VIRAMUNE 200 mg TABLETS

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 previously taken Viramune and had to stop taking it because you had:
• severe skin rash
• skin rash with other symptoms such as:
• fever
• blistering
• mouth sores
• eye inflammation
• facial swelling
• general swelling
• difficulty breathing
• muscle or joint pain
• general feeling of being unwell
• abdominal pain
• allergic reactions
• liver inflammation (hepatitis)
• if you have severe liver disease
• if you had to stop taking Viramune in the past because of changes in your liver function
• if you are taking any other medicine that contains St John's Wort (Hypericum perforatum). This product may stop Viramune from working properly.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Viramune.

During the first18weeksof treatment with Viramune, it is very important that you and your doctor monitor for signs of liver or skin reactions.These reactions can be severe and even life-threatening.The risk of these reactions is greater during the first 6weeks of treatment.

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

• women
• patients infected with hepatitis B or C
• abnormal liver function tests
• patients who have not taken antiretroviral therapy before and have higher CD4+ cell counts at the start of treatment with Viramune (women with more than 250 cells/mm³, men with more than 400 cells/mm³)

patients who have taken antiretroviral therapy before and have detectable plasma HIV-1 viral load and higher CD4+ cell counts at the start of treatment with Viramune (women with more than 250 cells/mm³, men with more than 400 cells/mm³)

In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (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 it to fight infections that had been present without causing symptoms. If you notice any symptoms of infection, please inform your doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a condition where the immune system attacks healthy body tissue) may also occur after you have started taking medicines for the treatment of your HIV infection. Autoimmune disorders can occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness that starts in the hands and feet and moves up towards the trunk of the body, palpitations, tremor, or hyperactivity, inform your doctor immediately to receive the necessary treatment.

Changes in body fat may occur in patients who are taking combined antiretroviral therapy. Talk to your doctor if you notice changes in body fat (see section 4 “Possible side effects”).

In some patients who are taking combined antiretroviral therapy, a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone) may occur. The duration of combined antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immune system suppression, and high body mass index may be some of the many risk factors for developing this disease. The 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 have your white blood cells checked.

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

Prednisone should not be used to treat rashes associated with Viramune.

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

If you are receiving hormone replacement therapy, talk to your doctor before taking this medicine.

If you are taking or are prescribed rifampicin to treat tuberculosis, inform your doctor before taking this medicine with Viramune.

Children and adolescents

Viramune tablets can be used in:

• children aged 16 years or older
• children under 16 years:
• who weigh 50 kg or more
• or whose body surface area is greater than 1.25 m².

A liquid form of Viramune is available for younger children.

Other medicines and Viramune

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Before you start taking Viramune, tell your doctor about all the other medicines you are taking. Your doctor may need to check that your other medicines are still working and make dose adjustments. Read the package leaflet carefully for all your other anti-HIV medicines that you take with Viramune.

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

• St John's Wort (Hypericum perforatum, a herbal remedy for depression)
• rifampicin (a medicine for treating tuberculosis)
• rifabutin (a medicine for treating tuberculosis)
• macrolides, e.g., clarithromycin (a medicine for treating bacterial infections)
• fluconazole (a medicine for treating fungal infections)
• ketoconazole (a medicine for treating fungal infections)
• itraconazole (a medicine for treating fungal infections)
• methadone (a medicine used to treat addiction to opiates)
• warfarin (a medicine used to prevent blood clots)
• hormonal contraceptives (e.g., “the pill”)
• atazanavir (another medicine for treating HIV infection)
• lopinavir/ritonavir (another medicine for treating HIV infection)
• fosamprenavir (another medicine for treating HIV infection)
• efavirenz (another medicine for treating HIV infection)
• etravirine (another medicine for treating HIV infection)
• rilpivirine (another medicine for treating HIV infection)
• zidovudine (another medicine for treating HIV infection)
• elvitegravir/cobicistat (another medicine for treating HIV infection)

Your doctor will carefully monitor the effect of Viramune and any of these medicines if you are taking them at the same time.

If you are having kidney dialysis, your doctor may need to adjust the dose of Viramune, as Viramune can be partially removed from the 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, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is recommended thatHIV-infected women do not breast-feed their babies because HIV can be passed on to the baby through breast milk.

If you are breast-feeding or think you might want to breast-feed, you must askyour doctor as soon as possible.

Driving and using machines

While you are taking Viramune, you may feel tired. You should be careful when performing tasks that require concentration, such as driving or operating machinery. If you feel tired, you should avoid tasks that may be dangerous, such as driving or operating machinery.

Viramune contains lactose and sodium

Viramune tablets contain lactose (milk sugar).

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Viramune tablets contain less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Viramune

Do not take Viramune on your own. You must take it with at least two other antiretroviral medicines. Your doctor will recommend the right medicines for you.

Follow the instructions for taking this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist again.

Dose:

The dose is one 200 mg tablet per day for the first 14 days of treatment (the “lead-in” period). After 14 days, the usual dose is one 200 mg tablet twice a day.

It is very important that you take only one tablet per day of Viramune during the first 14 days (the “lead-in” period). If you get a rash during this time, do not increase the dose and talk to your doctor.

The 14-day “lead-in” period has been shown to reduce the risk of getting a rash.

Since Viramune must always be taken with other antiretroviral medicines, you should carefully follow the instructions for your other medicines. These are provided in the package leaflets for those medicines.

Viramune is also available as a liquid form for oral suspension. This is particularly suitable if:

• you have problems swallowing tablets
• you are a child who weighs less than 50 kg
• you are a child whose body surface area is less than 1.25 m² (your doctor will determine your body surface area)

You must keep taking Viramune for as long as your doctor tells you.

As explained earlier in the section “Warnings and precautions”, your doctor will monitor you with liver tests and watch for signs of side effects such as rash. Depending on the results, your doctor may decide to stop or interrupt treatment with Viramune. Your doctor may also decide to restart treatment at a lower dose.

Viramune should only be taken by mouth. Do not chew the tablet. You can take Viramune with or without food.

If you take more Viramune than you should

Do not take more Viramune than your doctor has prescribed and as described in this package leaflet. There is limited information on the effects of overdosing with Viramune. If you have taken more Viramune than you should, talk to your doctor.

If you forget to take Viramune

Try not to miss any dose. If you realize you have missed 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, just take the next dose at the usual time.

If you stop taking Viramune

Taking your doses at the right times:

• greatly increases the effectiveness of your antiretroviral therapy
• reduces the chances of your HIV infection becoming resistant to antiretroviral therapy

It is important that you continue to take Viramune correctly, as described above, unless your doctor tells you to stop.

If you stop taking Viramune for more than 7 days, your doctor will tell you to start the 14-day “lead-in” period again (as described above) before going back to taking two doses a day.

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

4. Possible Adverse Effects

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 sometimes be due to HIV medications themselves. Your doctor will monitor these changes.

Like all medications, this medication can produce adverse effects, although not all people suffer from them.

As already mentioned in 'Warnings and Precautions',the most important adverse effects of Viramune are severe skin reactions and serious liver damage, which can be life-threatening. These reactions occur mainly during the first 18 weeks of treatment with Viramune. This is, therefore, an important period that requires close monitoring by your doctor.

If you observe 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), and there have been reported fatalities. 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 stop treatment and see your doctor immediately.

Hypersensitivity reactions (allergies) can occur. Such reactions can appear in the form of anaphylaxis (a severe allergic reaction) with symptoms such as:

• rash
• facial swelling
• difficulty breathing (bronchospasm)
• anaphylactic shock

Hypersensitivity reactions can also be presented as a rash with other adverse effects such as:

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

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

Abnormalities in liver function have been described with the use of Viramune. This includes some cases of liver inflammation (hepatitis), which can be sudden and severe (fulminant hepatitis) and liver failure, both of which can be fatal.

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

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

The following adverse effects have been reported in patients treated with 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 malaise (nausea)
• vomiting
• abdominal pain
• diarrhea
• liver inflammation (hepatitis)
• feeling of fatigue (fatigue)
• fever
• abnormalities in liver function tests

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 and potentially fatal skin rashes (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• hives
• fluid under the skin (angioedema)
• joint pain (arthralgia)
• muscle pain (myalgia)
• decrease in blood phosphorus
• increase in blood pressure

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

• sudden and severe liver inflammation (fulminant hepatitis)
• drug reaction with systemic symptoms (drug 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
• pancreatitis
• 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 Adverse Effects in Children and Adolescents

A decrease in white blood cells (granulocytopenia) may occur, more frequently in children. A decrease in red blood cells (anemia), which may be related to treatment with nevirapine, is also more frequent in children. As with symptoms of rash, inform your doctor of any adverse effect.

Reporting of Adverse Effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medication.

5. Storage of Viramune

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging and on the blister pack after "EXP". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Viramune

• The active ingredient is nevirapine. Each tablet contains 200 mg of nevirapine.
• The other ingredients are:
• microcrystalline cellulose,
• lactose (in the form of monohydrate),
• povidone K25,
• sodium carboxymethyl starch,
• colloidal silicon dioxide, and
• magnesium stearate.

Appearance and Package Contents

White, oval, biconvex tablets. One side is marked with the code "54 193", with a single score line separating the "54" from the "193". The other side is marked with the company symbol. The score line should not be used to break the tablet.

Viramune tablets are available in blister packs of 14, 60, or 120 tablets per box. Not all pack sizes may be marketed.

Viramune is also available as an oral suspension.

Marketing Authorization Holder

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

or

Boehringer Ingelheim Hellas Single Member S.A.

5th km Paiania – Markopoulo

Koropi Attiki, 19441

Greece

or

Boehringer Ingelheim France

100-104 avenue de France

75013 Paris

France

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

Date of Last Revision of this Leaflet:{MM/YYYY}

Other Sources of Information

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