Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Viramune XR.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the risks of you using
Viramune XR against the benefits they expect it will have for you.
If you have any concerns about using this medicine, ask your doctor or pharmacist.
This leaflet was last updated on the date at the end of this leaflet. More recent
information may be available. The latest Consumer Medicine Information is available
from your pharmacist, doctor, or from www.medicines.org.au and may contain important
information about the medicine and its use of which you should be aware.
Keep this leaflet with your medicine.
You may need to read it again.
What Viramune XR is used for
Viramune XR is used in the treatment of the infection caused by the Human Immunodeficiency
Virus (HIV-1). HIV-1 is the main virus responsible for the development of Acquired
Immunodeficiency Syndrome (AIDS).
Viramune XR contains the active ingredient Nevirapine. Nevirapine belongs to a group
of antiretroviral medicines called non-nucleoside reverse transcriptase inhibitors
(NNRTIs). It works by inhibiting or interrupting the enzyme reverse transcriptase
that the HIV virus needs to multiply.
Viramune XR does not cure or prevent HIV-1 infection or AIDS, but it does hinder the
growth of HIV-1.
Viramune XR is prescribed in combination with other antiretroviral medicines which
hinder the growth of HIV-1 in other ways. When these medicines are taken with Viramune
XR, the growth of HIV-1 is hindered more effectively.
Viramune XR has not been shown to reduce the likelihood that you will develop the
illnesses associated with advanced HIV-1 infection. It is important for you to continue
seeing your doctor regularly.
Viramune XR does not reduce or prevent transmission of HIV-1 to others through sexual
contact or blood contamination.
Before you take Viramune XR
When you must not take it
Do not take Viramune XR if you have an allergy to:
any medicine containing nevirapine
any of the other ingredients listed at the end of this leaflet.
Do not take Viramune XR if you have the rare inherited condition of galactose intolerance.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Do not take Viramune XR if you have:
severe liver dysfunction
previously experienced serious liver or skin reactions while on Viramune or Viramune
Do not give this medicine to a child under the age of 3 years.
Safety and effectiveness in children younger than 3 years have not been established.
Do not take this medicine after the expiry date printed on the carton or bottle or
if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives
It is essential that your doctor knows your medical history before prescribing Viramune
Tell your doctor if you have, or have had, any of the following conditions:
liver problem/disease or hepatitis
severe kidney disease undergoing dialysis treatment.
If you are not sure if you have, or have had, any of these conditions, you should
raise those concerns with your doctor.
Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.
Your doctor can discuss with you the risks and benefits involved.
Special care is recommended during pregnancy. The benefits of Viramune XR must be
assessed against possible effects on you and your unborn baby.
Breastfeeding is not recommended during your use of Viramune XR because:
Viramune XR enters the breast milk, so your doctor may suggest an alternate method
of feeding your child
there is a risk of passing the HIV-1 virus to your baby.
If you have not told your doctor about any of the above, tell him/her before you start
taking Viramune XR.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any
that you get without a prescription from your pharmacy, supermarket or health food
In particular, tell your doctor if you are taking:
other anti-HIV medicines
anti-Hepatitis B and C medicines
fluconazole, itraconazole, ketoconazole
corticosteroids (e.g. prednisone)
herbal medicines derived from St John's Wort (Hypericum perforatum)
medicines used in the treatment of:
cancer (e.g. cyclophosphamide)
gastrointestinal motility disorder (e.g. cisapride)
hypertension or heart conditions (calcium channel blockers)
irregular heartbeats (antiarrhythmics)
immune disorders or to prevent rejection of transplanted organ (immunosuppressants)
migraine (ergot derivatives)
severe pain (e.g. fentanyl).
These medicines may be affected by Viramune XR, or may affect how well it works. You
may need different amounts of the medicine, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.
As Viramune XR may reduce the effectiveness of oral contraceptives, talk to your doctor
about alternative methods of contraception.
How to take Viramune XR
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the carton or bottle, ask your doctor
or pharmacist for help.
How much to take
Follow the dosing instructions carefully, especially the once daily dosage during
the first 14 days ('lead-in' period) of Viramune 200 mg immediate-release tablets
or Viramune oral suspension.
Adults 16 years and older:
First 14 days: one Viramune 200 mg immediate-release tablet or 20 mL Viramune oral
suspension once daily
After the first 14 days: one Viramune XR 400 mg extended-release tablet once daily
(taken at about the same time each day).
Children (aged 3 years or older) and adolescents to 15 years:
Viramune XR can be taken by children aged 3 years or older. Your child's doctor will
calculate the dose for your child. The calculation will include your child's age and
body weight, or body surface area.
For younger children starting from birth an oral suspension is available.
First 14 days: Viramune oral suspension is given once daily
After the first 14 days: Your child may be switched to Viramune XR tablets once daily
(taken at about the same time each day). The tablets should not be broken, crushed
Ask your doctor for more information if you have been advised to take a different
dose, or if you are not sure what dose to give your child.
Your doctor will closely monitor you or your child for potential side effects of taking
the medicine, in particular during the first 18 weeks of treatment.
If you are switching from Viramune immediate-release tablets or oral suspension:
If you are already taking Viramune 200 mg immediate release tablets or oral suspension
twice daily in combination with other antiretroviral agents you can switch to Viramune
XR 400 mg extended-release tablets once daily without the 14 day 'lead-in' period.
Take your Viramune 200 mg immediate-release tablets or oral suspension as normal the
day before you switch. Then take your Viramune XR 400 mg extended-release tablet the
next morning and do not take any more of the Viramune immediate-release tablets or
How to take it
Swallow the tablets whole with a full glass of water.
The tablets should not be broken, crushed or chewed.
The tablets can be taken with or without food.
When to take it
Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
How long to take it
Continue taking your medicine for as long as your doctor tells you.
This medicine helps to control your condition, but does not cure it. It is important
to keep taking your medicine even if you feel well.
If you forget to take it
It is important to take Viramune XR as directed.
If you miss a dose, take it as soon as you remember. However, if you remember when
it is almost time for your next dose, take only your usual dose at that time.
Do not take a double dose to make up for the dose you missed.
If you have missed taking Viramune XR for more than 7 days, contact your doctor before
you start taking it again.
You may need to restart using the 14 days (lead-in) once daily dosing procedure.
If you are not sure what to do, talk to your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
If you take too much (overdose)
Immediately telephone your doctor, pharmacist or Poisons Information Centre (Australia
telephone 13 11 26) for advice, or go to Emergency at your nearest hospital if you
think that you or anyone else may have taken too much Viramune XR. Do this even if
there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Symptoms of an overdose may include oedema, fatigue, fever, headache, insomnia, lung
problems, rash, dizziness, nausea, vomiting, weight loss and erythema nodosum (a condition
causing red-purple swellings on the shins, thighs and less commonly, the arms, joint
and muscle pains and fever).
While you are taking Viramune XR
Things you must do
Contact your doctor if you experience rash on any parts of the body. Contact your
doctor immediately if the rash is accompanied by other symptoms such as fever, blisters,
mouth sores, conjunctivitis, facial swelling, muscle or joint aches, swollen lymph
glands, or tiredness.
These may be symptoms of a hypersensitivity reaction that requires urgent medical
Contact your doctor if you experience any symptoms of liver problems, such as loss
of appetite, nausea, vomiting, jaundice (yellowing of the skin and/or eyes), dark
coloured urine, pale coloured stools, pain/ache or sensitivity to touch in your right
abdominal area (below your ribs).
These could be signs of serious liver dysfunction which your doctor will need to monitor
closely and may require stopping treatment with Viramune XR.
Liver function tests should be performed at regular intervals, especially during the
first 18 weeks of treatment with Viramune XR. If the results are abnormal, your doctor
will consider either performing more frequent liver function tests (in less severe
cases) or stopping treatment with Viramune XR altogether (in more severe cases).
In rare instances, temporary weakness or pain of muscles has been seen in Viramune
XR patients experiencing skin and/or liver problems.
If you are about to be started on any new medicine, tell your doctor and pharmacist
that you are taking Viramune XR.
If you are taking oral contraceptives (to prevent pregnancy) you should use additional
or different type of contraception.
Viramune XR may reduce the effectiveness of oral contraceptives.
If you become pregnant while taking Viramune XR tell your doctor immediately.
If you have had a previous opportunistic infection, and you notice symptoms of inflammation
occurring when you first start taking Viramune XR, tell your doctor immediately.
Symptoms of inflammation include redness, swelling, heat and pain. These symptoms
have been reported in some patients who have previously had an infection when combination
antiretroviral therapy was started.
Contact your doctor if you experience any symptoms of an overactive thyroid gland,
such as rapid heart rate, tremors and increased sweating.
Autoimmune problems such as overactive or enlarged thyroid gland (goiter) have been
reported in some patients.
Things you must not do
Do not give Viramune XR to anyone else, even if they have the same condition as you.
Do not stop taking Viramune XR or change the dose without first checking with your
Viramune XR helps control your HIV infection but does not cure it. Therefore, Viramune
XR must be taken every day as your doctor prescribed it.
Things to be careful of
Be careful driving or operating machinery until you know how Viramune XR affects you.
Viramune XR may cause sleepiness or drowsiness in some people. Make sure you know
how you react to Viramune XR before you drive or operate machinery.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking Viramune XR.
It may be difficult to tell whether side effects are the result of taking Viramune
XR, effects of the HIV disease or side effects of other medicines you may be taking.
For this reason, it is very important to inform your doctor of any change in your
condition. Your doctor may need to change your dose or advise you to stop taking Viramune
All medicines can have side effects. Sometimes they are serious, most of the time
they are not. You may need medical treatment if you get some of the side effects.
Ask for the advice of your doctor or pharmacist if you have any concerns about the
effects of taking Viramune XR.
The frequently reported side effects for children were similar to those observed in
adults. However, a reduction of white blood cells (granulocytopenia) or red blood
cells (anaemia) has been more commonly seen in children.
The major side effect of Viramune XR is rash. Rashes are usually mild to moderate,
located on the trunk, face, arms and/or legs. However, severe and/or life-threatening
rashes (including Stevens Johnson Syndrome and Toxic Epidermal Necrolysis) have been
reported with the use of Viramune XR. Most of the cases of rash occur in the first
six weeks of treatment.
Hypersensitivity (allergic) reactions have also been reported. Such reactions may
appear in the form of:
anaphylaxis (sudden life-threatening allergic reaction) - sudden signs of rash, itching
or hives on the skin, swelling of the face, lips, tongue or other parts of the body,
shortness of breath, wheezing or trouble breathing
rash accompanied by other side effects such as fever, blisters, mouth sores, conjunctivitis,
facial swelling, muscle or joint aches, swollen lymph glands, or tiredness.
Contact your doctor immediately if you experience rash and/or any signs of hypersensitivity
The other most frequently reported side effects of Viramune XR are fever, nausea,
headache, fatigue, sleepiness, vomiting, diarrhoea, stomach pain, abnormal liver function
tests and myalgia (aching muscles, muscle tenderness or weakness, not caused by exercise).
Cases of jaundice (yellowing of the skin and/or eyes), hepatitis, severe and life-threatening
liver dysfunction (including fulminant hepatitis and liver failure) have been reported
in patients being treated with Viramune XR.
Contact your doctor immediately if you experience any symptoms of liver problems,
such as loss of appetite, nausea, vomiting, jaundice (yellowing of the skin and/or
eyes), dark coloured urine, pale coloured stools, pain/ache or sensitivity to touch
in your right abdominal area (below your ribs).
In some patients, combination antiretroviral therapy may cause changes in body shape
due to changes in fat distribution. These may include:
loss of fat from legs, arms and face
increased fat in the abdomen and other internal organs
fatty lumps on the back of the neck.
Tell your doctor as soon as possible if you experience any side effects during or
after taking Viramune XR, so that these may be properly treated.
In addition, other side effects, not listed above, can occur in some patients.
You should tell your doctor or pharmacist if you notice anything unusual, during or
after taking Viramune XR.
After taking Viramune XR
Keep your tablets in a cool dry place where the temperature stays below 30°C.
Do not store Viramune XR or any other medicine in the bathroom or near a sink. Do
not leave it on a window sill or in the car. Heat or dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
If your doctor tells you to stop taking this medicine or the expiry date has passed,
ask your pharmacist what to do with any medicine that is left over.
What it looks like
Viramune XR is the brand name of your medicine.
Viramune XR extended-release tablets 400 mg are yellow, oval, biconvex tablets. The
tablets are embossed with product identification "V04" on one side and the BI tower
logo on the other side.
Blister packs of 10* and 30 extended-release tablets.
* Not currently distributed in Australia.
Viramune XR 400 mg contains 400 mg nevirapine per tablet
iron oxide yellow (CI 77492)
Viramune XR extended-release tablets are supplied in Australia by:
Boehringer Ingelheim Pty Limited
ABN 52 000 452 308
This Consumer Medicine Information was updated in September 2018.
® Viramune is a registered trademark of Boehringer Ingelheim
© Boehringer Ingelheim Pty Limited 2018
Australian Registration Number
AUST R 176980