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NEVIRAPINE 200 MG TABLETS

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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.
• If you 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.
• If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
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. How to take Nevirapine Tablets
4. Possible side effects
5. How to store Nevirapine Tablets
6. Contents of the pack and other information
1. What Nevirapine Tablets is and what it is used for
Nevirapine Tablets 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 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. What you need to know before you take NEVIRAPINE TABLETS
Do not take Nevirapine Tablets
• if you are allergic to nevirapine or any of the other ingredients of
this medicine. See Section 6 of this leaflet for a list of other
ingredients (“What Nevirapine Tablets contains”).
• if you have taken Nevirapine Tablets 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 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.
Warning and precautions
Talk to your doctor before taking 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.

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 Tablets 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 Tablets.
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 Tablets and must
contact your doctor immediately.
If you 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-naïve 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. 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 (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. There is still a risk of passing HIV to others through blood

or sexual contact or contamination with blood when taking
Nevirapine Tablets. Use appropriate precautions to prevent passing
on HIV to other people. Please refer to your doctor.
Use in children
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 meters.
For smaller children an oral suspension liquid form is available in the
market.
Other medicines and Nevirapine Tablets
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 Tablets.
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 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)
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, your doctor may consider a
dose adjustment of Nevirapine Tablets. This is because Nevirapine
Tablets can be partly washed out of your blood by dialysis.
Nevirapine Tablets with food and drink
There are no restrictions on taking Nevirapine Tablets with food and
drink.
Pregnancy and breast-feeding
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.
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
You may experience fatigue when taking Nevirapine Tablets. 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.
3. How to take Nevirapine Tablets
You should not use Nevirapine Tablets 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.
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.
CRE-NEV200-PIL-032_02
25/10/2012

It is very important that you take only one Nevirapine Tablets tablet
a day for the first 14 days (“lead-in” period). If you 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 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.
Nevirapine is also available in the market in liquid form as an oral
suspension. This is particularly suitable:
• if you 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 ‘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 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 Nevirapine Tablets by mouth. Do not chew your tablets. You
may take Nevirapine Tablets with or without food.
The score line is only there to help you break the tablet if you have
difficulty swallowing it whole.
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 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, this medicine 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 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
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 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. 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 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 10 patients
treated
Uncommon: in at least 1 out of 1000 and less than 1 out 100 patients
treated
Rare: in at least 1 out of 10,000 and less than 1 out 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 (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:
• 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:
• 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 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 (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 side effects not listed in this leaflet.
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 Nevirapine Tablets 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 Nevirapine Tablets 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 60 tablets per carton.
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., KW20A Kordin Industrial Park,
Paola, PLA 3000, Malta
Distributed by
Creo Pharma Ltd, Felsted Business Centre, Felsted, Essex CM6 3LY, UK.
This leaflet was last revised in October 2012.
CRE-NEV200-PIL-032_02
25/10/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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