Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Loperamide hydrochloride
Wockhardt UK Ltd
A07DA03
Loperamide hydrochloride
2mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01040200; GTIN: 5012727912103
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Loperamide Hydrochloride 2mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains Loperamide Hydrochloride 2mg. Excipient with known effect: Each capsule contains 127mg of lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard (capsule) Grey-dark green coloured hard gelatine size 3 capsules, filled with a homogeneous white to off white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The symptomatic treatment of acute diarrhoea of any aetiology, including acute exacerbations of chronic diarrhoea, for periods of up to 5 days in adults and children over 9 years. The symptomatic treatment of chronic diarrhoea in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology: _ ACUTE DIARRHOEA Adults and Children (9 – 17) years: The initial dose is two capsules (4mg) for adults and one capsule (2mg) for children, followed by one capsule (2mg) after every subsequent loose stool for up to five days. The maximum daily dose should not exceed six capsules (12mg). CHRONIC DIARRHOEA Adults only The initial dosage is two capsules (4mg) daily. This initial dose should be adjusted until one to two solid stools per day are obtained, which is usually achieved with a maintenance dose of one to six capsules (2 mg-12 mg) daily. The maximum daily dose should not exceed six capsules (12 mg) daily. Paediatric population Loperamide is contraindicated in children less than 9 years of age. Elderly No dose adjustment is required for the elderly. Patients with renal impairment No dose adjustment is required for patients with renal impairment. Patients with hepatic impairment Although no pharmacokinetic data are available in patients with hepatic impairment, loperamide HCl should be used with caution in such patients because of reduced first pass metabolism. (See section 4.4 Special warnings and precautions for use). METHOD OF ADMINISTRATION For oral administration. The capsules should be taken with liquid Izlasiet visu dokumentu