Nevirapine Kern Pharma 200 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nevirapine KERN PHARMA 200 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Nevirapine KERN PHARMA is and what it is used for
2. Before you take Nevirapine KERN PHARMA
3. How to take Nevirapine KERN PHARMA
4. Possible side effects
5. How to store Nevirapine KERN PHARMA
6. Further information

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

NEVIRAPINA KERN PHARMA belongs to a group of medicines called antiretrovirals, which are used to treat infection with the Human Immunodeficiency Virus (HIV).

The active substance in this medicine is called 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 known as non-nucleoside reverse transcriptase inhibitors (NNRTIs). Reverse transcriptase is an enzyme that HIV needs to multiply. Nevirapine prevents the function of reverse transcriptase. By inhibiting the action of reverse transcriptase, nevirapine helps control HIV infection.

You must take NEVIRAPINA KERN PHARMA together with other antiretroviral medicines. Your doctor will advise you which medicines are appropriate for you.

2. BEFORE TAKING NEVIRAPINE KERN PHARMA

Do not take Nevirapine Kern Pharma

• if you are allergic (hypersensitive) to nevirapine or to any of the other components of Nevirapine Kern Pharma. See section 6 of this leaflet for a list of the other components (“Composition of Nevirapine Kern Pharma**”**)

• if you have previously taken Nevirapine Kern Pharma and had to stop treatment because you experienced:

• severe skin rash

• skin rash with other symptoms such as, for example:

• fever

• blistering

• mouth sores

• eye inflammation

• facial swelling

• general swelling

• difficulty breathing

• muscle or joint pain

• general malaise

• abdominal pain

• hypersensitivity reactions (allergy)

• liver inflammation (hepatitis)

• if you have severe liver disease

• if you have previously had to stop treatment with Nevirapine due to changes in liver function

• if you are taking any medicine containing St. John’s wort (Hypericum perforatum). This product may cause Nevirapine Kern Pharma to no longer work properly.

Take special care with Nevirapine Kern Pharma

During the first 18 weeks of treatment with Nevirapine, it is very important that you and your doctor monitor for the development of liver or skin reactions. These reactions can become severe and may even be life-threatening. The risk of such reactions is greatest 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
• treatment-naïve patients with higher CD4 cell counts at the start of nevirapine treatment (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 CD4 cell counts above the threshold at the start of nevirapine treatment (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 illnesses), signs and symptoms of inflammation from previous infections may appear shortly after starting anti-HIV treatment. These symptoms are believed to result from an improved immune response, enabling the body to fight infections that were previously present without apparent symptoms. If you notice any signs of infection, please inform your doctor immediately.

Changes in body fat distribution may occur in patients receiving combination antiretroviral therapy. Consult your doctor if you notice changes in body fat (see section 4, “POSSIBLE ADVERSE EFFECTS”).

In some patients receiving combination antiretroviral therapy, a bone disease called osteonecrosis (death of bone tissue due to reduced blood supply to the bone) may develop. Duration of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severely weakened immune system, and high body mass index may be among the many risk factors for developing this condition. Symptoms of osteonecrosis include: joint stiffness, pain and discomfort, especially in the hip, knee, and shoulder, and difficulty moving. If you experience any of these symptoms, inform your doctor.

Nevirapina Kern Pharma does not cure HIV infection. Therefore, you may continue to suffer from infections and other diseases associated with HIV infection. You should therefore maintain regular contact with your doctor. In addition, Nevirapina Kern Pharma does not prevent the risk of transmitting HIV to others through blood or sexual contact. Use appropriate precautions to avoid transmitting HIV to others. Please consult your doctor.

Use in children

Nevirapina Kern Pharma tablets may be used in:

• children aged 16 years or older
• children under 16 years of age:
• weighing 50 kg or more
• or whose body surface area exceeds 1.25 m².

Use of other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. Before starting treatment with Nevirapina Kern Pharma, inform your doctor about all other medicines you are taking. Your doctor may need to monitor whether your other medicines are still effective and may need to adjust their doses. Read carefully the leaflet of all other anti-HIV medicines you are taking in combination with Nevirapina Kern Pharma.

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 used to treat depression
• rifampicin (a medicine used to treat tuberculosis)
• rifabutin (a medicine used to treat tuberculosis)
• macrolides, e.g. clarithromycin (a medicine used to treat bacterial infections)
• fluconazole (a medicine used to treat fungal infections)
• ketoconazole (a medicine used to treat fungal infections)
• itraconazole (a medicine used to treat fungal infections)
• methadone (a medicine used to treat opioid addiction)
• warfarin (a medicine used to reduce blood clot formation)
• hormonal contraceptives (e.g. “the pill”)
• atazanavir (another medicine used to treat HIV infection)
• lopinavir/ritonavir (another medicine used to treat HIV infection)
• fosamprenavir (another medicine used to treat HIV infection)
• efavirenz (another medicine used to treat HIV infection)

Your doctor will carefully monitor the effects of Nevirapina Kern Pharma and any of these medicines if you are taking them simultaneously.

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

Taking Nevirapina Kern Pharma with food and drinks

There are no restrictions on taking Nevirapina Kern Pharma with food or drinks.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

You must stop breastfeeding if you are taking Nevirapina Kern Pharma. Breastfeeding is generally not recommended if you have HIV infection, as your child may become infected with HIV through breast milk.

Driving and using machines

There are no specific studies on the ability to drive or operate machinery. If you think your ability to drive or operate machinery is affected, do not drive or use machinery.

3. HOW TO TAKE NEVIRAPINE KERN PHARMA

You must not use Nevirapine Kern Pharma on your own. It must be used in combination with at least two other antiretroviral medicines. Your doctor will recommend the appropriate medicines for you.

Always follow exactly the instructions given by your doctor for taking Nevirapine Kern Pharma. If you are unsure, consult your doctor or pharmacist.

Nevirapine Kern Pharma is for oral use only. Do not chew the tablet. You may take Nevirapine Kern Pharma with or without food.

Dosage:

The usual dose is one 200 mg tablet once daily for the first 14 days of treatment (the "lead-in" period).

After 14 days, the usual dose is one 200 mg tablet twice daily.

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

Since Nevirapine Kern Pharma must always be taken in combination with other antiretroviral medicines, you must carefully follow the instructions provided for your other medications. These are included in the package leaflets of those medicines.

Nevirapine is also available in an oral suspension liquid form. This formulation is particularly suitable if:

• you have difficulty swallowing tablets
• in children weighing less than 50 kg
• in children with a body surface area less than 1.25 m² (your doctor will determine the body surface area)

You must continue taking Nevirapine Kern Pharma for as long as your doctor prescribes.

As explained earlier in the section “Take special care with Nevirapine Kern Pharma”, your doctor will monitor you through liver function tests and by watching for adverse effects such as rash. Depending on the results, your doctor may decide to interrupt or discontinue treatment with Nevirapine Kern Pharma.

If you take more Nevirapine Kern Pharma than you should

Do not take more Nevirapine Kern Pharma than prescribed by your doctor and described in this leaflet. Currently, there is limited information available on the effects of an overdose of nevirapine.

Contact your doctor if you have taken more Nevirapine Kern Pharma than you should.

If you forget to take Nevirapine Kern Pharma

Try not to miss any doses. If you realize you have missed a dose within 8 hours, take the missed dose as soon as possible and then continue with your regular dosing schedule. If more than 8 hours have passed, 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 Nevirapine Kern Pharma

Taking your doses at the scheduled times:

• greatly increases the effectiveness of your combination antiretroviral therapy
• reduces the chances that HIV infection will become resistant to antiretroviral medicines

It is important that you continue taking Nevirapine Kern Pharma correctly as described above, unless your doctor instructs you otherwise.

If you interrupt treatment with Nevirapine Kern Pharma for more than 7 days, your doctor will instruct you to restart with another initial 14-day period (as described above) before returning to the twice-daily dosing regimen.

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

4. Possible adverse effects

Like all medicines, Nevirapine Kern Pharma can cause adverse effects, although not everyone experiences them.

As already mentioned in 'Take special care with Nevirapine Kern Pharma', the most important adverse effects of nevirapine are severe, life-threatening skin reactions and serious liver damage. These reactions occur mainly during the first 18 weeks of treatment with nevirapine. This is therefore a critical period requiring close monitoring by your doctor.

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

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

If a rash develops and you also feel generally unwell, you must stop treatment and contact your doctor immediately.

Hypersensitivity reactions (allergy) may occur. Such reactions may present as anaphylaxis (a serious type of allergic reaction) with symptoms such as:

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

Hypersensitivity reactions may also present as a rash accompanied by other adverse effects such as:

• fever
• blistering of the skin
• mouth ulcers
• eye inflammation
• facial swelling
• generalised swelling
• difficulty breathing
• muscle or joint pain
• reduction in the number of white blood cells in the blood (granulocytopenia)
• general malaise
• serious liver or kidney problems (liver or kidney failure)

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

Abnormal liver function has been reported with the use of nevirapine. This includes some cases of liver inflammation (hepatitis), which may be sudden and severe (fulminant hepatitis), and liver failure, either of which may 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 assessment of adverse effects is based on the following frequencies:

The following adverse effects have been reported in patients treated with nevirapine:

Very common:

• Rash

Common:

• Decrease in white blood cells (granulocytopenia)
• Allergic reactions (hypersensitivity)
• Headache
• General malaise (nausea)
• Vomiting
• Abdominal pain
• Diarrhea
• Liver inflammation (hepatitis)
• Muscle pain (myalgia)
• Feeling of tiredness (fatigue)
• Fever
• Abnormal liver function tests

Uncommon:

• Drug rash with systemic symptoms (drug rash with eosinophilia and systemic symptoms)
• Allergic reactions characterized by rash, facial swelling, difficulty breathing (bronchospasm), or anaphylactic shock
• Decrease in red blood cells (anemia)
• Yellowing of the skin (jaundice)
• Severe and potentially life-threatening skin rashes (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• Urticaria
• Fluid under the skin (angioneurotic edema)
• Joint pain (arthralgia)

Rare:

• Severe and sudden liver inflammation (fulminant hepatitis)

Combined antiretroviral therapy may cause changes in body shape due to redistribution of body fat. These may include loss of fat from the legs, arms, and face; increased fat in the abdomen (belly) and other internal organs; increased breast size; and fatty lumps on the back of the neck (“buffalo hump”). The cause and long-term effects of these changes are currently unknown. Combined antiretroviral therapy may also lead to increased blood lactate levels and blood sugar, hyperlipidemia (increased blood fats), and insulin resistance.

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

• Decrease in red blood cells or platelets
• Inflammation of the pancreas
• Decreased or abnormal 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 nevirapine treatment itself.

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 nevirapine treatment, is also more frequent in children. As with rash symptoms, inform your doctor of any adverse effects.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of NEVIRAPINE KERN PHARMA

Keep out of the reach and sight of children.

Do not use Nevirapine Kern Pharma after the expiry date which is stated on the outer packaging following “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return empty containers and any unused medicines to the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. ADDITIONAL INFORMATION

Composition of Nevirapine Kern Pharma

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

Appearance of the product and contents of the pack

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

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

Each standard 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 summary of product characteristics was approved in June 2011

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/.