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Document: leaflet MAH GENERIC_PL 20117-0203 change

• leaflet MAH GENERIC_PL 16363-0345
• leaflet MAH GENERIC_PL 20117-0203
• leaflet MAH GENERIC_PL 29831-0571

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2024801

PACKAGE LEAFLET: INFORMATION FOR THE USER

Nevirapine 200 mg Tablets

Nevirapine

Read all of this leaflet carefully before you start

taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, askyourdoctor 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Nevirapine Tablets are and what they are used for

2.    Before you take Nevirapine Tablets

3.    How to take Nevirapine Tablets

4.    Possible side effects

5.    How to store Nevirapine Tablets

6.    Further information

1. WHAT NEVIRAPINE TABLETS ARE AND WHATTHEYARE USED FOR

Nevirapine Tablets belongs to a group of medicines called antiretrovirals, used in the treatment of Human Immunodeficiency Virus (HIV), strain 1 (HIV-1) infection.

The active ingredient of your medicine is called nevirapine. The active ingredient is the substance in this medicine that reduces the amount of viruses in the blood thus improving your medical condition. Nevirapine belongs to a class of anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). Reverse transcriptase is an enzyme that HIV needs in order to multiply. Nevirapine stops reverse transcriptase from working. By stopping reverse transcriptase from working, Nevirapine Tablets helps control HIV-1 infection.

You must take Nevirapine Tablets together with other antiretroviral medicines. Your doctor will recommend the best medicines for you.

2. BEFOREYOUTAKENEVIRAPINETABLETS

Do not take Nevirapine Tablets

•    if you are allergic (hypersensitive) to nevirapine or any of the other ingredients of Nevirapine Tablets. See Section 6 of this leaflet for a list of other ingredients (“What Nevirapine Tablets contain").

•    if you have taken Nevirapine Tablets before and had to stop the treatment because you suffered from:

■    severe skin rash

■    skin rash withothersymptomsforexample:

•    fever

-    blistering

•    mouth sores

•    inflammation of the eye

•    swelling of the face

-    general swelling

•    shortness of breath

-    muscle orjoint pain

•    general feelings of illness

-    abdominal pain

•    hypersensitivity (allergic) reactions

-    inflammation of the liver (hepatitis)

• if you have severe liverdisease

•    if you have had to stop Nevirapine Tablets treatment in the past because of changes in your liver function

•    if you are taking a medicine containing the herbal substance St John's Wort (Hypericum perforatum). This herbal substance may stop Nevirapine Tablets from working properly.

Take special care with Nevirapine Tablets

During the first 18 weeks of treatment with Nevirapine Tablets it is very important that you and your doctor watch out for signs of liver or skin reactions. These can become severe and even life threatening. You are at greatest risk of such a reaction during the first 6 weeks of treatment.

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

•    women

•    infected with hepatitis B or C

•    having abnormal liverfunction tests

•    treatment-na'ive patients with higher CD4 cell counts at the start of Nevirapine Tablets therapy (women more than 250 cells/mm³, men more than 400 cells/mm³)

•    pre-treated patients with detectable HIV-1 plasma viral load and higher CD4 cells counts at the start of Viramune 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 yourdoctorimmediately.

Changes of body fat may occur in patients receiving combination antiretroviral therapy. Contact your doctor if you notice changes in body fat (see section 4 ‘Possible side effects’).

Some patients taking combination antiretroviral 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 antiretroviral therapy, corticosteroid use, alcohol consumption, severe weakness of the immune system and 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 Tablets is not a cure for HIV infection. Therefore, you may continue to develop infections and other illnesses associated with HIV infection. You should therefore remain in regular contact with your doctor. In addition, Nevirapine Tablets does not prevent the risk of passing on HIV to others through blood or sexual contact. Use appropriate precautions to prevent passing on HIV to other people. Please refer to yourdoctor.

Use in children

Nevirapine Tablets can be taken by:

•    children 16yearsofageorolder

•    children under 16 years of age who:

■ weigh50kgormore

- or have a body surface area above 1.25 square meters.

For smaller children an oral suspension liquid form is available.

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. Inform your doctor about all other medicines you are taking before you start taking Nevirapine. Your doctor might need to monitor whether your other medicines are still working and adjust doses. Carefully read the package leaflet of all other HIV medicinal products you are taking in combination with Nevirapine Tablets.

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 treattuberculosis)

•    rifabutin (medicine to treat tuberculosis)

•    macrolides e.g. clarithromycin (medicine to treat bacterial infections)

•    fluconazole (medicine to treatfungal infections)

•    ketoconazole (medicine to treat fungal infections)

•    itraconazole (medicine to treatfungal 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 Tablets and any of these medicines if you are taking them together.

If you are undergoing kidney dialysis, yourdoctor may consider a dose adjustment of Nevirapine Tablets. This is because Nevirapine Tablets can be partly washed out of your blood by dialysis.

Taking Nevirapine Tablets with food and drink

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

Pregnancy and breast-feeding

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

You should stop breast-feeding if you are taking Nevirapine Tablets. It is in general recommended that you do not breast-feed if you have HIV infection because it is possible that your baby can become infected with HIV through your breast milk.

Driving and using machines

There are no specific studies on the ability to drive vehicles and use machinery. If you feel that your ability to drive or use machines may be affected you should not drive or use machines.

3. HOWTOTAKENEVIRAPINETABLETS

You should not use Nevirapine Tablets on their own. You must take them with at least two other antiretroviral medicines. Your doctor will recommend the best medicines for you.

mm

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

Dosage:

The dose is one 200 mg tablet per day for the first 14 days of treatment (“lead-in” period). After 14 days, the usual dose is one 200 mg tablet twice a day.

The 14-day “lead-in” period has been shown to lower the risk of skin rash.

As Nevirapine Tablets must always be taken together with other HIV antiretroviral medicines, you should follow the instructions for your other medicines carefully. These are supplied in the package leaflets for those medicines.

You should continue to take Nevirapine Tablets for as long as instructed by yourdoctor.

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

Only take Nevirapine Tablets by mouth. Do not chew your tablets. You may take Nevirapine Tablets with or without food.

If you take more Nevirapine Tablets than you should

Do not take more Nevirapine Tablets than prescribed by your doctor and described in this leaflet. There is at present little information on the effects of Nevirapine Tablets overdose. Consult your doctor if you have taken more Nevirapine Tablets than you should.

If you forget to take Nevirapine Tablets

Try not to miss a dose. If you notice that you have missed a dose within 8 hours, take the next dose as soon as possible. If you notice it more than 8 hours later, take the next dose at the usual time.

If you stop taking Nevirapine Tablets

Taking all doses at the appropriate times:

•    greatly increases the effectiveness of your combination antiretroviral medicines.

•    reduces the chances of your HIV infection becoming resistant to your antiretroviral medicines.

It is important that you continue taking Nevirapine Tablets correctly, as described above, unless your doctor instructs you to stop.

If you stop taking Nevirapine Tablets 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.

4. POSSIBLE SIDE EFFECTS

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

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

If you ever observe any rash symptoms, inform your doctorimmediately.

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 and you also feel sick, you must stop treatment and visit yourdoctor immediately.

Hypersensitivity (allergic) reactions can occur. Such reactions may appear in the form of anaphylaxis (a severe form of allergic reaction) with symptoms such as:

•    rash

•    swelling of the face

•    difficulty breathing (bronchial spasm)

•    anaphylactic shock

Hypersensitivity reactions can also occur as rash with other side effects such as:

•    fever

• blistering of your skin

•    mouth sores

• inflammation of the eye

•    swelling of the face

•    general swelling

•    shortness of breath

• muscle or joint pain

•    a reduction in the numbers of your white blood cells (granulocytopaenia)

•    general feelings of illness

•    severe problems with liver or kidneys (liver or kidney failure)

Tell your doctor immediately if you experience rash and any of the other side effects of a hypersensitivity (allergic) reaction. Such reactions can be life-threatening.

Abnormal liver functioning has been reported with the use of Nevirapine Tablets. This includes some cases of inflammation of the liver (hepatitis), which can be sudden and intense (fulminant hepatitis), and liver failure; both can be fatal.

Tell your doctor if you experience any of the following clinical symptoms of liver damage:

•    loss of appetite

•    feeling sick (nausea)

•    vomiting

•    yellow skin (jaundice)

•    abdominal pain

Evaluation of the side effects is based on the following frequencies:

Very common: in at least 1 out of 10 patients treated Common: in at least 1 out of 100 and less than 1 out of 10 patients treated

Uncommon: in at least 1 out of 1000 and less than 1 out of 100 patients treated

Rare: in at least 1 out of 10,000 and less than 1 out of 1000 patients treated

The side effects described below have been experienced by patients given NEVIRAPINE:

Very common:

•    rash

Common:

•    decreased numbers of white blood cells (granulocytopaenia)

• allergic reactions (hypersensitivity)

•    headache

•    feeling sick (nausea)

•    vomiting

•    abdominal pain

• loose stools (diarrhoea)

• inflammation of the liver (hepatitis)

•    muscle pain (myalgia)

•    feeling tired (fatigue)

•    fever

• abnormal liver function test Uncommon:

•    allergic reaction characterized by rash, swelling of the face, difficulty breathing (bronchial spasm) oranaphylacticshock

•    decreased numbersofred blood cells (anaemia)

•    yellow skin (jaundice)

•    severe and life-threatening skin rashes (Stevens Johnson Syndrome/toxic epidermal necrolysis)

•    hives (urticaria)

•    fluid underthe skin (angioedema)

•    joint pain (arthralgia)

•    muscle pain (myalgia)

•    decreased blood phosphorus

•    increased blood pressure

Rare:

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

•    drug rash with systemic symptoms (drug rash with eosinophilia and systemic symptoms)

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 Tablets has been used in combination with other antiretroviral agents:

•    decreased numbers of red blood cells or platelets

• inflammation of the pancreas

• decrease in or abnormal skin sensations

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

Use in children

A reduction in white blood cells (granulocytopaenia) 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.

5. HOWTO STORE NEVIRAPINE TABLETS

Keep out of the reach and sight of children.

Do not use Nevirapine Tablets 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.

6. FURTHER INFORMATION

What Nevirapine Tablets contain

•    The active substance is nevirapine. Each tablet contains 200 mg nevirapine.

•    The other ingredients are:

■    microcrystalline cellulose

■    croscarmellose sodium

■    maize starch

■    povidone (K30)

■    sodium starch glycolate

■    silica, colloidal anhydrous

■    magnesium stearate

What Nevirapine Tablets looks like and contents of pack

Off-white to pale yellow coloured, capsule shaped, biconvex tablets, embossed with 'H' on one side and '7' on the other side, with break-line on both sides. The tablets should not be divided.

Nevirapine Tablets are supplied in blisters, with 14,60 or 120 tablets per carton. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Morningside Healthcare Ltd 115 Narborough Road, Leicester, LE3 0PA, UK

Manufacturer

Pharmadox Healthcare Ltd.

KW20ACorradino Industrial Estate,

PaolaPLA3000, MALTA.

This leaflet was last revised in March 2014

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