Nevirapine Tarbis Farma 400 mg prolonged-release tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Nevirapine Tarbis Farma 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 other people, 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.

Leaflet Contents

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

1. What Nevirapina Tarbis is and what it is used for

Nevirapina Tarbis Farma 400 mg 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. Consequently, Nevirapina Tarbis Farma 400 mg tablets inhibit reverse transcriptase activity, thereby helping to control HIV-1 infection.

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

Nevirapine should only be used after a two-week treatment with another form of nevirapine (suspension or immediate-release tablets), unless you are currently taking one of these medicines and are switching to the extended-release formulation.

2. What you need to know before starting Nevirapina Tarbis Farma

Do not take Nevirapina Tarbis Farma

• if you are allergic to nevirapine or to any of the other ingredients of this medicine (listed in section 6)
• 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
    • blisters
    • mouth sores
    • eye inflammation
    • facial swelling
    • generalized 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 discontinued treatment with nevirapine due to changes in liver function
• if you are taking any medicine containing St. John’s wort (Hypericum perforatum). This substance may prevent nevirapine from working properly.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Nevirapina Tarbis Farma 400 mg prolonged-release tablets EFG.

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

If you experience a severe rash or hypersensitivity (allergic reactions that may appear as a rash) along with any of the following adverse effects:

• fever,
• blisters,
• mouth sores,
• 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 fatal. If you only experience mild rashes without any other symptoms, inform your doctor immediately, who will advise 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 develop 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 Nevirapina Tarbis Farma”).

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 prior treatment and have high CD4 cell counts when starting nevirapine treatment (in women, more than 250 cells/mm³; in men, more than 400 cells/mm³)
• previously treated patients with detectable HIV-1 viral load in plasma and high CD4 cell counts when starting nevirapine treatment (in women, more than 250 cells/mm³; in men, more than 400 cells/mm³)

Shortly after starting anti-HIV treatment, some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (AIDS-defining illnesses) may develop signs and symptoms of inflammation from previous infections. These symptoms are believed to result from improved immune response, allowing the body to fight infections that may have been 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 you start taking medicines to treat your HIV infection. Autoimmune disorders may appear many months after starting 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, contact your doctor immediately for 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”).

Osteonecrosis (bone tissue death due to reduced blood supply to the bone) may develop in some patients receiving combination antiretroviral therapy. Duration of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severely weakened immune system, and high body mass index may be among the numerous risk factors for developing this condition. Symptoms of osteonecrosis include joint stiffness, pain, and discomfort, especially in the hip, knee, or 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 Nevirapina 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 Nevirapina.

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

Prolonged-release tablets of Nevirapina Tarbis or parts of the tablets may occasionally be seen in the stools. These may resemble intact tablets, but have not been shown to affect the efficacy of nevirapine.

Children and adolescents

Nevirapina Tarbis Farma 400 mg prolonged-release tablets EFG can be used in children if:

• they are ≥ 8 years old and weigh at least 43.8 kg
• they are older than 3 and younger than 8 years and weigh at least 25 kg
• they have a body surface area of at least 1.17 m²

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

Other medicines and Nevirapina

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Before starting Nevirapina, inform your doctor about all other medicines you are taking. Your doctor may need to check 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 Nevirapina carefully.

It is especially important to 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 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 birth control 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)
• etravirine (another medicine used to treat HIV infection)
• rilpivirine (another medicine used to treat HIV infection)
• zidovudine (another medicine used to treat HIV infection)
• elvitegravir/cobicistat (another medicine used to treat HIV infection)

Your doctor will closely monitor the effects of Nevirapina and any of these medicines if taken together.

Use of Nevirapina with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant, think you might 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

Nevirapina may cause fatigue. Exercise caution when performing activities such as driving or operating tools or machinery. If you experience fatigue, avoid potentially dangerous activities such as driving or using tools or machinery.

Nevirapina Tarbis Farma 400 mg prolonged-release tablets EFG contains lactose

Nevirapina Tarbis Farma 400 mg prolonged-release tablets EFG contain lactose (milk sugar).

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

3. How to take Nevirapine Tarbis Farma

You must not use Nevirapine alone, but always 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. In case of doubt, consult your doctor or pharmacist again.

Dosage:

Adults

The dose is one 200 mg nevirapine tablet once daily for the first 14 days of treatment (the "lead-in" period). A separate starter pack containing 200 mg nevirapine tablets is available for this initial period. After 14 days, the usual dose is one 400 mg extended-release tablet once daily.

It is very important that you take only one nevirapine tablet per day during the first 14 days (the "lead-in" period). If you develop any rash during this period, do not proceed to the next stage and consult your doctor.

A 14-day "lead-in" period has been shown to reduce the risk of skin rash.

Patients already being treated with immediate-release tablets or oral suspension may switch directly to extended-release tablets without needing this lead-in period.

Since Nevirapine must always be taken in combination with other antiretroviral medicines, you must always carefully follow the instructions for your other medicines. These can be found in the package leaflets of the respective medicines.

Nevirapine is also available as an oral suspension (suitable for all age groups, body weights, and body surface areas).

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

As already explained in section 'Warnings and precautions', your doctor will monitor your liver function through blood tests and watch for adverse effects such as rash. Depending on the results, your doctor may decide to interrupt or stop treatment with Nevirapine Tarbis Farma 400 mg extended-release tablets EFG. Afterwards, your doctor may decide to restart treatment at a lower dose.

If you have any degree of renal or hepatic impairment, you may only take nevirapine 200 mg tablets or nevirapine 50 mg/5 ml oral suspension.

Take Nevirapine Tarbis Farma 400 mg extended-release tablets EFG by mouth only. Never chew the extended-release tablets. Nevirapine may be taken with or without food.

If you take more Nevirapine Tarbis Farma than 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 an overdose of Nevirapine. Contact your doctor if you have taken more Nevirapine than prescribed.

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

If you forget to take Nevirapine Tarbis Farma

Try not to miss any doses. If you remember 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 Tarbis Farma

Taking your doses on time:

• greatly increases the effectiveness of your antiretroviral combination therapy
• reduces the likelihood 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 to stop treatment.

If you interrupt treatment with Nevirapine for more than 7 days, your doctor will instruct you to restart with another 14-day "lead-in" period using nevirapine tablets (as described above), before resuming the daily dose of Nevirapine Tarbis Farma 400 mg extended-release tablets EFG.

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

4. Possible adverse effects

During HIV treatment, an increase in body weight and in blood glucose and lipid levels may occur. This may be partly related to improved health and lifestyle, and in the case of increased blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.

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

As already mentioned in ‘Warnings and precautions’, the most important adverse effects of Nevirapina Tarbis Farma 400 mg prolonged-release tablets EFG are severe, life-threatening skin reactions and severe 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 a rash develops, it is usually mild to moderate. However, in some patients, the rash may take the form of a severe or life-threatening blistering skin reaction (Stevens-Johnson syndrome and toxic epidermal necrolysis), and fatal cases have been reported. Most cases of rash, both severe and mild/moderate, occur during the first six weeks of treatment.

If a rash appears together with general malaise, treatment must be stopped and you should see your doctor immediately.

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

• rash
• swelling of the face
• difficulty breathing (bronchospasm)
• anaphylactic shock

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

• fever
• skin blisters
• mouth sores
• 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 develop a rash and any of the other adverse effects associated with a hypersensitivity reaction (allergy), inform your doctor immediately. These reactions can be potentially 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 may be fatal.

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

• loss of appetite
• 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:

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

• rash
• fever
• headache
• abdominal pain
• nausea
• diarrhea
• 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)
• sudden and severe liver inflammation (fulminant hepatitis)
• severe and potentially fatal skin rashes (Stevens-Johnson syndrome / toxic epidermal necrolysis)
• yellowing of the skin (jaundice)
• urticaria
• fluid under the skin (angioneurotic edema)
• vomiting
• muscle pain (myalgia)
• joint pain (arthralgia)
• decrease in white blood cells (granulocytopenia)
• abnormalities in liver function tests
• decreased blood phosphorus
• 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 prolonged-release tablets once daily during the maintenance phase:

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

• rash
• headache
• abdominal pain
• nausea
• liver inflammation (hepatitis)
• tiredness (fatigue)
• abnormalities in liver function tests
• fever
• vomiting
• 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 systemic symptoms (drug reaction with eosinophilia and systemic symptoms)
• sudden and severe liver inflammation (fulminant hepatitis)
• severe and potentially fatal 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 (angioneurotic edema)
• muscle pain (myalgia)
• joint pain (arthralgia)
• decreased blood phosphorus
• increased blood pressure

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

• decrease in red blood cells or platelets
• inflammation of the pancreas
• decrease or abnormalities in skin sensation

These effects are often associated with other antiretroviral agents and may be expected 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, 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 Tarbis Farma

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

Do not use this medicine after the expiry date stated on the carton, bottle, or blister pack. The expiry date refers to the last day of the month indicated.

Nevirapine Tarbis Farma 400 mg prolonged-release tablets EFG should be used within 30 days of first opening the bottle.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nevirapine Tarbis Farma 400 mg prolonged-release tablets EFG

• The active substance is nevirapine. Each tablet contains 400 mg of nevirapine (anhydrous form).

The other components are:

• lactose (in the form of monohydrate)
• hypromellose
• magnesium stearate.

Appearance of the product and contents of the pack

Nevirapine Tarbis Farma 400 mg prolonged-release tablets EFG are oval, biconvex, white to off-white tablets, marked with an "H" on one side and "N1" on the other. The prolonged-release tablet must not be split.

Nevirapine Tarbis Farma 400 mg prolonged-release tablets EFG are supplied in PVC-aluminum blisters containing 30, 90 or 180 tablets (2 packs of 90) of prolonged-release tablets, and in HDPE bottles containing 30 prolonged-release tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

The Netherlands

This medicinal product is authorized in the following EEA Member States under the following names:

Spain: Nevirapina Tarbis Farma 400 mg comprimidos de liberación prolongada EFG

The Netherlands: Nevirapine Amarox 400 mg tabletten met verlengde afgifte

United Kingdom: Nevirapine Amarox 400 mg prolonged-release tablets

Date of latest revision: January 2023

Detailed and up-to-date 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/)