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NEVIRAPINE ACTAVIS 200 MG TABLETS

Active substance(s): NEVIRAPINE ANHYDROUS

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PACKAGE LEAFLET

Package leaflet: Information for the user

Nevirapine 200 mg, tablets
Nevirapine anhydrous
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 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.
What is in this leaflet
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

1.

What Nevirapine is and what it is used for

Nevirapine contains the active substance nevirapine which belongs to a group of medicines called
antiretrovirals, used in the treatment of Human Immunodeficiency Virus (HIV-1) infection. HIV is
spread by contact with infected blood or sexual contact with an infected individual.
Nevirapine belongs to the class of non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Nevirapine is used to treat HIV-1 infection in adults and adolescents aged 16 years and older and
adolescents younger than 16 years but weighing more than 50 kg or whose body surface area is above
1.25 m2 according to the Mosteller formula, respectively by reducing the amount of the virus in the
blood.
Nevirapine is prescribed for use in combination with other HIV antiretrovirals. Your doctor will
determine which medicines are best for you.

2.

What you need to know before you 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 previously experienced inflammation of the liver (hepatitis), severe skin rash, or liver
damage while on nevirapine treatment.
if you have permanent liver disease or changes in liver function.
if you are taking products containing St John’s Wort (Hypericum perforatum) as this may stop
Nevirapine from working properly.
Warnings and precautions
During the first 18 weeks of treatment with Nevirapine you should watch out for signs of liver or skin
reactions as these can become severe and even life threatening.
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,
eye inflammation,
facial swelling,
general swelling,
shortness of breath,
muscle or joint aches,
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 a 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 hepatic, 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 more information in in section 3).
The following patients are at increased risk for 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 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 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.
Bone problems: Some patients taking combination antiretroviral therapy may experience death of
bone tissue (osteonecrosis). The length of combination antiretroviral therapy, corticosteroid use,
alcohol consumption, severe weakness of the immune system, 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 is not a cure for HIV infection and you may continue to develop infections or other
illnesses associated with HIV infection. It is therefore important to remain under the care of your
doctor while taking Nevirapine.

Even by taking anti-HIV medicinal product you still may pass HIV on to others through sexual contact
or contamination with blood.
Children and adolescents
Do not give this medicine to children and adolescents below the age of 16 years unless they are
weighing more than 50 kg or their body surface area is above 1.25 m2.
Other medicines and Nevirapine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. You should inform your doctor of all other medicines you are taking before you start
taking Nevirapine because he or she might need to monitor whether the other medicines are still
having their desired effects and make necessary dose adjustments.
You should carefully read the package leaflet of the other HIV medicinal products which you will be
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),
ketaconazole (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”, use additional contraceptives (e.g. barrier
contraceptives),
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 and any of these medicines if you are
taking Nevirapine and any of these medicines together.
Nevirapine with food and drink
There are no restrictions on taking {product name} 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 discontinue breast-feeding if you are taking Nevirapine. It is in general recommended that
you do not breast-feed if you have HIV infection in order to lower the risk of passing the infection on
to your baby.
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
Each Nevirapine tablet contains 318 mg of lactose. If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor before taking this medicinal product.

3.

How to 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.
Nevirapine is in a tablet form and should only be taken by mouth with some liquid. Do not chew or
chrush the tablet.
The recommended dose is one 200 mg tablet for the first 14 days of treatment (this 'lead in' period has
been shown to lower the incidence of skin rash) followed by one 200 mg tablet twice daily. Nevirapine
will always be taken in combination with other HIV antiretrovirals, for which you should follow the
instructions within the supplied package leaflet.
It is essential to follow strictly the once a day dosage during the 14-day ‘lead in’ period before rising
to the twice daily dosage. If you have any rash within this period see your doctor before increasing the
dose.
You should continue to take Nevirapine for as long as instructed by your doctor.
As explained in ‘Take special care with Nevirapine, above, your doctor will monitor you with liver
tests or for undesirable effects such as rash. Depending on the outcome he or she may decide to
interrupt or stop your Nevirapine treatment. He or she might then decide to restart you on a lower
dose.
If you are undergoing dialysis, your doctor may consider a dose adjustment of Nevirapine as
Nevirapine can be partly washed out of your blood by dialysis.
Use in children and adolescents
Nevirapine tablets can be taken by adolescents 16 years of age or older. Additionally Nevirapine
tablets can be taken by children and adolescents under 16 years of age who weigh 50 kg or more or
whose body surface area is above 1.25 m2.
If you take more Nevirapine than you should
Do not exceed the dose 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 an overdose.
If you forget to take Nevirapine
Try not to miss a dose. When you notice within 8 hours, take the next dose as soon as possible. If you
notice later take the next regular dose at the scheduled time.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Nevirapine
Taking all doses at the appropriate times greatly increase the effectiveness of your medicinal product
combination regimen and reduces the development of viral resistance. Therefore, unless your doctor
instructs you to stop treatment, it is important to keep taking Nevirapine correctly, as described above.
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.
If you have any further questions on the use of this medicine, 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 ', above, 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 please 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 with feeling sick, you must stop treatment and visit your doctor immediately.
Hypersensitivity (allergic) reactions can occur. Such reactions may appear in the form of anaphylaxis
(characterised by rash, facial swelling, bronchial spasm or shock), or rash accompanied by other side
effects such as fever, blistering, mouth sores, eye inflammation, facial swelling, general swelling,
shortness of breath, muscle or joint aches, a reduction in white blood cells (granulocytopenia), general
feelings of illness or severe problems with liver or kidneys.
If you experience rash and any of the other side effects of a hypersensitivity (allergic) reaction, please
be sure to tell your doctor immediately as such reactions can be potentially life-threatening.
Abnormal liver functioning has been reported with the use of Nevirapine, including some cases of
inflammation of the liver (hepatitis), which can be sudden and intense (fulminant hepatitis) and liver
failure, which have resulted in deaths.
If you experience clinical symptoms suggesting an injury of the liver, such as loss of appetite, feeling
sick (nausea), vomiting, yellow skin (jaundice), abdominal pain you should inform your doctor.
The side effects described below have been experienced by patients given nevirapine.
The frequency of possible side effects listed below is defined using the following convention:
Very common (may affect more than 1 in 10 people)
Common
(may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare
(may affect up to 1 in 1,000 people)
Very rare
(may affect up to 1 user in 10,000 people)
Not known
(frequency cannot be estimated from the available data)
Very common:
rash
Common:
reduction in white blood cells (granulocytopenia)
allergic reactions (hypersensitivity)
headache
feeling sick (nausea)
vomiting
abdominal pain
loose stools (diarrhoea)
inflammation of the liver (hepatitis)
fatigue

-

fever
liver function tests abnormal (hepatic enzymes increased)

Uncommon:
allergic reaction characterised by rash, swelling of the face, difficulty breathing (bronchial
spasm) or anaphylactic shock
reduction in red blood cells (anaemia)
yellow skin (jaundice)
Stevens Johnson Syndrome/toxic epidermal necrolysis (which can be fatal)
hives (urticaria)
fluid under the skin (angioneurotic oedema)
joint pain (arthralgia)
muscle pain (myalgia)
decreased blood phosphorus
increase blood pressure
Rare:
sudden and intense inflammation of the liver (hepatitis fulminant)
-

drug rash with eosinophilia (increased number of certain white blood cells) 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:
a reduction in red blood cells or in platelets
inflammation of pancreas
decrease in or abnormal skin sensations.
These events are commonly associated with other antiretroviral agents and may be expected to occur
when {product name} is used in combination with other agents; however, it is unlikely that these
events are due to a treatment with Nevirapine.
Some patients taking combination antiretroviral therapy may experience death of bone tissue
(osteonecrosis). The frequency of this adverse reaction is unknown.
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.
If you get any of the side effects, talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet.

5.

How to 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. 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 medicine 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 contains
- The active substance is nevirapine. Each tablet contains 200 mg nevirapine anhydrous .
- The other ingredients are microcrystalline cellulose, lactose monohydrate (see section 2
“Nevirapine contains lactose”), povidone K25, sodium starch glycolate (Type A) ,
colloidal anhydrous silica, magnesium stearate.
What Nevirapine looks like and contents of the pack
Nevirapine are white, oval tablets of 19.2 x 9.4 mm with “200” debossed on one side and “NVP”
debossed on the other side.
Nevirapine is available in PVC/PVDC-aluminium blister packs containing 14, 60 or 120 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland

Manufacturers
Helm AG
Nordkanalstraße 28
20097 Hamburg
Germany
This medicinal product is authorised in the Member States of the EEA under the following
names:
Germany
France
Spain

This leaflet was last revised June 2014.

Nevirapine Arriello 200 mg tablets
Nevirapine Arrow 200 mg comprimés
Nevirapina Actavis 200 mg comprimidos

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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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