Loperamide 2mg capsules

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Loperamide hydrochloride

Prieinama:

Alliance Healthcare (Distribution) Ltd

ATC kodas:

A07DA03

INN (Tarptautinis Pavadinimas):

Loperamide hydrochloride

Dozė:

2mg

Vaisto forma:

Oral capsule

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 01040200

Prekės savybės

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