Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
MORPHINE HYDROCHLORIDE
Lannacher Heilmittel Ges.m.b.H
60mg Milligram
Tablets
2000-01-21
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ticinan 60 mg prolonged release tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 tablet contains 60 mg morphine hydrochloride trihydrochlroide equivalent to 45.6 mg morphine. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release tablet. Yellow tablets, round and biconvex. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prolonged relief of severe and most severe pain (such as cancer pain), resistant to lower level analgesics. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION The prolonged release tablets should be swallowed completely with some liquid. Ticinan prolonged release tablets must not be divided or dissolved before administration. Dissolving or parting of the Ticinan prolonged release tablets will damage the prolonged release system and lead to rapid release of morphine which may entail substantial side effects. The treatment is initiated by titration with an immediate release morphine formulation (tablets or mixture) to a morphine dose which gives adequate pain control. Thereafter, the patient is transferred to the same daily dose of Ticinan prolonged release tablets. Breakthrough pain should be treated with immediate release morphine. Ticinan prolonged release tablets 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. For adults and adolescents from the age of 12 years: A patient presenting with severe pain should normally be started on 10-30 mg morphine hydrochloride 12-hourly, patients with low body-weight (weighing less than 70 kg) requiring a small starting dose. Caution should be exercised and the initial dose should be reduced in elderly patients and patients with impaired hepatic or renal function. Increasing s Read the complete document