Active substance(s): CITRIC ACID ANHYDROUS / MAGNESIUM CARBONATE HEAVY
NAME OF THE MEDICINAL PRODUCT
QUALITATIVE AND QUANTITATIVE COMPOSITION
Heavy Magnesium Carbonate BP:
Anhydrous Citric Acid BP:
} per sachet
White, effervescent powder with the odour of lemon and lime contained in a
foil, laminate sachet.
For the preparation of the patient for all radiological endoscopy or
colonoscopy examinations requiring a completely evacuated bowel. May also
be used for colorectal surgery.
Posology and Method of Administration
Citramag is for oral administration.
First dose - At 7.30am on the day before the examination, the contents of one
sachet is dissolved in 200m1 or 8 fi. oz of hot water. At 8.00 the aqueous
solution of magnesium citrate is taken orally.
Second dose - Between 2.00 and 4.00pm on the day prior to examination, one
sachet to be taken as above.
The dose may be reduced for very ill or very thin, elderly patients who may
tolerate vigorous purgation poorly.
Timings as for adults.
Age 10 or over
Reduce the dose to half the adult dose.
Reduce the dose to one third the adult dose.
The examination may be preceded by a low residue or fluid only diet
according to the instructions of the prescribing clinician. Throughout the day,
plenty of clear fluids should be drunk between taking Citramag and the
Citramag is contra-indicated in patients with severely reduced renal function.
Because of the risk of toxic hypermagnesaemia in certain patient groups Citramag is
contra-indicated in patients with known or suspected gastrointestinal obstruction or
perforation, ileus, gastric retention, acute intestinal or gastric ulceration, toxic colitis
or toxic megacolon, active inflammatory bowel disease. (Refer to sections 4.4 and 4.8
for further information.)
Special warnings and precautions for use
The risk of toxic hypermagnesaemia indicates the need for caution in the
administration of magnesium citrate to patients with renal impairment. Single
case reports of hypermagnesaemia in the scientific literature with magnesium
citrate containing medicinal products indicate that patients with
gastrointestinal passage disorders or intestinal inflammation may develop toxic
hypermagnesaemia in the absence of renal function impairment. Toxic
hypermagnesaemia should be considered in patients developing clinical
symptoms such as lethargy, hyporeflexia, arrhythmia, bradycardia, QT
prolongation or respiratory depression. (Refer to sections 4.3 and 4.8 for
The dosage may be reduced for very ill or very thin, elderly patients who may tolerate
vigorous purgation poorly.
4.5. Interactions with other Medicinal Products and other Forms of
Pregnancy and Lactation
Use at the discretion of the physician.
Effects on Ability to Drive and Use Machines
Toxic hypermagnesaemia should be considered in patients developing clinical
symptoms such as lethargy, hyporeflexia, arrhythmia, bradycardia, QT prolongation
or respiratory depression. (Refer to sections 4.3 and 4.4 for further information.)
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via the yellow card scheme at: www.mhra.gov.uk/yellowcard
The mechanism of action of osmotic laxative is unknown though it is believed
that the action results from the hyperosmotic effect of poorly absorbed
magnesium within the small intestine and from the retention of water which
indirectly stimulates stretch receptors and increases peristalsis. The laxative
action of magnesium may also be a result of cholecystokinin release or
decrease transit time.
When osmotic laxative containing magnesium are administered orally
approximately 15% - 30% may be absorbed (probably by the small intestine)
by an active process. Magnesium is excreted principally by the kidneys.
Pre-clinical Safety Data
There are no pre-clinical data of relevance to the prescriber which are
additional to that already included in other sections of the SPC.
List of Excipients
Saccharin Sodium BP
Special Precautions for Storage
Nature and Contents of Container
The product is contained in a hermetically sealed aluminium foil/plastic
laminate sachet which has been purged with oxygen free nitrogen gas to
produce an inert atmosphere within the sachet. Each sachet contains 29.5g of
powder and 10 sachets are subsequently packed in a printed boxboard carton.
Instructions for Use, Handling and Disposal
MARKETING AUTHORISATION HOLDER
Sanochemia Diagnostics UK Ltd.
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION / RENEWAL OF THE
23 January 2002
DATE OF REVISION OF THE TEXT