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NEVIRAPINE DR. REDDYS 400 MG PROLONGED-RELEASE TABLETS

Active substance(s): NEVIRAPINE ANHYDROUS / NEVIRAPINE ANHYDROUS

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Package leaflet: Information for the user

Nevirapine 400 mg Prolonged-Release 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 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 medicine (immediate-release
tablets or suspension), unless you are currently on these medicines and are
switching to the prolonged-release form.
2. What you need to know before you take Nevirapine

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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 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
- abnormal 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 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. 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 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 smaller prolonged-release tablets or other suitable
formulations (e.g. an oral suspension liquid form) may be checked for their
availability.
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 medicines
you are taking in combination with Nevirapine.
It is particularly important that you tell your doctor if you are taking or have
recently taken:
- St. John’s Wort (Hypericum perforatum, medicine to treat depression)
- rifampicin (medicine to treat tuberculosis)
- rifabutin (medicine to treat tuberculosis)
- macrolides e.g. clarithromycin (medicine to treat bacterial infections)
- fluconazole (medicine to treat fungal infections)
- 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.
Taking Nevirapine with food and drink
There are no restrictions on taking Nevirapine 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
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.
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.
Dosage:
Adults:
The dose is one 200 mg nevirapine tablet per day for the first 14 days of
treatment (“lead-in” period).
A separate treatment initiation pack with 200 mg nevirapine tablets may be
available in the market for this lead-in period.
After 14 days, the usual dose is one 400 mg prolonged-release tablet once a
day.
It is very important that you take only one 200 mg 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 prolonged-release tablets but consult
your doctor.

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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 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.
Nevirapine may also be available in the market 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).
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 a renal or hepatic dysfunction of any degree please use only
nevirapine 200 mg tablets or a nevirapine 50 mg/5 ml oral suspension,
which may be available in the market.
Only take Nevirapine prolonged-release tablets by mouth. Do not chew
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. 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.
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 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

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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 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 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 200 mg tablets during the 14 day lead-in phase:
Common (may affect up to 1 in 10 people):
- rash
- fever
- headache
- abdominal pain
- feeling sick (nausea)
- loose stools (diarrhoea)
- feeling tired (fatigue)
Uncommon (may affect up to 1 in 100 people):
- allergic reactions (hypersensitivity)
- allergic reaction characterized by rash, swelling of the face, difficulty
breathing (bronchial spasm) or anaphylactic shock
- drug reaction with systemic symptoms (drug reaction with eosinophilia
and systemic symptoms)
- sudden and intense inflammation of the liver (fulminant hepatitis)
- severe and life-threatening skin rashes (Stevens Johnson

-

Syndrome/toxic epidermal necrolysis)
yellow skin (jaundice)
hives (urticaria)
fluid under the skin (angioneurotic oedema)
vomiting
muscle pain (myalgia)
joint pain (arthralgia)
decreased numbers of white blood cells (granulocytopenia)
abnormal liver function tests
decreased blood phosphorus
increased blood pressure

Rare (may affect up to 1 in 1000 people):
- inflammation of the liver (hepatitis)
- decreased numbers of red blood cells (anaemia)
The side effects described below have been experienced by patients given
nevirapine prolonged-release tablets once daily in the maintenance phase:
Common (may affect up to 1 in 10 people):
- rash
- headache
- abdominal pain
- feeling sick (nausea)
- inflammation of the liver (hepatitis)
- feeling tired (fatigue)
- abnormal liver function tests
- fever
- vomiting
- loose stools (diarrhoea)
Uncommon (may affect up to 1 in 100 people):
- allergic reactions (hypersensitivity)
- allergic reaction characterized by rash, swelling of the face, difficulty
breathing (bronchial spasm) or anaphylactic shock
- drug reaction with systemic symptoms (drug reaction with eosinophilia
and systemic symptoms)
- sudden and intense inflammation of the liver (fulminant hepatitis)
- severe and life-threatening skin rashes (Stevens Johnson
Syndrome/toxic epidermal necrolysis)
- decreased numbers of red blood cells (anaemia)
- decreased numbers of white blood cells (granulocytopenia)
- yellow skin (jaundice)
- hives (urticaria)
- fluid under the skin (angioneurotic oedema)
- muscle pain (myalgia)
- joint pain (arthralgia)
- decreased blood phosphorus
- increased blood pressure
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 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
pack.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. 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 tablets contain
- The active substance is nevirapine. Each tablet contains 400 mg of
nevirapine.
The other ingredients are:
- lactose monohydrate
- hypromellose
- magnesium stearate
What Nevirapine tablets look like and contents of the pack
Nevirapine 400 mg Prolonged-Release Tablets are white to off-white oval
shaped, biconvex tablets debossed with ‘H’ on one side and ‘N1’ on other
side. The prolonged release tablet should not be divided.
Nevirapine tablets are available in PVC-Alu blisters containing 10, 30, 60
and 90 prolonged-release tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road, Beverley,
East Yorkshire, HU17 0LD, United Kingdom
Manufacturer
Pharmadox Healthcare Ltd, KW20A Kordin Industrial Park,
Paola, PLA 3000, Malta
This leaflet was last revised in 06/2017

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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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