PATIENT INFORMATION LEAFLET

Transcription

1 PATIENT INFORMATION LEAFLET Page 1 of 5

2 PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER Capreomycin (as sulfate) 1 g powder for injection * 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, ask your health care provider. - This medicine has been prescribed for you or your child only. Do not pass it on to others. It may harm them, even if the signs of their illness are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your health care provider. What is in this leaflet: 1. What Capreomycin (as sulfate) 1 g powder for injection is and what it is used for 2. What you need to know before you are given Capreomycin (as sulfate) 1 g powder for injection 3. How you are given Capreomycin (as sulfate) 1 g powder for injection 4. Possible side effects 5. How to store Capreomycin (as sulfate) 1 g powder for injection 6. Further information 1. WHAT CAPREOMYCIN (AS SULFATE) 1 G POWDER FOR INJECTION IS AND WHAT IT IS USED FOR Capreomycin (as sulfate) 1 g powder for injection contains the active ingredient capreomycin. Capreomycin is an antibiotic which is used to treat tuberculosis (TB) together with other medicines. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CAPREOMYCIN (AS SULFATE) 1 G POWDER FOR INJECTION Do not take Capreomycin (as sulfate) 1 g powder for injection if: you are allergic (hypersensitive) to capreomycin. An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue Take special care with Capreomycin (as sulfate) 1 g powder for injection if: you have kidney problems you are have hearing problems. Your health care provider may want to test your hearing and balance before you have Capreomycin (as sulfate) 1 g powder for injection you have a history of allergies, especially to other medicines If you suffer from any of the above, tell your health care provider. Taking other medicines with Capreomycin (as sulfate) 1 g powder for injection You should tell your health care provider if you are taking or have taken any medicines, including medicines obtained without a prescription. In particular, talk to your health care provider if you are taking any of the following medicines: streptomycin, viomycin (other treatments for tuberculosis [TB]) polymyxin, colistin sulfate, amikacin, gentamicin, tobramycin, vancomycin, kanamycin and neomycin (anti-infective agents) * Trade names are not prequalified by WHO. This is the national medicines regulatory authority s responsibility. Throughout this WHOPAR the proprietary name is given as an example only. Page 2 of 5

3 It may still be alright for you to be given Capreomycin (as sulfate) 1 g powder for injection and your health care provider will be able to decide what is suitable for you. Pregnancy and breastfeeding If you are pregnant, think you might be pregnant, planning to become pregnant or breast-feeding you should not take Capreomycin (as sulfate) 1 g powder for injection unless your health care provider tells you to. Ask your health care provider for advice before taking any medicine. Driving and using machines In large doses, capreomycin may cause muscle weakness and so affect your ability to drive or use machines. Use caution when driving or operating heavy machinery until you are aware of how this medicine affects you. 3. HOW YOU ARE GIVEN CAPREOMYCIN (AS SULFATE) 1 G POWDER FOR INJECTION Dose You will be given other TB antibiotic medicines while you are having Capreomycin (as sulfate) 1 g powder for injection. Capreomycin Sulfate may be administered intramuscularly or intravenously. It will usually be given by a health care provider. Adults The usual dose for an adult is 1 g of capreomycin injected every day (or on 5 days each week) for up to 4 months. After that, you may have 1 g two or three times a week. If you have kidney problems your health care provider may reduce your dose. Children The dose of capreomycin for a child is calculated according to the child s body weight. The dose is 15 to 30 mg/kg every day (or on 5 days each week) for up to 4 months. After that the child may have 15 to 30 mg/kg two or three times a week. If you have any further questions on the use of this product, ask your health care provider. 4. POSSIBLE SIDE EFFECTS Like all medicines, capreomycin can cause side effects, but not everybody gets them. Tell your health care provider about any change in your health. Very serious side effects All medicines can cause allergic reactions but serious allergic reactions are very rare. Tell your health care provider straightaway if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body). The following side effects have been reported: kidney or liver problems the amount of potassium, calcium and magnesium in your blood may decrease (symptoms are muscle weakness, muscle cramps, feeling thirsty all the time, drinking all the time, urinating frequently, vomiting and, possibly, having a fit) hearing or balance may get worse and you may hear noises in your ears or feel dizzy changes in the number of different types of blood cells (a blood test arranged by a health care provider will detect these). You may notice that you bruise easily (caused by low platelets) or you cannot fight off infections Page 3 of 5

4 rash (without other symptoms) itching injection-site pain, bleeding or development of lumps in the skin where injected fever If any side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your health care provider. 5. HOW TO STORE CAPREOMYCIN (AS SULFATE) 1 G POWDER FOR INJECTION Your health care provider knows how to store Capreomycin (as sulfate) 1 g powder for injection. Keep out of the sight and reach of children. Do not store above 30 C. Store in a dry place, protect from light. Single use vials. After reconstitution: The contents of vials reconstituted with sterile water for injection should be used immediately or may be stored for up to 24 hours under refrigerated storage. Reconstituted solutions diluted further with 0.9% Sodium Chloride Injection should be used within 1 hour. Single use vials. Discard unused portions. Reconstituted and further diluted solutions that show discoloration, haziness, visible particulate matter or precipitation should not be used. Do not use Capreomycin (as sulfate) 1 g powder for injection after the expiry date stated on the vial or carton. The expiry date refers to the last day of that month. Medicines should not be disposed of in wastewater or household waste. Ask your health care provider how to dispose of medicines you no longer use. These measures will help to protect the environment. 6. FURTHER INFORMATION What Capreomycin (as sulfate) 1 g powder for injection contains Each vial contains 1 g of the active substance capreomycin. What Capreomycin (as sulfate) 1 g powder for injection looks like and contents of the pack Capreomycin (as sulfate) 1 g powder for injection is filled in clear, transparent USP Type III flint glass vials that are free from visual defects. The filled vials are closed with gray bromo butyl rubber plugs and sealed with aluminium flip off seal. Supplier Macleods Pharmaceuticals Limited 304, Atlanta Arcade Marol Church road Andheri (East) Mumbai , India Tel: Fax: sjadhav@macleodspharma.com vijay@macleodspharma.com Manufacturer Macleods Pharmaceuticals Limited Phase I, Unit II Plot No Survey No. 366 Premier Industrial Estate Kachigam Daman India Tel: Fax: sushil@macleodspharma.com Page 4 of 5

5 This leaflet was last approved in September Detailed information on this medicine is available on the World Health Organization (WHO) web site: Page 5 of 5