Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
LOPERAMIDE HYDROCHLORIDE
Imbat Limited
A07DA03
LOPERAMIDE HYDROCHLORIDE
2 Milligram
Orodispersible Tablet
Product not subject to medical prescription
loperamide
Authorised
2014-08-01
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER IMODIUM ® INSTANTS 2MG ORODISPERSIBLE TABLETS (loperamide hydrochloride) Your medicine is available using the name Imodium Instants 2mg Orodispersible Tablets but will be referred to as Imodium Instants throughout this leaflet. This medicine is used to treat sudden short-lived (acute) attacks of diarrhoea in adults and children aged 12 years and over. DO NOT TAKE 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 are allergic to loperamide or any of the other ingredients of this medicine. _For the list of ingredients see Section 6_ _►_ SPEAK TO YOUR DOCTOR: If you suffer from any of the conditions mentioned in _Section 2 _ _►_ 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 Imodium Instants is a medicine which is used to treat sudden short-lived (acute) attacks of diarrhoea in adults and children aged 12 years and over. The tablets contain loperamide hydrochloride which helps reduce diarrhoea by slowing down an overactive bowel, which helps the body to absorb water and salts from the bowel. Imodium Instants should be used in conjunction with oral rehydration therapy which replace fluids and salts lost during diarrhoea. 2. BEFORE TAKING THIS MEDICINE This medicine is suitable for most people, but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist. DO NOT TAKE THIS MEDICINE… If you are allergic to loperamide or any of the other ingredients of this medicine (listed in section 6). If it is for a child UNDER 12 YEARS OLD. If you have SEVERE DIARRHOEA after taking antibiotics. If you are having a flare up of an INFLAMMATORY BOWEL condition l Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Imodium Instants 2mg Orodispersible Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2mg loperamide hydrochloride. Excipient: aspartame (E951), mannitol (E421) For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet. _Product imported from the UK:_ Imodium Instants are white to off-white, circular, freeze-dried tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an adjunct in the management of diarrhoea together with fluid and electrolyte replacement. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The orodispersible tablet should be placed on the tongue. The tablet will dissolve and is to be swallowed with saliva. No liquid intake is needed for the orodispersible tablet. Adults and children over 12 years only The usual dose is 2 tablets initially, followed by 1 tablet after each further episode of diarrhoea up to a maximum of 5 in 24 hours. Elderly No dose adjustment is required for the elderly. Renal impairment No dose adjustment is required for patients with renal impairment. Hepatic impairment Although no pharmacokinetic data are available in patients with hepatic impairment, Imodium Instants should be used with caution in such patients because of reduced first pass metabolism (see 4.4 Special warnings and precautions for use). Method of administration Oral. 4.3 CONTRAINDICATIONS o Imodium use is contraindicated in patients under 12 years of age. o Imodium Instants are contraindicated in patients with a known hypersensitivity to loperamide hydrochloride or to any of the excipients. o Imodium should not be used as the primary therapy: H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Lire le document complet