PATIENT INFORMATION LEAFLET

Transcription

1 PATIENT INFORMATION LEAFLET Page 1 of 7

2 PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER * Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, please ask the doctor, health care provider or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their illness seems to be the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor, health care provider or pharmacist. In this leaflet: 1. What is and what it is used for 2. Before you take 3. How to take 4. Possible side effects 5. How to store 6. Further information 1. WHAT EFAVIRENZ 600 MG TABLETS IS AND WHAT IT IS USED FOR belongs to a class of antiretroviral medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). It is an antiretroviral medicine that fights human immunodeficiency virus (HIV) infection by reducing the amount of the virus in the blood. is used in combination with other antiretroviral medicines to treat HIV infection. reduces the amount of HIV virus in your body and keeps it at a low level. It also increases CD4 cell counts. CD4 cells, which are a type of white blood cells, are important for maintaining a healthy immune system to help fight infection. Response to treatment with varies between patients. Your doctor or health care provider will be monitoring the effectiveness of the treatment. may improve your condition, but it is not a cure for HIV infection. HIV infection is spread by contact with blood from an infected individual or by sexual contact with an infected individual. You can still pass on HIV when taking efavirenz. Therefore, you must continue to take precautions to avoid passing the virus to others through sexual contact or by blood transfer. During your treatment, other infections linked to your weakened immunity (opportunistic infections) may arise. These will require specific and sometimes preventive treatment. 2. BEFORE YOU TAKE EFAVIRENZ 600 MG TABLETS Do not use if : - you are allergic (hypersensitive) to efavirenz or any of the other ingredients of Efavirenz 600 mg Tablets (see section 6, What contains); * Trade names are not prequalified by WHO. This is the national medicines regulatory authority s (NMRA) responsibility. Throughout this WHOPAR the proprietary name is given as an example only. Page 2 of 7

3 - if you are currently taking St. John s wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety) Take special care with Before using this medicine, you should have told your doctor or health care provider: - if you suffer from liver disease (such as hepatitis); - about past or present medical problems including allergies, seizures (fits), mental illness, or substance or alcohol abuse. A mild or moderate skin rash commonly develops in the first two weeks after starting Efavirenz 600 mg Tablets. It usually settles within four weeks of the beginning of treatment. If the rash becomes severe, you must tell the doctor or health care provider immediately and may have to be stopped. Central nervous system side effects are very common, usually starting in the first week of treatment with efavirenz. These may include dizziness, confusion, difficulty sleeping, feeling sleepy, difficulty concentrating and abnormal dreaming. Other side effects are amnesia, hallucinations, euphoria, depression, suicidal ideation or psychosis (see section 4). These usually settle within four weeks of starting treatment. In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after antiretroviral treatment is started. It is believed that these symptoms are due to an improvement in the body s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform the doctor or health care provider immediately. Autoimmune disorders (in which the immune system inappropriately reacts against healthy parts of the body) can also occur after you start taking medicines for HIV infection. These disorders may occur many months after starting the medicines. If you notice effects such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk, palpitations, tremor or hyperactivity, tell the doctor or health care provider at once. Some patients taking a combination of antiretroviral medicines may develop a bone disease called osteonecrosis (damage to bone tissue because of inadequate blood supply). The risk of developing the disease may be increased in those taking a corticosteroid medicine (such as prednisolone), consuming a high amount of alcohol, or who are overweight. Tell the doctor or health care provider of any signs of osteonecrosis such as joint stiffness, aches and pains (especially of the hip, knee and shoulder) or difficulty moving. You need to take every day. This medicine helps to control HIV infection, but it is not a cure. You may still develop other infections and other illnesses associated with HIV disease. You should keep in regular contact with your doctor or health care provider. Do not stop your medicine without first talking to the doctor or health care provider. Taking other medicines Please tell the doctor, health care provider or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription. These may affect the action of, or may affect their action. You must not take with herbal preparations containing St John s wort (Hypericum perforatum) Page 3 of 7

4 You should not take with the following: astemizole, cisapride, terfenadine, pimozide, bepridil and ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine). Taking these medicines with may cause serious or life-threatening side effects. should not be used as part of a regimen comprising efavirenz, didanosine and tenofovir because such regimens are less effective than other combination regimens; may also interact with the following medicines and may make any side effects worse or may reduce the effectiveness of either efavirenz or the other medicine: - amprenavir, atazanavir, darunavir, indinavir, lopinavir, maraviroc, nelfinavir, ritonavir, saquinavir and tipranavir (antiretroviral medicines). - methadone, buprenorphine (used to treat severe pain or opioid dependency); - clarithromycin, rifabutin or rifampicin (antibacterials/antituberculotics), - atorvastatin, pravastatin, or simvastatin (lipid-lowering medicines, also called statins) - hormonal contraceptives such as birth control pills, an injected contraceptive or a contraceptive implant. Therefore, an alternative contraceptive method such as barrier contraception (e.g. condoms) should be used while taking (see also pregnancy and breast-feeding ) - ketoconazole, voriconazole, itraconazole, posaconazole (antifungals) - artemether, amodiaquine/artesunate, atovaquone/proguanil, lumefantrine, halofantrine, artemisinin (antimalarials) - carbamazepine, phenytoin, phenobarbital (anticonvulsants) - diltiazem, verapamil, felodipine, nifedipine, nicardipine (calcium channel blocker) - midazolam, triazolam, (medicines used to help one sleep) - tacrolimus, ciclosporin, sirolimus (immunosuppressants) - warfarin, acenocoumarol (medicine for preventing blood clots) Taking with food and drink should be taken on an empty stomach or with a low-fat meal. Pregnancy should not be taken during the first trimester of pregnancy. Malformations have occurred in foetuses from animals and in newborns of women treated with efavirenz during pregnancy; therefore, pregnancy should be avoided in women receiving. If a woman becomes pregnant, or is planning to become pregnant, she should contact the doctor or health care provider to discuss the potential adverse effects and the benefits and risks of the antiretroviral therapy to the pregnant woman and her child. In women receiving, a reliable form of barrier contraception (for example a condom) should always be used, with other methods of contraception including oral (pill) or other hormonal contraceptives (for example implant, injection). Breastfeeding If a mother wants to breastfeed her baby, her doctor or healthcare provider should be asked for advice on the risks and benefits. Driving and using machines Dizziness, impaired concentration, and drowsiness have been reported during treatment with Efavirenz 600 mg Tablets. If one experiences these symptoms one should avoid potentially hazardous tasks such as driving or operating machinery. Page 4 of 7

5 Important information about some of the ingredients of If your doctor or health care provider has told you that you have an intolerance to some sugars, contact your doctor or health care provider before you take this medicine. 3. HOW TO TAKE EFAVIRENZ 600 MG TABLETS Always take exactly as the doctor or health care provider has told you. You should check with your doctor, health care provider or pharmacist if you are not sure. The usual dose for adults and adolescents weighing 40 kg or more is 600 mg, given once daily. should be taken on an empty stomach, e.g. in the evening before going to bed. will always be taken in combination with other antiretroviral medication; please make sure that you also follow the instructions in the package leaflets supplied with the other products. Children Since cannot be divided, the tablets are not suitable for patients whose body weight is less than 40 kg. In these cases another formulation should be used, e.g. a tablet or capsule containing smaller amount of efavirenz, or an oral solution. Efavirenz is not recommended for children weighing less than 10 kg due to a lack of data on safety and efficacy. If you take more than you should If you have taken too many tablets or if someone accidentally takes some, consult your doctor or local first aid hospital. Take the tablet container with you. If you forget to take Take care not to miss a dose. If you do miss a dose, take the next dose as soon as possible. However, if the next regular dose is due within 12 hours, then simply take your normal next dose at its due time. Do not double the dose to make up for a missed dose. If you stop taking Do not stop taking unless you experience serious side effects or your doctor has told you to. Taking the tablets regularly is very important because the amount of virus may start to increase if the medicine is stopped for even a short time. The infection may then become harder to treat. If you have any further questions on the use of this product, ask your doctor, health care provider or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, can cause side effects, but not everybody gets them. The most notable unwanted effects of efavirenz in combination with other antiretroviral medicines are skin rash and nervous system symptoms that include dizziness, insomnia, somnolence (drowsiness), impaired concentration and abnormal dreaming. Page 5 of 7

6 Consult the doctor if you have a rash, because some rashes may be serious; however, in most cases the rash disappears without any change to the treatment with Rash was more common in children than in adults treated with. Side effects of the nervous system usually occur when starting treatment and generally decrease in the first few weeks. If these effects are troublesome, the doctor or health care provider may suggest that you take at bedtime and on an empty stomach. Some patients may have more serious side effects that affect mood or the ability to think clearly. Some patients have committed suicide. These effects may occur more frequently in those who have had mental illness. Tell the doctor or health care provider if have these problems or if you have any other troublesome side effects. Very commonly reported (affects more than 1 in every 10 patients treated) side effects are rash. Commonly reported (affects more than 1 in every 100 patients treated) side effects are: - abnormal dreams, difficulty concentrating, dizziness, headache, difficulty sleeping, drowsiness, problems with coordination and maintaining balance - stomach pain, diarrhoea, feeling sick (nausea), vomiting - itching - tiredness - feeling worried, feeling depressed - increase in certain liver or pancreatic enzymes - increase in triglycerides The following side effects are uncommon (between 1 in 1000 and 1 in 100 patients treated): - blurred vision - a feeling of spinning or tilting (vertigo) - pain in the abdomen (stomach) caused by inflammation of the pancreas - allergic reaction (hypersensitivity) that may cause severe skin reactions (erythema multiforme, Stevens-Johnson syndrome) - yellow skin or eyes, itching, or pain in the abdomen (stomach) caused by inflammation of the liver - breast enlargement in males - aggression, mood being affected, seeing or hearing things that are not really there (hallucinations), mania (mental condition with episodes of overactivity, elation or irritability), paranoia, suicidal thoughts - whistling, ringing or other persistent noise in the ears - tremor (shaking) - flushing - increase in cholesterol Side effects reported rarely (between 1 in and 1 in 1000 patients treated): - itchy rash caused by a reaction to sunlight - liver failure, in some cases leading to death or requiring liver transplantation Most cases occurred in patients who already had liver disease, but there have been a few reports in patients who did not have liver disease. With an unknown frequency: Combination antiretroviral therapy may change your body shape by changing the distribution of body-fat. You may lose fat from your legs, arms and face, gain fat in the abdomen (tummy) and around internal organs, get larger breasts or develop fatty lumps on the back of the neck ('buffalo hump'). The cause and long-term health effects of these conditions are not yet known. Combination antiretroviral therapy may also raise lactic acid and sugar in the blood, increase fat levels in the blood (hyperlipaemia) and resistance to insulin. Your doctor or health care provider will test for these changes. Page 6 of 7

7 If any side effect gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor, health care provider or pharmacist. 5. HOW TO STORE EFAVIRENZ 600 MG TABLETS Keep out of the reach and sight of children. Do not store above 30 C, protect from light. Do not use after the expiry date stated on the label. The expiry date refers to the last day of that month. Do not use if you notice signs of deterioration. Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines you no longer use. 6. FURTHER INFORMATION What contains The active ingredient is 600 mg efavirenz. Core tablet: Croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulphate. Film coating (Opadry 03B52055 Yellow): Hypromellose, iron oxide yellow, polyethylene glycol 400 and titanium dioxide. Printing ink: Black Iron oxide E172, propylene glycol and shellac. What looks like and contents of the pack Yellow, capsule-shaped, biconvex, film-coated tablets engraved with ML 12 on one side and plain on the other side. 30 tablets packed in 75 cc white, round HDPE container with continuous thread polypropylene screw cap and finally induction sealed. Individual container is further packed in a box along with the pack insert. Supplier Macleods Pharmaceuticals Limited 304, Atlanta Arcade Marol Church Road Andheri (East) Mumbai , INDIA. Tel: Fax: Manufacturer Macleods Pharmaceuticals Ltd. Block No. 2, Village Theda P.O. Lodhi Majra Tehsil Baddi District Solan, Himachal Pradesh India Tel: Fax: For any information about this medicinal product, please contact the supplier. This leaflet was last approved in January 2014 Detailed information on this medicine is available on the World Health Organization (WHO) web site: Page 7 of 7