Author: Teva Pharma B.V.


Long information

What is it and how is it used?

Nevirapine Teva belongs to a group of medicines called antiretrovirals, used in the treatment of Human Immunodeficiency Virus (HIV-1) infection. HIV is spread by contact with infected blood or sexual contact with an infected individual.

Nevirapine Teva belongs to the class of non-nucleoside reverse transcriptase inhibitors (NNRTIs). Nevirapine Teva fights HIV-1 infection by reducing the amount of the virus in the blood.

Nevirapine Teva is prescribed for use in combination with other HIV antiretrovirals. Your doctor will determine which medicines are best for you.

Table of Contents
What do you have to consider before using it?
How is it used?
What are possible side effects?
How should it be stored?
Further information

What do you have to consider before using it?

Do not takeNevirapine Teva

  • if you are allergic (hypersensitive) to nevirapine or any of the other ingredients of Nevirapine Teva.
  • if you previously experienced inflammation of the liver (hepatitis), severe skin rash, or liver damage while on nevirapine treatment.
  • if you have permanent liver disease or changes in liver function
  • if you are taking products containing St John?s Wort ( Hypericum perforatum) as this may stop Nevirapine Teva from working properly.
Take special care with Nevirapine Teva

During the first 18 weeks of treatment with Nevirapine Teva you should watch out for signs of liver or skin reactions as these can become severe and even life threatening.

If you experience severe rash or hypersensitivity (allergic reactions) that may appear in the form of rash accompanied by other side effects such as

  • fever,
  • blistering,
  • mouth sores,
  • eye inflammation,
  • facial swelling,
  • general swelling,
  • shortness of breath,
  • muscle or joint aches,
  • general feelings of illness,
  • or abdominal pain YOU SHOULD DISCONTINUE TAKING NEVIRAPINE TEVA AND YOU MUST CONTACT your doctor IMMEDIATELY as such reactions can be potentially life-threatening or lead to death. If you ever have only mild rash symptoms without any other reaction please inform your doctor immediately, who will advise you whether you should stop taking Nevirapine Teva.
If you experience symptoms suggesting a damage of the liver, such as

  • loss of appetite,
  • feeling sick (nausea),
  • vomiting,
  • yellow skin (jaundice),
  • abdominal pain you should discontinue taking Nevirapine Teva and must contact your doctor immediately. If you develop severe hepatic, skin or hypersensitivity reactions whilst taking Nevirapine Teva, NEVER TAKE Nevirapine Teva again without referring to your doctor. You must take the dosage of Nevirapine Teva as prescribed by your doctor. This is especially important within the first 14 days of treatment (see more information inHow to take Nevirapine Teva).

The following patients are at increased risk for developing liver problems:

  • women
  • infected with hepatitis B or C
  • abnormal liver function tests
  • higher CD4 cell counts at start of Nevirapine Teva therapy (women more than 250 cells/mm³, men more than 400 cells/mm³)

In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection (AIDS defining illness), 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.

Changes of body fat may occur in patients receiving combination antiretroviral therapy. Contact your doctor if you notice changes in body fat.

Bone problems: Some patients taking combination antiretroviral therapy may experience death of bone tissue (osteonecrosis). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe weakness of the immune system, higher body mass index 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.

Nevirapine Teva is not a cure for HIV infection and you may continue to develop infections or other illnesses associated with HIV infection. It is therefore important to remain under the care of your doctor while taking Nevirapine Teva.

Even by taking anti-HIV medicinal product you still may pass HIV on to others through sexual contact or contamination with blood.

Use in children Nevirapine Teva tablets can be taken by children 16 years of age or older. Additionally Nevirapine Teva tablets can be taken by adolescents under 16 years of age who weigh 50 kg or more or whose body surface area is above 1.25 m 2.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. You should inform your doctor of all other medicines you are taking before you start taking Nevirapine Teva because he or she might need to monitor whether the other medicines are still having their desired effects and make necessary dose-adjustments. You should carefully read the package leaflet of the other HIV medicinal products which you will be taking in combination with Nevirapine Teva.

It is particularly important that you tell your doctor if you are taking or have recently taken:

  • St John?s Wort ( Hypericum perforatum, medicine to treat depression)
  • rifampicin (medicine to treat tuberculosis)
  • rifabutin (medicine to treat tuberculosis)
  • macrolides e.g. clarithromycin (medicine to treat bacterial infections)
  • fluconazole (medicine to treat fungal infections)
  • ketaconazole (medicine to treat fungal infections)
  • itraconazole (medicine to treat fungal infections)
  • methadone (medicine used for treatment of opiate addicts)
  • warfarin (medicine to reduce blood clotting)
  • hormonal contraceptives, e.g. the ?pill?
  • atazanavir (another medicine to treat HIV-infection)
  • lopinavir/ritonavir (another medicine to treat HIV-infection)
  • fosamprenavir (another medicine to treat HIV-infection)
  • efavirenz (another medicine to treat HIV-infection)

Your doctor will carefully monitor the effect of Nevirapine Teva and any of these medicines if you are taking Nevirapine Teva and any of these medicines together.

If you are undergoing dialysis, your doctor may consider a dose adjustment of Nevirapine Teva as Nevirapine Teva can be partly washed out of your blood by dialysis.

Taking Nevirapine Teva with food and drink

There are no restrictions on taking Nevirapine Teva with food and drink.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

You should discontinue breast-feeding if you are taking Nevirapine Teva. It is in general recommended that you do not breast-feed if you have HIV infection in order to lower the risk of passing the infection on to your baby.

Driving and using machines

There are no specific studies on the ability to drive vehicles and use machinery.

Important information about some of the ingredients of Nevirapine Teva

Each Nevirapine Teva 200 mg tablet contains 168 mg of lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How is it used?

Always take Nevirapine Teva exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Nevirapine Teva is in a tablet form and should only be taken by mouth. Do not chew the tablet. The usual dose is one 200 mg tablet for the first 14 days of treatment (this 'lead in' period has been shown to lower the incidence of skin rash) followed by one 200 mg tablet twice daily. Nevirapine Teva will always be taken in combination with other HIV antiretrovirals, for which you should follow the instructions within the supplied package leaflet.

It is essential to follow strictly the once a day dosage during the 14-day ?lead in? period before rising to the twice daily dosage. If you have any rash within this period see your doctor before increasing the dose.

You should continue to take Nevirapine Teva for as long as instructed by your doctor.

As explained in ? Take special care with Nevirapine Teva?, above, your doctor will monitor you with liver tests or for undesirable effects such as rash. Depending on the outcome he or she may decide to interrupt or stop your Nevirapine Teva treatment. He or she might then decide to restart you on a lower dose.

If you take more Nevirapine Teva than you should

Do not exceed the dose prescribed by your doctor and described in this leaflet. There is at present little information on the effects of Nevirapine Teva overdose. Consult your doctor if you have taken an overdose.

If you forget to takeNevirapine Teva

Try not to miss a dose. When you notice within 8 hours, take the next dose as soon as possible. If you notice later take the next regular dose at the scheduled time.

If you stop taking Nevirapine Teva

Taking all doses at the appropriate times greatly increase the effectiveness of your medicinal product combination regimen and reduces the development of viral resistance.
Therefore, unless your doctor instructs you to stop treatment, it is important to keep taking Nevirapine Teva correctly, as described above.

If you stop taking Nevirapine Teva for more than 7 days your doctor will instruct you to start the 14 day 'lead in' period (described above) once again before returning to the twice daily dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

What are possible side effects?

Like all medicines, Nevirapine Teva can cause side effects, although not everybody gets them.

As mentioned in ?Take special care with Nevirapine Teva', above, the most important side effects of Nevirapine Teva are severe and life threatening skin reactions and serious liver damage. These reactions occur mainly in the first 18 weeks of treatment with Nevirapine Teva. This is therefore an important period which requires close monitoring by your doctor.

If you ever observe any rash symptoms please inform your doctor immediately.

When rash occurs it is normally mild to moderate. However, in some patients a rash, which appears as a blistering skin reaction, can be severe or life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) and deaths have been recorded. Most of the cases of both severe rash and mild/moderate rash occur in the first six weeks of treatment.

If rash occurs with feeling sick, you must stop treatment and visit your doctor immediately.

Hypersensitivity (allergic) reactions can occur. Such reactions may appear in the form of anaphylaxis (characterised by rash, facial swelling, bronchial spasm or shock), or rash accompanied by other side effects such as fever, blistering, mouth sores, eye inflammation, facial swelling, general swelling, shortness of breath, muscle or joint aches, a reduction in white blood cells (granulocytopaenia), general feelings of illness or severe problems with liver or kidneys.

If you experience rash and any of the other side effects of a hypersensitivity (allergic) reaction, please be sure to tell your doctor immediately as such reactions can be potentially life-threatening.

Abnormal liver functioning has been reported with the use of Nevirapine Teva, including some cases of inflammation of the liver (hepatitis), which can be sudden and intense (fulminant hepatitis) and liver failure, which have resulted in deaths.

If you experience clinical symptoms suggesting an injury of the liver, such as loss of appetite, feeling sick (nausea), vomiting, yellow skin (jaundice), abdominal pain you should inform your doctor.

The side effects described below have been experienced by patients given nevirapine.

The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)
not known (frequency cannot be estimated from the available data).

Very common:

  • rash

Common:

  • reduction in white blood cells (granulocytopenia)
  • allergic reactions (hypersensitivity)
  • headache
  • feeling sick (nausea)
  • vomiting
  • abdominal pain
  • loose stools (diarrhoea)
  • inflammation of the liver (hepatitis)
  • muscle aches (myalgia)
  • fatigue
  • fever
  • liver function tests abnormal

Uncommon:

  • reduction in red blood cells (anaemia)
  • yellow skin (jaundice)
  • Stevens Johnson Syndrome/toxic epidermal necrolysis
  • hives (urticaria)
  • fluid under the skin (angioneurotic oedema)
  • joint pain (arthralgia)

Rare:

  • sudden and intense inflammation of the liver (hepatitis fulminant)

Not Known:

  • drug rash with systemic symptoms (drug rash with eosinophilia and systemic symptoms)
  • allergic reaction characterised by rash, facial swelling, bronchial spasm or shock (anaphylaxis)

Combination antiretroviral 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. Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipaemia (increased fats in the blood) and resistance to insulin.

The following events have also been reported when nevirapine has been used in combination with other antiretroviral agents:

  • a reduction in red blood cells or in platelets
  • inflammation of pancreas
  • decrease in or abnormal skin sensations.

These events are commonly associated with other antiretroviral agents and may be expected to occur when Nevirapine Teva is used in combination with other agents; however, it is unlikely that these events are due to a treatment with Nevirapine Teva.

Use in children:
A reduction in white blood cells (granulocytopenia) can occur, which is more common in children. A reduction in red blood cells (anaemia), which may be related to nevirapine therapy, is also more commonly observed in children. As with rash symptoms, please inform your doctor of any side effects.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Do not use Nevirapine Teva after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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

Further information

What Nevirapine Teva contains

  • The active substance is nevirapine. Each tablet contains 200 mg nevirapine (as nevirapine anhydrate).
  • The other ingredients are microcrystalline cellulose, lactose monohydrate, povidone K25, sodium starch glycolate (Type A), colloidal silicon dioxide and magnesium stearate.
What Nevirapine Teva looks like and contents of the pack

Nevirapine Teva tablets are supplied in blisters, with 60 or 120 tablets per carton. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Teva Pharma B.V.
Computerweg 10, 3542 DR Utrecht
The Netherlands

Manufacturer

TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13,
4042 Debrecen,
Hungary

TEVA Pharmaceutical Works Private Limited Company

H-2100 Gödöll-,

Táncsics Mihály út 82

Hungary

TEVA UK Ltd

Brampton Road,

Hampden Park,Eastbourne,East Sussex,
BN22 9AG

United Kingdom

Pharmachemie B.V.

Swensweg 5,

2031 GA Haarlem

The Netherlands

TEVA Santé SA,

Rue Bellocier, 89107,

Sens,

France

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

BelgiëBelgiqueBelgien Teva Pharma Belgium N.V.S.A. TelTél 32 3 820 73 73 LuxembourgLuxemburg Teva Pharma Belgium S.A. Tél 32 3 820 73 73

Te 359 2 489 95 82 Magyarország Teva Magyarország Zrt Tel. 36 1 288 64 00

eská republika Teva Pharmaceuticals CR, s.r.o. Tel 420 251 007 111 Malta Teva .. el 30 210 72 79 099

Danmark Teva Denmark AS Tlf 45 44 98 55 11 Nederland Teva Nederland B.V. Tel 31 0 800 0228400

Deutschland Teva Generics GmbH Tel 49 351 834 0 Norge Teva Sweden AB Tlf 46 42 12 11 00

Österreich Teva Generics GmbH Tel 49 351 834 0 Eesti Teva Eesti esindus UAB Sicor Biotech Eesti filiaal Tel 372 611 2409

Teva .. 30 210 72 79 099 Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel. 48 22 345 93 00

España Teva Genéricos Española, S.L.U Tél 34 91 387 32 80 Portugal Teva Pharma - Produtos Farmacêuticos Lda Tel 351 214 235 910

France Teva Santé Tél 33 1 55 91 7800 România Teva Pharmaceuticals S.R.L Tel 4021 230 65 24

Ireland Teva Pharmaceuticals Ireland Tel 353 042 9395 892 Slovenija Pliva Ljubljana d.o.o. Tel 386 1 58 90 390

Ísland Teva UK Limited Sími 44 1323 501 111. Italia Teva Italia S.r.l. Tel 39 0289179805 Slovenská republika Teva Pharmaceuticals Slovakia s.r.o. Tel 421 2 5726 7911 SuomiFinland Teva Sweden AB PuhTel 46 42 12 11 00

Teva .. 30 210 72 79 099 Sverige Teva Sweden AB Tel 46 42 12 11 00

Latvija UAB Sicor Biotech filile Latvij Tel 371 67 784 980 United Kingdom Teva UK Limited Tel 44 1323 501 111

Lietuva

UAB ?Sicor Biotech?
Tel: +370 5 266 02 03

This leaflet was last approved in {MM/YYYY}.

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