Summary of medicine characteristics - CITRAMAG POWDER
1 NAME OF THE MEDICINAL PRODUCT
1 NAME OF THE MEDICINAL PRODUCTCitramag
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient:
Heavy Magnesium Carbonate BP: 11.57g }
} per sachet
Anhydrous Citric Acid BP: 17.79g }
3. PHARMACEUTICAL FORM
White, effervescent powder with the odour of lemon and lime contained in a foil, laminate sachet.
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
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.
4.2. Posology and Method of Administration
Citramag is for oral administration.
Adults:
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.
Children:
Timings as for adults.
Age 10 or over
Reduce the dose to half the adult dose.
Age 5–9
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 examination.
4.3 Contraindications
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.)
4.4 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 further information.)
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 Interaction
None.
4.6. Pregnancy and Lactation
Use at the discretion of the physician.
4.7. Effects on Ability to Drive and Use Machines
None.
4.8 Undesirable effects
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
4.9. Overdose
Treat symptomatically.
5.
PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
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.
5.2. Pharmacokinetic Properties
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.
5.3. 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.
6. PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Saccharin Sodium BP
Lemon-Lime Flav-o-lok
6.2. Incompatibilities
None.
6.3. Shelf-Life
3 years.
6.4. Special Precautions for Storage
None.
6.5. 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.
6.6. Instructions for Use, Handling and Disposal
6.6. Instructions for Use, Handling and DisposalNone.
7 MARKETING AUTHORISATION HOLDER
7 MARKETING AUTHORISATION HOLDERSanochemia Diagnostics UK Ltd.
1 Friary
Temple Quay
Bristol
BS1 6EA
United Kingdom
8. MARKETING AUTHORISATION NUMBER(S)
PL 19088/0001