Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
MEBENDAZOLE
PCO Manufacturing
MEBENDAZOLE
100 Milligram
Tablets
Withdrawn
2013-12-31
PATIENT INFORMATION LEAFLET VERMOX ® 100 MG TABLETS Mebendazole ■ This medicine is used to treat threadworm and other common worm infections of the gut. ■ This medicine is for use by adults and children aged over 2 years. ■ DO NOT USE THIS MEDICINE: − There are some people who should not use this medicine. _To find out if you are one of them see section 2_. − If you have ever had a BAD REACTION to any of the ingredients. _To view the list of ingredients see section 6_. ■ SPEAK TO YOUR DOCTOR: − If you are taking any other medicines. _See section 2._ − ■ FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY. These are shown in the dosage table. _See section 3_. NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE. Keep the leaflet: you might need it again. 1 WHAT THE MEDICINE IS FOR Vermox Tablets is a medicine which is used to treat threadworms (sometimes known as pinworms) and other common worm infections eg (whipworm, roundworm, hookworm). The tablets contain mebendazole, which is one of a group of medicines called ‘anthelmintics’. This medicine is for use in adults and children aged over 2 years. 2 BEFORE TAKING THIS MEDICINE This medicine is suitable for most adults and children, but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist. DO NOT USE THIS MEDICINE… ■ If you are HYPERSENSITIVE (allergic) to any of the ingredients ■ If it is for a CHILD UNDER 2 YEARS. ■ If you are PREGNANT OR THINK YOU ARE PREGNANT. If you are BREASTFEEDING. . If any of these apply to you, GET ADVICE FROM A DOCTOR OR PHARMACIST WITHOUT USING VERMOX TABLETS. TALK TO YOUR DOCTOR OR PHARMACIST... ■ If you are taking any OTHER MEDICINES, INCLUDING: − Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vermox 100 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100mg mebendazole. Excipients: Each tablet also contains sunset yellow (E110) _For full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Tablet. _Products imported from the UK and Greece:_ Faintly-orange, circular, flat, bevel-edged tablet with ‘ME/100’ and a breakline on one side and ‘JANSSEN’ on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an anthelmintic against gastrointestinal infestations caused by nematodes and cestodes, including enterobiasis, ascariasis, trichuriasis, ancylostomiasis, strongyloidiasis and taeniasis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration: Oral Use. _Adults and children 2 years or older:_ Ascariasis, Trichuriasis, Ancylostomiasis and mixed infestations: 100mg twice daily for three consecutive days. Enterobiasis: 100 mg as a single dose repeated after 2 and 4 weeks. Taeniasis and Strongyloidiasis: _Adults:_ 200mg twice daily for three consecutive days. _Children 2 years or older:_ 100mg twice daily for three consecutive days. Tablets may be chewed or swallowed whole. Crush the tablet before giving it to a young child. Always supervise a child while they are taking this medicine. 4.3 CONTRAINDICATIONS Use in pregnancy or lacatation in women breast feeding infants. It is not known if mebendazole crosses the placenta or is excreted in human breast milk. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 20/12/2013_ _CRN 2137079_ _page number: 1_ In persons with a known hypersensitivity to the drug or its components 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Not reco Lue koko asiakirja