Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Loperamide hydrochloride; Simeticone
Johnson & Johnson (Ireland) Limited
A07DA; A07DA53
Loperamide hydrochloride; Simeticone
2 mg/125 milligram(s)
Tablet
Product not subject to medical prescription
Antipropulsives; loperamide, combinations
Marketed
2007-04-20
PACKAGE LEAFLET: INFORMATION FOR THE USER 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 pharmacist has told you. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your pharmacist. • If you get any side effects, talk to your pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. • You must talk to a doctor if you do not feel better or if you feel worse after 2 days. WHAT IS IN THIS LEAFLET 1. What IMODIUM ® Plus 2mg/125mg tablets are, and what they are used for. 2. What you need to know before you take IMODIUM ® Plus 2mg/125mg tablets. 3. How to take IMODIUM ® Plus 2mg/125mg tablets. 4. Possible side effects. 5. How to store IMODIUM ® Plus 2mg/125mg tablets. 6. Contents of the pack and other information. 1. WHAT IMODIUM ® PLUS 2MG/125MG TABLETS ARE, AND WHAT THEY ARE USED FOR The tablets contain two active ingredients: • 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. • Simeticone, which breaks up the gas bubbles in the bowel that causes cramps and bloating. IMODIUM ® Plus 2mg/125mg tablets are used in adults and adolescents aged 12 years and above, to treat a short‑lived attack of diarrhoea when it occurs with stomach cramps, bloating and wind. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IMODIUM® PLUS 2MG/125MG TABLETS DO NOT TAKE IMODIUM ® PLUS 2MG/125MG TABLETS: • In children less than 12 years old. • If you are allergic (hypersensitive) to loperamide hydrochloride, simeticone or any of the other ingredients of the tablets (see section 6). • If you have a high temperature (e.g. above 38° C) or blood in your stools. • If you are having a flare up of an inflammatory bowel condition like ulcerative colitis. • If you have severe diarrhoea afte Read the complete document
Health Products Regulatory Authority 12 April 2023 CRN00CPN7 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Imodium Plus 2 mg/125 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains loperamide hydrochloride 2 mg and simeticone equivalent to 125 mg dimeticone. _Excipient(s) with known effect_ Each tablet contains less than 0.026 mg of benzyl alcohol and less than 4.4 mg of maltodextrin (which contains glucose). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet, uncoated. White, capsule-shaped tablets debossed with "IMO" on one side, the other side is debossed with a line between "2_" _and _"_125_"_. The score line is not intended for breaking the tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Imodium 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 Posology _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. _Paediatric population_ Imodium Plus is contraindicated in children under 12 years (see section 4.3). _Use in the elderly_ No dosage adjustments are required for the elderly. _Use in renal impairment_ No dosage adjustment is necessary in patients with renal impairment. _Use in hepatic impairment_ Although no pharmacokinetic data are available in patients with hepatic insufficiency, Imodium Plus should be used with caution in such patients because of reduced first pass metabolism (see section 4.4). Health Products Regulatory Authority 12 April 2023 CRN00CPN7 Page 2 o Read the complete document