Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I taking Viramune XR?
Viramune XR contains the active ingredient nevirapine. Viramune XR is used in the
treatment of the infection caused by the Human Immunodeficiency Virus (HIV-1). For
more information, see Section
1. Why am I taking Viramune XR? in the full CMI.
2. What should I know before I take Viramune XR?
Do not take Viramune XR if you have ever had an allergic reaction to nevirapine or
any of the ingredients listed at the end of the CMI. Do not take Viramune XR if you
have an intolerance to some sugars, an allergy to milk proteins, severe liver dysfunction
or if you previously experienced serious liver or skin reactions while taking Viramune
or Viramune XR.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section
2. What should I know before I take Viramune XR? in the full CMI.
3. What if I am taking other medicines?
4. How do I take Viramune XR?
Adults 16 years and older:
First 14 days: Take one nevirapine 200 mg immediate release tablet or 20 mL Viramune oral suspension
once daily
After the first 14 days: Take one Viramune XR tablet once daily.
Children (aged 3 years or older) and adolescents to 15 years:
Your child's doctor will determine the dose of Viramune XR based on your child's age
and body weight, or body surface area.
First 14 days: Viramune oral suspension is given once daily.
After the first 14 days: Your child may be switched to Viramune XR tablet, given once daily.
5. What should I know while taking Viramune XR?
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Things you should do
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Remind any doctor or pharmacist you visit that you are taking Viramune XR.
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Things you should not do
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Do not stop taking Viramune XR or change the dose without first checking with your
doctor.
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Driving or using machines
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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
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Looking after your medicine
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Keep Viramune XR tablets in a cool dry place where the temperature stays below 30°C.
Keep out of reach of children.
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6. Are there any side effects?
Common side effects include fever, stomach complaints, headache, fatigue, sleepiness,
muscle pain/weakness.Serious potential side effects that require medical attention
include rash, allergic reaction and symptoms of a liver problem (such as yellowing
of the skin/eyes, dark coloured urine, pale coloured stools, pain in the right side
of the stomach area). For more information, including what to do if you have any side
effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient:
nevirapine
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Viramune XR. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Viramune XR.
Where to find information in this leaflet:
1. Why am I taking Viramune XR?
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.
2. What should I know before I take Viramune XR?
Warnings
Do not take Viramune XR if:
You are allergic to nevirapine, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
You have been told by your doctor that you have an intolerance to some sugars, or
an allergy to milk proteins (which may be contained in small amounts in the ingredient
lactose monohydrate).
You have severe liver dysfunction.
You have previously experienced serious liver or skin reactions while on Viramune
or Viramune XR treatment.
Tell your doctor if you:
Have or have had liver problem/disease or hepatitis.
Have or have had severe kidney disease undergoing dialysis treatment.
Have allergies to any other medicines, foods, preservatives or dyes.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Tell your doctor if you are pregnant or intend to become pregnant. Special care is
recommended during pregnancy. The benefits of Viramune XR must be assessed against
possible effects on you and your unborn baby.
Tell your doctor if you are breastfeeding or intend to breastfeed. 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.
Children
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.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
In particular, tell your doctor if you are taking:
other anti-HIV medicines
anti-hepatitis B and C medicines
cimetidine
clarithromycin
fluconazole, itraconazole, ketoconazole
methadone
oral contraceptives
corticosteroids (e.g. prednisone)
rifampicin, rifabutin
herbal medicines derived from St John's Wort (Hypericum perforatum)
warfarin
medicines used in the treatment of:
allergies (antihistamines)
bacterial/fungal infections
cancer (e.g. cyclophosphamide)
depression
epilepsy
gut movement disorders (e.g. cisapride)
high blood pressure 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.
As Viramune XR may reduce the effectiveness of oral contraceptives, talk to your doctor
about alternative methods of contraception.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Viramune XR.
4. How do I 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.
How much to take
Follow the dosing instructions carefully, especially the once daily dosage during
the first 14 days ('lead-in' period) of nevirapine 200 mg immediate-release tablets
or Viramune oral suspension.
Adults 16 years and older:
First 14 days: Take one nevirapine 200 mg immediate-release tablet or 20 mL of Viramune oral suspension
once daily
After the first 14 days: Take one Viramune XR 400 mg extended-release tablet once daily.
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 over the age of 2 months Viramune 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.
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 nevirapine immediate-release tablets or oral suspension:
If you are already taking nevirapine 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 nevirapine 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 nevirapine immediate-release tablets
or oral suspension.
When to take Viramune XR
Take Viramune XR 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 to take Viramune XR
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.
How long to take Viramune XR
Continue taking Viramune XR 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 Viramune XR
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 take too much Viramune XR
If you think that you have taken too much Viramune XR, you may need urgent medical
attention.
You should immediately:
phone the Poisons Information Centre (in Australia telephone 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
Symptoms of an overdose may include oedema (fluid retention), 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).
5. What should I know while taking Viramune XR?
Things you should 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
attention.
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 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 should 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
doctor. 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.
Driving or using machines
Be careful before you drive or use any machines or tools 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.
Looking after your medicine
Keep your Viramune XR tablets in a cool dry place where the temperature stays below
30°C.
Store it in a place away from moisture, heat or sunlight; for example, do not store
it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If your doctor tells you to stop taking this medicine or it is out of date, take it
to any pharmacy for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
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
XR.
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 your doctor or pharmacist for advice 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.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you experience any side effects or notice anything
unusual during or after taking Viramune XR.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Viramune XR contains
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Active ingredient
(main ingredient)
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nevirapine 400 mg
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Other ingredients
(inactive ingredients)
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lactose monohydrate
hypromellose
iron oxide yellow (CI 77492)
magnesium stearate.
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Potential allergens
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lactose
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Do not take this medicine if you are allergic to any of these ingredients.
What Viramune XR looks like
Viramune XR extended-release tablets 400 mg are yellow, oval, biconvex tablets. The
tablets are debossed 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 (AUST R 176980).
* Not currently distributed in Australia.
Who distributes Viramune XR
Viramune XR extended-release tablets are supplied in Australia by:
Boehringer Ingelheim Pty Limited
ABN 52 000 452 308
Sydney, Australia
® Viramune is a registered trademark of Boehringer Ingelheim
© Boehringer Ingelheim Pty Limited 2023
This Consumer Medicine Information was updated in March 2023.