国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
LOPERAMIDE HYDROCHLORIDE, DIMETICONE, ACTIVATED
Rowex Ltd
A07DA53
LOPERAMIDE HYDROCHLORIDE, DIMETICONE, ACTIVATED
2/125 Milligram
Tablets
Product not subject to medical prescription
Antipropulsives
Authorised
2014-08-01
PACKAGE LEAFLET: INFORMATION FOR THE USER IMODEX PLUS 2 MG/125 MG TABLETS loperamide hydrochloride, simeticone READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. - You must talk to a doctor if you do not feel better or if you feel worse after two days. See section 4. WHAT IS IN THIS LEAFLET 1. What Imodex Plus 2 mg/125 mg Tablets are and what it is used for 2. What you need to know before you Imodex Plus 2 mg/125 mg Tablets 3. How to take Imodex Plus 2 mg/125 mg Tablets 4. Possible side effects 5. How to store Imodex Plus 2 mg/125 mg Tablets 6. Contents of the pack and other information 1. WHAT IMODEX PLUS 2 MG/125 MG TABLETS ARE AND WHAT IT IS USED FOR The tablets are used to treat a short-lived attack of diarrhoea when it occurs with stomach cramps, bloating and wind. The tablets contain loperamide hydrochloride, which helps reduce diarrhoea by slowing down an overactive bowel. It also helps the body to absorb more water and salts from the bowel. The tablets also contain simeticone, which breaks up the trapped wind in the bowel that causes cramps and bloating. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IMODEX PLUS 2 MG/125 MG TABLETS DO NOT TAKE IMODEX PLUS TABLETS 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Imodex Plus 2 mg/125mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains loperamide hydrochloride 2 mg and simeticone equivalent to 125 mg dimeticone. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White to off white capsule shaped tablet (approximately 16.6 x 6.8 mm) with “LO-SI” debossed on one side and ‘2’ & ‘125’ debossed on the opposite side at either side of a score line The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Imodex Plus 2 mg/125 mg Tablets are indicated for the symptomatic treatment of acute diarrhoea in adults and adolescents over 12 years when acute diarrhoea is associated with gas-related abdominal discomfort including bloating, cramping or flatulence. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The tablets should be taken with liquid. Adults over 18 years: Take two tablets initially, followed by one tablet after every loose stool. Not more than 4 tablets should be taken in a day, limited to no more than 2 days. Adolescents between 12 and 18 years: Take one tablet initially, followed by one tablet after every loose stool. Not more than 4 tablets should be taken in a day, limited to no more than 2 days. Use in children: Imodex Plus 2 mg/125 mg Tablets must not be used in children under 12 years. Use in older people: No dosage adjustments are required for older people. Use in renal impairment: No dosage adjustment is necessary in renal impairment. Hepatic impairment: Although no pharmacokinetic data are available in patients with hepatic insufficiency, Imodex Plus 2 mg/125 mg Tablets should be used with caution 完全なドキュメントを読む