IMODIUM 1MG/5ML 0.2mg/5ml MG/5ml

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

LOPERAMIDE HYDROCHLORIDE

Fáanlegur frá:

McNeil Healthcare (Ireland) Ltd

INN (Alþjóðlegt nafn):

LOPERAMIDE HYDROCHLORIDE

Skammtar:

0.2mg/5ml MG/5ml

Gerð lyfseðils:

Product subject to prescription which may be renewed (B)

Leyfisstaða:

Authorised

Leyfisdagur:

0000-00-00

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imodium 1mg/5ml Oral Solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of oral solution contains 1mg loperamide hydrochloride.
Excipients: Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Alcohol
3 PHARMACEUTICAL FORM
Oral solution.
A clear, red, slightly viscous fruit-flavoured oral solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults
As an adjunct in the management of acute diarrhoea, together with appropriate fluid and electrolyte replacement.
In the symptomatic control of diarrhoea associated with chronic inflammatory bowel disease, eg., Crohn’s disease and
ulcerative colitis, as an adjunct to specific measures such as corticosteroids and sulphasalazine. Use in these conditions
should be under specialist supervision.
In the adjunctive short-term, control of post-surgical diarrhoea, including ileostomy.
Children
For the occasional use in the control of intractable diarrhoea under specialist supervision.
Since persistent diarrhoea can be an indicator of potentially serious conditions, the underlying cause must always be
investigated.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of Administration
Oral use.
a.
As an adjunct in the management of acute diarrhoea
_Adults and children 9-12 years_
2 to 4mg (10 to 20ml) is the usual initial dose, followed by 2mg (10ml) three times daily. The maximum daily dose
should not exceed 10mg.
_Children 4-8 years_
A total maximum daily dose of 4mg (20ml) in divided doses.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 29/02/2012_
_CRN 2100711_
_page number: 1_
_Children under 4 years_
Not recommended.
_Use in Elderly_
No dose adjustment is required for the eld