NEVIRAPINE KERN PHARMA 200 mg TABLETS

Introduction

Package Leaflet: Information for the User

Nevirapine KERN PHARMA 200 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What is Nevirapine Kern Pharma and what is it used for
2. Before taking Nevirapine Kern Pharma
3. How to take Nevirapine Kern Pharma
4. Possible side effects
5. Storage of Nevirapine Kern Pharma
6. Further information

1. What is NEVIRAPINE KERN PHARMA and what is it used for

Nevirapine Kern Pharma belongs to a group of medicines called antiretrovirals, which are used to treat HIV infection.

The active substance in this medicine is nevirapine. This active substance reduces the amount of virus in the blood, thereby improving your condition.

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 replicate. Nevirapine prevents the reverse transcriptase from working. By preventing the reverse transcriptase from working, nevirapine helps to control the HIV infection.

You must take Nevirapine Kern Pharma with other antiretroviral medicines. Your doctor will recommend the medicines that are right for you.

2. BEFORE TAKING NEVIRAPINA KERN PHARMA

Do not take Nevirapina Kern Pharma

• if you are allergic (hypersensitive) to nevirapine or any of the other ingredients of Nevirapina Kern Pharma. See section 6 of this leaflet for the list of other ingredients (“Composition of Nevirapina Kern Pharma”)
• if you have previously taken Nevirapina Kern Pharma and had to stop treatment because you had:
• severe skin rash
• skin rash with other symptoms such as:
• fever
• blistering
• mouth sores
• eye inflammation
• facial swelling
• generalized 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 treatment with Nevirapine in the past due to changes in liver function
• if you are taking any medicine that contains St. John's Wort (Hypericum perforatum). This product may cause Nevirapina Kern Pharma to stop working properly.

Be especially careful with Nevirapina Kern Pharma

During the first 18 weeks of treatment with Nevirapine, 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 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
• abnormal liver function tests
• naive patients with higher CD4 cell counts at the start of treatment with nevirapine (women with more than 250 cells/mm³, men with more than 400 cells/mm³)
• pre-treated patients with detectable HIV-1 viral load in plasma and higher CD4 cell counts at the start of treatment with nevirapine (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 of previous infections may appear soon after starting anti-HIV treatment. These symptoms are thought to be due to an improvement in the body's immune response, allowing it to fight infections that were present without any apparent symptoms. If you notice any symptoms of infection, please inform your doctor immediately.

Changes in body fat may occur in patients who are taking combination antiretroviral therapy. Consult your doctor if you notice changes in body fat (see section 4 “POSSIBLE SIDE EFFECTS”).

In some patients taking combination antiretroviral therapy, a bone disease called osteonecrosis (death of bone tissue due to loss of blood supply to the bone) may develop. The duration of combination antiretroviral therapy, the 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. 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.

Nevirapine Kern Pharma does not cure HIV infection. Therefore, you may still experience infections and other diseases associated with HIV infection. You must therefore remain in regular contact with your doctor. Additionally, Nevirapine Kern Pharma does not prevent the risk of transmitting HIV to others through blood or sexual contact. Use appropriate precautions to prevent the transmission of HIV to others. Please consult your doctor.

Use in children

Nevirapine Kern Pharma tablets can be used in:

• children aged 16 years or older
• children under 16 years:
• weighing 50 kg or more
• or with a body surface area of 1.25 m² or more (your doctor will determine the body surface area)

Use of other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. Before starting treatment with Nevirapine Kern Pharma, tell your doctor about all other medicines you are taking. Your doctor may need to check if your other medicines are still working and adjust the dose. Read the leaflet of all other anti-HIV medicines you are taking in combination with Nevirapine Kern Pharma carefully.

It is especially important that you inform 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 the treatment of tuberculosis)
• rifabutin (a medicine for the treatment of tuberculosis)
• macrolides, e.g. clarithromycin (a medicine for the treatment of bacterial infections)
• fluconazole (a medicine for the treatment of fungal infections)
• ketoconazole (a medicine for the treatment of fungal infections)
• itraconazole (a medicine for the treatment of fungal infections)
• methadone (a medicine used to treat opiate addiction)
• warfarin (a medicine to prevent blood clots)
• hormonal contraceptives (e.g. “the pill”)
• atazanavir (another medicine for the treatment of HIV infection)
• lopinavir/ritonavir (another medicine for the treatment of HIV infection)
• fosamprenavir (another medicine for the treatment of HIV infection)
• efavirenz (another medicine for the treatment of HIV infection)

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

If you are undergoing kidney dialysis, your doctor may consider it necessary to adjust the dose of Nevirapine Kern Pharma, because nevirapine may be partially removed from the blood by dialysis.

Taking Nevirapina Kern Pharma with food and drink

There are no restrictions on taking Nevirapina Kern Pharma with food and drink.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

You must stop breastfeeding if you are taking Nevirapina Kern Pharma. It is not recommended to breastfeed if you have HIV infection, as it is possible that your child may become infected with HIV through breast milk.

Driving and using machines

There are no specific studies on the ability to drive and use machines. If you feel that your ability to drive or use machines may be affected, do not drive or use machines.

3. HOW TO TAKE NEVIRAPINA KERN PHARMA

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

Follow your doctor's instructions for taking Nevirapina Kern Pharma exactly. Ask your doctor or pharmacist if you have any questions.

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

Dose:

The normal 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 has been shown that the 14-day “lead-in” period reduces the risk of experiencing a rash.

Since Nevirapina Kern Pharma must always be taken in combination with other antiretroviral medicines, you must follow the instructions for your other medicines carefully. These are provided in the leaflets of these medicines.

Nevirapine is also available in a liquid form as an oral suspension. It is particularly suitable if:

• you have problems swallowing tablets
• you are a child weighing less than 50 kg
• you are a child with a body surface area of less than 1.25 m² (your doctor will determine the body surface area)

You must continue to take Nevirapina Kern Pharma for as long as your doctor tells you.

As explained earlier in the section ‘Be especially careful with Nevirapina Kern Pharma’, your doctor will monitor you with liver tests and watch for the appearance of side effects such as rash. Depending on the results, your doctor may decide to stop or interrupt treatment with Nevirapina Kern Pharma.

If you take more Nevirapina Kern Pharma than you should

Do not take more Nevirapina Kern Pharma than your doctor has prescribed and as described in this leaflet. There is currently little information on the effects of an overdose of nevirapine.

Consult your doctor if you have taken more Nevirapina Kern Pharma than you should.

If you forget to take Nevirapina Kern Pharma

Try to take each dose at the right time. If you realize you have missed a dose when it is less than 8 hours late, take the next dose as soon as possible. If it is more than 8 hours late, take the next dose at the usual time.

Do not take a double dose to make up for a missed dose.

If you stop taking Nevirapina Kern Pharma

Taking your doses at the right times:

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

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

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Nevirapina Kern Pharma can produce adverse effects, although not all people suffer from them.

As already mentioned in 'Be especially careful with Nevirapina Kern Pharma',the most important adverse effects of nevirapine are severe skin reactions and life-threatening liver damage. These reactions occur mainly during the first 18 weeks of treatment with nevirapina. 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 blistering 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 interrupt treatment and go immediately to your doctor.

Hypersensitivity reactions (allergies) may occur. Such 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 (bronchial spasm)
• anaphylactic shock

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

• fever
• blistering of the skin
• sores in the mouth
• eye inflammation
• swelling of the face
• general swelling
• difficulty breathing
• muscle or joint pain
• decrease in the number of white blood cells in the blood (granulocytopenia)
• general malaise
• severe liver or kidney problems (liver or kidney failure)

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

Abnormalities of liver function have been described with the use of nevirapine. 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 evaluation of adverse effects is based on the following frequencies:

The following adverse effects have been reported in patients who received nevirapine:

Very common:

• rash

Common:

• decrease in the number of white blood cells in the blood (granulocytopenia)
• allergic reactions (hypersensitivity)
• headache
• general malaise (nausea)
• vomiting
• abdominal pain
• diarrhea
• liver inflammation (hepatitis)
• muscle pain (myalgia)
• feeling of fatigue (fatigue)
• fever
• abnormalities in liver function tests

Uncommon:

• drug rash with systemic symptoms (drug rash with eosinophilia and systemic symptoms)
• allergic reactions characterized by rash, facial inflammation, difficulty breathing (bronchial spasm), or anaphylactic shock
• decrease in the number of red blood cells in the blood (anemia)
• yellowing of the skin (jaundice)
• severe and potentially fatal skin rashes (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• urticaria
• fluid under the skin (angioneurotic edema)
• joint pain (arthralgia)

Rare:

• sudden and severe liver inflammation (fulminant hepatitis)

Combined antiretroviral therapy may produce changes in body shape due to changes in fat distribution. These can include loss of fat from the legs, arms, and face, increased fat in the abdomen (belly) and other internal organs, increased breast size, and fat deposits on the back of the neck ("buffalo hump"). The cause and long-term effects of these changes are currently unknown. Combined antiretroviral therapy can also cause increased lactic acid and sugar in the blood, hyperlipidemia (increased fat in the blood), and insulin resistance.

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

• decrease in the number of red blood cells or platelets
• pancreatitis
• decrease or abnormalities in skin sensations

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

Use in Children

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 a rash, inform your doctor of any adverse effect.

If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of NEVIRAPINA KERN PHARMA

Keep out of the reach and sight of children.

Do not use Nevirapina Kern Pharma after the expiration date stated on the carton after "CAD". The expiration date is the last day of the month indicated.

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicinal products in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicinal products. By doing so, you will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Nevirapina Kern Pharma

• The active ingredient is nevirapine. Each tablet contains 200 mg of nevirapine.
• The other ingredients are: microcrystalline cellulose, sodium croscarmellose, pregelatinized corn starch, povidone K-25, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate.

Appearance of the product and packaging contents

Nevirapina Kern Pharma 200 mg tablets are presented in blister packs.

The tablets are white, round, with a unilateral line on one side and marked with a "K" on the other.

Each normal pack contains 14 or 60 tablets. Each clinical pack contains 120 tablets.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Polígono Ind. Colón II

Venus 72

08228 Terrassa (Barcelona)

This leaflet was approved in June 2011

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/.