Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
LOPERAMIDE HYDROCHLORIDE DIMETICONE
McNeil Healthcare (Ireland) Ltd
2 mg/125mg Milligram
Tablets Chewable
2009-12-04
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Imodium Plus 2mg/125mg Chewable Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains loperamide hydrochloride 2 mg and simeticone equivalent to 125 mg dimeticone. Excipients: include 300 mg sorbitol (E420) and approximately 50 mg sucrose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable tablet. Whhite, round, flat-faced tablets wiht a vanilla-mint odour debossed with "IMO" on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Imodium Plus is 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 Adults over 18 years: Chew 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: Chew 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. Use in children: Imodium Plus must not be used in children under 12 years. Use in the elderly: No dosage adjustments are required for the elderly. Renal impairment: No dosage adjustment is necessary in renal impairment. 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 4.4 Special warnings and special precautions for use). IRISH MEDICINES BOARD _______________________________________________________________________________________________ Izlasiet visu dokumentu