Nevirapine Mylan 200 Mg Tablets
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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.
• If you have any further questions, askyour 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 symptoms are the same as yours.
• If you get any side effects, talkto your doctor or pharmacist.This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Nevirapine is and what it is used for.
2. Whatyou need to know before you take Nevirapine.
3. How to take Nevirapine.
4. Possible side effects.
5. Howto store Nevirapine.
6. Contents of the pack and other information.
1. WHAT NEVIRAPINE 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 ingredient of your medicine is called nevirapine. Nevirapine 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 helps control HIV-1 infection.
You must take Nevirapine together with other antiretroviral medicines. Your doctor will recommend the best medicines for you.
2. WHATYOU NEEDTO KNOW BEFOREYOU TAKE NEVIRAPINE
Do not take Nevirapine:
• 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.
Warnings and precautions
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 stop 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 whetheryou should stop taking Nevirapine.
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Nevirapine, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk.
Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).These potentially life-threatening skin rashes are often accompanied by flu-like symptoms.
The rash may progress to widespread blistering or peeling of the skin.
If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Nevirapine, you must not be re-started on Nevirapine at any time.
If you develop a rash or these skin symptoms, stop taking Nevirapine, seek urgent advice from a doctor and tell him thatyou are taking this medicine.
• If you experience symptoms suggesting damage of the liver, such as:
* loss of appetite
* feeling sick (nausea)
* vomiting (being sick)
* yellow skin (jaundice)
* abdominal pain
you should stop 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 dosage of Nevirapine as prescribed by your doctor. This is especially important within the first 14 days of treatment (see Section 3 '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/mm^, men more than 400 cells/mm^).
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. Contactyour 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 together 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 told 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 precautions to prevent passing on HIV to other people. Please refer to 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, askyour 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.
Children and adolescents
Nevirapine tablets can be taken by:
• children 16 years of age or older
• children under 16years of age who weigh 50 kg or more or have a body surface area above 1.25 square metres (your doctor will work out your surface area).
For smaller children an oral suspension liquid form is available.
Other medicines and Nevirapine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines obtained without a prescription 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 thatyou 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'). Nevirapine might reduce their effectiveness. When used for birth control,you must also use a reliable barrier method of contraception (for example, a condom).
• other medicines to treat HIV infection (e.g. atazanavir, lopinavir/ritonavir, fosamprenavir, efavirenz, zidovudine).
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.
Nevirapine with food and drink
Food and drink have no effect on the medicine.The tablets can be taken with or without food.
Pregnancy and breast-feeding
Askyour doctor or pharmacist for advice before taking any medicine.
If you become pregnant or are planning to become pregnant, you must contact your doctor to discuss the potential adverse effects and the benefits and risks of your antiretroviral therapy to you and your child.
You should stop breast-feeding if you are taking Nevirapine. It is in general recommended thatyou 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
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
Nevirapine tablets contain lactose (milk sugar).
If you have been told by your doctor that you have an intolerance to some sugars, contactyour doctor before taking this medicine.
3. HOWTO TAKE NEVIRAPINE
You should not use Nevirapine 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 if you are not sure.
Only take Nevirapine tablets by mouth with liquid. Do not chew or crush your tablets. You may take Nevirapine with or without food.
If you have problems swallowing tablets, an oral suspension liquid form is available.
Code No.: MH/DRUGS/25/NKD/89 10004794
Dosage
The recommended dose is one 200 mg tablet per day for the first 14 days of treatment ('lead-in' period).
After 14-days, the recommended dose is one 200 mg tablet twice a day.
It is very important thatyou take only one Nevirapine forthe first 14-days. Ifyou have a rash during this period do not increase the dose but tell your doctor. The 14 day 'lead-in' period has been shown to lower the risk of skin rash.
As Nevirapine 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 for as long as instructed by your doctor.
As explained in Section 2, above, your doctor will monitoryou with livertests orfor undesirable effects such as rash. Depending on the outcome your doctor may decide to interrupt or stop your Nevirapine treatment. Your doctor might then decide to restart you on a lower dose.
Use in children and adolescents
Nevirapine tablets can be taken by:
• children 16years of age or older
• children under 16years of age who weigh 50 kg or more or have a body surface area above 1.25 square metres (your doctor will work out your surface area).
For smaller children an oral suspension liquid form is recommended.
Ifyou take more Nevirapine than you should
Do not take more Nevirapine than prescribed by your doctorand described in this leaflet.There is at present little information on the effects of Nevirapine overdose. Consult your doctor ifyou have taken more Nevirapine than you should for further advice.
Ifyou forget to take Nevirapine
Try notto missa dose. Ifyou notice thatyou have missed a dose within 8 hours of when it was due, take the next 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
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 thatyou continue taking Nevirapine correctly, as described above, unless your doctor instructs you to stop.
Ifyou 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.
If you have any further questions on the use of this medicine, askyour doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
As mentioned in Section 2, the most important side effects of Nevirapine are severe and life-threatening skin reactions and serious liver damage. These reactions occur mainly in the first 18 weeks of treatment with Nevirapine.This is therefore an important period, which requires close monitoring by your doctor.
If you 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 (sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties in swallowing).
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 (being sick)
• 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 up to 1 in 10 people):
• decreased numbers of white blood cells (granulocytopenia)
• allergic reactions (hypersensitivity)
• headache
• feeling sick (nausea)
• vomiting (being sick)
• abdominal pain
• loose stools (diarrhoea)
• inflammation of the liver (hepatitis)
• feeling tired (fatigue)
• fever
• abnormal liver function tests.
Uncommon (may affect up to 1 in 100 people):
• allergic reaction characterised 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 potentially life-threatening skin rashes (Stevens-Johnson syndrome/toxic epidermal necrolysis) (see Section 2)
• hives (urticaria)
• fluid under the skin (angioedema)
• joint pain (arthralgia)
• muscle pain (myalgia)
• decreased blood phosphorus
• increased blood pressure.
Rare (may affect up to 1 in 1,000 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 (symptoms can include severe upper stomach pain, often with nausea (feeling sick) and vomiting (being sick)
• decrease in or abnormal skin sensations.
These events are commonly associated with other antiretroviral agents and may be expected to occur when Nevirapine is used in combination with other agents; however, it is unlikely that these events are due to treatment with Nevirapine .
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.
Ifyou get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
'Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.'
5. HOWTO STORE NEVIRAPINE
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 medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Askyour pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Nevirapine contains:
• The active substance is nevirapine. Each tablet contains 200 mg nevirapine.
• The other ingredients are Lactose Monohydrate, Microcrystalline Cellulose (E460), Povidone (E1201), Sodium Starch Glycolate (Type A), Silica Colloidal Anhydrous (E551), and Magnesium Stearate (E572).
What Nevirapine looks like and contents of the pack
The 200 mg tablet is a white to off-white, oval shaped tablet, debossed with 'NE 200' on one side with a score line separating the NE and 200 and debossed with 'M' on the other side with a score line.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Nevirapine is packed in PVC/Aluminium blisters, of 14, 14x1 (unit dose blister), 30,60,60 x 1 (unit dose blister), 100,120,200 and HDpE bottle pack comprises of white coloured HDPE bottle with white opaque polypropylene (PP) screw cap containing 60 tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.A.S, 117 Allee des Parcs,
69 800 Saint Priest, France.
Manufacturers
Generics [UK] Ltd., Potters Bar, Herts., EN6 1TL,
United Kingdom.
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Mylan Hungary Kft, H-2900 Komarom,
Mylan utca 1, Hungary.
This leaflet was last revised in: Code No.: MH/DRUGS/25/NKD/89
02/2013 10004794