Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PILOCARPINE HYDROCHLORIDE
Novartis Pharmaceuticals UK Ltd
5 Milligram
Tablets
2000-10-16
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Salagen 5mg Film-coated Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Pilocarpine Hydrochloride 5 mg. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, circular, biconvex film-coated tablets, marked “SAL” on one side and “5mg” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS i. Alleviation of symptoms of salivary gland hypofunction due to post-radiation xerostomia. ii. Treatment of symptoms of dry mouth and dry eyes in patients with Sjögren’s syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION I. FOR PATIENTS WITH POST-RADIATION XEROSTOMIA The recommended oral dose for adults is 1 tablet of 5 mg three times daily. Tablets should be taken with a glass of water during or directly after meals. The last tablet should always be taken in conjunction with the evening meal. The maximal therapeutic effect is obtained after 4-8 weeks of therapy. For patients who have not responded sufficiently and who tolerate the dose of 5 mg three times daily, doses of up to a maximum of 30 mg daily may be considered. However, higher daily doses are probably accompanied by an increase in drug-related adverse effects. Therapy should be discontinued if no improvement in xerostomia is noted after 3 months of therapy. II. FOR SJÖGREN’S SYNDROME PATIENTS The recommended dose for adults is one tablet of 5 mg four times daily. Tablets should be taken with a glass of water at mealtimes and bedtime. Efficacy was established by 6 weeks of use. USE IN THE ELDERLY There is no evidence to suggest that dosage should be different in the elderly. USE IN CHILDREN Safety and effectiveness of this drug in children have not been established. IRISH MEDICINES BOARD Read the complete document