Item Number: TRAMADOL
Treatment of moderate to severe pain.
Posology and method of administration
The capsules are intended for twice daily oral administration and can be taken independently of meal times, swallowed whole with water.
The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected.
The usual initial dose is 50-100 mg twice daily, morning and evening. This dose may be titrated up to 150-200 mg twice daily according to pain severity.
If long-term pain treatment with tramadol is necessary in view of the nature and severity of the illness, then careful and regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether and to what extent further treatment is necessary.
A total oral daily dose of 400 mg should not be exceeded except in special clinical circumstances.
A dose adjustment is not usually necessary in patients up to 75 years without clinically manifest hepatic or renal insufficiency. In elderly patients over 75 years elimination may be prolonged. There is a 17% increase in the terminal elimination half-life. Therefore, if necessary the dosage interval is to be extended according to the patient's requirements.
Patients with renal or hepatic insufficiency:
In patients with renal and/or hepatic insufficiency the elimination of tramadol is delayed. In these patients prolongation of the dosage intervals should be carefully considered according to the patient's requirements. In patients with severe renal and/or hepatic impairment, the use of Tramquel SR prolonged-release capsules, hard is not recommended..
Patients who have difficulty in swallowing:
Tramquel SR prolonged-release capsules, hard can be opened, carefully, so that the pellets are deposited on a spoon. The spoon and pellets should be taken into the mouth, followed by a drink of water to rinse the mouth of all pellets. The pellets must not be chewed or crushed.
Children and adolescents:
Over 12 years: Dosage as for adults.
Under 12 years: Tramquel SR prolonged-release capsules, hard have not been studied in children. Therefore, safety and efficacy have not been established and the product should not be used in children.
For Full Data Sheet go to:https://www.medicines.org.uk/emc/product/7643/smpc
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