البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
LOPERAMIDE HYDROCHLORIDE
McNeil Healthcare (Ireland) Ltd
A07DA03
LOPERAMIDE HYDROCHLORIDE
2mg Milligram
Tablets
Product not subject to medical prescription
Antipropulsives
Authorised
2009-06-25
Orodispersible TOP AW_117787.pdf - Page 1 of 3 - April 6, 2017 - 07:14:14 _Instants _ 2mg T ablets _Loperamide _ _Hydrochloride_ ■ 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 su ff er from any of the conditions mentioned in _Section 2 _ ▶ 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 like ULCERATIVE COLITIS . ■ If you are CONSTIPATED or your STOMACH APPEARS SWOLLEN (particularly in children with severe dehydration). ■ If you have ACUTE DYSENTERY, the symptoms of which may include BLOOD IN YOUR STOOLS and a HIGH TEMPERATURE . ■ If you have had a BACTERIAL INFECTION of the small intestine or colon. ■ If you have a BLOCKAGE OF THE BOWEL, including a blockage due to paralysis of the bowel wall. ■ If you have an ENLARGEMENT OF THE COLON, particularly if this enlargement is very rapid. If any of these apply to you, GET ADVICE FROM A DOCTOR OR ® If you are unsure about any of the medicines you are taking, show the bottle or pack to your pharmacist. If any of these bullet points apply to you now or in the past, TALK TO A DOCTOR OR PHARMACIST. IF YOU ARE PREGNANT OR BREAST-FEEDING ■ Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant, think you are pregnant or planning to become pregnant. ■ Do not take this medicine if you are breast-feeding as small amounts may get into your milk. Talk to your d اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Imodium Instants 2 mg Orodispersible Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Loperamide hydrochloride 2 mg per tablet. Excipients: Each tablet contains 750 micrograms of Aspartame (E951) and the Mint flavouring contains traces of Sulphites. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet. 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. 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_ _ _ _2_ _3_ _/_ _0_ _5_ _/_ _2_ اقرأ الوثيقة كاملة