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BRINAF 400MG PROLONGED-RELEASE TABLETS

Active substance(s): NEVIRAPINE ANHYDROUS / NEVIRAPINE ANHYDROUS

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Brinaf 400 mg
prolonged-release
tablets
Nevirapine

PHARMA CODE

Package leaflet: Information for the user

Brinaf 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 Brinaf is and what it is used for
2. What you need to know before you take Brinaf
3. How to take Brinaf
4. Possible side effects
5. How to store Brinaf
6. Contents of the pack and other information
1. What Brinaf is and what it is used for
Brinaf 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, Brinaf 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.
Brinaf 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 Brinaf
Do not take Brinaf
- if you are allergic to nevirapine or any of the other ingredients of this medicine (listed in section 6 “What
Brinaf 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 Brinaf from working properly.

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 Brinaf after an exposure to HIV unless you have been diagnosed with HIV and instructed to do so
by your doctor. Brinaf 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 Brinaf.
If you are taking oral contraceptives (e.g. “pill”) or other hormonal methods of birth control during treatment
with Brinaf, 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 Brinaf.
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.
Children and adolescents
Brinaf 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 Brinaf
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 Brinaf. 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 Brinaf.
It is particularly important that you tell your doctor if you are taking or have recently taken:

Warnings and precautions

- St. John's Wort (Hypericum perforatum, medicine to treat depression)

Talk to your doctor or pharmacist before taking Brinaf:

- rifampicin (medicine to treat tuberculosis)

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

- rifabutin (medicine to treat tuberculosis)

threatening. You are at greatest risk of such a reaction during the first 6 weeks of treatment.

- fluconazole (medicine to treat fungal infections)

If you experience severe rash or hypersensitivity (allergic reactions that may appear in the form of rash)
accompanied by other side effects such as

- ketoconazole (medicine to treat fungal infections)

- 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,

- macrolides e.g. clarithromycin (medicine to treat bacterial 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)

- feeling sick (nausea),

Your doctor will carefully monitor the effect of Brinaf and any of these medicines if you are taking them
together.

- vomiting,

Taking Brinaf with food and drink

- yellow skin (jaundice),

There are no restrictions on taking Brinaf with food and drink.

- abdominal pain

Pregnancy and breast-feeding

you should discontinue taking nevirapine and must contact your doctor immediately.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.

If you 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 Brinaf”).
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

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You should stop breast-feeding if you are taking Brinaf. It is in general recommended that you do not breastfeed 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 Brinaf. 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.
Brinaf contains lactose
Brinaf 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 Brinaf.
3. How to take Brinaf
You should not use Brinaf on its own. You must take it with at least two other antiretroviral medicines. Your

PHARMA CODE
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 is 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 Brinaf 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 Brinaf 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 Brinaf 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
Brinaf 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 available in the market.
Only take Brinaf prolonged-release tablets by mouth. Do not chew your prolonged-release tablets. You may
take Brinaf with or without food.
If you take more Brinaf than you should
Do not take more Brinaf than prescribed by your doctor and described in this leaflet. There is at present little
information on the effects of Brinaf overdose. Consult your doctor if you have taken more Brinaf than you
should.
If you forget to take Brinaf
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 Brinaf
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 Brinaf correctly, as described above, unless your doctor instructs you
to stop.
If you stop taking Brinaf 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 Brinaf
prolonged-release tablets.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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.

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
Brinaf 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

As mentioned in 'Warnings and precautions', above, the most important side effects of Brinaf 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.

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.

If you ever observe any rash symptoms, inform your doctor immediately.

Reporting of side effects

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 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 Car Scheme, Website
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety
of this medicine.

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 Brinaf. 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):

5. How to store Brinaf
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the box, bottle, blister. The expiry date refers
to the last day of that month.
This medicine does not require any special storage conditions.
Brinaf 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.
6. Contents of the pack and other information
What Brinaf contains
- The active substance is nevirapine. Each tablet contains 400 mg of nevirapine (as anhydrous).
The other ingredients are:
- lactose monohydrate
- hypromellose
- magnesium stearate
What Brinaf looks like and contents of the pack
Brinaf 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.
Brinaf tablets are available in PVC-Alu blisters containing 30, 90 and 180 (2 packs of 90) 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
Zentiva
One Onslow Street
Guildford, Surrey,
GU1 4YS, UK
Manufacturer
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park,
Paola, PLA 3000
Malta
This medicinal product is authorised in the Member States of the EEA under the following names:
The Netherlands
Brinaf 400 mg Tabletten met verlengde afgifte
United Kingdom
Brinaf 400 mg prolonged-release tablets
This leaflet was last revised in February 2017.

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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