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NEVIRAPINE ACTAVIS 200 MG TABLETS

Active substance(s): NEVIRAPINE ANHYDROUS / NEVIRAPINE ANHYDROUS / 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 further questions, please 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.
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 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

Do not take Nevirapine

if you are allergic to nevirapine or any of the other ingredients of this medicine (listed in
section
6“What nevirapine contains”).
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 {product name} 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 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 dosage 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-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.
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.
Nevirapine is not a cure for HIV infection and you may continue to develop infections or other
illnesses associated with 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. You can still pass on HIV when taking this medicine, although the
risk is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions
needed to avoid infecting other people.
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.
Children and adolescents

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 may be available.
Other medicines and Nevirapine

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 {product name}.
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)

-

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)
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.
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 stop breast-feeding if you are taking Nevirapine. 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. 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 tablets contains lactose (milk sugar)
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking Nevirapine.

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.
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 tablet a day for the first 14 days (‘leadin’ 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 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 may also be available in liquid form as an oral suspension. This is particularly
suitable if:
you have problems swallowing tablets
or you are a child weighing less than 50 kg
or you are a child having a body surface area less than 1.25 square metres (your doctor
will work out your surface area).
You should continue to take Nevirapine 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 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
with or without food.
If you take more Nevirapine than you should
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.
If you forget to take Nevirapine

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.
If you 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 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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This
is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV
medicines themselves. Your doctor will test for these changes.
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 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
Hypersensitivity reactions can also occur as a 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 both be 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
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
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 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 up to 1 in 1,000 people):
sudden and intense inflammation of the liver (fulminant hepatitis)
drug reaction with systemic symptoms (drug reaction with eosinophilia and
systemic symptoms)

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 {product name} is used in combination with other agents; however, it is
unlikely that these events are due to treatment with {product name}.
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
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 the 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

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 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 October 2016.

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

Expand Transcript

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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