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CARBALAX SUPPOSITORIES

Active substance: SODIUM BICARBONATE

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

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)
Sodium Bicarbonate Ph.Eur.

3

1.30g

1.08g

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 contraindicated.

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.

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
CHEMIDEX HOUSE, UNIT 7, EGHAM BUSINESS VILLAGE
CRABTREE ROAD
EGHAM
SURREY
TW20 8RB
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
23/04/2008

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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