be taken either two or three times a day with a meal. Table 1 below shows the usual doses.
Dose to be taken by adults and children older than 13 years | ||
How often you take it | Number of scoops Blue Scoop White Scoop (5 g) (1 g) | How much you take each time (in grams) |
Two times a day | 5 - | 25 g |
Three times a day | 3 - | 15 g |
For children aged 3 to 13 years, the recommended dose of Viracept powder 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.
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Dose to be given two times a day to children aged 3 to 13 | ||
Body weight of your child | Number of scoops Blue Scoop White Scoop (5 g) (1 g) | How much to give each time (in grams) |
7.5 to 8.5 kg | 1 plus 3 | 8 g |
8.5 to 10.5 kg | 2 - | 10 g |
10.5 to 12 kg | 2 plus 2 | 12 g |
12 to 14 kg | 2 plus 4 | 14 g |
14 to 16 kg | 3 plus 1 | 16 g |
16 to 18 kg | 3 plus 3 | 18 g |
18 to 22 kg | 4 plus 1 | 21 g |
over 22 kg | 5 - | 25 g |
Dose to be given three times a day to children aged 3 to 13 | ||||
Body weight of your child | Number of scoops Blue Scoop White Scoop (5 g) (1 g) | How much to give each time (in grams) | ||
7.5 to 8.5 kg | 1 | 5 g | ||
8.5 to 10.5 kg | 1 | plus | 1 | 6 g |
10.5 to 12 kg | 1 | plus | 2 | 7 g |
12 to 14 kg | 1 | plus | 3 | 8 g |
14 to 16 kg | 2 | 10 g | ||
16 to 18 kg | 2 | plus | 1 | 11 g |
18 to 22 kg | 2 | plus | 3 | 13 g |
over 22 kg | 3 | 15 g |
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 a dose, take it as soon as you remember it.
However if it is nearly time for your next dose, skip the missed dose.
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Do not take a double dose to make up for a forgotten dose.
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.
If you notice any of the above, contact your doctor straight away.
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.
Diarrhoea.
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.
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.
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).
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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).
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.
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.
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.
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 gram
scoop (white) and a 5 gram scoop (blue).
Roche Registration Limited 6 Falcon Way
Shire Park
Welwyn Garden City AL7 1TW
United Kingdom
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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:
N.V. Roche S.A.
Tél/Tel: +32 (0) 2 525 82 11
(Voir/siehe Belgique/Belgien)
Рош България ЕООД Тел: +359 2 818 44 44
Roche (Magyarország) Kft. Tel: +36 - 23 446 800
Roche s. r. o.
Tel: +420 - 2 20382111
(See United Kingdom)
Roche a/s
Tlf: +45 - 36 39 99 99
Roche Nederland B.V. Tel: +31 (0) 348 438050
Roche Pharma AG Tel: +49 (0) 7624 140
Roche Norge AS
Tlf: +47 - 22 78 90 00
Roche Eesti OÜ
Tel: + 372 - 6 177 380
Roche Austria GmbH Tel: +43 (0) 1 27739
Roche (Hellas) A.E.
Τηλ: +30 210 61 66 100
Roche Polska Sp.z o.o. Tel: +48 - 22 345 18 88
Roche Farma S.A.
Tel: +34 - 91 324 81 00
Roche Farmacêutica Química, Lda Tel: +351 - 21 425 70 00
Roche
Tél: +33 (0) 1 47 61 40 00
Roche România S.R.L. Tel: +40 21 206 47 01
Roche Products (Ireland) Ltd. Tel: +353 (0) 1 469 0700
Roche farmacevtska družba d.o.o. Tel: +386 - 1 360 26 00
Roche a/s
c/o Icepharma hf Sími: +354 540 8000
Roche S.p.A.
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Tel: +39 - 039 2471
Roche Oy
Puh/Tel: +358 (0) 10 554 500
Γ.Α.Σταµάτης & Σια Λτδ. Τηλ: +357 – 22 25 72 00
Roche AB
Tel: +46 (0) 8 726 1200
Roche Latvija SIA Tel: +371 – 6 7039831
Roche Products Ltd.
Tel: +44 (0) 1707 366000
UAB “Roche Lietuva” Tel: +370 5 2546799
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