Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Ethambutol hydrochloride
Morningside Healthcare (Malta) Limited
J04AK; J04AK02
Ethambutol hydrochloride
400 milligram(s)
Film-coated tablet
Other drugs for treatment of tuberculosis; ethambutol
Not marketed
2010-10-01
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER ETHAMBUTOL HYDROCHLORIDE 100MG AND 400MG FILM-COATED TABLETS 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 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 serious, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What Ethambutol Tablets are and what they are used for 2. What you need to know before you take Ethambutol Tablets 3. How to take Ethambutol Tablets 4. Possible side effects 5. How to store Ethambutol Tablets 6. Contents of the pack and other information 1. WHAT ETHAMBUTOL TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Ethambutol Tablets. Ethambutol belongs to a group called antituberculosis drugs and is used for the treatment and prevention of tuberculosis, an infectious disease mainly affecting the lungs. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ETHAMBUTOL TABLETS DO NOT TAKE ETHAMBUTOL TABLETS if you are allergic to ethambutol hydrochloride or any of the other ingredients of this medicine (listed in section 6). if you have sight problems Problems with your sight: You should have your eyesight checked before taking these tablets, and if you notice any changes to your vision whilst taking these tablets, you should stop taking them and notify your doctor immediately. In the majority of cases, any changes to vision will return to normal within a few weeks/months after stopping treatment however, in rare cases, it may take longer for eyesight to recover or the changes may become permanent. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Ethambutol Tablets if you have a history of Прочетете целия документ
Health Products Regulatory Authority 01 February 2021 CRN009ZDD Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ethambutol Hydrochloride 400mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains: 400 mg of ethambutol hydrochloride For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Grey, circular biconvex film-coated tablets, plain on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The primary treatment and re-treatment of tuberculosis and for prophylaxis in cases of inactive tuberculosis or large-tuberculin-positive reaction. Ethambutol should only be used in conjunction with other anti-tuberculosis drugs to which the patient's organisms are susceptible. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Route of administration:_ Oral _Posology: _ The dosage of ethambutol must be adjusted according to the body weight of the patient. _Adults _ _For primary treatment and prophylaxis_: Ethambutol should be administered in a single daily oral dose of 15mg/kg, concomitant drugs being maintained at their recommended dosage levels. _For re-treatment_: For the first 60 days of treatment, ethambutol should be administered in a single daily oral dose of 25mg/kg. Thereafter the dosage should be reduced to 15mg/kg, concomitant drugs being maintained at their recommended dosage levels. _Children _ _For primary treatment and re-treatment_: For the first 60 days of treatment, a single daily oral dose of 25mg/kg. Thereafter the dosage should be reduced to 15mg/kg, concomitant drugs being maintained at their recommended dosage levels. _For prophylaxis_: A single daily oral dose of 15mg/kg, concomitant drugs being used at their recommended dosage levels. _Elderly _ As for adults. However, patients with decreased renal function may need to have the dosage adjusted as determined by blood levels of ethambutol. In order to obtain maximum effect due to high serum levels, drug administration should be once daily. _ _ _Renal Impairment_ Прочетете целия документ