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1. Name of the medicinal product
Rhotard Morphine SR 30 mg Tablets
Morphgesic SR 30 mg Tablets
2. Qualitative and quantitative composition
Rhotard Morphine SR 30 mg Tablets/ Morphgesic SR 30 mg Tablets.
Each tablet contains 30 mg of morphine sulphate.
Excipients with known effect:
Lactose (63.000 mg per tablet).
3. Pharmaceutical form
Controlled release tablets
Each 30 mg tablet is a violet coloured biconvex round film coated tablet.
4. Clinical particulars
4.1 Therapeutic indications
Rhotard Morphine SR / Morphgesic SR tablets are indicated in adults for the prolonged relief of severe pain.
4.2 Posology and method of administration
Posology
Paediatric population
Rhotard Morphine SR / Morphgesic SR tablets are not recommended for paediatric use.
Adults:
The dosage is dependent upon the severity of the pain and the patient’s previous history of analgesic requirements. The tablets should normally be administered twice daily at 12 hourly intervals. One or two 10 mg tablets (10 mg) twice daily is the recommended starting dosage for a patient presenting with severe pain. With increasing severity of pain it is recommended that the dosage of morphine be increased to achieve the desired relief. The dosage may be varied by choosing combinations of available strengths (10, 30, 60, and 100 mg) or by using higher strength tablets alone.
It is recommended that a patient transferred from another oral morphine preparation, having similar bioavailability to oral morphine liquid, should receive the same total morphine dose in one 24-hour period. This total dose should be divided between the morning and evening administration. Dosage titration and clinical assessment may be appropriate.
Where a patient had previously received parenteral morphine prior to being transferred to Rhotard Morphine SR/ Morphgesic SR tablets, a higher dosage of morphine may be required. Individual dosage adjustment will be necessary to compensate for any reduction in analgesic effect associated with oral administration.
When Rhotard Morphine SR/ Morphgesic SR tablets is to be given for the relief of postoperative pain, it is not advisable to administer it during the first 24 hours. Following this initial period, the dosage should be at the physician’s discretion.
Some patients may require supplemental parenteral morphine which is perfectly acceptable. Careful attention should be paid to the total morphine dosage however, and the prolonged effects of morphine in the Rhotard Morphine SR/ Morphgesic SR formulation should also be borne in mind.
Rhotard Morphine SR/ Morphgesic SR tablets should be used with caution post-operatively (as with all morphine preparations) but especially following abdominal surgery.
Gastric motility should have returned and be maintained.
