Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
MORPHINE SULFATE
Napp Pharmaceuticals Limited
MORPHINE SULFATE
100 Milligram
Granules Prolonged Release
Product subject to prescription which may not be renewed (A)
Withdrawn
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT MST CONTINUS suspension 100 mg. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Morphine equivalent to Morphine Sulphate 100 mg For excipients see 6.1 3 PHARMACEUTICAL FORM Pink granules Prolonged release granules for oral suspension 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prolonged relief of severe and intractable pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: oral The contents of one sachet should be mixed with at least 20 ml water or sprinkled on to soft food, for example yogurt. The controlled release granules must be suspended whole and ingested immediately, but not be broken, chewed or crushed. The administration of broken, chewed or crushed morphine granules leads to a rapid release and absorption of a potentially fatal dose of morphine _(see section 4.9, Overdose)._ MST CONTINUS suspension should be used at 12-hourly intervals. The dosage is dependent upon the severity of the pain, the patient's age and previous history of analgesic requirements. Adults: A patient presenting with severe pain, uncontrolled by weaker opioids (e.g. dihydrocodeine) should normally be started on 30 mg 12 hourly. Patients previously on normal release oral morphine should be given the same total daily dose as MST CONTINUS suspension but in divided doses at 12-hourly intervals. Increasing severity of pain will require an increased dosage of the suspension. Higher doses should be made, where possible in 30-50% increments as required. The correct dosage for any individual patient is that which is sufficient to control pain with no, or tolerable, side effects for a full 12 hours. It is recommended that the 200 mg strength is reserved for patients who have already been titrated to Read the complete document