Label: information for the user

Viramune 50mg/5ml oral suspension

nevirapina

Read this label carefully before starting to take this medication, as it contains important information for you.

-Keep this label, as you may need to refer to it again.

-If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1.What is Viramune and for what it is used

2.What you need to know before starting to take Viramune

3.How to take Viramune

4.Possible adverse effects

5.Storage of Viramune

6.Contents of the package and additional information

Viramune belongs to a group of medicines called antiretrovirals, which are used in the treatment of Human Immunodeficiency Virus (HIV) infection.

The active ingredient of this 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 to multiply. Nevirapine prevents the functioning of reverse transcriptase. By preventing the functioning of reverse transcriptase, Viramune helps to control HIV-1 infection.

Viramune is indicated for the treatment of adults, adolescents, and children of any age infected with HIV-1. You should take Viramune along with other antiretroviral medicines. Your doctor will tell you which medicines are suitable for you.

If Viramune has been prescribed for your child, please note that all the information in this leaflet is directed at your child (in this case, when reading “you” substitute it with “your child”).

Do not take Viramune

• if you are allergic to nevirapine or any of the other components of this medication (listed in section 6)

• if you have taken Viramune previously and had to interrupt treatment because you experienced:
• eruptive skin rash
• skin rash with other symptoms such as:
• fever
• blistering
• mouth ulcers
• inflammation of the eye
• swelling of the face
• generalized swelling
• difficulty breathing
• muscle or joint pain
• general malaise
• abdominal pain
• reactions of hypersensitivity (allergy)
• inflammation of the liver (hepatitis)
• if you have a severe liver disease
• if you have had to interrupt treatment with Viramune in the past due to changes in liver function
• if you are using any medication that contains hypericum or St. John's Wort (Hypericum perforatum).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Viramune.

During the first 18 weeks of treatment with Viramune, it is very important that you and your doctor monitor the appearance of liver or skin reactions. These reactions can be severe and even life-threatening. The risk of developing these reactions is higher during the first 6 weeks of treatment.

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

• women
• patients infected with hepatitis B or C
• abnormalities in liver function tests
• patients naïve with higher CD4+ cell counts at the start of treatment with Viramune (women with more than 250cells/mm³, men with more than 400cells/mm³)
• patients pre-treated with detectable HIV-1 viral load in plasma and higher CD4+ cell counts at the start of treatment with Viramune (women with more than 250cells/mm³, men with more than 400cells/mm³)

In some patients with advanced HIV (AIDS) infection and a history of opportunistic infections (defining AIDS illness), signs and symptoms of previous infections may appear shortly after starting antiretroviral therapy. It is believed that these symptoms are due to an improvement in the body's immune response, allowing it to fight off infections that were present without apparent symptoms. If you notice any symptoms of infection, please inform your doctor immediately.

Aside from opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also appear after you start taking medications for HIV treatment. Autoimmune disorders can appear many months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and ascending to the trunk of the body, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive necessary treatment.

Changes in body fat may occur in patients receiving combination antiretroviral therapy. Consult your doctor if you notice changes in body fat (see section 4 “Possible side effects”).

In some patients receiving combination antiretroviral therapy, a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone) may develop. The duration of antiretroviral therapy, use of corticosteroids, alcohol consumption, severe immune system weakness, and high body mass index may be some of the many risk factors for developing this disease. Symptoms of osteonecrosis are: joint stiffness, pain, and discomfort, especially in the hip, knee, and shoulder, and difficulty moving. If you notice any of these symptoms, inform your doctor.

If you are taking nevirapine and zidovudine together, inform your doctor because you may need to check your white blood cell count.

Do not take Viramune after exposure to HIV unless you have been diagnosed with HIV and your doctor has instructed you to do so.

Do not use prednisone to treat rashes associated with Viramune.

If you are taking oral contraceptives (e.g. “the pill”) or other hormonal birth control methods while taking Viramune, you must use an additional barrier method (e.g. condoms) to prevent pregnancy and HIV transmission.

If you are receiving hormone replacement therapy, consult your doctor before taking this medication.

If you are taking or have been prescribed rifampicin for tuberculosis treatment, inform your doctor before taking this medication with Viramune.

Children and adolescents

Viramune oral suspension can be used in children of all ages. Follow the administration instructions provided by your child's doctor exactly.

Viramune is also available in tablet form. Viramune tablets can be used in:

• children 16 years of age or older
• children under 16 years:
• with a weight of 50kg or more
• or with a body surface area of more than 1.25m2.

Other medications and Viramune

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Before starting to take Viramune, inform your doctor of all other medications you are taking. Your doctor may need to check if your other medications are still working and make dose adjustments. Read the prospectus of all other antiretroviral medications you are taking in combination with Viramune carefully.

It is especially important to inform your doctor if you are taking or have taken recently:

• hypericum or St. John's Wort (Hypericum perforatum, medicinal plant for the treatment of depression)
• rifampicin (medication for tuberculosis treatment)
• rifabutina (medication for tuberculosis treatment)
• macrolides, e.g. clarithromycin (medication for bacterial infections)
• fluconazole (medication for fungal infections)
• ketoconazole (medication for fungal infections)
• itraconazole (medication for fungal infections)
• methadone (medication used for opioid addiction treatment)
• warfarin (medication to reduce blood clotting)
• hormonal contraceptives (e.g. “the pill”)
• atazanavir (other medication for HIV treatment)
• lopinavir/ritonavir (other medication for HIV treatment)
• fosamprenavir (other medication for HIV treatment)
• efavirenz (other medication for HIV treatment)
• etravirina (other medication for HIV treatment)
• rilpivirina (other medication for HIV treatment)
• zidovudina (other medication for HIV treatment)
• elvitegravir/cobicistat (other medication for HIV treatment)

Your doctor will closely monitor the effect of Viramune and any of these medications if you are taking them together.

If you are undergoing kidney dialysis, your doctor may need to adjust the dose of Viramune, as Viramune may be partially removed from the blood by dialysis.

Taking Viramune with food and drinks

There are no restrictions on taking Viramune with food and drinks.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

It is not recommendedthat women living with HIV breastfeed, as HIV infection can be transmitted to the baby through breast milk.

If you are breastfeeding or plan to breastfeed,you must consult withyour doctoras soon as possible.

Driving and operating machines

While taking Viramune, you may experience fatigue. You must be cautious when performing activities such as driving or operating machines. If you experience fatigue, you must avoid performing potentially hazardous tasks such as driving or operating machines.

Viramune contains saccharose, sorbitol, parahydroxybenzoate of methyl, parahydroxybenzoate of propyl, and sodium

The oral suspension of Viramune contains 150mg of saccharose per ml. This should be taken into account in patients with diabetes mellitus. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication. It may be detrimental to teeth.

The oral suspension of Viramune contains 162mg of sorbitol per ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have a certain sugar intolerance, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult with your doctor (or your child) before taking this medication.

The oral suspension of Viramune contains parahydroxybenzoate of methyl and parahydroxybenzoate of propyl, which may cause allergic reactions (possibly delayed).

The oral suspension of Viramune contains less than 1mmol of sodium (23mg) per dose unit; it is essentially “sodium-free”.

Do not use Viramune on your own. You must use it with at least two other antiretroviral medications. Your doctor will recommend the appropriate medications for you.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The usual dose is the same for all adults (20ml).

Your child's doctor will calculate the dose for your child. The calculation will take into account your child's age and weight or body surface area. Make sure your child's doctor informs you clearly about the dose you should give to your child.

For adults

The dose for adults is 20ml (200mg) once a day for the first 14 days of treatment (initial period). After 14 days, the usual dose is 20ml (200mg) twice a day.

It is very important that you take only 20ml of Viramune per day for the first 14 days (initial period). If you experience any rash during this period, do not increase the dose and consult your doctor.

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

For children

The dose for children is 4mg/kg of body weight or 150mg/m2of body surface area once a day for the first 14 days of treatment (initial period). From then on, your child's dose will be modified to a twice-daily dosing regimen, and your child's doctor will decide on the appropriate dose based 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 (initial period). If your child experiences any rash during this period, do not increase the dose and consult your child's doctor.

Viramune is also available in the form of 200mg tablets for older children, particularly adolescents, weighing more than 50kg or with a body surface area greater than 1.25m2. Your child's doctor will inform you exactly which dosage is correct for your child. Your child's doctor will continuously monitor your child's weight or body surface area to ensure the correct dose.

If you are unsure, consult your child's doctor or pharmacist.

The oral suspension of Viramune should be shaken gently before administration. Measure the exact dose using a dosing syringe.

If you are an adult and wish to use another measuring device (e.g. a cup or spoon), please make sure to take the full dose, as some amount of Viramune may remain in the cup or spoon. To do this, rinse the device thoroughly with water and drink the contents.

The oral dosing syringe and measuring cup are not supplied with the oral suspension of Viramune. Ask your pharmacist for a syringe or measuring cup if you do not have one.

It has been demonstrated that the initial 14-day period reduces the risk of skin rash.

As Viramune must always be taken in combination with other antiretroviral medications, you must carefully follow the instructions for your other medications. These are provided in the packaging of these medications.

You must continue taking Viramune as directed by your doctor.

As explained in the section"Warnings and precautions", your doctor will monitor your liver function and watch for the appearance of adverse effects such as rash. Depending on the results, your doctor may decide to interrupt or reduce the treatment with Viramune.Additionally, your doctor may decide to restart the treatment at lower doses.

Viramune oral suspension is presented in the form of a liquid suspension and should only be taken orally. Gently shake the bottle before using the medication.

If you take more Viramune than you should

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

If you forget to take Viramune

Make sure not to forget any dose.If you realize you have forgotten to take a dose within 8 hours of the scheduled time, take the next dose as soon as possible. If more than 8 hours have passed since the scheduled time,onlytake the next dose at the usual time.

If you interrupt treatment with Viramune

Take the doses at the indicated times:

• This greatly increases the effectiveness of your antiretroviral medication combination.
• This reduces the likelihood that the HIV infection will become resistant to antiretroviral medications.

It is essential that you continue taking Viramune correctly, as described above, unless your doctor instructs you to stop treatment.

If you interrupt the administration of Viramune for more than 7 days, your doctor will instruct you to start again with the initial 14-day period (as described above), before returning to the twice-daily dosing regimen.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

During HIV treatment, there may be an increase in body weight and blood glucose and lipid levels. This may be partly related to health recovery and lifestyle, and in the case of increased blood lipids, it may be due to HIV medications themselves. Your doctor will monitor these changes.

Like all medications, this medication can produce side effects, although not everyone will experience them.

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

If you notice any symptoms of a rash, inform your doctor immediately.

When a rash occurs, it is usually mild to moderate. However, in some patients, a rash appears in the form of a vesicular skin reaction that can be severe or life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis), with fatal cases reported. Most cases of rash, both severe and mild/moderate, occur during the first six weeks of treatment.

If a rash appears and you also feel unwell, you should interrupt treatment and visit your doctor immediately. Be particularly attentive to any rash that may appear in your child. Although they may seem normal (for example, diaper irritation), they could be rashes caused by Viramune. In case of doubt, consult your child's doctor.

Severe hypersensitivity reactions (allergies) can occur. These reactions can appear in the form of anaphylaxis (a severe type of allergic reaction) with symptoms such as:

• rash
• swelling of the face
• difficulty breathing (bronchospasm)
• anaphylactic shock

Hypersensitivity reactions can also present as a rash with other side effects such as:

• fever
• blistering of the skin
• mouth sores
• inflammation of the eye
• swelling of the face
• general swelling
• difficulty breathing
• muscle or joint pain
• decrease in white blood cell count (granulocytopenia)
• general feeling of illness
• serious liver or kidney problems (liver or kidney failure)

If you experience a rash and any of the other side effects of a hypersensitivity reaction (allergy), inform your doctor immediately. These reactions can be fatal.

Abnormal liver function has been described with the use of Viramune. This includes some cases of liver inflammation (hepatitis), which can be sudden and intense (fulminant hepatitis) and liver failure, which can be fatal.

Inform your doctor if you experience any of the following clinical symptoms of liver damage:

• loss of appetite
• general feeling of illness (nausea)
• vomiting
• yellowing of the skin (jaundice)
• abdominal pain

The following side effects have been reported in patients who received Viramune:

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

• rash

Common (may affect up to 1 in 10 people):

• decrease in white blood cell count (granulocytopenia)
• allergic reactions (hypersensitivity)
• headache
• general feeling of illness (nausea)
• vomiting
• abdominal pain
• diarrhea
• inflammation of the liver (hepatitis)
• feeling of fatigue (fatigue)
• fever
• abnormal liver function test results

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

• allergic reactions characterized by rash, facial inflammation, difficulty breathing (bronchospasm), or anaphylactic shock
• decrease in red blood cell count (anemia)
• yellowing of the skin (jaundice)
• severe skin rashes that can be life-threatening (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• urticaria
• fluid under the skin (angioedema)
• joint pain (arthralgia)
• muscle pain (myalgia)
• decrease in phosphorus in the blood
• increased blood pressure

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

• intense and sudden liver inflammation (fulminant hepatitis)
• medication reaction with systemic symptoms (medication reaction with eosinophilia and systemic symptoms)

When Viramune has been used in combination with other antiretroviral medications, the following events have also been reported:

• decrease in red blood cell or platelet count
• inflammation of the pancreas
• decrease or abnormalities in skin sensations

These effects are generally associated with other antiretroviral agents and may occur when Viramune is used in combination with other agents; however, it is unlikely that these effects are due to treatment with Viramune.

Other side effects in children and adolescents

A decrease in white blood cell count (granulocytopenia) may occur more frequently in children. The decrease in red blood cell count (anemia), which may be related to nevirapine treatment, also occurs more frequently in children. As with symptoms of rash, inform your doctor of any side effects.

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and on the bottle after “CAD”. The expiration date is the last day of the month indicated.

Viramune should be used within the 6 months following the opening of the bottle.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Viramune

-The active ingredient is nevirapina. Each 5ml contains 50mg of the active ingredient nevirapina (in the form of hemihydrate).

-The other components are:

• carbomer,
• methyl parahydroxybenzoate,
• propyl parahydroxybenzoate,
• sorbitol,
• sucrose,
• polysorbate 80,
• sodium hydroxide and
• water

Appearance of the product and contents of the package

Viramune oral suspension is a homogeneous, white or almost white suspension.

Viramune oral suspension is presented in plastic oral suspension bottles, with

240ml of suspension per bottle.

Viramune is also available in tablets for older children and adults.

Marketing Authorization Holder

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Responsible for manufacturing

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

or

Boehringer Ingelheim France

100-104 avenue de France

75013 Paris

France

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet:{MM/AAAA}

Other sources of information

The detailed information about this medication is available on the website of the European Medicines Agency:http://www.ema.europa.eu.