Loperamide 2mg capsules

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Loperamide hydrochloride

Dostopno od:

Sigma Pharmaceuticals Plc

Koda artikla:

A07DA03

INN (mednarodno ime):

Loperamide hydrochloride

Odmerek:

2mg

Farmacevtska oblika:

Oral capsule

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 01040200

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Loperamide 2 mg Capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 2mg loperamide hydrochloride.
Excipient(s) with known effect:
Each capsule contains 109.00 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard (Capsule)
Size '4' (about 14 mm in length) Hard gelatin capsule with Green cap
imprinted with
'L' in black ink & grey body imprinted with '2mg' in black ink,
containing white to
off-white powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic treatment of acute diarrhoea in adults and
children aged 12 years
and over.
For the symptomatic treatment of acute episodes of diarrhoea
associated with Irritable
Bowel Syndrome in adults aged 18 years and over following initial
diagnosis by a
doctor.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ACUTE DIARRHOEA
Adults and children over 12:
Two capsules (4 mg) initially, followed by one capsule (2 mg) after
each loose stool.
The usual dose is 3-4 capsules (6 mg – 8 mg) a day. The total 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).
PAEDIATRIC POPULATION
Loperamide 2 mg Capsules are contraindicated in children less than 12
years of age.
USE IN 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,
Loperamide 2 mg Capsules 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
Or