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NEVIRAPINE MYLAN 200 MG TABLETS

Active substance(s): NEVIRAPINE ANHYDROUS

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Package leaflet: Information for the patient

Nevirapine
200 mg Tablets
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.
2.
3.
4.
5.
6.

What Nevirapine is and what it is used for
What you need to know before you take Nevirapine
How to take Nevirapine
Possible side effects
How to store Nevirapine
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 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 used 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.

• treatment-naïve 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/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 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”).

If you are taking nevirapine and zidovudine together
please inform your doctor since he might need to check
your white blood cells.

2. What you need to know before you
take Nevirapine

Do not take nevirapine after an exposure to HIV unless
you have been diagnosed with HIV and told to do so by
your doctor.

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.

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. You can still
pass on HIV when taking this medicine, although the
risk is lowered by effective antiretroviral therapy. Talk to
your doctor the precautions needed to prevent passing
on HIV to 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 (your doctor will work out your surface area).

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.

For children weighing less than 50 kg or who have
a body surface area less than 1.25 square metres
(your doctor will work out body surface area) an oral
suspension liquid form is available.

• 
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 whether you should stop taking 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.

Potentially life-threatening skin rashes (StevensJohnson 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, swelling of the face and conjunctivitis
(red and swollen eyes). These potentially life-threatening
skin rashes are often accompanied by flu-like symptoms
(fever, muscle or joint aches and general fatigue). 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 that you 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 you 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

Other medicines and Nevirapine

Do not take Nevirapine if you are taking or have
recently taken:
• 
St John’s Wort (Hypericum perforatum, medicine to
treat depression)
It is particularly important that you tell your doctor
if you are taking or have recently taken:
• 
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, etravirine, rilpivirine, delavirdine,
zidovudine, elvitegravir/cobicistat)
• 
boceprevir or telaprevir (medicines used to
treat hepatitis C).
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.

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.
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 generally 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.

Code No.: MH/DRUGS/25/NKD/89
574309

Description Nevirapine 200 mg ALL

Date: 21 Jul 2015

Component Type Leaflet

Pharma Code TBC

No. of colours

Affiliate Item Code 574309

SAP No. N/A

Colours

Superceded Affiliate Item Code 10004794
TrackWise PR No. 574309
MA No. N/A
Packing Site/Printer N/A
Supplier Code N/A

Vendor Job No. 246197
Trackwise Proof No. 5
Glams Proof No. N/A
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

1

Time: 13:49
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro

Body Text Size 9pt

Dimensions 170 x 560mm

Min Text Size used 7pt

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ARTWORK FOR SUBMISSION ONLY, DUMMY KEYLINES IN USE. NO KEYLINE AVAILABLE AT THE TIME OF ARTWORK
CREATION AS PACK SITE TO BE DEFINED. UPDATE REQUIRED ONCE ACTUAL PACKAGING SITE IS CONFIRMED.

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, contact your doctor before
taking this medicine.

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 or
pharmacist 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.

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 that you take only one Nevirapine
for the first 14-days. If you 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 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.

Use in 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(your doctor will work out your surface area).
For children weighing less than 50 kg or who have
a body surface area less than 1.25 square metres
(your doctor will work out body surface area) an oral
suspension liquid form is recommended.

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,
but you may feel tired, sick, be sick, or have a spinning
sensation (vertigo), a fever, headache, skin rashes or
notice weight loss fluid retention or lung problems.
Consult your doctor if you have taken more Nevirapine
than you should for further advice.

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 next dose as soon as possible. If it has been more
than 8hours since the dose was due only take the next
dose at the usual time. Do not take a double dose to
make up for a forgotten dose.

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
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 (StevensJohnson syndrome and toxic epidermal necrolysis) and
deaths have been recorded. Drug rash with eosinophilia
and systemic symptoms (DRESS) has also been rarely
reported. 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
• hives (urticaria)
• 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, including swollen or enlarged
lymph nodes
• shortness of breath
• muscle or joint pain
• inflammation of internal organs
• changes in your blood including a reduction
in the numbers of your white blood cells
(granulocytopenia), your blood platelets
(thrombocytopenia) or an increase in the number of

Description Nevirapine 200 mg ALL

a certain type of white blood cell (eosinophils)
• 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 (being sick)
• yellow skin (jaundice)
• abdominal pain
The side effects described below have been
experienced by patients given nevirapine:

Common (may affect up to 1 in 10 people):
• 
headache
• 
feeling sick (nausea)
• 
vomiting (being sick)
• 
abdominal pain
• 
loose stools (diarrhoea)
• 
feeling tired (fatigue)
• 
fever
• 
abnormal liver function tests

Uncommon (may affect up to 1 in 100 people)

• 
decreased numbers of red blood cells (anaemia)
• 
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):

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, hyperlipidaemia
(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.

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 medicine 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 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, 14 x
1 (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
Manufacturer
Generics [UK] Limited, Potters Bar, Herts, EN6 1TL,
United Kingdom
Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland
Mylan Hungary Kft, H-2900, Komárom, Mylan útca.1,
Hungary

This leaflet was last revised in:
07/2015

Date: 21 Jul 2015

Component Type Leaflet

Pharma Code TBC

No. of colours

Affiliate Item Code 574309

SAP No. N/A

Colours

Superceded Affiliate Item Code 10004794
TrackWise PR No. 574309
MA No. N/A
Packing Site/Printer N/A
Supplier Code N/A

Vendor Job No. 246197
Trackwise Proof No. 5
Glams Proof No. N/A
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

1

Code No.: MH/DRUGS/25/NKD/89
574309

Time: 13:49
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro

Body Text Size 9pt

Dimensions 170 x 560mm

Min Text Size used 7pt

Sign-offs

ARTWORK FOR SUBMISSION ONLY, DUMMY KEYLINES IN USE. NO KEYLINE AVAILABLE AT THE TIME OF ARTWORK
CREATION AS PACK SITE TO BE DEFINED. UPDATE REQUIRED ONCE ACTUAL PACKAGING SITE IS CONFIRMED.

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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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