Nevirapine 200mg Tablets

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Nevirapine is and what it is used for
2. What you need to know before you take Nevirapine
3. How to take Nevirapine
4. Possible side effects
5. How to store Nevirapine
6. Contents of the pack and other information

• if you are allergic to nevirapine or any of the other ingredients of this medicine (listed in section 6).
• if you have taken Nevirapine before and had to stop the treatment because you suffered from:
  • severe skin rash
  • skin rash with other symptoms for example:
    • fever
    • blistering
    • mouth sores
    • inflammation of the eye
    • swelling of the face
    • general swelling
    • shortness of breath
    • muscle or joint pain
    • general feelings of illness
    • abdominal pain
  • hypersensitivity (allergic) reactions
  • inflammation of the liver (hepatitis)
    • if you have severe liver disease
    • if you have had to stop Nevirapine 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 from working properly.

Talk to your doctor or pharmacist before taking Nevirapine.

During the first 18 weeks of treatment with Nevirapine 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.

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,
• inflammation of the eye,
• swelling of the face,
• general swelling,
• shortness of breath,
• muscle or joint pain,
• general feelings of illness,
• or abdominal pain

YOU SHOULD DISCONTINUE TAKING NEVIRAPINE 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.

If you experience symptoms suggesting damage of the liver, such as

• loss of appetite,
• feeling sick (nausea),
• vomiting,
• yellow skin (jaundice),
• abdominal pain

You should discontinue taking Nevirapine and must contact your doctor immediately.

If you develop severe liver, skin or hypersensitivity reactions whilst taking Nevirapine, NEVER TAKE Nevirapine again without referring to your doctor.

You must take the dose of Nevirapine as prescribed by your doctor. This is especially important within the first 14 days of treatment (see more information in “How to take Nevirapine”).

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

• women
• infected with hepatitis B or C
• abnormal liver function tests
• treatment-naive patients with higher CD4+ cell counts at the start of Nevirapine 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+ cell counts at the start of Nevirapine 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.

In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.

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.

If you are taking nevirapine and zidovudine concomitantly please inform your doctor since he might need to check your white blood cells.

Do not take Nevirapine after an exposure to HIV unless you have been diagnosed with HIV and instructed to do so by your doctor.

Prednisone should not be used to treat a rash related to Nevirapine.

If you are taking oral contraceptives (e.g. “pill”) or other hormonal methods of birth control during treatment with Nevirapine, you should use a barrier contraception (e.g. condoms) in addition to prevent pregnancy and further HIV transmission. If you are receiving post-menopausal hormone therapy, ask your doctor for advice before taking this medicine.

If you are taking or are prescribed rifampicin to treat tuberculosis please inform your doctor before taking this medicine with Nevirapine.

Nevirapine tablets can be taken by:

• children 16 years of age or older
• children under 16 years of age who:
• weigh 50 kg or more
• or have a body surface area above 1.25 square metres.

For smaller children an oral suspension liquid form is available.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 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.

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)
• ketoconazole (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)
• etravirine (another medicine to treat HIV-infection)
• rilpivirine (another medicine to treat HIV-infection)
• zidovudine (another medicine to treat HIV-infection)
• elvitegravir/cobicistat (another medicine to treat HIV-infection)

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

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

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

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk.

If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible.

You may experience fatigue when taking nevirapine. Use caution when engaging in activities such as driving, using any tools or machines. If you experience fatigue you should avoid potentially hazardous tasks such as driving or using any tools or machines.

Nevirapine contains 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.

Nevirapine contains sodium starch glycolate. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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

Try not to miss a dose. If you notice that you have missed a dose within 8 hours of when it was due, take the missed dose as soon as possible. If it has been more than 8 hours since the dose was due only take the next dose at the usual time.

Do not take a double dose to make up for a forgotten dose.

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 correctly, as described above, unless your doctor instructs you to stop.

If you stop taking Nevirapine 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.

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 you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is nevirapine. Each tablet contains 200 mg nevirapine.
• The other ingredients are Lactose monohydrate, cellulose microcrystalline, sodium starch glycolate (Type-A), povidone (K-30), silica colloidal anhydrous, magnesium stearate.

Tablet.

White to off-white, oval shaped, biconvex tablets, debossed with ‘J’ and ‘80’ on either side of break line on one side and with break line on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Nevirapine tablets are available in clear PVC/ PVdC/ Aluminium foil blister pack and HDPE bottle pack with polypropylene closure.

Pack sizes:

Blister pack: 1, 7, 10, 14, 60 and 120 tablets

Bottle pack: 60 and 500 tablets

Not all pack sizes may be marketed.

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