Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
MEBENDAZOLE
McNeil Healthcare (Ireland) Ltd
P02CA01
MEBENDAZOLE
100 Milligram
Tablets
Product not subject to medical prescription
Benzimidazole derivatives
Authorised
2009-07-17
■ 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 fi nd 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 LEAFL ET CAREFULLY BEFORE YOU USE THIS MEDICINE. Keep the leafl et: 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 BREAST-FEEDING. If any of these apply to you, GET ADVICE FROM A DOCTOR OR PHARMACIST BEFORE USING VERMOX TABLETS. TALK TO YOUR DOCTOR OR PHARMACIST... ■ If you are taking any OTHER MEDICINES, INCLUDING: ■ _Metronidazole_ (a drug used to treat BACTERIAL AND PROTOZOAN INFECTIONS) as a serious skin reaction can rarely occur. ■ _Cimetidine_ (a medicine used to treat excess STOMACH ACIDITY). OTHER WORM INFECTIONS _(TAENIASIS AND STRONGYLOI Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vermox 100mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg mebendazole. Excipients: Each tablet also contains 0.06 mg Sunset Yellow (E110). For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet. Faintly orange circular, flat, half –scored, bevel-edged tablet with ‘ME 100’ inscribed on one side and ‘Janssen’ on the other. The half-score is only to facilitate breaking for ease of swallowing and not to divide into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an anthelmintic against gastrointestinal infestations caused by nematodes and cestodes, including enterobiasis, ascariasis, trichuriasis, ankylostomiasis, strongyloidiasis and taeniasis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration: Oral Use. Adults and children 2 years or older: 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 lactation in women breast feeding infants. It is not known if mebendazole crosses the placenta or is excreted in breast milk. Ascariasis, trichuriasis, ankylostomiasis and mixed infections: 100 mg twice daily for three consecutive days. Enterobiasis: 100 mg as a single dose repeated after 2 to 4 weeks. Taeniasis and strongyloidiasis: _Adults: _200 mg twice daily for three consecutive days. _Children 2 years or older: _100 mg twice daily for three consecutive days. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 05/12/2016_ _CRN 2185339_ _page number: 1_ In persons with a known hypersensitivity to Read the complete document