Nevirapine Aurovitas 400 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nevirapine Aurovitas 400 mg prolonged-release tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• 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 only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Nevirapine Aurovitas is and what it is used for
2. What you need to know before taking Nevirapine Aurovitas
3. How to take Nevirapine Aurovitas
4. Possible adverse effects
5. How to store Nevirapine Aurovitas
6. Contents of the pack and other information

1. What Nevirapine Aurovitas is and what it is used for

This medicine 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 blocks the action of reverse transcriptase. By inhibiting 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 and 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.

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

2. What you need to know before starting to take Nevirapine Aurovitas

Do not take Nevirapine Aurovitas

• If you are allergic to nevirapine or to any of the other ingredients of this medicine (listed in section 6 “Contents of the container and additional information”).
• If you have previously taken nevirapine and had to stop treatment because you experienced:
  • Severe skin rash.
  • Skin rash with other symptoms such as, for example:
  • fever
  • blistering
  • mouth ulcers
  • 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 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

Talk to your doctor or pharmacist before starting to take Nevirapine Aurovitas.

During the first 18 weeks of treatment with nevirapine, it is very important that you and your doctor monitor for the appearance of liver or skin reactions. These reactions can become serious and even life-threatening. The risk of such reactions is highest during the first 6 weeks of treatment.

If you experience severe rash or hypersensitivity (allergic reactions which may appear as rash) along with other adverse effects such as:

-fever,

-blistering,

-mouth ulcers,

-eye inflammation,

-facial swelling,

-general 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 fatal.

If you ever experience only mild rash symptoms without any other reaction, inform your doctor immediately, who will advise you whether you should stop taking nevirapine.

If you experience symptoms suggesting liver damage, such as:

-loss of appetite,

-general malaise (nausea),

-vomiting,

-yellowing of the skin (jaundice),

-abdominal pain

you must stop taking nevirapine and contact your doctor immediately.

If you experience 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 Aurovitas”).

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 who have never received treatment and have high 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 high CD4 cell counts 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 improved immune response, enabling the body to fight infections that were previously present without apparent symptoms. If you notice any signs of infection, 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 starting medications for the treatment of your HIV infection. Autoimmune disorders may appear many months after starting treatment. If you notice any signs 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 to receive appropriate treatment.

Body fat redistribution 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 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.

If you are taking nevirapine and zidovudine together, inform your doctor, as your white blood cell counts 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 must not be used to treat rashes associated with nevirapine.

If you are taking oral contraceptives (e.g., “the pill”) or other hormonal birth control methods while on nevirapine treatment, you must additionally use a barrier contraceptive method (e.g., condoms) to prevent pregnancy and transmission of HIV. If you are receiving postmenopausal hormone therapy, consult your doctor before taking this medicine.

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

Some patients taking other extended-release formulations of nevirapine have reported finding tablet residues in their stools that may resemble intact tablets. According to available data, this has not been shown to affect the therapeutic response of these other formulations. Inform your doctor if you find pieces of tablets in your stools.

Children and adolescents

This medicine may be used in children if:

• they are ≥ 8 years old and weigh 43.8 kg or more.
• they are over 3 years and under 8 years old 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.

Other medicines and Nevirapine Aurovitas

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Before starting 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 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 for opioid addiction treatment).
• 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 using them at the same time.

Taking Nevirapine Aurovitas with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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, because 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 engaging 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.

Nevirapine Aurovitas contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Nevirapine Aurovitas contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per prolonged-release tablet; this is essentially “sodium-free”.

3. How to take Nevirapine Aurovitas

You must not take nevirapine 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 your doctor's instructions 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 "initial" period). A starter pack of nevirapine 200 mg tablets is available for this initial period. After 14 days, the usual dose is one 400 mg prolonged-release tablet once daily.

It is very important that you take only one nevirapine tablet per day during the first 14 days (the "initial" period). If you develop a rash during this period, do not start taking the prolonged-release nevirapine tablets and consult your doctor.

The 14-day "initial" period has been shown to reduce the risk of developing a skin rash.

Patients already being treated with immediate-release tablets or oral suspension may be switched directly to prolonged-release tablets without undergoing the initial period.

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

Nevirapine is also available as an oral suspension (for all age groups, body weight, and body surface area).

You must continue taking nevirapine for as long as your doctor prescribes.

As explained earlier in the section “Warnings and precautions”, your doctor will monitor you with 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. Your doctor may also 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.

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

If you take more Nevirapine Aurovitas than you should

Do not take more nevirapine than prescribed by your doctor or stated in this leaflet. Currently, there is limited information on the effects of nevirapine overdose. Contact your doctor if you have taken more nevirapine than you should.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Nevirapine Aurovitas

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 regular time.

If you stop taking Nevirapine Aurovitas

Taking your doses at the prescribed 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 instructs you otherwise.

If you interrupt nevirapine treatment for more than 7 days, your doctor will instruct you to restart with another 14-day "initial" period using nevirapine tablets (as described above), before resuming the daily dose with prolonged-release nevirapine 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 health recovery and lifestyle, and, in the case of increased blood lipids, sometimes due to HIV medicines themselves. Your doctor will monitor these changes.

Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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. These 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.
• 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 and 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 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 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).
• soft stools (diarrhea).
• 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 eosinophilia and systemic symptoms (DRESS).
• sudden and severe liver inflammation (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 (anemia).

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.
• fever.
• vomiting.
• soft stools (diarrhea).

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 eosinophilia and systemic symptoms (DRESS).
• sudden and severe liver inflammation (fulminant hepatitis).
• severe and potentially life-threatening skin rashes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
• decrease in red blood cells (anemia).
• decrease in white blood cells (granulocytopenia).
• yellowing of the skin (jaundice).
• urticaria.
• fluid under the skin (angioedema).
• muscle pain (myalgia).
• joint pain (arthralgia).
• decreased blood phosphorus levels.
• increased blood pressure.

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.
• decreased or altered skin sensations.

These effects are generally associated with other antiretroviral agents and may occur when nevirapine is used in combination with them; 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, which is more common in children. A decrease in red blood cells (anemia), which may be related to nevirapine treatment, is also more common 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nevirapine Aurovitas

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

Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. 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 Nevirapina Aurovitas

• The active substance is nevirapine. Each prolonged-release tablet contains 400 mg of nevirapine.
• The other components are: lactose monohydrate, hypromellose (4000 mPas, controlled release grade), yellow iron oxide (E172), anhydrous colloidal silica, sodium stearyl fumarate and sodium.

Appearance of the product and contents of the pack

Prolonged-release tablet.

Light yellow or yellow, oval-shaped, biconvex tablets, marked with "N" on one side and "400" on the other.

Nevirapina Aurovitas prolonged-release tablets are available in blister packs.

Pack sizes:

Blister packs: 10, 30, 50, 60 and 90 tablets.

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

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

Germany: Nevirapin Aurobindo 400 mg Retardtabletten

Spain: Nevirapina Aurovitas 400 mg prolonged-release tablets EFG

France: NEVIRAPINE ARROW LP 400 mg, prolonged-release tablet

Netherlands: Nevirapine Aurobindo 400 mg, tablets with prolonged release

Portugal: Nevirapina Generis

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

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/).