Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
MEBENDAZOLE
Cupal Limited
100 Milligram
2003-09-05
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mebendazole Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Mebendazole 100 mg. _For excipients, see 6.1._ 3 PHARMACEUTICAL FORM Chewable tablet Mottled, pale orange, round tablets, shallow, concave with a breakline. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of threadworm (enterobiasis) infestation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults, the elderly and children over two years old: One tablet to be chewed or swallowed whole. The efficacy in threadworm infestations is such that treatment failure will be rare. However, the possibility of re-infection means that some patients may require a second tablet after two weeks, if re-infected. It is strongly recommended that all members of the family are treated at the same time. Not recommended for children under two years of age. 4.3 CONTRAINDICATIONS Pregnancy: Mebendazole has not been studied extensively in children under two years of age - for this reason it is not currently recommended for children under two years of age. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 1. Not to be taken during pregnancy, or whilst breast feeding. 2. Not recommended for children under two years. 3. Keep out of the reach and sight of children. 4. If after two weeks you need to take a second tablet following which your symptoms persist, then consult your doctor. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None stated. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/04/2010_ _CRN 2080858_ _page number: 1_ 4.6 PREGNANCY AND LACTATION Mebendazole has shown embryotoxic and teratogenic activity in rats at single oral doses. N Preberite celoten dokument