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NEVIRAPINE ZENTIVA 200MG TABLETS

Active substance(s): NEVIRAPINE ANHYDROUS

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Nevirapine Zentiva 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 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 Zentiva is and what it is used for
2.
What you need to know before you take Nevirapine Zentiva
3.
How to take Nevirapine Zentiva
4.
Possible side effects
5.
How to store Nevirapine Zentiva
6.
Contents of the pack and other information
1.

WHAT NEVIRAPINE ZENTIVA IS AND WHAT IT IS USED FOR

Nevirapine Zentiva 200 tablets belong 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
Zentiva helps control HIV-1 infection.
Nevirapine Zentiva 200 mg tablets are indicated for the treatment of HIV-1 infected adults,
adolescents and children of any age. You must take Nevirapine Zentiva together with other
antiretroviral medicines. Your doctor will recommend the best medicines for you.
If Nevirapine Zentiva 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
ZENTIVA

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Do not take Nevirapine Zentiva if you are allergic to nevirapine or any of the other
ingredients of this medicine (listed in section 6).
 if you have taken Nevirapine Zentiva 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 Zentiva 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 Zentiva from working properly.
Warnings and precautions
Talk to your doctor or pharmacist before taking Nevirapine Zentiva
During the first 18 weeks of treatment with Nevirapine Zentiva 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
 abdominal pain.

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YOU SHOULD DISCONTINUE TAKING Nevirapine Zentiva AND YOU MUST
CONTACT your doctor IMMEDIATELY as such reactions can be potentially lifethreatening 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 Zentiva.
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 Zentiva and must contact your doctor
immediately.
If you develop severe liver, skin or hypersensitivity reactions whilst taking Nevirapine
Zentiva, NEVER TAKE Nevirapine Zentiva again without referring to your doctor.
You must take the dose of Nevirapine Zentiva as prescribed by your doctor. This
is especially important within the first 14 days of treatment (see more information
in ‘How to take Nevirapine Zentiva’).

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 Zentiva
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 Zentiva 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.

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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 Zentiva after an exposure to HIV unless you have been diagnosed
with HIV and instructed to do so by your doctor. Nevirapine Zentiva 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 Zentiva. 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 Zentiva
If you are taking oral contraceptives (e.g. ‘pill’) or other hormonal methods of birth control
during treatment with Nevirapine Zentiva, 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 Zentiva
Children and adolescents
Nevirapine Zentiva 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 is available.
Other medicines and Nevirapine Zentiva
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 Zentiva. 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 Zentiva
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)
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rifampicin, rifabutin (medicines to treat tuberculosis)
macrolides e.g. clarithromycin (medicine to treat bacterial infections)
fluconazole, ketoconazole, itraconazole (medicines 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, lopinavir/ritonavir, fosamprenavir, efavirenz, zidovudine, etravirine,
rilpivirine, delavirdine, elvitegravir/cobicistat (another medicines to treat HIV-infection)
boceprevir, telaprevir (medicine to treat hepatitis C)

Your doctor will carefully monitor the effect of Nevirapine Zentiva 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 Zentiva. This is because Nevirapine Zentiva can be partly washed out of your
blood by dialysis.
Nevirapine Zentiva with food and drink
There are no restrictions on taking Nevirapine Zentiva 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 Zentiva. 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 Zentiva. 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 ZENTIVA

You should not use Nevirapine Zentiva 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.

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It is very important that you take only one Nevirapine Zentiva 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 Zentiva 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 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 Zentiva 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 Zentiva treatment. Your doctor might then decide
to restart you on a lower dose.
Only take Nevirapine Zentiva tablets by mouth. Do not chew your tablets. You may take
Nevirapine Zentiva 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 Zentiva than you should
Do not take more Nevirapine Zentiva than prescribed by your doctor and described in this
leaflet. There is at present little information on the effects of Nevirapine Zentiva overdose.
Consult your doctor if you have taken more Nevirapine Zentiva than you should.
If you forget to take Nevirapine Zentiva
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 Zentiva
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 Zentiva correctly, as described above,
unless your doctor instructs you to stop.

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If you stop taking Nevirapine Zentiva 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 ‘Warnings and precautions’, above, the most important side effects
of Nevirapine Zentiva are severe and life-threatening skin reactions and serious liver
damage. These reactions occur mainly in the first 18 weeks of treatment with Nevirapine
Zentiva. 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 Zentiva.
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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.
The side effects described below have been experienced by patients given Nevirapine
Zentiva:
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 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 up to 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
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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 Zentiva 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 Zentiva is used in combination with other agents; however,
it is unlikely that these events are due to treatment with Nevirapine Zentiva
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 or pharmacist. 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 ZENTIVA

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 Zentiva 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, colloidal anhydrous silica, magnesium stearate.
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What Nevirapine Zentiva looks like and contents of the 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 Zentiva 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
The Manufacturer is Pharmadox HeaIthcare Ltd., KW20A Kordin Industrial Park, Paola, PLA
3000, Malta or S.C. ZENTIVA S.A. B-dul. Theodor Pallady nr. 50, district 3, Bucuresti, cod
032266, Romania
The Marketing Authorisation Holder is Zentiva, One Onslow Street, Guilford, Surrey, GU1
4YS, UK.
This medicinal product is authorised in the Member States of the EEA under
the following names:
Portugal, Italy
Nevirapina Zentiva
United Kingdom
Nevirapine Zentiva 200 mg
This leaflet was last revised in April 2014

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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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