DIARREST RF

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

LOPERAMIDE HYDROCHLORIDE POTASSIUM CHLORIDE SODIUM CHLORIDE SODIUM CITRATE

Commercializzato da:

Galen Limited

Dosaggio:

1/40/50/50 MG/5ml

Forma farmaceutica:

Oral Solution

Data dell'autorizzazione:

1998-11-27

Scheda tecnica

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diarrest Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENTS:
Each 5ml contains:
EQUIVALENT TO APPROXIMATELY:
For excipients see 6.1.
3 PHARMACEUTICAL FORM
Oral Solution
Straw coloured liquid with a cream soda/orange odour.
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, e.g. 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 may be an indicator of a potentially serious condition, the underlying cause must always be investigated.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
For oral administration.
Loperamide hydrochloride
1.0
mg
Potassium chloride
40.0
mg
Sodium chloride
50.0
mg
Sodium citrate
50.0
mg
Potassium
0.5
mmol/5 ml
Sodium
1.4
mmol/5 ml
Chloride
1.4
mmol/5 ml
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 20/06/2006_
_CRN 2024590_
_page number: 1_
Diarrest Oral Solution administration should be accompanied by an adequate daily fluid intake.
If no improvement in the condition of the patient is seen within two days of commencing treatment then further
investigation into the underlying cause of the diarrhoea should be performed.
ADULTS, THE ELDERLY AND CHILDREN OVER 12�