BY-MADOL SR
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
01-04-2023
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Active ingredient:
TRAMADOL HYDROCHLORIDE
Available from:
Helsinn Birex Therapeutics Ltd
Dosage:
50 Milligram
Pharmaceutical form:
Prolonged Release Capsules
Authorization date:
2009-04-24
Summary of Product characteristics
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Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
By-Madol SR 50 mg prolonged-release capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 prolonged-release capsule contains 50 mg of tramadol hydrochloride equivalent to 43.91mg tramadol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release capsule, hard
Capsules with opaque white cap and 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 mg of tramadol hydrochloride/day),
morning and evening administration recommended. If required, other forms of administration can be used.
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
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