Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
PYRIDOXINE HYDROCHLORIDE
Seton Products Ltd
100mg Milligram
Tablets
1993-02-06
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Comploment 100mg Prolonged – Release Tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Pyridoxine Hydrochloride 100mg. _For excipients, see 6.1_ 3 PHARMACEUTICAL FORM Prolonged release tablet. Yellow, biconvex, film-coated prolonged release tablet, marked ‘C’ on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Isoniazid-induced peripheral neuritis. Idiopathic sideroblastic anaemia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral Adults only: The usual daily dose is 100mg. Tablets should be swallowed whole and not chewed. 4.3 CONTRAINDICATIONS Hypersensitivity to vitamin B6 or any of the ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE High doses taken continuously for prolonged periods of time may be associated with the development of sensory neuropathy. The symptoms are generally reversible on withdrawal of pyridoxine. Do not exceed the stated dose. Short term use is recommended. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Pyridoxine may increase the peripheral metabolism of levodopa, reducing therapeutic efficacy in patients with Parkinson’s Disease. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 23/02/2010_ _CRN 2079000_ _page number: 1_ 4.6 PREGNANCY AND LACTATION Use in pregnancy is not recommended unless considered essential by a physician. In high doses, pyridoxine may interfere with prolactin and should be used with caution in nursing mothers. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None stated. 4.8 UNDESIRABLE EFFECTS Gastric hyperacidity and indigestion may occur at doses above 200mg/day. Nausea and breast tenderness have also been reported. 4.9 OVERDOSE Ingest Baca dokumen lengkapnya