Label: information for the user

Nevirapina Tarbis Farma 400 mg prolonged-release tablets EFG

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

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

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

3. How to take Nevirapina Tarbis Farma

4. Possible adverse effects

5. Storage of Nevirapina Tarbis Farma

6. Contents of the package and additional information

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 ingredient of this medicine is called nevirapina. Nevirapina belongs to a class of anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). The reverse transcriptase is an enzyme that HIV needs to multiply. Nevirapina prevents the action of the reverse transcriptase. Consequently, Nevirapina Tarbis Farma 400 mg tablets prevent the action of the reverse transcriptase, thus helping to control HIV-1 infection.

Nevirapina 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. Nevirapina should be taken with other antiretroviral medicines. Your doctor will advise you on the most suitable medicines for your case.

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

Do not take Nevirapina Tarbis Farma

• if you are allergic to nevirapina or any of the other components of this medication (listed in section 6)
• if you have taken nevirapina previously and had to interrupt treatment because you suffered:
• • severe skin rash
  • skin rash with other symptoms such as:
  • • fever
    • blistering
    • mouth sores
    • inflammation of the eye
    • swelling of the face
    • general swelling
    • difficulty breathing
    • muscle or joint pain
    • general discomfort
    • abdominal pain
  • hypersensitivity reactions (allergies)
  • inflammation of the liver (hepatitis)
• if you have any severe liver disease
• if you have had to interrupt treatment with nevirapina in the past due to changes in liver function
• if you are using any medication that contains hypericum or St. John's Wort (Hypericum perforatum). This substance may prevent nevirapina from working properly.

Warnings and precautions

Consult 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 nevirapina, it is very important that you and your doctor are aware of the manifestation of liver or skin reactions. These reactions can be severe and even life-threatening. The risk of developing these reactions is higher during the first 6 weeks of treatment.

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

• fever,
• blistering,
• mouth sores,
• inflammation of the eye,
• swelling of the face,
• general swelling,
• difficulty breathing,
• muscle or joint pain,
• general discomfort,
• or abdominal pain

YOU MUST STOP TAKING NEVIRAPINA AND CONTACT YOUR DOCTOR IMMEDIATELY, as these reactions can be life-threatening or fatal. If you only experience mild rashes without any other reaction, inform your doctor immediately, who will indicate whether you should stop taking nevirapina.

If you experience symptoms that suggest liver damage, such as:

• loss of appetite,
• nausea,
• vomiting,
• yellowing of the skin (jaundice),
• abdominal pain

you must stop taking nevirapina and contact your doctor immediately.

If you develop severe liver, skin, or hypersensitivity reactions while taking NEVIRAPINA, DO NOT TAKE NEVIRAPINA AGAIN without consulting your doctor first.

You must take your dose of nevirapina exactly as indicated 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 treatment and have high CD4 cell counts at the start of nevirapina treatment (in women, more than 250 cells/mm³; in men, more than 400 cells/mm³)
• pre-treated patients, with detectable HIV-1 plasma viral load and high CD4 cell counts at the start of nevirapina treatment (in women, more than 250 cells/mm³; in men, more than 400 cells/mm³)

A short time after starting antiretroviral treatment, some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (defining AIDS disease) may experience signs and symptoms of inflammation of previous infections. It is believed that these symptoms are due to an improvement in the body's immune response, which allows it to fight off infections that may have been present without any apparent symptoms. If you notice any symptoms of infection, do not hesitate to 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 medications to treat your HIV infection. Autoimmune disorders can occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms, such as muscle weakness, weakness that starts in the hands and feet and ascends to the trunk of the body, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive necessary treatment.

Changes in body fat 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 loss of blood supply to the bone) may develop. The duration of combination antiretroviral therapy, 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 stiffness in the joints, pain, and discomfort, especially in the hip, knee, and shoulder, and difficulty moving. If you notice any of these symptoms, inform your doctor.

If you are taking nevirapina and zidovudine together, inform your doctor because you may need to monitor your white blood cell counts.

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

Do not use prednisone to treat rashes associated with Nevirapina.

If you are taking oral contraceptives (e.g., "the pill") or other hormonal methods of birth control during treatment with Nevirapina, you should also use a barrier method (e.g., condoms) to prevent pregnancy and HIV transmission. If you are receiving hormone replacement therapy, consult your doctor before taking this medication.

If you are taking or have been prescribed rifampicin to treat tuberculosis, inform your doctor before taking this medication with Nevirapina.

The prolonged-release tablets of Nevirapina Tarbis or parts of the tablets may be eliminated and appear in the stool from time to time. These may appear as whole tablets, but it has not been seen to affect the efficacy of nevirapina.

Children and adolescents

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

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

For younger children, a liquid oral suspension is available.

Other medications and Nevirapina

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Before starting to take Nevirapina, inform your doctor of all other medications you are taking. Your doctor may need to verify if your other medications are still working and adjust the doses. Read the leaflet of all other antiretroviral medications you are taking in combination with Nevirapina.

It is especially important to inform your doctor if you are taking or have taken recently:

• hypericum or St. John's Wort (Hypericum perforatum, medicinal plant for the treatment of depression)
• rifampicin (medication for treating tuberculosis)
• rifabutina (medication for treating tuberculosis)
• macrolides, e.g. claritromycin (medication for treating bacterial infections)
• fluconazol (medication for treating fungal infections)
• ketoconazol (medication for treating fungal infections)
• itraconazol (medication for treating fungal infections)
• metadona (medication for treating opioid addiction)
• warfarina (medication for reducing blood clot formation)
• hormonal contraceptives (e.g. "the pill")
• atazanavir (other medication for treating HIV infection)
• lopinavir/ritonavir (other medication for treating HIV infection)
• fosamprenavir (other medication for treating HIV infection)
• efavirenz (other medication for treating HIV infection)
• etravirina (other medication for treating HIV infection)
• rilpivirina (other medication for treating HIV infection)
• zidovudina (other medication for treating HIV infection)
• elvitegravir/cobicitstat (other medication for treating HIV infection)

Your doctor will closely monitor the effect of Nevirapina and any of these medications if taken together.

Use of Nevirapina with food and drinks

There are no restrictions for taking Nevirapina with food and drinks.

Pregnancy and breastfeeding

If you are pregnant or believe you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

It is not recommendedthat women living with HIV breastfeed because HIV infection can be transmitted to the baby through breast milk.

If you are breastfeeding or plan to breastfeed,you must consult withyour doctoras soon as possible.

Driving and operating machines

The use of Nevirapina may cause fatigue. Be cautious when developing activities such as driving or using tools or machines. If you experience fatigue, you should avoid potentially hazardous activities such as driving and using tools or machines.

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

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

If your doctor has informed you that you have a lactose intolerance, consult with him before taking this medication.

Do not use Nevirapina alone, but in combination with at least two other antiretroviral medications. Your doctor will recommend the appropriate medications for you.

Follow the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Dosage:

Adults

The dosage is one 200 mg nevirapina tablet per day for the first 14 days of treatment (initial period). There is a starter pack available with 200 mg nevirapina tablets for this initial period. After 14 days, the usual dosage is one prolonged-release 400 mg nevirapina tablet per day.

It is very important to take only one tablet per day of nevirapina during the first 14 days (initial period). If you develop any rash during this period,do not start taking Nevirapina and consult your doctor.

The initial period of 14 days has been shown to reduce the risk of skin rash.

Patients already on treatment with immediate-release tablets or oral suspension may switch to prolonged-release tablets without the need for this initial period.

Since Nevirapina must always be taken in combination with other antiretroviral medications, you must carefully follow the instructions for your other medications. You can find this information in the respective medication leaflets.

Nevirapina is also available in oral suspension form (for all age groups, weights, and body surface areas).

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

As explained in the ‘Warnings and precautions’section, your doctor will monitor you through liver function tests and watch for the appearance of adverse effects such as rash. Depending on the results, your doctor may decide to interrupt or suspend treatment with Nevirapina Tarbis Farma 400 mg prolonged-release tablets EFG. After that, your doctor may decide to restart treatment with lower doses.

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

Only take Nevirapina Tarbis Farma 400 mg prolonged-release tablets EFG orally. Never chew the prolonged-release tablets. Nevirapina can be taken with or without food.

If you take more Nevirapina Tarbis Farma than you should

Do not take more Nevirapina than your doctor has prescribed and as described in this leaflet. There is currently little information available on the effects of a Nevirapina overdose. Consult your doctor if you have taken more Nevirapina than you should.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Nevirapina Tarbis Farma

Make sure not to forget any doses. If you realize you have forgotten 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, only take the next dose at your usual time.

If you interrupt treatment with Nevirapina Tarbis Farma

Take your doses as scheduled:

• This significantly increases the effectiveness of your antiretroviral medication combination.
• This reduces the likelihood that the HIV infection will become resistant to antiretroviral medications.

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

If you interrupt Nevirapina administration for more than 7 days, your doctor will instruct you to start again with the initial period of 14 days with nevirapina tablets (as described above), before resuming a daily dose of Nevirapina Tarbis Farma 400 mg prolonged-release tablets EFG.

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

During HIV treatment, weight gain and changes in blood glucose and lipid levels may occur. This may be related to recovery of health and lifestyle, and in the case of increased lipid levels in the blood, it may be due to the HIV medications themselves. Your doctor will monitor these changes.

Like all medications, this medication may cause side effects, although not everyone will experience them.

As mentioned in ‘Warnings and Precautions’,the most important side effects of Nevirapina Tarbis Farma 400 mg prolonged-release tablets are severe and potentially life-threatening skin reactions, and severe liver damage. These reactions occur mainly during the first 18 weeks of nevirapina treatment. This is an important period that requires close monitoring by your doctor.

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

When a rash develops, it is usually mild to moderate. However, in some patients, the rash takes the form of a severe and potentially life-threatening skin reaction (Stevens-Johnson syndrome and toxic epidermal necrolysis), and even fatal cases have been reported. Most cases of rash, both severe and mild/moderate, occur within the first six weeks of treatment.

If a rash develops, and you also feel unwell, you should interrupt treatment and visit your doctor immediately.

Severe allergic reactions (hypersensitivity) may occur. These 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 (bronchospasm)
• anaphylactic shock

Severe allergic reactions can also present as a rash with other side effects such as:

• fever
• blistering of the skin
• mouth sores
• inflammation of the eye
• swelling of the face
• generalized swelling
• difficulty breathing
• muscle or joint pain
• decrease in white blood cell count (granulocytopenia)
• general feeling of illness
• severe liver or kidney problems (hepatic or renal insufficiency)

If you experience a rash and any of the other side effects of a severe allergic reaction, inform your doctor immediately. These reactions can be potentially fatal.

Abnormal liver function has been described with the use of Nevirapina. This includes some cases of liver inflammation (hepatitis), which can be sudden and intense (fulminant hepatitis), and liver insufficiency. Both can 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 side effects have been reported in patients who received nevirapina 200 mg tablets during the initial phase of 14 days:

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

• rash
• fever
• headache
• abdominal pain
• nausea
• diarrhea
• fatigue

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

• allergic reactions (hypersensitivity)
• allergic reactions characterized by rash, facial inflammation, difficulty breathing (bronchospasm), or anaphylactic shock
• drug reaction with systemic symptoms (drug reaction with eosinophilia and systemic symptoms)
• sudden and intense liver inflammation (fulminant hepatitis)
• severe and potentially fatal skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis)

/necrólisis epidérmica tóxica)

• yellowing of the skin (jaundice)
• urticaria
• fluid under the skin (angioneuritic edema)
• vomiting
• muscle pain (myalgia)
• joint pain (arthralgia)
• decrease in white blood cell count (granulocytopenia)
• abnormal liver function tests
• decrease in blood phosphorus
• increase in blood pressure

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

• liver inflammation (hepatitis)
• decrease in red blood cell count (anemia)

The following side effects have been reported in patients who received nevirapina prolonged-release tablets once a day during the maintenance phase:

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

• rash
• headache
• abdominal pain
• nausea
• liver inflammation (hepatitis)
• fatigue
• abnormal liver function tests
• fever
• vomiting
• diarrhea

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

• allergic reactions (hypersensitivity)
• allergic reactions characterized by rash, facial inflammation, difficulty breathing (bronchospasm), or anaphylactic shock
• drug reaction with systemic symptoms (drug reaction with eosinophilia and systemic symptoms)
• sudden and intense liver inflammation (fulminant hepatitis)
• severe and potentially fatal skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis)

/necrólisis epidérmica tóxica)

• decrease in red blood cell count (anemia)
• decrease in white blood cell count (granulocytopenia)
• yellowing of the skin (jaundice)
• urticaria
• fluid under the skin (angioneuritic edema)
• muscle pain (myalgia)
• joint pain (arthralgia)
• decrease in blood phosphorus
• increase in blood pressure

The following side effects have been reported when nevirapina is used in combination with other antiretroviral medications:

• decrease in red blood cell or platelet count
• pancreatitis
• decrease or abnormalities in skin sensation.

These effects are often associated with other antiretroviral agents and may be expected when Nevirapina is used in combination with other agents; however, it is unlikely that these effects are due to nevirapina treatment.

Other side effects in children and adolescents

A decrease in white blood cell count (granulocytopenia) may occur, which is more common in children. A decrease in red blood cell count (anemia), which may be related to nevirapina treatment, is also more common in children. As with rash symptoms, inform your doctor of any side effects.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box, bottle, or blister pack. The expiration date is the last day of the month indicated.

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

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

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

• The active ingredient 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 content of the container

Nevirapina Tarbis Farma 400 mg prolonged-release tablets EFG are oval, biconvex, white to off-white, and have a “H” on one face and “N1” on the other. The prolonged-release tablet should not be broken.

Nevirapina Tarbis Farma 400 mg prolonged-release tablets EFG are presented in PVC-Aluminio blisters with 30, 90, or 180 (2 packs of 90) prolonged-release tablets and in HDPE bottles of 30 prolonged-release tablets.

It may be that only some container sizes are marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

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

Spain:Nevirapina Tarbis Farma 400 mg prolonged-release tablets EFG

Netherlands:Nevirapine Amarox 400 mg tablets with prolonged release

United Kingdom:Nevirapine Amarox 400 mg prolonged-release tablets

Last reviewed date: January 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)