Package Leaflet: Information for the User

Nevirapina Normon 200 mg Tablets EFG

Nevirapina

Read this leaflet carefully before you start taking this medicine because 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

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

2. What you need to know before taking Nevirapina Normon

3. How to take Nevirapina Normon

4. Possible side effects

5. Storage of Nevirapina Normon

6. Contents of the pack and additional information

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

The active ingredient of this medication is called nevirapina. This active ingredient reduces the amount of virus in the blood, thereby improving the disease.

Nevirapina belongs to a class of anti-HIV medications called non-nucleoside reverse transcriptase inhibitors (NNRTIs). The reverse transcriptase is an enzyme that HIV needs to multiply. Nevirapina prevents the functioning of the reverse transcriptase. By preventing the functioning of the reverse transcriptase, Nevirapina Normon helps to control HIV infection.

You should take Nevirapina Normon along with other antiretroviral medications. Your doctor will indicate the appropriate medications for you.

• Do not take Nevirapina Normon− If you are allergic to nevirapina or to any of the other components of this medication (listed in section 6).

• if you have taken Nevirapina Normon previously and had to interrupt treatment because you experienced:
• severe skin eruption
• skin eruption with other symptoms such as:
• fever
• blister formation
• mouth sores
• eye inflammation
• facial swelling
• general swelling
• difficulty breathing
• muscle or joint pain
• general malaise
• abdominal pain
• hypersensitivity reactions (allergies)
• liver inflammation (hepatitis)
• if you have a severe liver disease
• if you have had to interrupt treatment with Nevirapina Normon in the past due to changes in your liver function
• if you are using any medication that contains Hypericum or St. John's Wort (Hypericum perforatum). This product may cause Nevirapina Normon to stop working properly.

• Warnings and precautions

During the first 18 weeks of treatment with Nevirapina Normon, it is very important that you and your doctor monitor the appearance 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.

The following patients are at higher risk of developing liver problems:

• women
• patients infected with hepatitis B or C
• abnormal liver function test results
• naïve patients with higher CD4 cell counts at the start of treatment with Nevirapina Normon (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 Nevirapina Normon (women with more than 250 cells/mm³, men with more than 400 cells/mm³)

In some patients with advanced HIV (AIDS) infection and a history of opportunistic infections (AIDS-defining illnesses), signs and symptoms of previous infections may appear shortly after starting antiretroviral treatment. It is believed that these symptoms are due to an improvement in the body's immune response, allowing it to fight off infections that were present without apparent symptoms. If you notice any symptoms of infection, please inform your doctor immediately.

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 Adverse 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 antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immunodeficiency, and high body mass index may be some of the many risk factors for developing this disease. The symptoms of osteonecrosis are: joint stiffness, 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, as you may need to have your white blood cell count checked.

Nevirapina Normon does not cure HIV infection. Therefore, you may still be experiencing infections and other diseases associated with HIV infection. You should therefore maintain regular contact with your doctor. Additionally, Nevirapina Normon does not prevent the risk of HIV transmission to others through blood or sexual contact. Use appropriate precautions to avoid HIV transmission to others. Please consult your doctor.

Children and adolescents

Nevirapina Normon tablets can be used in:

• children aged 16 years or older
• children under 16 years:
• with a body weight of 50 kg or more
• or with a body surface area of 1.25 m2or more.

For smaller children, a liquid oral suspension is available.

• Use of Nevirapina Normon with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription. Before starting treatment with Nevirapina Normon, inform your doctor of all other medications you are taking. Your doctor may need to check if your other medications are still working and make dose adjustments. Read the prospectus of all other antiretroviral medications you are taking in combination with Nevirapina Normon.

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

• hypericum or St. John's Wort (Hypericum perforatum, a medicinal plant for the treatment of depression)
• rifampicin (a medication for the treatment of tuberculosis)
• rifabutina (a medication for the treatment of tuberculosis)
• macrolides, e.g. clarithromycin (a medication for the treatment of bacterial infections)
• fluconazol (a medication for the treatment of fungal infections)
• ketoconazol (a medication for the treatment of fungal infections)
• itraconazol (a medication for the treatment of fungal infections)
• metadona (a medication used for the treatment of opioid addiction)
• warfarina (a medication to reduce blood clot formation)
• hormonal contraceptives (e.g. "the pill")
• atazanavir (another medication for the treatment of HIV infection)
• lopinavir/ritonavir (another medication for the treatment of HIV infection)
• fosamprenavir (another medication for the treatment of HIV infection)
• efavirenz (another medication for the treatment of HIV infection)
• zidovudina (another medication for the treatment of HIV infection)

Your doctor will carefully monitor the effect of Nevirapina Normon and any of these medications if you are taking them together.

If you are undergoing kidney dialysis, your doctor may need to adjust the dose of Nevirapina Normon, as Nevirapina Normon may be partially removed from the blood by dialysis.

• Taking Nevirapina Normon with food and drinks

There are no restrictions on taking Nevirapina Normon with food and drinks.

• Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

You should stop breastfeeding if you are taking Nevirapina Normon. In general, it is not recommended to breastfeed if you have HIV infection, as it is possible for your baby to become infected with HIV through breast milk.

• Driving and operating machinery

While taking Nevirapina Normon, you may experience fatigue. You should exercise caution when performing activities such as driving or operating machinery. If you experience fatigue, you should avoid performing tasks that could be hazardous, such as driving or operating machinery.

• Nevirapina Normon contains lactose

This medication contains lactose. If your doctor has told you that you have a intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially "sodium-free".

Do not use Nevirapina Normon on your own. You must use it with at least two other antiretroviral medications. Your doctor will recommend the appropriate medications for you.

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

Nevirapina Normon should only be taken orally. Do not chew the tablet. You can take Nevirapina Normon with or without food.

Dosage:

The dosage is one 200 mg tablet per day for the first 14 days of treatment (initial period). After 14 days, the usual dosage is one 200 mg tablet twice a day.

It has been demonstrated that the initial period of 14 days reduces the risk of skin rash.

Since Nevirapina Normon must always be taken in combination with other antiretroviral medications, you must carefully follow the instructions for your other medications. These are provided in the prospectuses for these medications.

Nevirapina is also available in a liquid oral suspension form. It is particularly suitable if:

• You have difficulty swallowing tablets.
• You are a child weighing less than 50 kg.
• You are a child with a body surface area less than 1.25 m² (your doctor will determine the body surface area).

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

As explained earlier in the Advertencias y precauciones section, your doctor will monitor your liver function and watch for the appearance of adverse effects such as rash. Depending on the results, your doctor may decide to interrupt or reduce the treatment with Nevirapina Normon. Your doctor may also decide to restart the treatment at lower doses.

• If you take more Nevirapina Normon than you should

Do not take more Nevirapina Normon than your doctor has prescribed and what is described in this prospectus. Currently, there is little information available on the effects of a Nevirapina Normon overdose.

Consult your doctor if you have taken more Nevirapina Normon than you should.

• If you forget to take Nevirapina Normon

Make sure not to forget any dose. If you realize you have forgotten to take a dose within less than 8 hours, take the next dose as soon as possible. If you realize after 8 hours, take the next dose at the usual time.

• If you interrupt treatment with Nevirapina Normon

Take the doses at the indicated hours:

• This greatly 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 Normon correctly, as described above, unless your doctor tells you to stop treatment.

If you interrupt the administration of Nevirapina Normon for more than 7 days, your doctor will instruct you to start again with the initial period of 14 days (as described above), before returning to taking two doses per day.

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

Like all medicines, Nevirapina Normon can cause side effects, although not everyone will experience them.

As mentioned in Advertencias and precauciones, the most important side effects of Nevirapina Normon are severe skin reactions and liver damage that can be life-threatening. These reactions mainly occur during the first 18 weeks of treatment with Nevirapina Normon. 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 occurs, it is usually mild to moderate. However, in some patients, a vesicular skin reaction can occur that can be severe or life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis), and there have been reported fatalities. Most cases of both severe and mild/moderate rashes occur during the first six weeks of treatment.

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

Allergic reactions (hypersensitivity) can 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

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
• general swelling
• difficulty breathing
• muscle or joint pain
• decrease in white blood cell count (granulocytopenia)
• general feeling of illness
• serious liver or kidney problems (liver or kidney failure)

If you experience a rash and any of the other side effects of an allergic reaction (hypersensitivity), inform your doctor immediately. These reactions can be 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 failure, which can be fatal.

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

• loss of appetite
• general feeling of illness (nausea)
• vomiting
• yellowing of the skin (jaundice)
• abdominal pain.

The evaluation of side effects is based on the following frequencies:

The following side effects have been described in patients who received Nevirapina Normon:

Very common:

• rash

Common:

• decrease in white blood cell count (granulocytopenia)
• allergic reactions (hypersensitivity)
• headache
• general feeling of illness (nausea)
• vomiting
• abdominal pain
• diarrhea
• inflammation of the liver (hepatitis)
• muscle pain (myalgia)
• fatigue
• fever
• abnormal liver function tests

Uncommon:

• allergic reactions characterized by rash, facial swelling, difficulty breathing (bronchospasm), or anaphylactic shock
• decrease in red blood cell count (anemia)
• yellowing of the skin (jaundice)
• severe skin reactions that can be life-threatening (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• urticaria
• fluid under the skin (angioedema)
• joint pain (arthralgia)
• muscle pain (myalgia)
• decrease in phosphorus in the blood
• increased blood pressure

Rare:

• intense and sudden liver inflammation (fulminant hepatitis)
• drug rash with systemic symptoms (drug rash with eosinophilia and systemic symptoms)

Combination antiretroviral therapy can cause changes in body shape due to changes in fat distribution. These can include loss of fat from the legs, arms, and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement, and fatty lumps on the back of the neck ("buffalo hump"). The cause and long-term effects of these changes are currently unknown. Combination antiretroviral therapy can also cause increased lactic acid and blood sugar, hyperlipidemia (increased blood fats), and insulin resistance.

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

• decrease in red or white blood cells
• inflammation of the pancreas
• decrease or abnormalities in skin sensations.

These effects are generally associated with other antiretroviral agents and may occur when Nevirapina Normon is used in combination with other agents; however, it is unlikely that these effects are due to treatment with Nevirapina Normon.

Other side effects in children and adolescents

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

If you consider that any of the side effects you are experiencing are severe or if you notice any side effects not mentioned in this prospectus, inform your doctor or pharmacist.

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

Do not use this medication after the expiration date that appears on the packaging and in the blister pack after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Nevirapina Normon Composition

Product Appearance and Packaging Contents

Nevirapina Normon is presented in the form of white or almost white, elongated, biconvex tablets with a breaking bar on one face and printed. Each package contains 60 or 120 tablets.

Marketing Authorization Holder and Responsible Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

This leaflet was approved in April 2022

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