Страна: Мальта
Язык: английский
Источник: Medicines Authority
PYRAZINAMIDE
Macleods Pharma UK Ltd Wynyard Park House, Wynyard Avenue, Wynyard, Billingham TS22 5TB , United Kingdom
J04AK01
PYRAZINAMIDE 500 mg
TABLET
PYRAZINAMIDE 500 mg
POM
ANTIMYCOBACTERIALS
Withdrawn
2018-11-20
Page 1 of 4 PACKAGE LEAFLET: INFORMATION FOR THE USER PYRAZINAMIDE 500 MG TABLETS PYRAZINAMIDE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 doctor or pharmacist. - 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 are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Pyrazinamide tablets are and what they are used for 2. What you need to know before you take Pyrazinamide tablets 3. How to take Pyrazinamide tablets 4. Possible side effects 5. How to store Pyrazinamide tablets 6. Contents of the pack and other information 1. WHAT PYRAZINAMIDE TABLETS ARE AND WHAT THEY ARE USED FOR Pyrazinamide tablets contain pyrazinamide, which is an antituberculous agent. Pyrazinamide tablets are used for treating tuberculosis, commonly called ‘TB’. These products work by killing a particular type of bacteria which causes tuberculosis. Pyrazinamide tablets are always given in combination with other antituberculous agents. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PYRAZINAMIDE TABLETS DO NOT TAKE PYRAZINAMIDE TABLETS: • if you are allergic to pyrazinamide or any of the other ingredients of this medicine (listed in section 6 ); • if you are breast-feeding; • if you have liver disease; • if you have gouty arthritis (arthritis associated with inflammation of the joints); • if you have an abnormally high concentration of uric acid in your blood; • if you have a condition that results in a high level of porphyrin in your urine and extreme sensitivity to light. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Pyrazinamide tablets • if you are or think you may be pregnant; • if you have kidney problem Прочитать полный документ
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Pyrazinamide 500 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500 mg of pyrazinamide Ph. Eur. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. Round, white to off white uncoated, scored tablets with notches, debossed ‘F’ above the score and ‘43’ below the score and plain on other side. Diameter of 12.0 ± 0.2 mm. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ‘Pyrazinamide’ is indicated in patients with active tuberculosis caused by _Mycobacterium _ _tuberculosis_ . ‘Pyrazinamide’ is not active against the atypical mycobacteria. ‘Pyrazinamide’ should only be given in combination with other antituberculous agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Recommended dosage for standard unsupervised 2-month treatment: _Adults_ : Under 50kg bodyweight: maximum of 3 tablets or 1.5g daily. Patients ≥ 50kg and over bodyweight: maximum of 4 tablets or 2g daily. _Children: _ 35mg/kg daily. Recommended dosage for intermittent supervised 2-month treatment: _Adults_ : Under 50kg bodyweight: maximum of 4 tablets or 2g 3 times a week. Patients ≥ 50kg and over bodyweight: maximum of 5 tablets or 2.5g 3 times a week. _Children: _ 50mg/kg 3 times a week. ‘Pyrazinamide’ should be administered with at least one other effective antituberculous drug. The use of ‘Pyrazinamide’ in combination therapy does not modify the accepted dosages of other antituberculous agents. _Use in elderly_ : The general considerations outlined above should also apply to elderly patients. _Immunocompromised patients_ : Multi-resistant _M. tuberculosis _ may be present in immunocompromised patients. The organism should always be cultured to confirm its type and drug sensitivity. Confirmed _M. Tuberculosis _ infection sensitive to first-line drugs should be treated with a stand Прочитать полный документ