CITRAFLEET Powder for Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SODIUM PICOSULFATE MAGNESIUM OXIDUM LEVE CITRIC ACID

Available from:

Laboratorios Casen-Fleet S.L.U.

INN (International Name):

SODIUM PICOSULFATE MAGNESIUM OXIDUM LEVE CITRIC ACID

Pharmaceutical form:

Powder for Oral Solution

Prescription type:

Product subject to prescription which may not be renewed (A)

Authorization status:

Authorised

Authorization date:

0000-00-00

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
CitraFleet, Powder for oral solution in sachet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet (15.08 g) contains the following active ingredients:
Each sachet also contains 5 mmol (or 195 mg) potassium (see section 4.4).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution, in sachet
White crystalline powder with a lemon flavour
.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For bowel cleansing prior to any diagnostic procedures requiring a clean bowel e.g. colonoscopy or x-ray examination.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Route of administration: Oral_
A low residue diet is recommended on the day prior to the hospital procedure. To avoid dehydration during treatment
with CitraFleet, it is recommended to drink approximately 250 ml per hour, of water or other clear fluid while the
washout effect persists.
_Directions for reconstitution_:
Refer to section 6.6.
_Adults (including the elderly) aged 18 years and over:_
One sachet reconstituted in water as directed, taken before 8 am on the day before the procedure. Second sachet 6 to 8
hours later.
4.3 CONTRAINDICATIONS
Hypersensitivity to any of the ingredients of the product, congestive cardiac failure, severe dehydration,
hypermagnesaemia,gastric retention, gastro-intestinal ulceration, toxic colitis, toxic megacolon, ileus, nausea and
vomiting, ascites
,
acute surgical abdominal conditions such as acute appendicitis and known or suspected gastro-
intestinal obstruction or perforation.
Sodium picosulfate
10.0 mg
Light magnesium oxide
3.5 g
Citric acid anhydrous
10.97 g
IRISH MEDICINES BOARD
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_Date Printed 30/05/