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NEVIRAPINE MYLAN 400 MG PROLONGED-RELEASE TABLETS

Active substance(s): NEVIRAPINE ANHYDROUS

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(nevirapine anhydrous)

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.

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• K
 eep 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 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 three
years and above and able to swallow tablets. You must
take Nevirapine together with other antiretroviral
medicines. Your doctor will recommend the best
medicines for you.
Nevirapine prolonged-release tablets should only be
used after a two-week treatment with another type of
nevirapine (immediate-release tablets or suspension)
unless you are currently on nevirapine and are
switching to the prolonged-release form.
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).
• if you have taken nevirapine before and had to stop
the treatment because you suffered from:
* s evere skin rash
* s kin 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
* h
 ypersensitivity (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.
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 dose 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
• a bnormal liver function tests
• 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

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).
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. 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.
Because of the way Nevirapine prolonged-release
tablets are made, parts of tablets may occasionally
be passed and seen in the stool (faeces). These may
look like whole tablets, but will not affect the way
your medicine works. Inform your doctor if you are
concerned about tablet pieces in your faeces.

Children and adolescents

Nevirapine 400 mg prolonged-release tablets can be
taken by children if they:
• are ≥ 8 years of age and weigh 43.8 kg or more
• are older than 3 years of age and below 8 years of
age and weigh 25 kg or more
• have a body surface area of 1.17 square metres
or above.
For smaller children other forms of this medicine may
be more suitable; ask your doctor or pharmacist.

Other medicines and 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 medicines you are
taking in combination with Nevirapine.
Do not take Nevirapine if you are taking or have
recently taken:
• St John’s wort (Hypericum perforatum, a 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”)
• 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.

Pregnancy, breast-feeding and fertility

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 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.

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 prolonged-release 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 Nevirapine.
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Nevirapine 400 mg
Prolonged-release Tablets

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.

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Package leaflet: Information for the patient

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.

Dosage:
Adults:

The recommended dose is one 200 mg nevirapine
tablet per day for the first 14 days of treatment (“leadin” period). A separate treatment initiation pack with
200 mg nevirapine tablets is available for this lead-in
period. After 14 days, the usual dose is one Nevirapine
400 mg prolonged-release tablet once a day.
It is very important that you take only one
nevirapine tablet a day for the first 14 days
(“lead-in” period). If you have any rash during this
period, do not start taking Nevirapine prolongedrelease tablets but consult your doctor.
The 14-day “lead-in” period has been shown to lower
the risk of skin rash.
Patients who are already on immediate-release tablets
or oral suspension can switch to prolonged-release
tablets without a lead-in period.
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.

Use in children and adolescents:

Nevirapine may also be available as smaller
prolonged-release tablets (for children 3 years of
age and above after the lead-in period) or as an oral
suspension for all age groups (not marketed by the
marketing authorisation holder, but may be available
from other companies for all age groups).
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.
If you have kidney or liver problems of any degree
please use only nevirapine 200 mg tablets or
nevirapine 50 mg/5 ml oral suspension.
Only take Nevirapine prolonged-release tablets by
mouth with a liquid. Do not chew or break your
prolonged-release 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
but you may feel tired, sick, be sick, have difficulty
sleeping, or have a spinning sensation (vertigo), have
a fever, headache, skin rashes/lesions or notice wight
loss, fluid retention, liver or lung problems. 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 you missed a dose
within 12 hours of when it was due, take the missed
dose as soon as possible. If it has been more than
12 hours 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 ‘leadin’ period with Nevirapine tablets (described above)
once again, before returning to the once daily dose
with Nevirapine prolonged-release tablets.
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 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 and peeling skin reaction, can be severe or
life-threatening (Stevens-Johnson syndrome and toxic
epidermal necrolysis) and deaths have been recorded.
Drug rash with eosinophilia and systemic symptoms
(DRESS) has also been 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, lips, mouth, tongue or throat
(angioedema)
• general swelling, including swollen or enlarged
glands in the neck, armpit or groin
• 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 characterised by
frequent infections such as fever, severe chills, sore
throat and mouth ulcers (granulocytopenia), your

blood platelets (thrombocytopenia) or an increase
in the number of a certain type of white blood
cell (eosinophils)
• g
 eneral feelings of illness
• s evere 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
• f eeling sick (nausea)
• vomiting
• y ellow skin (jaundice)
• abdominal pain
The side effects described below have been
experienced by patients given nevirapine prolongedrelease tablets once daily in the maintenance phase:

Common (may affect up to 1 in 10 people):










headache
abdominal pain
feeling sick (nausea)
feeling tired (fatigue)
abnormal liver function tests
being sick (vomiting)
loose stools (diarrhoea)
decreased blood phosphorus
increased blood pressure

Uncommon (may affect up to 1 in 100 people):

• d
 ecreased numbers of red blood cells characterised
by tiredness, dizziness, looking pale and being short
of breath when exercising (anaemia)
• hives (urticaria)
• fluid under the skin (angioedema)
• muscle pain (myalgia)
• joint pain (arthralgia)
• fever
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 belly (abdomen)
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 prolonged-release tablets have 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 is used in combination with other
agents; however, it is unlikely that these events are
due to treatment with Nevirapine. Liver or kidney
failure syndromes have been reported rarely.

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.

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 or bottle
after “EXP”. The expiry date refers to the last day of
that month.
This medicine does not require any special
storage conditions.
For bottle packs. Once opened, use within 100 days.
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

• T he active substance is nevirapine. Each prolongedrelease tablet contains 400 mg nevirapine.
• The other ingredients are lactose monohydrate
(see section 2 Nevirapine contains lactose),
hypromellose, and sodium stearylfumarate.

What Nevirapine looks like and contents of
the pack

Nevirapine is a white to off-white, oval shaped
prolonged-release tablet, debossed with M on one
side of the tablet and N403 on the other side.
Nevirapine is packed in PVC/Aluminium foil blisters
containing 14, 30, 30 x 1 (unit dose blister), 60, 90,
100 and 120 prolonged-release tablets and white
HDPE bottles with white opaque polypropylene screw
caps containing 30, 90, 250, and 500 prolongedrelease tablets. The bottles also contain cotton wool.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, UK

Manufacturer
Generics [UK] Ltd., Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom
Mylan Dublin, 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 06/2016

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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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