Nevirapine 200mg Tablet WHOPAR part 3 May 2005 Updated: May 2016 PACKAGE LEAFLET

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Ashley Green
6 years ago
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1 PACKAGE LEAFLET

2 PACKAGE LEAFLET Read this entire leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. WARNING Severe, life -threatening and in some cases fatal hepatotoxicity, particularly in the first 18 weeks, has been reported in patients treated with nevirapine. In some cases, patients presented with non-specific prodromal signs or symptoms of hepatitis and progressed to hepatic failure. These events are often associated with rash. Female gender and higher CD4 counts at initiation of therapy place patients at increased risk; women with CD4 counts >250 cells/mm3, including pregnant women receiving nevirapine in combination with other antiretroviral agents are at the greatest risk. However, hepatotoxicity associated with nevirapine use can occur in both genders, at all CD4 counts and at any time during treatment. Patients with signs or symptoms of hepatitis, or with increased transaminase levels combined with rash or other systemic symptoms, must discontinue nevirapine and seek medical evaluation immediately. Severe, life -threatening skin reactions, including fatal cases, have occurred in patients treated with nevirapine. These have included cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and hypersensitivity reactions characterized by rash, constitutional findings, and organ dysfunction. Patients developing signs or symptoms of severe skin reactions or hypersensitivity reactions must discontinue nevirapine and seek medical evaluation immediately. It is essential that patients be monitored intensively during the first 18 weeks of therapy with nevirapine to detect potentially life-threatening hepatotoxicity or skin reactions. Extra vigilance is warranted during the first 6 weeks of therapy, which is the period of greatest risk of these events. Do not restart nevirapine following severe hepatic, skin or hypersensitivity reactions. In some cases, hepatic injury has progressed despite discontinuation of treatment. In addition, the 14-day lead-in period with Nevirapine 200mg Tablet daily dosing must be strictly followed. In this leaflet 1. What is Nevirapine 200mg Tablet and what is it used for? 2. Before you take Nevirapine 200mg Tablet 3. How to take Nevirapine 200mg Tablet? 4. Possible side effects 5 Storing Nevirapine 200mg Tablet 6. Further information Nevirapine 200mg Tablet The active pharmaceutical ingredient in Nevirapine 200mg Tablet is nevirapine. The inactive ingredients are microcrystalline cellulose, lactose, croscarmellose sodium, povidone, colloidal anhydrous silica,

3 purified talc, magnesium stearate and purified water. Nevirapine 200mg Tablet is a white to off white oval shaped tablets engraved N2 with a single bisect separating N and 2 on one side and plain on the other side. The Marketing Authorization Holder for Nevirapine 200mg Tablet is: Strides Shasun Limited Strides House, Opp. IIM Bilekahalli, Bannerghatta Road Bangalore , INDIA Nevirapine 200 mg Tablet is manufactured by: Strides Shasun Limited 36/7, Suragajakkanahalli, Indlavadi Cross, Anekal Taluk Bangalore , INDIA 1. WHAT IS NEVIRAPINE 200mg Tablet AND WHAT IS IT USED FOR Nevirapine 200mg Tablet is used to treat Human Immunodeficiency Virus (HIV), the virus that causes AIDS (Acquired Immune Deficiency Syndrome). Nevirapine is a type of anti-hiv medicine called a "non-nucleoside reverse transcriptase inhibitor" (NNRTI). It works by lowering the amount of HIV in the blood. You must take Nevirapine 200mg Tablet with other anti-hiv medicines. When taken with other anti-hiv medicines, Nevirapine 200mg Tablet can reduce viral load and increase the number of CD4 cells ("T cells"). CD4 cells are a type of immune helper cell in the blood. Nevirapine may not have these effects in every patient. Nevirapine 200mg Tablet does not cure HIV or AIDS and it is not known if it will help you live longer with HIV. People taking nevirapine may still get infections common in people with HIV (opportunistic infections). Therefore, it is very important that you stay under the care of your doctor. 2. BEFORE YOU TAKE NEVIRAPINE 200mg TABLET Do not take Nevirapine 200mg Tablet: if you are allergic to Nevirapine 200mg Tablet or any of its ingredients. The active ingredient is nevirapine. The inactive ingredients are listed above, your doctor or pharmacist can tell you more about them; after you recover from serious liver or skin reactions that happened when you took nevirapine; if you are not infected with HIV. Take special care with Nevirapine: Before starting Nevirapine 200mg Tablet tell your doctor about all of your medical conditions, including if you: Have problems with your liver or have had hepatitis, Are undergoing dialysis, Have skin conditions, such as a rash, Are pregnant, planning to become pregnant, or are breast feeding.

4 Taking Nevirapine 200mg Tablet with food and drink: You may take Nevirapine 200mg Tablet with water, milk, or soda, with or without food. Pregnancy There are no adequate and well-controlled studies in pregnant women. Nevirapine 200mg Tablet should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Severe hepatic events, including fatalities, have been reported in pregnant women receiving chronic nevirapine therapy as part of combination treatment of HIV infection. It is unclear if pregnancy augments the already increased risk observed in non-pregnant women Breast-feeding It is recommended that HIV-infected mothers do not breast-feed their infants to avoid risking postnatal transmission of HIV. Nevirapine is excreted in breast milk. Because of both the potential for HIV transmission and the potential for serious adverse reactions in nursing infants, mothers should not breast-feed if they are receiving nevirapine. Driving and using machines: There are no studies on the effect of nevirapine on the ability to drive and operate machinery. However, you should consider your general health condition and the possible effects of nevirapine before deciding to drive and/or use machinery. Taking other medicines: Nevirapine may change the effect of other medicines, and other medicines can change the effect of nevirapine. Tell your doctor and pharmacist about all medicines you take, including non-prescription medicines, vitamins and herbal supplements. Do not take ketoconazole or rifampin with nevirapine. Tell your doctor if you are taking clarithromycin, fluconazole, methadone, or rifabutin. If you are taking any of these medicines, nevirapine may not be right for you, or you may need careful monitoring. It is recommended that you do not take products containing St. John s Wort, which can reduce the amount of nevirapine in your body. If you take birth control pills, you should not rely on them to prevent pregnancy. They may not work if you take nevirapine. Talk to your doctor about other types of birth control that you can use. 3. HOW TO TAKE NEVIRAPINE Adults The recommended starting dose for nevirapine is 200 mg daily for the first 14 days (this lead-in period should be used because it has been found to lessen the frequency of rash), followed by one 200 mg tablet twice daily, in combination with other antiretroviral agents. Pediatric Patients: The recommended oral dose of nevirapine for pediatric patients is: From 2 months to 8 years of age: 4 mg/kg once daily for the first 14 days followed by 7 mg/kg twice daily thereafter For children 8 years of age and older: 4 mg/kg once daily for the first 14 days followed by 4 mg/kg twice daily thereafter. The total daily dose should not exceed 400 mg for any patient. Monitoring of Patients: Intensive clinical and laboratory monitoring, including liver function tests, is essential at baseline and

5 during the first 18 weeks of treatment with nevirapine. The optimal frequency of monitoring during this period has not been established. Some experts recommend clinical and laboratory monitoring more often than once per month. In particular, this would include monitoring of liver function tests at baseline, prior to dose escalation, and at two weeks post dose escalation. After the initial 18-week period, frequent clinical and laboratory monitoring should continue throughout nevirapine treatment. In some cases, hepatic injury has progressed despite discontinuation of treatment. Dosage Adjustment: Nevirapine should be discontinued if patients experience severe rash or a rash accompanied by constitutional findings. Patients experiencing rash during the 14-day lead-in period of 200 mg/day (4 mg/kg/day in pediatric patients) should not have their nevirapine dose increased until the rash has resolved. If a clinical hepatic event occurs, nevirapine should be permanently discontinued. Do not restart nevirapine after recovery! Patients who interrupt nevirapine dosing for more than 7 days should restart the recommended dosing, using one 200 mg tablet daily (4 mg/kg/day in pediatric patients) for the first 14 days (lead-in) followed by one 200 mg tablet twice daily (4 or 7 mg/kg twice daily, according to age, for pediatric patients). If you take more nevirapine than you should: If you take an overdose of nevirapine tablets, get medical help straight away. Contact your doctor or the nearest hospital emergency department for advice. If you forget to take nevirapine: Do not miss a dose of nevirapine, because this could make the virus harder to treat. If you forget to take nevirapine, take the missed dose right away. If it is almost time for your next dose, do not take the missed dose. Instead, follow your regular dosing schedule by taking the next dose at its regular time. Effects when treatment with nevirapine is stopped: If you stop taking nevirapine for more than 7 days, ask your doctor how much to take before you start taking it again. You may need to start with once-a-day dosing. 4. POSSIBLE SIDE EFFECTS Nevirapine can cause serious liver damage and skin reactions that can cause death. Any patient can experience such side effects, but some patients are more at risk than others. Other common side effects of nevirapine include nausea, fatigue, fever, headache, vomiting, diarrhea, abdominal pain, and myalgia. This list of side effects is not complete. Ask your doctor or pharmacist for more information. Changes in body fat have also been seen in some patients taking antiretroviral therapy. The changes may include increased amount of fat in the upper back and neck ( buffalo hump ), breast, and around the trunk. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these conditions are not known at this time. If you notice any side effects, even those not mentioned in this leaflet, please inform your doctor. 5. STORING NEVIRAPINE 0 Store below 30 C Protect from light Keep in a well closed container

6 Do not take nevirapine tablets after the expiry date stated on the packaging 6. FURTHER INFORMATION If you have any questions or concerns, please consult your doctor. Remember, no written summary can replace a doctor s advice. This leaflet was last approved in May Updated in May 2016.

Nevirapine 200mg Tablet WHOPAR part 4 May 2005 Section 7 updated: May 2016 SUMMARY OF PRODUCT CHARACTERISTICS

Nevirapine 200mg Tablet WHOPAR part 4 May 2005 Section 7 updated: May 2016 SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Nevirapine 200mg Tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains nevirapine 200 mg. For excipients, see section