Nevirapine Teva 400 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nevirapine Teva 400 mg prolonged-release tablets EFG

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Nevirapine Teva 400 mg prolonged-release tablets EFG is and what it is used for
2. What you need to know before taking Nevirapine Teva 400 mg
3. How to take Nevirapine Teva 400 mg
4. Possible side effects
5. How to store Nevirapine Teva 400 mg
6. Contents of the pack and other information

1. What is Nevirapine Teva 400 mg prolonged-release tablets EFG and what is it used for

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

The active substance in this medicine is called nevirapine. 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 in order to multiply. Nevirapine prevents reverse transcriptase from working. By blocking the action of reverse transcriptase, nevirapine helps control HIV-1 infection.

Nevirapine is indicated for the treatment of HIV-1 infected adults, adolescents, and children aged three years or older who are able to swallow tablets. Nevirapine must be taken in combination with other antiretroviral medicines. Your doctor will advise you which medicines are appropriate for you.

Nevirapine prolonged-release tablets should only be used after a two-week lead-in period with another type of nevirapine-containing medicine (oral suspension or immediate-release tablets), unless you are already being treated with nevirapine and are switching to the prolonged-release formulation.

2. What you need to know before starting Nevirapina Teva 400 mg

DO NOT take Nevirapina Teva 400 mg

• if you are allergic to nevirapine or to any of the other ingredients of this medicine (listed in section 6 “Composition of Nevirapina Teva”).

• if you have previously taken nevirapine and had to stop treatment because you experienced:

• 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 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 to stop working properly.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Nevirapina Teva 400 mg.

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 serious and may even be life-threatening. The risk of experiencing these reactions is highest during the first 6 weeks of treatment.

If you experience a severe rash or hypersensitivity (allergic reactions which may appear as a rash) together with other adverse effects such as: fever, blistering, mouth ulcers, eye inflammation, facial swelling, generalized swelling, difficulty breathing, muscle or joint pain, general malaise, or abdominal pain YOU MUST STOP TAKING NEVIRAPINE AND CONTACT YOUR DOCTOR IMMEDIATELY, as these reactions may be life-threatening or lead to death. If you ever experience only mild rash symptoms without any other reaction, inform your doctor immediately; your doctor will advise you whether you should stop taking nevirapine. If you experience symptoms suggesting liver damage, such as: loss of appetite, nausea, vomiting, yellowing of the skin (jaundice), abdominal pain you must stop taking nevirapine and contact your doctor immediately. If you have severe liver, skin, or hypersensitivity reactions while taking nevirapine, DO NOT RETAKE NEVIRAPINE without first consulting your doctor. You must take your dose of nevirapine exactly as prescribed by your doctor. This is especially important during the first 14 days of treatment (see more information in “How to take Nevirapine Teva 400 mg”).

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 beginning 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 infection (AIDS-defining illness), signs and symptoms of inflammatory reactions to 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 symptoms of infection, please inform your doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after you have started taking medications for the treatment of your HIV infection. Autoimmune disorders may appear many months after the initiation of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and moving upward toward the trunk, palpitations, tremors, or hyperactivity, inform your doctor immediately so you can receive the necessary treatment.

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 side effects”).

In some patients receiving combination antiretroviral therapy, a bone disease called osteonecrosis (death of bone tissue caused by reduced blood supply to the bone) may develop. Duration of combination antiretroviral therapy, use of corticosteroids, alcohol consumption, severe immune deficiency, and high body mass index may be among the many risk factors for developing this disease. 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.

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

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

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

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

If you are receiving post-menopausal hormone therapy, consult your doctor before taking this medication.

If you are taking or are prescribed rifampicin for the treatment of tuberculosis, inform your doctor before taking this medication with nevirapine.

Extended-release nevirapine tablets or parts of the tablets may occasionally be eliminated and seen in the stool. These may resemble intact tablets, but have not been shown to affect the efficacy of nevirapine.

Children and adolescents

Nevirapine Teva 400 mg prolonged-release tablets may be used in children if:

• they are ≥ 8 years of age and weigh 43.8 kg or more
• they are more than 3 years of age and less than 8 years of age and weigh 25 kg or more
• they have a body surface area of 1.17 square meters or greater

For smaller children, an oral liquid suspension formulation is available.

Use of Nevirapine Teva 400 mg prolonged-release tablets EFG with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicine. Before starting treatment with nevirapine, 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 the package leaflet of all other anti-HIV medicines you are taking in combination with nevirapine carefully.

It is especially important that you inform your doctor if you are using or have recently used:

• St. John’s wort (Hypericum perforatum, a herbal remedy for the treatment of 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 for the treatment of opioid addiction)
• warfarin (a medicine to reduce blood clot formation)
• 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)
• etravirine (another medicine for the treatment of HIV infection)
• rilpivirine (another medicine for the treatment of HIV infection)
• zidovudine (another medicine for the treatment of HIV infection)
• elvitegravir/cobicistat (another medicine for the treatment of HIV infection)

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

Taking Nevirapine Teva 400 mg with food and drink

There are no restrictions regarding taking nevirapine with food and drink.

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 medicine.

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

If you are breastfeeding or considering breastfeeding, you must consult your doctor as soon as possible.

Driving and using machines

When taking nevirapine, you may experience fatigue. Exercise caution when participating in activities such as driving or operating tools or machinery. If you experience fatigue, you should avoid potentially dangerous activities such as driving and operating tools or machinery.

3. How to take Nevirapina Teva 400 mg

You must not take nevirapine on your own. It must be taken in combination with at least two other antiretroviral medicines. Your doctor will recommend the appropriate medicines for you.

Always follow exactly the instructions provided by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Dosage:

Adults:

The dose is one 200 mg nevirapine tablet daily for the first 14 days of treatment (the “lead-in” period). Other formulations are available for this lead-in period. After 14 days, the usual dose is one extended-release 400 mg tablet once daily.

It is very important that you take only one 200 mg nevirapine tablet per day during the first 14 days (the “lead-in” period). If you develop any rash during this period, do not start taking Nevirapine Teva 400 mg prolonged-release tablets and consult your doctor.

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

Patients who are already being treated with immediate-release tablets or oral suspension may be switched to extended-release tablets without an initial period.

Since nevirapine 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 package leaflets of those medicines.

Your doctor will check, if necessary, the availability of other formulations of nevirapine, for example an oral suspension (for all age groups, weight, and body surface area).

You must continue taking nevirapine for as long as your doctor tells you to.

As explained earlier in the section ‘Warnings and precautions’, your doctor will monitor you with liver function tests and by watching for the appearance of adverse effects such as rash. Depending on the results, your doctor may decide to interrupt or discontinue treatment with nevirapine. Likewise, your doctor might decide to restart treatment at a lower dose.

If you have any degree of renal or hepatic impairment, take only nevirapine 200 mg tablets or nevirapine 50 mg/5 ml oral suspension. If needed, your doctor will consider these additional formulations.

Take nevirapine extended-release tablets only by mouth. Do not chew the extended-release tablets. You may take nevirapine with or without food.

If you take moreNevirapine Teva 400 mgthan you should

Do not take more nevirapine than prescribed by your doctor and described in this leaflet. Currently, there is limited information on the effects of a nevirapine overdose. Contact your doctor if you have taken more nevirapine than you should. In case of overdose or accidental ingestion, contact the Toxicology Information Service, telephone: 91 562 04 20, and state the amount ingested.

If you forget to takeNevirapine Teva 400 mg

Try not to miss any doses. If you realize you have missed a dose within 12 hours of the scheduled time, take the missed dose as soon as possible. If more than 12 hours have passed since the scheduled time, take only the next dose at your usual time.

If you stop takingNevirapine Teva 400 mg

Taking your doses at the scheduled times:

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

It is important that you continue taking nevirapine correctly as described above, unless your doctor tells you to stop treatment.

If you interrupt nevirapine treatment for more than 7 days, your doctor will instruct you to start again with the initial 14-day period using nevirapine tablets (as described earlier), before resuming daily dosing with nevirapine extended-release tablets.

If you have any further 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 in blood glucose and lipid levels. This may be partly related to improved health and lifestyle, and in the case of increased blood lipids, sometimes due to HIV medications themselves. Your doctor will monitor these changes.

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

As already mentioned in ‘Warnings and precautions’, 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 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 fatal cases have been reported. Most cases of both severe and mild/moderate rash occur during the first six weeks of treatment.

If a rash appears 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 sores
• eye inflammation
• facial swelling
• general swelling
• difficulty breathing
• muscle or joint pain
• decrease in white blood cells (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.

Liver function abnormalities have 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, 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 nevirapine 200 mg tablets during the initial 14-day phase:

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

• rash
• fever
• headache
• abdominal pain
• general malaise (nausea)
• diarrhoea
• feeling of tiredness (fatigue)

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

• allergic reactions (hypersensitivity)
• allergic reactions characterized by rash, facial swelling, difficulty breathing (bronchospasm) or anaphylactic shock
• drug reaction with systemic symptoms (drug reaction with eosinophilia and systemic symptoms)
• severe and sudden inflammation of the liver (fulminant hepatitis)
• severe and potentially life-threatening skin rashes (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• yellowing of the skin (jaundice)
• urticaria
• fluid under the skin (angioedema)
• vomiting
• muscle pain (myalgia)
• joint pain (arthralgia)
• decrease in white blood cells (granulocytopenia)
• abnormalities in liver function tests
• decreased blood phosphorus levels
• increased blood pressure

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

• liver inflammation (hepatitis)
• decrease in red blood cells (anaemia)

The following adverse effects have been reported in patients treated with nevirapine extended-release tablets once daily during the maintenance phase:

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

• rash
• headache
• abdominal pain
• general malaise (nausea)
• liver inflammation (hepatitis)
• feeling of tiredness (fatigue)
• abnormalities in liver function tests
• decreased blood phosphorus levels
• increased blood pressure
• vomiting
• soft stools (diarrhoea)

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

• allergic reactions (hypersensitivity)
• allergic reactions characterized by rash, facial swelling, difficulty breathing (bronchospasm) or anaphylactic shock
• drug reaction with systemic symptoms (drug reaction with eosinophilia and systemic symptoms)
• severe and sudden inflammation of the liver (fulminant hepatitis)
• severe and potentially life-threatening skin rashes (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• decrease in red blood cells (anaemia)
• decrease in white blood cells (granulocytopenia)
• yellowing of the skin (jaundice)
• urticaria
• fluid under the skin (angioedema)
• muscle pain (myalgia)
• joint pain (arthralgia)
• fever

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

• decrease in red blood cells or platelets
• inflammation of the pancreas
• 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 nevirapine treatment itself.

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 (anaemia), which may be related to nevirapine treatment, is also more frequent in children. As with rash symptoms, inform your doctor of any adverse effects.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish national pharmacovigilance system for human medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nevirapine Teva 400 mg

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

Do not use this medicine after the expiry date stated on the carton, blister pack, or label of the bottle 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. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nevirapine Teva 400 mg

• The active substance is nevirapine.

Each prolonged-release tablet contains 400 mg of nevirapine.

• The other components are microcrystalline cellulose, povidone, polyethylene oxide, anhydrous colloidal silica and magnesium stearate.

Appearance of the product and contents of the pack

Nevirapine Teva 400 mg prolonged-release tablets EFG are white to off-white, oval, biconvex tablets, approximately 20.5 mm long and 10 mm wide, engraved with "400" on one side and flat on the other.

Aluminium blisters containing 10, 10x1, 30, 30x1, 60, 60x1, 90, 90x1, 100 and 100x1 prolonged-release tablets and high-density polyethylene (HDPE) bottles containing 30 prolonged-release tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

TEVA PHARMA, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, Madrid

28108 Spain

Manufacturers

TEVA Gyógyszergyár Zrt.

Pallagi út 13, Debrecen,

4042 Hungary

or

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80, Kraków

31-546 Poland

This medicinal product is authorized in the European Economic Area member states under the following names:

DE Nevirapin-ratiopharm 400 mg Retardtabletten

DK Nevirapine Teva B.V.

ES Nevirapina Teva 400 mg prolonged-release tablets EFG

FR Nevirapine Teva LP 400 mg, comprimé à libération prolongée

IT Nevirapina Teva Italia

NL Nevirapine retard Teva 400 mg, tabletten met verlengde afgifte

PT Nevirapina Teva

Date of the most recent review of this leaflet: April 2023

Other sources of information

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