Nevirapine 200 Mg Tablets
Package leaflet: Information for the user
Nevirapine 200 mg tablets
Nevirapine
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• Ifyou have any further questions, ask your doctor, pharmacist or nurse.
• 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.
• Ifyou get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Nevirapine Tablets is and what it is used for
2. What you need to know before you take Nevirapine Tablets
3. HowtotakeNevirapineTablets
4. Possible side effects
5. Howto store NevirapineTablets
6. Contents of the pack and other information
1. What NevirapineTablets is and what it is used for Nevirapine belongs to a group of medicines called antiretrovirals, used in the treatment of Human Immunodeficiency Virus (HIV-1) infection. The active substance of your medicine is called nevirapine. 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 helps control HIV-1 infection.
Nevirapine is indicated for the treatment of HIV-1 infected adults, adolescents, and children of any age.
You must take Nevirapine together with other antiretroviral medicines. Your doctor will recommend the best medicines for you.
If Nevirapine has been prescribed for your child, please note that all information in this leaflet is addressed to your child (in this case please read "your child" instead of "you").
2. What you need to know before you take NEVIRAPINE TABLETS Do not take NevirapineTablets
• ifyou are allergic to nevirapine or any of the other ingredients of this medicine (listed in section 6 "What Nevirapine contains").
• ifyou have taken NevirapineTablets 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)
• ifyou have severe liver disease
• ifyou have had to stop Nevirapine Tablets treatment in the past because of changes in your liver function
• ifyou are taking a medicine containing the herbal substance St John's Wort (Hypericum perforatum). This herbal substance may stop NevirapineTablets from working properly.
Warning and precautions
Talk to your doctor or pharmacist before taking Nevirapine.
During the first 18 weeks of treatment with NevirapineTablets 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.
Ifyou 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 Tablets AND YOU MUST CONTACT your doctor IMMEDIATELY as such reactions can be potentially life-threatening or lead to death.
Ifyou 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 Tablets. Ifyou 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 Tablets and must contact your doctor immediately.
Ifyou develop severe liver, skin or hypersensitivity reactions whilst taking Nevirapine Tablets, NEVER TAKE Nevirapine Tablets again without referring to your doctor.
You must take the dosage of Nevirapine Tablets as prescribed by your doctor. This is especially important within the first 14 days of treatment (see more information in "How to take Nevirapine Tablets").
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 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 Nevirapine Tablets 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. Ifyou 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 occurafteryou start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. Ifyou 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 ifyou notice changes in body fat (see section 4“PossibleSide Effects").
Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bonetissue 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. Ifyou notice any of these symptoms please inform your doctor.
Ifyou 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. Nevirapine 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. There is still a risk of passing HIV to others through blood or sexual contact or contamination with blood when taking Nevirapine. Use appropriate precautionsto prevent passing on HIV to other people. Please referto your doctor.
Prednisone should not be used to treat a rash related to Nevirapine. Ifyou are taking oral contraceptives (e.g.„pill") or other hormonal methods of birth control during treatment withNevirapine, you should use a barrier contraception (e.g. condoms) in addition to prevent pregnancy and further HIV transmission. Ifyou are receiving post-menopausal hormone therapy, ask your doctor for advice before taking this medicine.
Ifyou are taking or are prescribed rifampicin to treat tuberculosis please inform your doctor before taking this medicine with Nevirapine.
Children and adolescents Nevirapine Tablets can betaken 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 meters.
For smaller children an oral suspension liquid form is available in the market.
Other medicinesand NevirapineTablets
Tell your doctor or pharmacist ifyou 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 NevirapineTablets. 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 NevirapineTablets.
It is particularly important that you tell your doctor ifyou 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)
• delavirdine (another medicine to treat HIV-infection)
• zidovudine (another medicine to treat HIV-infection)
• boceprevir (medicine to treat hepatitis C)
• telaprevir (medicine to treat hepatitis C)
Your doctor will carefully monitor the effect of NevirapineTablets and any of these medicines ifyou are taking them together.
Ifyou are undergoing kidney dialysis, your doctor may consider a dose adjustment of Nevirapine Tablets. This is because NevirapineTablets can be partly washed out of your blood by dialysis.
NevirapineTablets with food and drink
There are no restrictions on taking NevirapineTablets with food and
drink.
Pregnancy and breast-feeding
Ifyou 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.
You should stop breast-feeding ifyou are taking NevirapineTablets. It is in general recommended that you do not breast-feed ifyou have HIV infection because it is possible that your baby can become infected with HIV through your breast milk.
Size: 260 x 245 mm
Driving and using machines
You may experience fatigue when taking NevirapineTablets. Use caution when engaging in activities such as driving, using any tools or machines. Ifyou experience fatigue you should avoid potentially hazardous tasks such as driving or using any tools or machines.
3. How to take Nevirapine Tablets
You should not use NevirapineTablets on its own. You must take it with at least two other antiretroviral medicines. Your doctor will recommend the best medicines for you.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist ifyou are not sure.
Dose:
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.
It is very important that you take only one Nevirapine Tablets tablet a day for the first 14 days ("lead-in" period). Ifyou have any rash during this period, do not increase the dose but consult your doctor.
The 14-day "lead-in" period has been shown to lower the risk of skin rash. As NevirapineTablets must always betaken 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.
Nevirapine is also available in the market in liquid form as an oral suspension.This is particularly suitable:
• ifyou have problems swallowing tablets, or
• for a child weighing less than 50 kg, or with a body surface area less than 1.25 square metres (your doctor will work out your surface area).
You should continue to take Nevirapine Tablets for as long as instructed by your doctor.
As explained in 'Warnings and precautions', above, your doctor will monitor you with liver tests or for undesirable effects such as rash. Depending on the outcome your doctor may decide to interrupt or stop your Nevirapine Tablets treatment. Your doctor might then decide to restart you on a lower dose.
Only take NevirapineTablets by mouth. Do not chew your tablets. You may take NevirapineTablets with or without food.
The score line is only thereto help you break the tablet ifyou have difficulty swallowing it whole.
Ifyou take more NevirapineTablets than you should Do not take more Nevirapine Tablets than prescribed byyourdoctor and described in this leaflet. There is at present little information on the effects of nevirapine overdose. Consult your doctor ifyou have taken more Nevirapine Tablets than you should.
Ifyou forget to take Nevirapine Tablets
Try not to miss a dose. Ifyou notice that you have missed a dose within 8 hours 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.
Ifyou 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 NevirapineTablets correctly, as described above, unless your doctor instructs you to stop.
Ifyou stop taking NevirapineTablets 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.
Ifyou have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
As mentioned in ‘Warnings and precautions', 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 NevirapineTablets. This is therefore an important period which requires close monitoring by your doctor.
Ifyou ever observe any rash symptoms, 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 and you also feel sick, you must stop treatment and visit your doctor 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 (granulocytopenia)
• general feelings of illness
• severe problems with liver or kidneys (liver or kidney failure).
Tell your doctor immediately ifyou 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. This includes some cases of inflammation of the liver (hepatitis), which can be sudden and intense (fulminant hepatitis), and liver failure, which can be both fatal.
Tell your doctor ifyou experience any of the following clinical symptoms of liver damage:
• loss of appetite
• feeling sick (nausea)
• vomiting
• yellow skin (jaundice)
• abdominal pain
The side effects described below have been experienced by patients given nevirapine:
Very common (may affect more than 1 in 10 people):
• rash
Common (may affect upto 1 in 10 people):
• decreased numbers of white blood cells (granulocytopenia)
• allergic reactions (hypersensitivity)
• headache
• feeling sick (nausea)
• vomiting
• abdominal pain
• loose stools (diarrhoea)
• inflammation of the liver (hepatitis)
• feeling tired (fatigue)
• fever
• abnormal liver function test Uncommon (may affect up to 1 in 100 people):
• allergic reaction characterized by rash, swelling of the face, difficulty breathing (bronchial spasm) or anaphylactic shock
• decreased numbers of red blood cells (anaemia)
• yellow skin (jaundice)
• severe and life-threatening skin rashes (Stevens Johnson Syndrome/toxic epidermal necrolysis)
• hives (urticaria)
• fluid under the skin (angioedema)
• joint pain (arthralgia)
• muscle pain (myalgia)
• decreased blood phosphorus
• increased blood pressure
Rare (may affect upto 1 in 1000 people):
• 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 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 NevirapineTablets is used in combination with other agents; however, it is unlikely that these events are due to treatment with Nevirapine Tablets.
Additional side effects In children and adolescents 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.
Reporting of side effects
Ifyou 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 at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Nevirapine Tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine 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. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information What NevirapineTablets contains
• 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 NevirapineTablets looks like and contents of pack
Off-white to pale yellow coloured, capsule shaped, biconvex tablets, debossed with 'H' on one side and '7' on the other side with breakline on both sides.
Nevirapine tablets are supplied in blisters, with 14,60 or 120 tablets per carton. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Hetero Europe S.L.,Viladecans Business Park - Edificio Brasil
Catalunya 83-85,08840 Viladecans (Barcelona), Spain
Manufacturer
Pharmadox Healthcare Ltd.
KW20AKordin Industrial Park, Paola, PLA3000, Malta Distributed by
Creo Pharma Ltd, Felsted Business Centre, Felsted, Essex CM6 3LY, UK. This leaflet was last revised in December 2013.
