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?
Viramune contains the active ingredient nevirapine. Viramune 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? in the full CMI.
2. What should I know before I take Viramune?
Do not take Viramune 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 if you have
rare inherited problems of galactose or fructose intolerance, severe liver dysfunction
or if you previously experienced serious liver or skin reactions while taking Viramune.
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? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with Viramune and affect how it works.
4. How do I take Viramune?
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 nevirapine 200 mg immediate release tablet or 20 mL Viramune oral suspension
twice daily (i.e. at regular 12-hour intervals at about the same time each day: morning
and night).
Children (aged 2 months or older) and adolescents to 15 years:
Your child's doctor will determine the dose of Viramune 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: Viramune oral suspension is given twice daily.
5. What should I know while taking Viramune?
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Things you should do
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Remind any doctor or pharmacist you visit that you are taking Viramune.
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Things you should not do
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Do not stop taking Viramune or change the dose without first checking with your doctor.
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Driving or using machines
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Viramune may cause sleepiness or drowsiness in some people. Make sure you know how
you react to Viramune before you drive or operate machinery
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Looking after your medicine
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Keep Viramune oral suspension in a cool dry place where the temperature stays below
30°C and keep out of reach of children.
Viramune oral suspension should be used within 6 months after opening the bottle.
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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).
Active ingredient:
nevirapine
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Viramune. 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.
Where to find information in this leaflet:
1. Why am I taking Viramune?
Viramune 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 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 does not cure or prevent HIV-1 infection or AIDS, but it does hinder the
growth of HIV-1. Viramune 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, the growth of HIV-1 is hindered more effectively.
Viramune 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 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?
Warnings
Do not take Viramune 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 rare inherited problems of galactose or fructose intolerance.
You have severe liver dysfunction.
You have previously experienced serious liver or skin reactions while on Viramune
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 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 because:
Viramune 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 2 months. Safety and effectiveness in children younger than 2 months have not been established.
Sorbitol
Viramune oral suspension contains 6.7 g of sorbitol per maximum recommended daily
dose. Products containing sorbitol may have a laxative effect or cause diarrhoea.
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, 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 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.
4. How do I take Viramune?
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).
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 nevirapine 200 mg immediate release tablet or 20 mL of Viramune oral suspension
twice daily (i.e. at regular 12-hour intervals at about the same time each day: morning
and night).
Children (aged 2 months or older) and adolescents to 15 years:
Viramune can be taken by children aged 2 months or older. Your child's doctor will
determine the right dose of Viramune oral suspension 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: Viramune oral suspension is given twice daily (i.e. at regular 12-hour intervals
at about the same time each day: morning and night).
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.
When to take Viramune
Take Viramune 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
It is important that the entire dose of Viramune oral suspension is taken. Always
use a metric measure to measure the required dose of Viramune oral suspension.
Provided with each bottle of Viramune oral suspension is a 5mL dispensing syringe
and bottle-syringe adapter.
Viramune oral suspension should only be taken by mouth. The suspension can be taken
with or without food.
How to administer Viramune oral suspension:
1.
Shake the bottle gently.
3.
Fit the blue adapter onto the bottle neck. Make sure the adapter is tightly fitted.
4.
Insert the syringe into the adapter. Make sure the syringe is tightly inserted.
5.
Turn the bottle upside down and gently withdraw the required amount of Viramune oral
suspension.
6.
Take the dose of Viramune oral suspension.
7.
The maximum volume which can be measured using the dispensing syringe is 5 mL. Repeat
steps 4 to 6 for dosage volumes greater than 5 mL.
8.
Replace cap after use.
If you choose to use another metric measure, be sure that the entire dose is taken
as some Viramune oral suspension can remain in the measuring cup/device. To ensure
that the entire dose is taken, rinse the measuring cup/device with water and swallow
the rinse water.
Viramune oral suspension should be used within 6 months after opening the bottle.
Any suspension remaining after 6 months should be returned to your pharmacist for
disposal.
How long to take Viramune
Continue taking Viramune 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
It is important to take Viramune 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 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
If you think that you have taken too much Viramune, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre (in Australia telephone 13 11 26; in New Zealand telephone 0800 764 766), 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?
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.
Liver function tests should be performed at regular intervals, especially during the
first 18 weeks of treatment with Viramune. 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 altogether (in more severe cases).
In rare instances, temporary weakness or pain of muscles has been seen in Viramune
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.
If you are taking oral contraceptives (to prevent pregnancy) you should use additional
or different type of contraception. Viramune may reduce effectiveness of oral contraceptives.
If you become pregnant while taking Viramune 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, 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 to anyone else, even if they have the same condition as you.
Do not stop taking Viramune or change the dose without first checking with your doctor.
Viramune helps control your HIV infection but does not cure it. Therefore, Viramune
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
affects you.
Viramune may cause sleepiness or drowsiness in some people. Make sure you know how
you react to Viramune before you drive or operate machinery.
Looking after your medicine
Keep your Viramune oral suspension 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.
When to discard your medicine
Viramune oral suspension should be used within 6 months after opening the bottle.
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.
It may be difficult to tell whether side effects are the result of taking Viramune,
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 your doctor or pharmacist for advice if you have any concerns about the effects
of taking Viramune.
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.
Other side effects not listed here may occur in some people.
Reporting side effects
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 contains
Viramune oral suspension 50 mg/5 mL
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Active ingredient
(main ingredient)
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nevirapine (as nevirapine hemihydrate)
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Other ingredients
(inactive ingredients)
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carbomer 934P
methyl hydroxybenzoate
propyl hydroxybenzoate
polysorbate 80
sucrose
sorbitol solution 70% (non-crystallising)
sodium hydroxide
purified water
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Potential allergens
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Sucrose, sorbitol, methyl hydroxybenzoate and propyl hydroxybenzoate.
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Do not take this medicine if you are allergic to any of these ingredients.
What Viramune looks like
Viramune oral suspension is a white to off white liquid. The suspension is supplied
in a bottle containing 240 mL of the suspension. A 5 mL dispensing syringe and a bottle-syringe
adapter are provided with each pack (AUST R 72099).
Who distributes Viramune
Viramune oral suspension is supplied in Australia by:
Boehringer Ingelheim Pty Limited
ABN 52 000 452 308
Sydney, Australia
Viramune oral suspension is supplied in New Zealand by:
Boehringer Ingelheim (N.Z.) Limited
Auckland
® Viramune is a registered trademark of Boehringer Ingelheim
© Boehringer Ingelheim Pty Limited 2023
This Consumer Medicine Information was updated in March 2023.