产品特点
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
阅读完整的文件
产品特点 