Section 1 Name of the medicinal product
“in sachet” added to the product name
Section 2 Qualitative and quantitative composition
Weight of each sachet added.
Number of mmoles of potassium in each sachet added.
Section 3 Pharmaceutical form
“in sachet” added to pharmaceutical form
Product description amended to “white crystalline powder with a lemon flavour”
Section 4.1 Therapeutic indications
Indications amended to “for bowel cleansing prior to any diagnostic procedures requiring a clean bowel e.g. colonoscopy or x-ray examination”
Section 4.2 Posology and method of administration
Directions for reconstitution moved to section 6.6
Children’s dosage removed
Adults classified as aged 18 years and over:
Section 4.3 Contraindications
Severe dehydration, hypermagnesaemia, and ascites added
Do not use in patients with rhabdomyolysis as laxatives may induce rhabdomyolysis and may therefore exacerbate the condition.
Section 4.4 Special warnings and precautions for use
Extensive updates to this section please refer to the SPC.
Section 4.5 Interaction with other medicinal products and other forms of interaction
Tetracycline and fluoroquinolone antibiotics, and pencillamine, should be taken at least 2 hours before and not less than 6 hours after administration of CitraFleet to avoid chelation with magnesium.
Section 4.6 Pregnancy and lactation
No clinical data on exposed pregnancy or reproductive toxicity available. As picosulfate is a stimulant laxative, for safety measure, it is preferable to avoid the use of CitraFleet during pregnancy.
There is no experience with the use of CitraFleet in nursing mothers. However, due to the pharmacokinetic properties of the active ingredients, treatment with CitraFleet may be considered for females who are breastfeeding.
Section 4.7 Effects on ability to drive and use machines
CitraFleet may cause fatigue or dizziness, probably as a result of dehydration, and this may have a mild to moderate effect on the ability to drive or use machinery.
Section 4.8 Undesirable effects
Extensive updates to this section please refer to the SPC.
Section 4.9 Overdose
No cases of overdose with CitraFleet, or similar combinations have been reported. However, due to its modes of action, an overdose of CitraFleet would be expected to cause profuse diarrhoea with dehydration and electrolyte loss. Dehydration could also lead to orthostatic hypotension and dizziness. Dehydration and electrolyte imbalances should be corrected with fluid and electrolytes as necessary.
Section 5.1 Pharmacodynamic properties
The action is of a powerful 'washing out' effect …is replaced with “the action is of a potent 'washing out' effect …
Section 5.2 Pharmacokinetic properties
In patients with severely reduced renal function, accumulation of magnesium in plasma may occur.
Section 5.3 Preclinical safety data
Prenatal developmental studies in rats and rabbits did not reveal any teratogenic potential after oral dosing of sodium picosulfate up to 100 mg/kg/d, but embryotoxicity had been observed in both species at this dose level. In rat’s daily doses of 10mg/kg during late gestation (fetal development) and lactation reduced body weights and survival of the offspring. Male and female fertility was not affected by oral doses of sodium picosulfate up to 100 mg/kg.
Section 6.1 List of excipients
Components of the lemon flavour added
Section 6.3 Shelf life
Shelf life of unopened sachets reduced from 24 months to 18 months
Use immediately after reconstitution added.
Section 6.6 Special precautions for disposal
Directions for reconstitution added from section 4.2
Section 10 Date of Revision of the Text
September 2007
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