产品特点
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Picosulfate Ferring 5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains
5 mg sodium picosulfate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off-white round tablets, 6 mm in diameter, debossed with 5.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short term relief of functional constipation.
Sodium Picosulfate Ferring is indicated in adults and in children aged from 10 years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and children from 10 years of age_
One to two tablets (5 – 10mg) swallowed whole at bedtime.
Dosage can be titrated individually. Once regularity has re-started dosage should be reduced and can usually be
stopped.
SODIUM PICOSULFATE FERRING SHOULD NOT BE TAKEN EVERY DAY FOR MORE THAN FIVE DAYS WITHOUT INVESTIGATING THE
CAUSE OF CONSTIPATION.
_Paediatric population_
Sodium Picosulfate Ferring should not be used in children below 10 years of age.
The safety and efficacy of Sodium Picosulfate Ferring in children below 10 years of age have not been established. No
data are available.
Method of administration
The tablet should be swallowed whole with adequate fluid.
The maintenance of an adequate fluid intake during treatment is essential, especially for younger patients and the
elderly who are more susceptible to the effects of dehydration.
4.3 CONTRAINDICATIONS
Sodium Picosulfate Ferring is contraindicated in patients with ileus, gastrointestinal obstruction, gastrointestinal
ulceration or perforation, acute abdominal surgical conditions including appendicitis, acute inflammatory bowel
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date P
阅读完整的文件
产品特点 