Loperamide 2mg capsules

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Loperamide hydrochloride

Saatavilla:

Almus Pharmaceuticals Ltd

ATC-koodi:

A07DA03

INN (Kansainvälinen yleisnimi):

Loperamide hydrochloride

Annos:

2mg

Lääkemuoto:

Oral capsule

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 01040200; GTIN: 05060057402870

Valmisteyhteenveto

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