Nevirapine Accord

Leaflet accompanying the packaging: patient information

Nevirapine Accord, 200 mg, tablets

Nevirapine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Nevirapine Accord and what is it used for
• 2. Important information before taking Nevirapine Accord
• 3. How to take Nevirapine Accord
• 4. Possible side effects
• 5. How to store Nevirapine Accord
• 6. Contents of the packaging and other information

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

Nevirapine belongs to a group of medicines called antiretrovirals and is used to treat infections with the human immunodeficiency virus (HIV-1). The active substance of the medicine is nevirapine. Nevirapine belongs to a group of HIV medicines called non-nucleoside reverse transcriptase inhibitors. Reverse transcriptase is an enzyme that the HIV virus needs to multiply. Nevirapine inhibits the action of reverse transcriptase. By stopping the action of reverse transcriptase, nevirapine helps control HIV-1 infection. Nevirapine is indicated for the treatment of HIV-1 infected adults, adolescents, and children of any age. Nevirapine must always be taken with other antiretroviral medicines. The doctor will decide which medicines are best for the patient.

If nevirapine is prescribed for a child, remember that all the information in this leaflet is addressed to the child (in this case, the word "patient" should be understood as "child").

2. Important information before taking Nevirapine Accord

When not to take Nevirapine Accord

• severe skin rash,
• skin rash with other symptoms, such as:
• fever,
• blistering,
• herpes simplex mouth inflammation,
• eye inflammation,
• facial swelling,
• generalized swelling,
• shortness of breath,
• muscle or joint pain,
• general feeling of being unwell,
• abdominal pain.
• allergic reactions,
• liver inflammation.

Warnings and precautions

Before starting to take nevirapine, consult your doctor or pharmacist.

During the first 18 weeks of taking nevirapine, it is very important for the patient or doctor to pay attention to symptoms from the liver or skin reactions, as they can be severe or even life-threatening. The greatest risk of such reactions exists within the first 6 weeks of treatment.

These reactions can be severe or life-threatening.

In case of severe rash or allergic reactions (which may occur in the form of a rash) accompanied by other side effects, such as:

• - fever,
• - blistering on the skin,
• - herpes simplex mouth inflammation,
• - eye inflammation,
• - facial swelling,
• - generalized swelling,
• - shortness of breath,
• - muscle or joint pain,
• - general feeling of being unwell,
• - or abdominal pain

STOP TAKING NEVIRAPINE

AND CONTACT YOUR DOCTOR IMMEDIATELY, as these reactions can be life-threatening or lead to death.

In case of mild rash symptoms without other reactions, you should immediately inform your doctor, who may decide to stop taking nevirapine.

In case of symptoms indicating liver damage, such as:

• - loss of appetite,
• - feeling of nausea (nausea),
• - vomiting,
• - yellowing of the skin (jaundice),
• - abdominal pain - stop taking nevirapine and contact your doctor immediately.

In case of severe liver reactions, skin reactions, or allergic reactions during nevirapine treatment, NEVER TAKE NEVIRAPINE AGAIN without consulting your doctor.

Take nevirapine doses as recommended by your doctor. This is especially important during the first 14 days of treatment (for more information, see the "How to take Nevirapine Accord" section).

The following patients are at increased risk of liver problems:

• women
• patients with viral hepatitis B or C
• patients with abnormal liver function test results
• untreated patients with increased CD4 cell count at the start of nevirapine treatment (in women more than 250 cells/mm^3, in men more than 400 cells/mm^3)
• previously treated patients with detectable HIV-1 plasma levels and increased CD4 cell count after starting nevirapine treatment (women above 250 cells/mm^3, men above 400 cells/mm^3).

In some patients with advanced HIV infection (AIDS), who have had opportunistic infections (AIDS-defining illnesses) in the past, objective and subjective signs of inflammatory reactions may appear soon after starting antiretroviral therapy. It is believed that these symptoms result from the improvement of the body's ability to respond immunologically, allowing it to fight off infections that may not have caused symptoms. If symptoms of infection are observed, the doctor should be contacted immediately. In addition to opportunistic infections, autoimmune disorders (a condition in which the immune system attacks healthy tissues) may also occur after starting antiretroviral therapy. Autoimmune disorders may occur several months after starting treatment. If symptoms of infection or other symptoms such as muscle weakness, tingling or numbness starting from the hands and feet and progressing towards the torso, palpitations, tremors, or hyperactivity are observed, the doctor should be contacted immediately to initiate necessary treatment. In patients receiving combination antiretroviral therapy, changes in body fat may occur. If changes in body fat are observed, the doctor should be contacted (see section 4 "Possible side effects"). In some patients receiving combination antiretroviral therapy, a bone disease called osteonecrosis (death of bone tissue due to lack of blood supply to the bone) may occur. The duration of combination antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immune system weakness, and increased body mass index may be some of the risk factors for the development of the disease. Symptoms of osteonecrosis are joint stiffness, pain (especially in the hips, knees, and shoulders), and difficulty moving. People who notice any of these symptoms should contact their doctor. You should inform your doctor about taking nevirapine and zidovudine at the same time, as it may be necessary to check the white blood cell count. Do not take nevirapine after exposure to HIV, unless the patient has been diagnosed with HIV infection and the medicine has been prescribed by a doctor. Do not use prednisone to treat a rash caused by nevirapine. To prevent pregnancy and prevent the transmission of HIV, women taking oral contraceptives ("the pill") or using other hormonal contraceptives during nevirapine treatment should also use a mechanical contraceptive method (e.g., condoms). Postmenopausal women using hormone replacement therapy should consult their doctor before taking this medicine. If the patient is taking rifampicin to treat tuberculosis, they should consult their doctor before taking this medicine with nevirapine.

Children and adolescents

Nevirapine Accord can be used in:

• -children aged 16 and older
• children under 16:
• with a body weight of 50 kg or more
• or with a body surface area of more than 1.25 m^2.

In younger children, the medicine is used in the form of an oral suspension.

Nevirapine Accord and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take. Inform your doctor about all the medicines you are taking before starting nevirapine, as it may be necessary to monitor whether these medicines are still effective and make any necessary dose changes. Carefully read the leaflet accompanying the packaging of other HIV medicines that will be taken with nevirapine. In particular, it is essential to inform your doctor about taking the following medicines:

• St. John's wort products (Hypericum perforatum, medicines used to treat depression)
• rifampicin (a medicine used to treat tuberculosis)
• rifabutin (a medicine used to treat tuberculosis)
• macrolide antibiotics, 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 that reduces blood clotting)
• hormonal contraceptives (e.g., "the pill")
• atazanavir (another medicine used to treat HIV infections)
• lopinavir and ritonavir (other medicines used to treat HIV infections)
• fosamprenavir (another medicine used to treat HIV infections)
• efavirenz (another medicine used to treat HIV infections)
• etravirine (another medicine used to treat HIV infections)
• rilpivirine (another medicine used to treat HIV infections)
• zidovudine (a medicine used to treat HIV infections)
• elvitegravir, cobicistat (another medicine used to treat HIV infections)

The doctor will carefully monitor the effect of nevirapine and all the above medicines if they are used in combination with them. In the case of kidney dialysis, the doctor may decide to increase the dose of nevirapine, as nevirapine may be partially removed from the blood during dialysis.

Taking Nevirapine Accord with food and drink

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

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to have a baby, consult your doctor before taking this medicine. Breastfeeding by HIV-infected women is not recommended, as the baby may become infected with HIV through breast milk. If you are breastfeeding or thinking of breastfeeding, discuss thiswith your doctor as soon as possible.

Driving and using machines

While taking nevirapine, fatigue may occur. Be careful when performing tasks such as driving, using tools, or operating machines. If fatigue occurs, avoid performing potentially hazardous activities such as driving or using tools or operating machines.

Nevirapine Accord contains sodium

Nevirapine Accord contains less than 1 mmol (23 mg) of sodium per tablet, which means the product is considered "sodium-free".

3. How to take Nevirapine Accord

Do not take nevirapine alone. The medicine should be taken with at least two other antiretroviral medicines. The doctor will prescribe the appropriate medicines. This medicine should always be taken as directed by your doctor. If you have any doubts, consult your doctor or pharmacist. Dosage: The usual dose is one 200 mg tablet once a day for the first 14 days of treatment (lead-in period). After 14 days, the usual dose is one 200 mg tablet twice a day. It is very important to take only one 200 mg nevirapine tablet per day for the first 14 days (lead-in period). If a rash occurs during this period, do not increase the dose and consult your doctor. It has been shown that using a 14-day lead-in period reduces the risk of skin rash. Nevirapine must always be taken with other antiretroviral medicines. Follow the instructions for the other medicines, which are available in the leaflets accompanying their packaging. This is especially important: if the patient has difficulty swallowing tablets, for patients or children with a body weight of less than 50 kg, for children with a body surface area of less than 1.25 m^2 (the doctor will calculate the body surface area). Continue taking nevirapine for the time prescribed by your doctor. As described in the "Warnings and precautions" section above, the doctor will monitor the effects of treatment by checking liver function test results or looking for side effects such as rash. Based on the results of the monitoring, the doctor may decide to stop or discontinue nevirapine treatment. The doctor may then recommend taking a lower dose of the medicine. Nevirapine Accord should be taken orally only. Do not chew the tablets. Nevirapine Accord can be taken with or without food.

Taking a higher dose of nevirapine than recommended

Do not take a higher dose of nevirapine than recommended by your doctor and described in this leaflet. There is currently little data on the effects of nevirapine overdose. If a higher dose of nevirapine than recommended is taken, consult your doctor.

Missing a dose of nevirapine

Do not miss a dose of the medicine. If it has been less than 8 hours since the scheduled dose, take the dose as soon as possible. If it has been more than 8 hours since the scheduled dose, take only the next dose at the planned time.

Stopping nevirapine treatment

Taking all doses at the right time:

• significantly increases the effectiveness of the prescribed combination of antiretroviral medicines
• reduces the development of HIV resistance to antiretroviral medicines.

It is essential to take nevirapine exactly as directed above until the doctor decides to stop treatment. If nevirapine treatment is stopped for more than 7 days, the doctor will recommend restarting treatment from the 14-day lead-in period (described above) before returning to taking the medicine twice a day. If you have any doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

During HIV treatment, weight gain and increased lipid and glucose levels in the blood may occur. This is partly related to improved health and lifestyle, and in the case of lipid levels in the blood, sometimes to the use of HIV medicines themselves. The doctor will order tests to check these changes. Like all medicines, this medicine can cause side effects, although not everybody gets them. As mentioned above in the "Warnings and precautions" section, the most important side effects of nevirapine are severe and life-threatening skin reactions and severe liver damage. These reactions usually occur within the first 18 weeks of taking nevirapine. This is a critical period during which the patient requires close monitoring by the doctor. If a rash is observed at any time, the doctor should be informed immediately. If a rash occurs, it is usually mild to moderate. However, in some patients, a rash with blisters may be severe or life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis), and cases of death have been reported. Most cases of both severe and mild or moderate rash occur within the first 6 weeks of treatment. If a rash and a general feeling of being unwell occur, stop taking the medicine and inform your doctor immediately. Allergic reactions may occur. Such reactions may occur in the form of anaphylaxis (a severe form of allergic reaction) with symptoms such as: rash, facial swelling, difficulty breathing (bronchospasm), and anaphylactic shock. Allergic reactions may also occur in the form of a rash or other side effects, such as: fever, blistering on the skin, herpes simplex mouth inflammation, eye inflammation, facial swelling, generalized swelling, shortness of breath, muscle or joint pain, general feeling of being unwell, and severe liver or kidney disorders (liver or kidney failure). If a rash or other symptoms of an allergic reaction occur, inform your doctor immediately, as these reactions can be life-threatening. There have been reports of liver function disorders after taking nevirapine, including several cases of liver inflammation, which can be sudden and severe (fulminant hepatitis) and lead to liver failure and death. Inform your doctor if symptoms indicating liver damage occur, such as: loss of appetite, nausea, vomiting, yellowing of the skin (jaundice), and abdominal pain. The following side effects have been reported in patients taking nevirapine: Very common (may affect more than 1 in 10 people): rash. Common (may affect up to 1 in 10 people): decreased white blood cell count (granulocytopenia), allergic reactions (hypersensitivity), headache, nausea, vomiting, abdominal pain, diarrhea, liver inflammation, fatigue, fever, abnormal liver function test results. Uncommon (may affect up to 1 in 100 people): allergic reaction with symptoms such as rash, facial swelling, difficulty breathing (bronchospasm), or anaphylactic shock, decreased red blood cell count (anemia), yellowing of the skin (jaundice), severe and life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis), hives, angioedema, muscle pain, joint pain, decreased phosphate levels in the blood, increased blood pressure. Rare (may affect up to 1 in 1,000 people): sudden and severe liver inflammation (fulminant hepatitis), rash with systemic symptoms (drug reaction with eosinophilia and systemic symptoms). When nevirapine is used in combination with other antiretroviral medicines, the following symptoms have also been reported: decreased red or white blood cell count, pancreatitis, impaired or abnormal skin sensations. These symptoms are usually related to the use of other antiretroviral medicines and can be expected to occur when taking nevirapine in combination with other medicines; however, it is unlikely that they are caused solely by nevirapine.

Additional 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) may also occur more frequently in children, which may be related to nevirapine treatment. As with rash symptoms, inform your doctor about any side effects.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides, Al. Jerozolimskie 181C, 02-222 Warsaw, tel: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nevirapine Accord

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month. There are no special precautions for storing the medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Nevirapine Accord contains

The active substance is nevirapine. Each tablet contains 200 mg of nevirapine (in the form of anhydrous nevirapine). The other ingredients are: microcrystalline cellulose, sodium croscarmellose, cornstarch, povidone (K30), sodium carboxymethylcellulose (type A), colloidal anhydrous silica, magnesium stearate.

What Nevirapine Accord looks like and contents of the pack

Nevirapine Accord is almost white to pale yellow, oblong, biconvex tablets with "H" engraved on one side and "7" on the other and a score line on both sides. Nevirapine Accord is packaged in PVC/Aluminum blisters containing 14, 60, or 120 tablets in a cardboard box or perforated PVC/Aluminum blisters containing 60x1, 120x1, or 180x1 tablets in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder:

Accord Healthcare Polska Sp. z o.o., ul. Taśmowa 7, 02-677 Warsaw, Tel: +48 22 577 28 00

Manufacturer/Importer:

Pharmadox Healthcare Limited, KW20A Kordin Industrial Park, Paola, PLA 3000, Malta, Accord Healthcare Polska Sp. z o.o., ul. Lutomierska 50, 95-200 Pabianice, Accord Healthcare B.V., Winthontlaan 200, 3526 KV Utrecht, Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: February 2023