WHO-PQ RECOMMENDED PATIENT INFORMATION LEAFLET

Transcription

1 WHO-PQ RECOMMENDED PATIENT INFORMATION LEAFLET Page 1 of 8

2 Information for the patient Efavirenz 600 mg Tablets 1 Efavirenz 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 questions about the medicine, ask your health care provider. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness seem to be the same as yours. - If you get any side effects, talk to your health care provider. This includes unwanted effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Efavirenz 600 mg Tablets is and what it is used for 2. What you need to know before you take Efavirenz 600 mg Tablets 3. How to take Efavirenz 600 mg Tablets 4. Possible side effects 5. How to store Efavirenz 600 mg Tablets 6. Contents of the pack and other information 1. What Efavirenz 600 mg Tablets is and what it is used for Efavirenz 600 mg Tablets 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. Efavirenz 600 mg Tablets is used in combination with other antiretroviral medicines to treat HIV infection. Efavirenz 600 mg Tablets 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 Efavirenz 600 mg Tablets varies between patients. Your health care provider will be monitoring the effectiveness of the treatment. 2. What you need to know before you take Efavirenz 600 mg Tablets Do not use Efavirenz 600 mg Tablets: if you are allergic to efavirenz or any of the other ingredients of this medicine (listed in section 6). Contact your health care provider for advice. if you have severe liver disease. if you have a heart condition, such as changes in the rhythm or rate of the heart beat, a slow heart beat, or severe heart disease. if any member of your family (parents, grandparents, brothers or sisters) has died suddenly due to a heart problem or was born with heart problems. 1 Trade names are not prequalified by WHO. This is the national medicines regulatory agency s (NMRA) responsibility. Throughout this WHOPAR the proprietary name is given as an example only. Page 2 of 8

3 if your health care provider has told you that you have high or low levels of electrolytes such as potassium or magnesium in your blood. if you are currently taking any of the following medicines(see also Other medicines and Efavirenz 600 mg Tablets ): o astemizole or terfenadine (used to treat allergy symptoms) o bepridil (used to treat heart disease) o cisapride (used to treat heartburn) o ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraine and cluster headaches) o midazolam or triazolam (used to help you sleep) o pimozide, imipramine, amitriptyline or clomipramine (used to treat certain mental conditions) o St. John's wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety) o flecainide, metoprolol (used to treat irregular heart beat) o certain antibiotics (macrolides, fluoroquinolones, imidazole) o triazole antifungal agents o certain antimalarial treatments o methadone (used to treat opiate addiction) If you are taking any of these medicines, tell your health care provider immediately. Taking these medicines with Efavirenz 600 mg Tablets could create the potential for serious and/or life-threatening sideeffects or stop Efavirenz 600 mg Tablets from working properly. Warnings and precautions Before using this medicine, you should have told your 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. - if you have a heart disorder, such as abnormal electrical signal called prolongation of the QT interval. 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 health care provider immediately and Efavirenz 600 mg Tablets 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 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 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 Page 3 of 8

4 amount of alcohol, or who are overweight. Tell the 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 Efavirenz 600 mg Tablets 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 (e.g. opportunistic infections). These will require specific and sometimes preventive treatment. You should keep in regular contact with your health care provider. Do not stop your medicine without first talking to the health care provider. HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles). You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your health care provider the precautions needed to avoid infecting other people. Other medicines and Efavirenz 600 mg Tablets Please tell the health care provider if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription. These may affect the action of Efavirenz 600 mg Tablets, or Efavirenz 600 mg Tablets mg may affect their action. You must not take Efavirenz 600 mg Tablets with herbal preparations containing St John s wort (Hypericum perforatum) You must not take Efavirenz 600 mg Tablets with the following: astemizole, terfenadine, bepridil, cisapride, pimozide, midazolam, triazolam, and ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine). Taking these medicines with Efavirenz 600 mg Tablets may cause serious or life-threatening side effects. You must not take Efavirenz 600 mg Tablets with medicines that impact heart rhythm, such as: - medicines used to treat heart rhythm problems such as flecainide or metoprolol. - medicines used to treat depression such as imipramine, amitriptyline or clomipramine. - antibiotics, including the following types: macrolides, fluoroquinolones or imidazole - methadone Efavirenz 600 mg Tablets should not be used as part of a regimen comprising efavirenz, didanosine and tenofovir because such regimens are less effective than other combination regimens Efavirenz 600 mg Tablets 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) - buprenorphine (used to treat severe pain) - some medicines used to treat hepatitis C - 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 Efavirenz 600 mg Tablets (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) - tacrolimus, ciclosporin, sirolimus (immunosuppressants) - warfarin, acenocoumarol (medicine for preventing blood clots) - sertraline, bupropion (medicines used to treat depression) - Ginkgo biloba extracts (a herbal preparation) Page 4 of 8

5 Efavirenz 600 mg Tablets with food and drink Efavirenz 600 mg Tablets should be taken on an empty stomach or with a low-fat meal. Grapefruit juice should be avoided when taking Efavirenz 600 mg Tablets. Pregnancy Current treatment guidelines recommend efavirenz in pregnant women and women of childbearing potential. Breastfeeding If a mother wants to breastfeed her baby, her health care 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. If one experiences these symptoms one should avoid potentially hazardous tasks such as driving or operating machinery. Important information about some of the ingredients of Efavirenz 600 mg Tablets Efavirenz 600 mg Tablets contains lactose. If your health care provider has told you that you have an intolerance to some sugars, contact your health care provider before you take this medicine 3. How to take Efavirenz 600 mg Tablets Always take Efavirenz 600 mg Tablets exactly as the health care provider has told you. You should check with your health care provider if you are not sure. The usual dose for adults and adolescents is 600 mg, given once daily. Efavirenz 600 mg Tablets should be taken on an empty stomach, e.g. in the evening before going to bed. Efavirenz 600 mg Tablets 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 Efavirenz 600 mg Tablets cannot be divided, the tablets are not suitable for patients whose body weight is less than 40 kg. Efavirenz is not recommended for children under age 3 and weighing less than 10 kg. If you take more Efavirenz 600 mg Tablets than you should If you have taken too many tablets or if someone accidentally takes some, consult your health care provider or local first aid hospital. Take the tablet container with you. If you forget to take Efavirenz 600 mg Tablets 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 Efavirenz 600 mg Tablets Do not stop taking Efavirenz 600 mg Tablets unless you experience serious side effects or your healthcare provider 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. Page 5 of 8

6 If you have any further questions on the use of this product, ask your health care provider. If you have missed a dose or vomited after a dose It is important that you take the medicine regularly as prescribed. Missing doses can increase the risk of resistance to Efavirenz 600 mg Tablets and reduce its effectiveness. You should take a missed dose if it was due fewer than 12 hours ago. If more than 12 hours have passed since the dose was due, you should omit the missed dose and take the next scheduled dose at the usual time. You should not take a double dose. If you vomit within 1 hour of taking Efavirenz 600 mg Tablets, you should take an extra dose. If vomiting occurs more than an hour after taking the dose, you do not need to take an extra dose and can take the next dose as usual when it is due. 4. Possible side effects Like all medicines, Efavirenz 600 mg Tablets 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. Consult the health care provider 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 efavirenz. Rash was more common in children than in adults treated with efavirenz. 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 health care provider may suggest that you take Efavirenz 600 mg Tablets 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 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): - nervousness, forgetfulness, confusion, fitting (seizures), abnormal thoughts - 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 Page 6 of 8

7 - angry behaviour, 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, catatonia (condition in which the patient is rendered motionless and speechless for a period) - 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. - unexplained feelings of distress not associated with hallucinations, but it may be difficult to think clearly or sensibly - suicide If any side effect gets serious, or if you notice any side effects not listed in this leaflet, tell your health care provider. Reporting of side effects If you get any side effects,talk to your health care provider. This includes unwanted effects not listed in this leaflet.if available, you can also report side effects directly through the national reporting system. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Efavirenz 600 mg Tablets Do not store above 30 C. Store in the original container. Protect from light. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the label/bottle. The expiry date refers to the last day of that month. Do not use this medicine if you notice visible signs of deterioration. Do not throw away any medicines via wastewater or household waste. Ask your healthcare provider how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Efavirenz 600 mg Tablets contains The active substance is 600 mg efavirenz. Core tablet: lactose monohydrate, sodium starch glycolate, polyvinylpyrrolidone, sodium lauryl sulphate, microcrystalline cellulose, magnesium stearate. Film coat: hypromellose, titanium dioxide, polyethylene glycol, iron oxide yellow. What Efavirenz 600 mg Tablets looks like and contents of the pack Yellow, film coated, modified capsule-shaped, biconvex tablets debossed with "D03" on one side and plain on the other side. Page 7 of 8

8 Tablets are packed in 75 cc HDPE bottles with 38 mm neck. Closure is 38 mm, child-resistant white PP cap with liner. Each bottle contains 30 film-coated tablets. Supplier and Manufacturer Supplier Shanghai Desano Bio-pharmaceutical Co., Ltd Zhangheng Road China (Shanghai) Pilot Free Trade Zone Shanghai P.R. China Tel: (86) (86) Manufacturer Shanghai Desano Bio-Pharmaceutical Co., Ltd Zhangheng Road China (Shanghai) Pilot Free Trade Zone Shanghai P.R. China For any information about this medicine, contact the local representative of the supplier: Country: China Shanghai Desano Bio-Pharmaceutical Co., Ltd Zhangheng Road China (Shanghai) Pilot Free Trade Zone Shanghai P.R. China Tel:(86) Fax: (86) This leaflet was last revised on 11 July 2018 Detailed information on this medicine is available on the World Health Organization (WHO) web site: Page 8 of 8