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NEVIRAPINE MORNINGSIDE 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
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.

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.

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

It is particularly important that you tell your doctor if you are taking or have
recently taken:

The side effects described below have been experienced by patients given
nevirapine 200 mg tablets during the 14 day lead-in phase:

-

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
Nevirapine is indicated for the treatment of HIV-1 infected adults, adolescents medicines if you are taking them together.
and children three years and above and able to swallow tablets. You must
Taking Nevirapine with food and drink
take nevirapine together with other antiretroviral medicines. Your doctor will
There are no restrictions on taking Nevirapine with food and drink.
recommend the best medicines for you.
Pregnancy and breast-feeding
Nevirapine prolonged-release tablets should only be used after a two-week
If you are pregnant or breast-feeding, think you may be pregnant or are
treatment with another type of nevirapine medicine (immediate-release
planning to have a baby, ask your doctor or pharmacist for advice before
tablets or suspension), unless you are currently on these medicines and are taking this medicine.
switching to the prolonged-release form.
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
2. What you need to know before you take Nevirapine
infection because it is possible that your baby can become infected with HIV
Do not take Nevirapine
through your breast milk.
- if you are allergic to nevirapine or any of the other ingredients of this
Driving and using machines
medicine (listed in section 6 “What Nevirapine contains”).
- if you have taken nevirapine before and had to stop the treatment because You may experience fatigue when taking Nevirapine.
Use caution when engaging in activities such as driving, using any tools or
you suffered from:
machines. If you experience fatigue you should avoid potentially hazardous
- severe skin rash
tasks such as driving or using any tools or machines.
- skin rash with other symptoms for example:
- fever
Nevirapine contains lactose
- blistering
Nevirapine prolonged-release tablets contain lactose (milk sugar).
- mouth sores
If you have been told by your doctor that you have an intolerance to some
- inflammation of the eye
sugars, contact your doctor before taking Nevirapine.
- swelling of the face
3. How to take Nevirapine
- general swelling
- shortness of breath
You should not use Nevirapine on its own. You must take it with at least
- muscle or joint pain
two other antiretroviral medicines. Your doctor will recommend the best
- general feelings of illness
medicines for you.
- abdominal pain
Always take this medicine exactly as your doctor has told you. Check with
- hypersensitivity (allergic) reactions
your doctor or pharmacist if you are not sure.
- inflammation of the liver (hepatitis)
- if you have severe liver disease
Dosage:
- if you have had to stop nevirapine treatment in the past because of
Adults:
changes in your liver function
The dose is one 200 mg nevirapine tablet per day for the first 14 days of
- if you are taking a medicine containing the herbal substance
treatment (“lead-in” period).
St. John’s Wort (Hypericum perforatum). This herbal substance may stop
A separate treatment initiation pack with 200 mg nevirapine tablets may be
Nevirapine from working properly.
available in the market for this lead-in period.
Warnings and precautions
After 14 days, the usual dose is one 400 mg prolonged-release tablet once a
Talk to your doctor or pharmacist before taking Nevirapine
day.
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
It is very important that you take only one 200 mg nevirapine tablet a day
reactions. These can become severe and even life threatening. You are
for the first 14 days (“lead-in” period). If you have any rash during this
at greatest risk of such a reaction during the first 6 weeks of treatment.
period, do not start taking Nevirapine prolonged-release tablets but consult
your doctor.
If you experience severe rash or hypersensitivity (allergic reactions that
may appear in the form of rash) accompanied by other side effects such The 14-day ”lead-in” period has been shown to lower the risk of skin rash.
as
Patients who are already on immediate-release tablets or oral suspension
- fever,
can switch to prolonged-release tablets without lead-in period.
- blistering,
As Nevirapine must always be taken together with other HIV antiretroviral
- mouth sores,
medicines, you should follow the instructions for your other medicines
- inflammation of the eye,
carefully. These are supplied in the package leaflets for those medicines.
- swelling of the face,
- general swelling,
Nevirapine may also be available in the market as smaller prolonged-release
- shortness of breath,
tablets (for children 3 years of age and above after the lead-in period) or as
- muscle or joint pain,
an oral suspension (for all age groups).
- general feelings of illness,
You should continue to take Nevirapine for as long as instructed by your
- or abdominal pain
doctor.
YOU SHOULD DISCONTINUE TAKING NEVIRAPINE AND YOU MUST
CONTACT your doctor IMMEDIATELY as such reactions can be
As explained in ‘Warnings and precautions’, above, your doctor will monitor
potentially life-threatening or lead to death. If you ever have only mild
you with liver tests or for undesirable effects such as rash. Depending on
rash symptoms without any other reaction please inform your doctor
the outcome your doctor may decide to interrupt or stop your Nevirapine
immediately, who will advise you whether you should stop taking
treatment. Your doctor might then decide to restart you on a lower dose.
nevirapine.
If you have a renal or hepatic dysfunction of any degree please use only
If you experience symptoms suggesting damage of the liver, such as
nevirapine 200 mg tablets or a nevirapine 50 mg/5 ml oral suspension, which
- loss of appetite,
may be available in the market.
- feeling sick (nausea),
Only take Nevirapine prolonged-release tablets by mouth. Do not chew your
- vomiting,
prolonged-release tablets. You may take Nevirapine with or without food.
- yellow skin (jaundice),
- abdominal pain
If you take more Nevirapine than you should
you should discontinue taking nevirapine and must contact your doctor Do not take more Nevirapine than prescribed by your doctor and described in
immediately.
this leaflet. There is at present little information on the effects of Nevirapine
If you develop severe liver, skin or hypersensitivity reactions whilst overdose. Consult your doctor if you have taken more Nevirapine than you
taking nevirapine, NEVER TAKE NEVIRAPINE again without referring should.
to your doctor.
If you forget to take Nevirapine
You must take the dose of nevirapine as prescribed by your doctor.
Try not to miss a dose. If you notice you missed a dose within 12 hours of
This is especially important within the first 14 days of treatment
when it was due, take the missed dose as soon as possible. If it has been
(see more information in “How to take Nevirapine”).
more than 12 hours since the dose was due only take the next dose at the
usual time.
The following patients are at increased risk of developing liver problems:
If you stop taking Nevirapine
- women
Taking all doses at the appropriate times:
- infected with hepatitis B or C
- greatly increases the effectiveness of your combination antiretroviral
- abnormal liver function tests
medicines
- treatment-naïve patients with higher CD4 cell counts at the start of
- reduces the chances of your HIV infection becoming resistant to your
nevirapine therapy (women more than 250 cells/mm³, men more than
antiretroviral medicines.
400 cells/mm³)
- pre-treated patients with detectable HIV-1 plasma viral load and higher
It is important that you continue taking Nevirapine correctly,
CD4 cell counts at the start of nevirapine therapy (women more than
as described above, unless your doctor instructs you to stop.
250 cells/mm³, men more than 400 cells/mm³)
If you stop taking Nevirapine for more than 7 days your doctor will instruct
In some patients with advanced HIV infection (AIDS) and a history of
you to start the 14 day ‘lead-in’ period with nevirapine tablets (described
opportunistic infection (AIDS defining illness), signs and symptoms of
above) once again, before returning to the once daily dose with Nevirapine
inflammation from previous infections may occur soon after anti-HIV
prolonged-release tablets.
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
If you have any further questions on the use of this medicine, ask your doctor
infections that may have been present with no obvious symptoms. If you
or pharmacist.
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.

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.

Changes of body fat may occur in patients receiving combination antiretroviral As mentioned in ‘Warnings and precautions’, above, the most
therapy. Contact your doctor if you notice changes in body fat (see section
important side effects of Nevirapine are severe and life threatening
4 “Possible side effects”).
skin reactions and serious liver damage. These reactions occur mainly
in the first 18 weeks of treatment with nevirapine. This is therefore an
Some patients taking combination antiretroviral therapy may develop a
important period which requires close monitoring by your doctor.
bone disease called osteonecrosis (death of bone tissue caused by loss of
blood supply to the bone). The length of combination antiretroviral therapy,
If you ever observe any rash symptoms, inform your doctor immediately.
corticosteroid use, alcohol consumption, severe weakness of the immune
When rash occurs it is normally mild to moderate. However, in some patients
system and higher body mass index may be some of the many risk factors for
a rash, which appears as a blistering skin reaction, can be severe or lifedeveloping this disease. Signs of osteonecrosis are joint stiffness, aches and
threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) and
pains (especially of the hip, knee and shoulder) and difficulty in movement.
deaths have been recorded. Most of the cases of both severe rash and mild/
If you notice any of these symptoms please inform your doctor.
moderate rash occur in the first six weeks of treatment.
If you are taking nevirapine and zidovudine concomitantly please inform your
If rash occurs and you also feel sick, you must stop treatment and visit your
doctor since he might need to check your white blood cells.
doctor immediately.
Do not take Nevirapine after an exposure to HIV unless you have been
Hypersensitivity (allergic) reactions can occur. Such reactions may appear
diagnosed with HIV and instructed to do so by your doctor. Nevirapine is not a
in the form of anaphylaxis (a severe form of allergic reaction) with symptoms
cure for HIV infection. Therefore, you may continue to develop infections and
such as:
other illnesses associated with HIV infection. You should therefore remain in
- rash
regular contact with your doctor.
- swelling of the face
You can still pass on HIV when taking this medicine, although the risk is
- difficulty breathing (bronchial spasm)
lowered by effective antiretroviral therapy. Discuss with your doctor the
- anaphylactic shock
precautions needed to avoid infecting other people.
Hypersensitivity reactions can also occur as rash with other side effects such
Prednisone should not be used to treat a rash related to Nevirapine.
as:
If you are taking oral contraceptives (e.g. „pill“) or other hormonal methods
- fever
of birth control during treatment with Nevirapine, you should use a barrier
- blistering of your skin
contraception (e.g. condoms) in addition to prevent pregnancy and further
- mouth sores
HIV transmission.
- inflammation of the eye
- swelling of the face
If you are receiving post-menopausal hormone therapy, ask your doctor for
- general swelling
advice before taking this medicine.
- shortness of breath
- muscle or joint pain
If you are taking or are prescribed rifampicin to treat tuberculosis please
- a reduction in the numbers of your white blood cells (granulocytopenia)
inform your doctor before taking this medicine with Nevirapine.
- general feelings of illness
Some patients taking other nevirapine prolonged-release formulations have
- severe problems with liver or kidneys (liver or kidney failure)
reported the occurrence of remnants in faeces which may resemble intact
Tell your doctor immediately if you experience rash and any of the other side
tablets. Based on the data available, this has not been shown to affect the
effects of a hypersensitivity (allergic) reaction. Such reactions can be
therapeutic response of these other formulations.
life-threatening.
Children and adolescents
Abnormal liver functioning has been reported with the use of nevirapine.
Nevirapine 400 mg prolonged-release tablets can be taken by children if they:
This includes some cases of inflammation of the liver (hepatitis), which can
- are ≥ 8 years of age and weigh 43.8 kg or more
be sudden and intense (fulminant hepatitis), and liver failure, which can be
- are older than 3 years of age and below 8 years of age and weigh 25 kg or
both fatal.
more
- have a body surface area of 1.17 square metres or above.

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.
Nevirapine 400mg prolonged release tablets should be taken within 30 days
of opening the HDPE 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.
6. Contents of the pack and other information
What Nevirapine contains
- The active substance is nevirapine. Each tablet contains 400 mg of
nevirapine.
The other ingredients are:
- lactose monohydrate
- hypromellose
- magnesium stearate
What Nevirapine looks 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 400 mg prolonged release tablets are available in PVC-Alu
blisters containing 30 and 90 prolonged release tablets and HDPE bottles
containing 30 prolonged release tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Morningside Healthcare Ltd
115 Narborough Road
Leicester
LE3 0PA
UK
Manufacturer
Pharmadox HeaIthcare Ltd.
KW20A Kordin Industrial Park, Paola
PLA 3000
Malta
This medicinal product is authorised in the Member States of the EEA
under the following names:
Netherlands: Nevirapine Morningside 400 mg, tabletten met verlengde afgifte
UK: Nevirapine Morningside 400 mg prolonged-release tablets
This leaflet was last revised in March 2017

For smaller children smaller prolonged-release tablets orother suitable
formulations (e.g. an oral suspension liquid form) may be checked for their
availability.
M0303LAMUKNAS-S-001

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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