Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ethambutol hydrochloride
Kent Pharma (UK) Ltd
J04AK02
Ethambutol hydrochloride
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010900; GTIN: 5015201009443
• you notice any changes to your vision THE FOLLOWING OTHER SIDE EFFECTS HAVE ALSO BEEN REPORTED: COMMON (may affect up to 1 in 10 people) • eye problems; inflammation of the optic nerve, loss of the sharpness of vision UNCOMMON (may affect up to 1 in 100 people) • high levels of uric acid in the blood (hyperuricaemia) RARE SIDE EFFECTS (may affect up to 1 in 1,000 people) • numbness, pins and needles sensation • low blood platelet count (which may result in nosebleeds, pinpoint red spots, prolonged bleeding after injury) • minor allergic reactions such as rashes, itching and swollen, pale red bumps or plaques (wheals) on the skin VERY RARE SIDE EFFECTS (may affect up to 1 in 10,000 people) • hypersensitivity or anaphylactic reaction • blood disorders such as reduction in the number of white cells in the blood and low level of neutrophils, a type of white blood cell • dizziness, confusion, disorientation, hallucinations, headache, fever, generally feeling unwell • joint pains, burning pain, weakness in hands and feet • fluid in the lungs or inflammation of the lungs which may cause breathlessness, cough and raised temperature • gout (which results in warmth, swelling, reddish discoloration, and marked tenderness of joint especially common to affect big toe) • liver failure NOT KNOWN (frequency cannot be estimated from the available data) • shaking • stomach problems, including loss of appetite, feeling or being sick, diarrhoea, flatulence (wind), stomach pain, metallic taste and weight loss • hepatitis, jaundice, transient increase in liver enzymes, abnormal liver function tests in patients on multiple medications REPORTING OF SIDE EFFECTS If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provi Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ethambutol 100 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Ethambutol hydrochloride 100 mg For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. Yellow, round biconvex, film coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For 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. Consideration should be given to official guidance on the appropriate use of antimicrobial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posolo gy Dosage should be determined according to the body weight of the patient. The usual daily dosage is 15-25mg/kg body weight given as a single dose. Ethambutol should not be used as a sole anti-tuberculosis agent, but should be given with at least one other anti-tuberculosis drug to avoid development of resistant strains. Adults _For primary treatment and prophylaxis: _Ethambutol should be administered in a single daily dose of 15 mg/kg body weight; concomitant drugs should be maintained at their usual recommended dosage. _For re-treatment: _For the first 60 days of treatment, ethambutol should be administered in a single daily dose of 25 mg/kg body weight. Thereafter the dosage should be reduced to 15 mg/kg body weight; concomitant drugs should be maintained at their usual recommended dosage levels. Paediatric population _For primary treatment and re-treatment: _For the first 60 days of treatment, a single daily dose of 25 mg/kg body weight. Thereafter the dosage should be reduced to 15 mg/kg body weight; concomitant drugs being maintained at their usual recommended dosage levels. _For prophylaxis: _A single daily dose of 15 mg/kg body weight; concomitant drugs being maintained at their usual recommended dosage levels. Прочетете целия документ