Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
LOPERAMIDE HYDROCHLORIDE
McNeil Healthcare (Ireland) Ltd
A07DA03
LOPERAMIDE HYDROCHLORIDE
2 Milligram
Capsules, Soft
Product not subject to medical prescription
Antipropulsives
Authorised
2011-04-01
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. n This medicine is used to treat the sudden short-lived (acute) attacks of diarrhoea in adults and children aged 12 years and over. n Do not take this medicine: n There are some people who should not use this medicine. To find out if you are one of them. _See Section 2_ n I f you have ever had a bad reaction to any of the ingredients. For the list of ingredients. _See Section 6_ n Speak to your doctor: n If you suffer from any of the conditions mentioned in _Section 2_ n If you are taking any other medicines. See _Section 2_ n Follow the dosage instructions carefully. These are shown in the dosage tables. _See Section 3_ Now read this whole leaflet carefully before you use this medicine. n Keep this leaflet. You may need to read it again. n Ask your pharmacist if you need more information or advice. n If you get any side effects, talk to your pharmacist. This includes any possible side effects not listed in this leaflet. _See Section 4_ n You must talk to a doctor if you do not feel better or if you feel worse after 24 hours. What is in this leaflet 1. What IMODIUM ® LiquiRelief Capsules are, and what they are used for. 2. What you need to know before you take IMODIUM ® LiquiRelief Capsules. 3. How to take IMODIUM ® LiquiRelief Capsules. 4. Possible side effects. 5. How to store IMODIUM ® LiquiRelief Capsules. 6. Contents of the pack and other information. 1 What IMODIUM ® LiquiRelief Capsules are and what they are used for IMODIUM ® LiquiRelief Capsules 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 capsules contain loperamide hydrochloride which helps reduce diarrhoea by slowing down an overactive bowel to its normal rhythm, which helps the body to absorb water and salts from the bowel. 2 read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Imodium LiquiRelief 2mg Soft Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 2 mg Loperamide hydrochloride. Contains trace amounts of soya lecithin. For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Capsule, soft (Capsules) A clear blue size 2, oval soft gelatin capsule 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic treatment of acute diarrhoea in adults and children aged 12 years and over. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ACUTE DIARRHOEA Adults and children aged 12 years and over: 2 capsules initially followed by 1 capsule after every loose stool. The capsules should be taken with water. The maximum daily dose should not exceed 5 capsules. USE IN 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 LiquiRelief should be used with caution in such patients because of reduced first pass metabolism. (see 4.4 Special warnings and special precautions for use). Method of administration Oral use. 4.3 CONTRAINDICATIONS Imodium LiquiRelief must not be used in: Children less than 12 years of age Patients with a known hypersensitivity (allergy) to any component of the product 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _6_ _/_ _0_ _7_ _/_ _2_ _0 read_full_document