Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
LOPERAMIDE HYDROCHLORIDE
McNeil Healthcare (Ireland) Ltd
A07DA03
LOPERAMIDE HYDROCHLORIDE
2mg Milligram
Capsule
Product not subject to medical prescription
Antipropulsives
Authorised
2008-08-15
FACE 1 – 1 – Loperamide Hydrochloride 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. ■ 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. ■ 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 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 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 24 hours. WHAT IS IN THIS LEAFLET 1. What ARRET™ Capsules are, and what they are used for. 2. What you need to know before you take ARRET™ Capsules. 3. How to take ARRET™ Capsules. 4. Possible side effects. 5. How to store ARRET™ Capsules. 6. Contents of the pack and other information. 1 WHAT ARRET™ CAPSULES ARE AND WHAT THEY ARE USED FOR ARRET™ 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, which helps the body to absorb water and salts from the bowel. ARRET™ Capsules should be used in conjunction with oral re Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Arret 2mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains loperamide hydrochloride 2 mg. Excipients contain Lactose Monohydrate 127.0 mg per capsule. For a full list of excipients see Section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard (short term: capsule) Brown and light green hard gelatine capsules containing a white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an adjunct in the management of acute diarrhoea together with fluid and electrolyte replacement. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. The capsules should be taken with water. Adults and children over 12 years only: The usual dose is 2 capsules initially, followed by 1 capsule after each further episode of diarrhoea up to a maximum of 5 in 24 hours. 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, Arret should be used with caution in such patients because of reduced first pass metabolism_ (see 4.4 Special warning and precautions for use)._ Method of Administration: Oral. 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_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _9_ _2_ _3_ _7_ _0_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.3 CONTRAINDICATIONS Arret Lees het volledige document