Patient leaflet - Viramune 50 mg / 5 ml oral suspension

1. What Viramune is and what it is used for

Viramune 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, Viramune helps control HIV-1 infection.

Viramune is indicated for the treatment of HIV-1 infected adults, adolescents, and children of any age. You must take Viramune together with other antiretroviral medicines. Your doctor will recommend the best medicines for you.

If Viramune has been prescribed for your child, please note that all information in this leaflet is addressed to your child (in this case please read “your child” instead of “you”).

2. What you need to know before you take Viramune

Do not take Viramune

if you are allergic to nevirapine or any of the other
ingredients of this medicine (listed in section 6).
if you have taken Viramune 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 Viramune 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 Viramune from working properly.

Warnings and precautions

Talk to your doctor or pharmacist before taking Viramune. During the first 18 weeks of treatment with Viramune 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 threatening. You are at greatest risk of such a reaction during the first 6 weeks of treatment.

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

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 VIRAMUNE 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 Viramune.

If you experience symptoms suggesting damage of the liver, such as

loss of appetite,
feeling sick (nausea),
vomiting,
yellow skin (jaundice),
abdominal pain you should discontinue taking Viramune and must contact your doctor immediately.

If you develop severe liver, skin or hypersensitivity reactions whilst taking Viramune, NEVER TAKE VIRAMUNE again without referring to your doctor. You must take the dose of Viramune as prescribed by your doctor. This is especially important within the first 14 days of treatment (see more information in “How to take Viramune”).

The following patients are at increased risk of developing liver problems:

women
patients infected with hepatitis B or C
patients with abnormal liver function tests
treatment-naïve patients with higher CD4+ cell counts
at the start of Viramune 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 Viramune 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 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 Viramune after an exposure to HIV unless you have been diagnosed with HIV and instructed to do so by your doctor.

Prednisone should not be used to treat a rash related to Viramune.

If you are taking oral contraceptives (e.g. “pill”) or other hormonal methods of birth control during treatment with Viramune, 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 Viramune.

Children and adolescents:

Viramune oral suspension can be taken by children of all age groups. Always follow the exact instructions given by your child’s doctor.

Viramune is also available as tablets. Viramune tablets can be taken by:

children 16 years of age or older
children under 16 years of age who:
- weigh 50 kg or more
- or have a body surface area above 1.25 square
  metres.

Other medicines and Viramune

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 Viramune. 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 Viramune.

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

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)
zidovudine (another medicine to treat HIV-infection)
elvitegravir/cobicistat (another medicine to treat
HIV-infection).
Your doctor will carefully monitor the effect of Viramune and any of these medicines if you are taking them together.
If you are undergoing kidney dialysis, your doctor may consider a dose adjustment of Viramune. This is because Viramune can be partly washed out of your blood by dialysis.
Taking Viramune with food and drink
There are no restrictions on taking Viramune with food and drink.
Pregnancy and breast-feeding
If you are pregnant or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk.
If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible.
Driving and using machines
You may experience fatigue when taking Viramune. 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.
Viramune contains sucrose, sorbitol, methyl parahydroxybenzoate, propyl parahydroxybenzoate and sodium
Viramune oral suspension contains 150 mg sucrose per mL. This should be taken into account in patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. May be harmful to the teeth.
Viramune oral suspension contains 162 mg sorbitol per mL. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
Viramune oral suspension contains methyl parahydroxybenzoate and propyl parahydroxybenzoate. These excipients can cause allergic reactions over time.
Viramune oral suspension contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’.

3. How to take Viramune

You should not use Viramune on its own. You must take it with at least two other antiretroviral medicines. Your 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.

The usual dose is the same for all adults (20 mL). 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. Make sure that your child’s doctor clearly tells you what dose you must give to your child.

For adults

The dose for adults is 20 mL (200 mg) once a day for the first 14 days of treatment (“lead in” period). After 14 days, the usual dose is 20 mL (200 mg) twice a day.

It is very important that you take only 20 mL of Viramune a day for the first 14 days (“lead-in” period). If you have any rash during this period, do not increase the dose but consult your doctor.

Viramune is also available as 200 mg tablets for adults (16 years of age and older).

C50001297/03

Package leaflet: Information for the user

Viramune® 50 mg/5 mL oral suspension

nevirapine

abcd

Additional Requirements of Packaging Site

Dimensions: 400.05 mm x 311.150 mm

TD Reference Drawing/Revision: R-088

Other: Prints Head-to-Head

Fill ISEE mark and barcodes (files provided) with text color.

File information
			Issue date of TD:

Perigord No : 955584 P1

	Mandatory in
	TD	Printfile
20/August/2024	Yes	Yes
PPM SKU: P055772	No	Yes
PPM SKU version: 003	No	Yes
	No	Yes
Print colors: PAN BLACK	No	Yes
Mat. No. Pack. Site: C50001297/03			No	Yes

For children

The dose for children is 4 mg/kg body weight or 150 mg/m²body surface area once a day for the first 14 days of treatment (“lead-in period”). Thereafter your child will be switched to a twice daily dosing schedule and your child’s doctor will decide the right dose based either on your child’s weight or body surface area.

It is very important that your child takes Viramune only once a day for the first 14 days (“lead-in” period). If your child develops any rash during this period, do not increase the dose but consult your child’s doctor.

Viramune is also available as 200 mg tablets for older children, particularly adolescents, weighing more than 50 kg or having a body surface of more than 1.25 m². Your child’s doctor will inform you exactly of the correct dose for your child. Your child’s doctor will continually check your child’s weight or body surface area to ensure the correct dose. If you are uncertain please be sure to ask your child’s doctor or pharmacist.

Viramune oral suspension should be shaken gently prior to administration. Measure the exact dose using a measuring syringe.

If you are an adult and choose to use another measuring device (e.g. cup or teaspoon) please make sure that you take the whole dose. This is because some Viramune can remain in the cup or spoon. To do so, rinse the used device thoroughly with water and drink it.

The oral dosing syringe, and dosing cup are not provided with Viramune oral suspension. Ask your pharmacist for a syringe or cup if you do not have one.

The 14-day “lead-in” period has been shown to lower the risk of skin rash.

As Viramune 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.

You should continue to take Viramune 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 Viramune treatment. Your doctor might then decide to restart you on a lower dose.

Viramune oral suspension is in a liquid suspension form and should only be taken by mouth. Shake the bottle gently before you take your medicine.

If you take more Viramune than you should

Do not take more Viramune than prescribed by your doctor and described in this leaflet. There is at present little information on the effects of Viramune overdose. Consult your doctor if you have taken more Viramune than you should.

If you forget to take Viramune

Try not to miss a dose. If you notice that you have missed a dose within 8 hours of when it was due, take the missed dose as soon as possible. If it has been more than 8 hours since the dose was due only take the next dose at the usual time.

If you stop taking Viramune

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 Viramune correctly, as described above, unless your doctor instructs you to stop.

If you stop taking Viramune for more than 7 days your doctor will instruct you to start the 14-day ‘lead in’ period (described above) once again, before returning to the twice daily dose.

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.

As mentioned in ‘Warnings and precautions’, above, the most important side effects of Viramune are severe and life threatening skin reactions and serious liver damage. These reactions occur mainly in the first 18 weeks of treatment with Viramune. This is therefore an important period which requires close monitoring by your doctor.

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

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 rash occurs and you also feel sick, you must stop treatment and visit your doctor immediately. Pay special attention to any rashes that your child develops. Although these may appear normal (for example nappy rash), they might be rashes due to Viramune. If in doubt ask your child’s doctor.

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 number 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 Viramune. 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 Viramune:

Very common (may affect more than 1 in 10 people):

rash.
Common (may affect up to 1 in 10 people):
- decreased number of white blood cells
  (granulocytopenia)
- allergic reactions (hypersensitivity)
- headache
- feeling sick (nausea)
- vomiting
- abdominal pain
- loose stools (diarrhoea)
- inflammation of the liver (hepatitis)
- feeling tired (fatigue)
- fever
- abnormal liver function tests.

Uncommon (may affect up to 1 in 100 people):

allergic reaction characterized by rash, swelling of
the face, difficulty breathing (bronchial spasm) or anaphylactic shock
decreased numbers of red blood cells (anaemia)
yellow skin (jaundice)
severe and life-threatening skin rashes (Stevens-
Johnson syndrome/ toxic epidermal necrolysis)
hives (urticaria)
fluid under the skin (angioedema)
joint pain (arthralgia)
muscle pain (myalgia)
decreased blood phosphorus
increased blood pressure.

Rare (may affect up to 1 in 1 000 people):

sudden and intense inflammation of the liver
(fulminant hepatitis)
drug reaction with systemic symptoms (drug reaction
with eosinophilia and systemic symptoms).

The following events have also been reported when Viramune 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 Viramune is used in combination with other agents; however, it is unlikely that these events are due to treatment with Viramune.

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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

5. How to store Viramune

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 carton and on the bottle after “EXP”. The expiry date refers to the last day of that month. Viramune should be used within 6 months of opening the bottle.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. 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 Viramune contains

The active substance is nevirapine. Each 5 mL contains 50 mg of the active substance nevirapine (as hemihydrate).
The other ingredients are:
carbomer, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sorbitol, sucrose, polysorbate 80, sodium hydroxide and water.

What Viramune looks like and contents of the pack

Viramune oral suspension is a white to off-white homogenous suspension.

Viramune oral suspension is supplied in plastic bottles of suspension for oral use, with 240 mL suspension per bottle.

Viramune is also supplied as 200 mg tablets for older children and adults.

Marketing Authorisation Holder

Boehringer Ingelheim International GmbH Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG Binger Strasse 173