Summary of Product Characteristics (SmPC) - Carbalax suppositories
1 NAME OF THE MEDICINAL PRODUCT
CARBALAX SUPPOSITORIES
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains:
Sodium acid phosphate anhydrous
(equivalent to Sodium Acid Phosphate Ph.Eur. 1.69g) 1.30g
Sodium Bicarbonate Ph.Eur. 1.08g
3 PHARMACEUTICAL FORM
Suppository for rectal administration
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Chronic simple constipation. Constipation due to prolonged bed-rest or to drugs. Bowel evacuation before childbirth, surgery, sigmoidoscopy, radiological examination and post-operatively. To avoid discomfort associated with straining. To regularise bowel movement and keep stools to normal consistency in local anal conditions such as haemorrhoids, fissures and fistulae.
4.2 Posology and method of administration
Adults and the Elderly:
Administer one suppository 30 minutes before evacuation is required.
Children under 12:
Not recommended.
4.3 Contraindications
Conditions where any bowel medication for the relief of constipation is contra-indicated.
4.4 Special warnings and precautions for use
The suppository should be moistened with water, not lubricated with oil before insertion.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Pregnancy and lactation
No restriction.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Side effects are unlikely.
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
Overdose has not been reported.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Carbalax Suppositories function by a physical induction of reflex bowel evacuation caused when carbon dioxide is liberated when the suppository contacts moisture. Bowel action will usually take place within half an hour of administration.
5.2 Pharmacokinetic properties
If any bicarbonate is not converted to carbon dioxide it may be absorbed and excreted as bicarbonate ions in the urine. Any absorbed phosphate will also eventually be excreted in the urine.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber that might add to the safety data provided in other sections of this SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Polyethylene glycol 1500
6.2 Incompatibilities
None stated.
6.3 Shelf life
One year.
6.4 Special precautions for storage
Store below 25°C in a dry place.
6.5 Nature and contents of container
Each suppository is contained in a PVC shell. The shells are supplied in strips of 12 in a cardboard carton of 12 or 60 suppositories.
6.6 Special precautions for disposal
None stated.
7 MARKETING AUTHORISATION HOLDER
CHEMIDEX PHARMA LIMITED
8a CRABTREE ROAD
EGHAM
SURREY
TW20 8RN
UNITED KINGDOM
8 MARKETING AUTHORISATION NUMBER(S)
PL 17736/0103
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
02 May 1990 / 22 September 1997
10 DATE OF REVISION OF THE TEXT
17/02/2026