NEVIRAPINE NORMON 200 mg TABLETS

2. What you need to know before you take Nevirapine Normon

• Do not take Nevirapine Normon- if you are allergic to nevirapine or any of the other ingredients of this medicine (listed in section 6).

• if you have previously taken Nevirapine Normon 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 feeling of illness
• abdominal pain
• allergic reactions
• liver inflammation (hepatitis)
• if you have severe liver disease
• if you have had to stop treatment with Nevirapine Normon in the past due to changes in your liver function
• if you are taking any medicine containing St John's Wort (Hypericum perforatum). This product may cause Nevirapine Normon to stop working properly.

• Warnings and precautions

During the first 18 weeks of treatment with Nevirapine 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 experiencing 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 tests
• naive patients with higher CD4 cell count at the start of treatment with Nevirapine 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 count at the start of treatment with Nevirapine Normon (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 of previous infections may appear shortly after starting anti-HIV 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 any apparent symptoms. If you notice any symptoms of infection, please inform your doctor immediately.

Changes in body fat may occur in patients receiving combined antiretroviral therapy. Consult your doctor if you notice changes in body fat (see section 4 “Possible side effects”).

In some patients receiving combined 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 combined antiretroviral therapy, the 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: 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 nevirapine and zidovudine together, inform your doctor, as you may need to have your white blood cell count checked.

Nevirapine Normon does not cure HIV infection. Therefore, you may still experience infections and other diseases associated with HIV infection. You must therefore remain in regular contact with your doctor. Additionally, Nevirapine Normon does not prevent the risk of transmitting HIV to others through blood or sexual contact. Use appropriate precautions to prevent the transmission of HIV to others. Please consult your doctor.

Children and adolescents

Nevirapine Normon tablets can be used in:

• children aged 16 years or older
• children under 16 years:
• with a weight of 50 kg or more
• or with a body surface area of more than 1.25 m2.

For younger children, a liquid form in oral suspension is available.

• Using Nevirapine Normon with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. Before starting treatment with Nevirapine Normon, inform your doctor of all other medicines you are taking. Your doctor may need to check if your other medicines are still working and make dose adjustments. Read carefully the package leaflet of all other anti-HIV medicines you are taking in combination with Nevirapine Normon.

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 medicine 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 for reducing 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)
• zidovudine (another medicine for the treatment of HIV infection)

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

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

• Taking Nevirapine Normon with food and drink

There are no restrictions on taking Nevirapine Normon with food and drink.

• Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You must stop breastfeeding if you are taking Nevirapine Normon. It is not recommended to breastfeed if you have HIV infection, as it is possible that your baby may become infected with HIV through your breast milk.

• Driving and using machines

While taking Nevirapine Normon, you may experience fatigue. You should be careful when performing activities such as driving or using machines. If you experience fatigue, you should avoid performing tasks that may be potentially hazardous, such as driving or using machines.

• Nevirapine Normon contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

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

3. How to take Nevirapine Normon

Do not take Nevirapine Normon on your own. You must take it with at least two other antiretroviral medicines. Your doctor will recommend the medicines to be taken in combination with Nevirapine Normon.

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

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

Dose:

The dose is one 200 mg tablet per day for the first 14 days of treatment (the “lead-in” period). After 14 days, the usual dose is one 200 mg tablet twice a day.

It has been shown that the 14-day “lead-in” period reduces the risk of experiencing a skin rash.

As Nevirapine Normon 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 of these medicines.

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

• you have problems swallowing tablets
• in children with a weight of less than 50 kg
• in children with a body surface area of less than 1.25 m2 (your doctor will determine the body surface area)

You must continue taking Nevirapine Normon for as long as your doctor recommends.

As explained earlier in the section “Warnings and precautions”, your doctor will monitor you with liver tests and monitor the appearance of side effects such as rash. Depending on the results, your doctor may decide to stop or discontinue treatment with Nevirapine Normon. Your doctor may also decide to restart treatment at a lower dose.

• If you take more Nevirapine Normon than you should

Do not take more Nevirapine Normon than your doctor has prescribed and as described in this package leaflet. Currently, there is little information on the effects of an overdose of Nevirapine Normon.

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

• If you forget to take Nevirapine Normon

Try to avoid missing any dose. If you realize you have missed a dose when less than 8 hours have passed, take the next dose as soon as possible. If more than 8 hours have passed, take the next dose at the usual time.

• If you stop taking Nevirapine Normon

Taking the doses at the right times:

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

It is important that you continue taking Nevirapine Normon correctly, as described above, unless your doctor advises you to stop treatment.

If you stop taking Nevirapine Normon for more than 7 days, your doctor will advise you to start again with the 14-day “lead-in” period (as described above) before returning to the usual dose of two tablets per day.

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

4. Possible Adverse Effects

Like all medicines, Nevirapina Normon can produce adverse effects, although not all people suffer from them.

As already mentioned in Warnings and Precautions,the most important adverse effects of Nevirapina Normon are severe skin reactions and serious liver damage, which can be life-threatening. These reactions occur mainly during the first 18 weeks of treatment with Nevirapina Normon. This is, therefore, an important period that requires close monitoring by your doctor.

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

When a rash occurs, it is usually mild to moderate. However, in some patients, a rash appears in the form of a blistering skin reaction that can be severe or life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis), and there have been reported fatalities. Most cases of rash, both severe and mild/moderate, occur during the first six weeks of treatment.

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

Hypersensitivity reactions (allergy) may occur. Such reactions can appear in the form of anaphylaxis (a severe allergic reaction) with symptoms such as:

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

Hypersensitivity reactions can also present as a rash with other adverse effects such as:

• fever
• blistering of the skin
• mouth sores
• eye inflammation
• swelling of the face
• generalized swelling
• difficulty breathing
• muscle or joint pain
• decrease in the number of white blood cells in the blood (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.

Abnormalities in liver function have been described with the use of nevirapine. This includes some cases of liver inflammation (hepatitis), which can 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 evaluation of adverse effects is based on the following frequencies:

The following adverse effects have been reported in patients treated with Nevirapina Normon:

Very common:

• rash

Common:

• decrease in the number of white blood cells in the blood (granulocytopenia)
• allergic reactions (hypersensitivity)
• headache
• general malaise (nausea)
• vomiting
• abdominal pain
• diarrhea
• liver inflammation (hepatitis)
• muscle pain (myalgia)
• feeling of fatigue (fatigue)
• fever
• abnormalities in liver function tests

Uncommon:

• allergic reactions characterized by rash, facial inflammation, difficulty breathing (bronchospasm), or anaphylactic shock
• decrease in the number of red blood cells in the blood (anemia)
• yellowing of the skin (jaundice)
• severe and potentially fatal skin rashes (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• hives
• fluid under the skin (angioedema)
• joint pain (arthralgia)
• muscle pain (myalgia)
• decrease in blood phosphorus
• increase in blood pressure

Rare:

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

Combined antiretroviral therapy may produce 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, increased breast size, and fat deposits on the back of the neck ("buffalo hump"). The cause and long-term effects of these changes are currently unknown. Combined antiretroviral therapy can also cause an increase in lactic acid and sugar in the blood, hyperlipidemia (increase in blood fats), and insulin resistance.

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

• decrease in the number of red blood cells or platelets
• pancreatitis
• 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 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 (anemia), which may be related to treatment with nevirapine, is also more frequent in children. As with symptoms of rash, inform your doctor of any adverse effect.

If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Nevirapina Normon

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

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

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Additional Information

Composition of Nevirapina Normon

• The active ingredient is nevirapine. Each tablet contains 200 mg of nevirapine.
• The other ingredients are:
• microcrystalline cellulose
• lactose monohydrate
• povidone
• sodium starch glycolate (from potato)
• colloidal silicon dioxide
• magnesium stearate

Appearance of the Product and Packaging Contents

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

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

This leaflet was approved in April 2022

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