Loperamide 2mg capsules

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Loperamide hydrochloride

Dostupné s:

Kent Pharma (UK) Ltd

ATC kód:

A07DA03

INN (Mezinárodní Name):

Loperamide hydrochloride

Dávkování:

2mg

Léková forma:

Oral capsule

Podání:

Oral

Třída:

No Controlled Drug Status

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: 01040200

Charakteristika produktu

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