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NEVIRAPINE ACCORD 400 MG PROLONGED-RELEASE TABLETS

Active substance(s): NEVIRAPINE ANHYDROUS / NEVIRAPINE ANHYDROUS

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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.

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What is in this leaflet
1. What Nevirapine prolonged-release tablets is and what it is used for
2. What you need to know before you take Nevirapine prolonged-release tablets
3. How to take Nevirapine prolonged-release tablets
4. Possible side effects
5. How to store Nevirapine prolonged-release tablets
6. Contents of the pack and other information

1. What Nevirapine prolonged-release tabletsis and what
it is used for
Nevirapine prolonged-release tablets 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 prolonged-release tablets 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
prolonged-release tablets
Do not take Nevirapine prolonged-release tablets
- if you are allergic to nevirapine or any of the other ingredients of this medicine
(listed in section 6 “What Nevirapine prolonged-release tabletscontains”).
- 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
prolonged-release tablets from working properly.
Warnings and precautions
Talk to your doctor or pharmacist before taking Nevirapine prolonged-release
tablets :
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




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Package leaflet: Information for the user

become severe and even life threatening. You are at greatest risk of such a
reaction during the first 6 weeks of treatment.

Prednisone should not be used to treat a rash related to Nevirapine
prolonged-release tablets .

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 are taking oral contraceptives (e.g.pill“) or other hormonal methods of birth
control during treatment with Nevirapine prolonged-release tablets , you should use a
barrier contraception (e.g. condoms) in addition to prevent pregnancy and further HIV
transmission.

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.

Nevirapine 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.

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 prolonged-release tablets ”).
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 CD 4 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 CD 4 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 prolonged-release tablets after an exposure to HIV unless you
have been diagnosed with HIV and instructed to do so by your doctor. Nevirapine
prolonged-release tablets 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.

Nevirapine prolonged-release 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 prolonged-release tablets .

3. How to take Nevirapine prolonged-release tablets

If you are receiving post-menopausal hormone therapy, ask your doctor for advice
before taking this medicine.

You should not use Nevirapine prolonged-release tablets on its own. You must take it
with at least two other antiretroviral medicines. Your doctor will recommend the best
medicines for you.

If you are taking or are prescribed rifampicin to treat tuberculosis please inform your
doctor before taking this medicine with Nevirapine prolonged-release tablets .

Always take this medicine exactly as your doctor has told you. Check with your
doctor or pharmacist if you are not sure.

Some patients taking other nevirapine prolonged-release formulations have reported
the occurrence of remnants in faeces which may resemble intact tablets. Based on
the data available, this has not been shown to affect the therapeutic response of
these other formulations.

Dosage:

Children and adolescents

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 prolonged-release tablets .
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 prolonged-release tablets . 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 prolonged-release tablets .
It is particularly important that you tell your doctor if you are taking or have recently
taken:

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.
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 prolonged-release tablets 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).

- 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)

You should continue to take Nevirapine prolonged-release tablets for as long as
instructed by your doctor.

Your doctor will carefully monitor the effect of Nevirapine prolonged-release tablets
and any of these medicines if you are taking them together.

If you forget to take Nevirapine prolonged-release tablets
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.

Taking Nevirapine prolonged-release tablets with food and drink
There are no restrictions on taking Nevirapine prolonged-release tablets 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 prolonged-release
tablets . 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 prolonged-release tablets. 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.

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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 prolonged-release tablets
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 prolonged-release tablets with
or without food.
If you take more Nevirapine prolonged-release tablets than you should
Do not take more Nevirapine prolonged-release tablets than prescribed by your
doctor and described in this leaflet. There is at present little information on the effects
of Nevirapine prolonged-release tablets overdose. Consult your doctor if you have
taken more Nevirapine prolonged-release tablets than you should.

If you stop taking Nevirapine prolonged-release tablets 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 prolonged-release tablets
correctly, as described above, unless your doctor instructs you to stop.
If you stop taking Nevirapine prolonged-release tablets 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.

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4. Possible side effects
During HIV therapy there may be an increase in weight and in levels of blood lipids
and glucose. This is partly linked to restored health and life style, and in the case of
blood lipids sometimes to the HIV medicines themselves. Your doctor will test for
these changes.
Like all medicines, this medicine can cause side effects, although not everybody gets
them.
As mentioned in ‘Warnings and precautions', above, the most important side
effects of Nevirapine prolonged-release tablets 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.

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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

blister.The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Nevirapine prolonged-release tablets tablets should be taken within 30 days of
opening the bottle.
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.

Rare (may affect up to 1 in 1000 people):
- inflammation of the liver (hepatitis)
- decreased numbers of red blood cells (anaemia)

6. Contents of the pack and other information
What Nevirapine prolonged-release tablets contains

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)

- The active substance is nevirapine. Each tablet contains 400 mg of nevirapine.
The other ingredients are:
- lactose monohydrate
- hypromellose
- magnesium stearate
What Nevirapine prolonged-release tablets looks like and contents of the pack
Nevirapine prolonged-release tablets are white to off-white oval shaped, approx. 9.3
x 19.2 mm, biconvex tablets debossed with ‘H’ on one side and ‘N1’ on other side.
The prolonged release tablet should not be divided.

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 prolonged-release tablets is used in combination
with other agents; however, it is unlikely that these events are due to treatment with
Nevirapine prolonged-release tablets .

Nevirapine prolonged-release tablets are available in PVC-Alu blisters containing
30x1 and 90x1 prolonged release tablets and HDPE bottles containing 30 prolonged
release tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow, Middlesex, HA1 4HF
United Kingdom
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow, Middlesex, HA1 4HF
United Kingdom
Pharmadox Healthcare, Ltd.
KW20A Kordin Industrial Park,
Paola, PLA 3000, Malta
This leaflet was last revised in 3/2017

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 national reporting system (see contact details below).
By reporting side effects you can help provide more information on the safety of this
medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt//adrportal

5. How to store Nevirapine prolonged-release tablets
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 box, bottle,

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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