Држава: Велика Британија
Језик: Енглески
Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ethambutol hydrochloride
A A H Pharmaceuticals Ltd
J04AK02
Ethambutol hydrochloride
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010900
_Colours_ _(Printed)_ _Title:_ _Ref:_ _Date:_ _Size (mm):_ _Modified:_ Ethambutol 100mg PIL Eth/100/10 25/04/20 145x297.5 22/06/20 PROCESS BLACK READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. 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. Do not pass it on to others. It may harm them, even if their symptoms 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. IN THIS LEAFLET: 1. What Ethambutol Tablets are and what they are used for 2. Before you take Ethambutol Tablets 3. How to take Ethambutol Tablets 4. Possible side effects 5. How to store Ethambutol Tablets 6. Further 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 of medicines called antituberculosis drugs and is used for the treatment and prevention of tuberculosis, an infectious disease mainly affecting the lungs. 2. BEFORE YOU TAKE ETHAMBUTOL TABLETS DO NOT TAKE ETHAMBUTOL TABLETS: - if you have sight problems. - if you are allergic (hypersensitive) to ethambutol hydrochloride or any of the other ingredients (see list under ‘What Ethambutol Tablets contain’ in section 6). Problems with your sight You should have your eyesight checked before taking these tablets. 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. Take special care with Ethambutol if you have a history of kidney problems. Before treatment with Ethambutol you should have your kidneys checked. If you develop symptoms suggestive of hepatitis (e.g. ab Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ethambutol 100 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 100mg Ethambutol Hydrochloride. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablet. Smooth, yellow, circular, biconvex film coated tablet, 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-tuberculinpositive reaction. Ethambutol should only be used in conjunction with other anti-tuberculous drugs to which the patient’s organisms are susceptible. Consideration should be given to official guidance on the appropriate use of antibacterial agents 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Route of administration_: Oral _Posology: _ Recommended Dosage The dosage of ethambutol must be adjusted according to the body weight of the patient. This drug should not be used as a sole anti-tuberculosis agent, but should be given with at least one other antituberculosis drug to avoid development of resistant strains. The usual daily dosage is 15-25mg/kg body weight given as a single dose. _ _ _ADULTS _ For primary treatment and prophylaxis: Ethambutol should be administered in a single daily 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 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 As chil Прочитајте комплетан документ