BY-MADOL SR
Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Karakteristik produk
(SPC)
05-05-2024
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Bahan aktif:
TRAMADOL HYDROCHLORIDE
Tersedia dari:
Helsinn Birex Therapeutics Ltd
Dosis:
100 Milligram
Bentuk farmasi:
Prolonged Release Capsules
Tanggal Otorisasi:
2009-04-24
Karakteristik produk
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
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