Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
TRAMADOL HYDROCHLORIDE
Helsinn Birex Therapeutics Ltd
100 Milligram
Prolonged Release Capsules
2009-04-24
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT By-Madol SR 100 mg prolonged-release capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 prolonged-release capsule contains 100 mg of tramadol hydrochloride equivalent to 87.82 mg tramadol. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Prolonged-release capsule, hard Capsules with opaque yellow cap and natural transparent body, containing white spherical microgranules 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For moderate to severe pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dosage should be adjusted to the severity of the patient's pain and his/her sensitivity. Adults and adolescents aged 12 years and over: 100 - 200 mg tramadol hydrochloride twice daily (corresponding to 200 - 400 of mg tramadol hydrochloride/day), morning and evening administration recommended. The smallest effective analgesic dose should always be used. Daily doses of 400 mg of active substance must not be exceeded, unless exceptional medical reasons require so. A minimum interval of 8 hours must be respected between administrations. Children: BY-MADOL SR is not suitable for use in children below 25 kg body weight which in general does not allow for individualized dosage in children below 12 years of age. Consequently, a more suitable form of administration should be used. Elderly people (over 75 years) As a rule, dosage adjustment in elderly patients (up to 75 years of age) is not required in the absence of clinically manifest hepatic or renal insufficiency. Elimination may be prolonged in elderly patients (over 75 years of age). Consequently, dosage intervals should be prolonged according to individual needs. Hepatic and renal insufficiency/dialysis BY-MADOL SR should not be administered to Read the complete document