País: Reino Unido
Língua: inglês
Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)
Loperamide hydrochloride
Accord-UK Ltd
A07DA03
Loperamide hydrochloride
2mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01040200; GTIN: 5012617020697
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Loritax 2mg Capsules Loperamide 2mg Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Loperamide hydrochloride 2mg per capsule Excipients with known effect: Contains lactose 100mg per capsule. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule Size 4, green opaque cap and a mauve opaque body, hard gelatin capsule. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Loperamide is indicated for the symptomatic treatment of acute diarrhoea in adults and children aged 12 years and over. Loperamide is also indicated for the symptomatic treatment of acute episodes of diarrhoea associated with Irritable Bowel Syndrome (IBS) in adults aged 18 years and over following initial diagnosis by a doctor. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Loperamide hydrochloride 2mg capsules are for oral administration. The capsules should be taken with liquid. _Adults and children aged 12 years and over _ _ _ _Acute diarrhoea:_ Two capsules initially (4mg), followed by 1 capsule (2mg) after every loose stool. The maximum daily dose should not exceed 6 capsules (12 mg). _Symptomatic treatment of acute episodes of diarrhoea associated with irritable bowel syndrome in _ _adults aged 18 years and over _ Two capsules (4 mg) to be taken initially, followed by 1 capsule (2 mg) after every loose stool, or as previously advised by your doctor. The maximum daily dose should not exceed 6 capsules (12 mg). _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, this medicine should be used with caution in such patients because of reduced first pass metabolism (see section 4.4). Method of administration Oral use. 4.3 CONTRAINDICATIONS Loperamide hydrochloride 2mg capsule is contraindicated: • in patients with known hypersensitivity to loperamide hydr Leia o documento completo