Carbex
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
CARBEX
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients
Each 2.8 gram sachet of granules contains:
Sodium Bicarbonate Ph. Eur. 1.26g
Simethicone 0.042g
Each 10ml bottle of Carbex solution contains:
Citric Acid Ph. Eur. 1g in 10ml
3. PHARMACEUTICAL FORM
Separate granules and solution for oral administration.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Gas producing agent for double contrast radiography of the gastrointestinal tract. Carbex is given orally.
4.2 Posology and Method of Administration
The contents of one sachet (2.8g) of Carbex granules are placed on the patient's tongue and then immediately washed down with 10ml of the solution. It is recommended that the barium should be swallowed thirty seconds later.
4.3
Contra-indications
None
4.4 Special Warnings and Precautions for Use
None
4.5 Interactions with other Medicaments and other forms of Interaction
None Known
4.6 Pregnancy and Lactation
No known effect
4.7 Effects on Ability to Drive and Use Machines
No known effects
4.8 Undesirable Effects
No known effect
4.9 Overdose
Not applicable
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic Properties
Sodium bicarbonate and citric acid react to produce carbon dioxide in the gastrointestinal tract. Simethicone is present to prevent excessive bubble formation during the release of gas.
5.2 Pharmacokinetic Properties
Not applicable
5.3 Preclinical 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 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Carbex Granules
Povidone BP Mannitol Ph. Eur.
Lemon Flavour
Carbex Solution
Methylparaben Ph. Eur.
Propylparaben Ph. Eur.
Saccharin Sodium BP Orange Flavour Purified Water
6.2 Incompatibilities
None known
6.3 Shelf-Life
Shelf life of sachets and solution (unopened): 36 months.
6.4
Special Precautions for Storage
Do not store above 25°C
6.5 Nature and contents of container
Carbex is supplied as a pack containing sufficient for one patient treatment. The outer package contains the following:
Part 1: 1 x 2.8g sachets of Carbex granules. The sachet is composed of paper/polyethylene/aluminium foil/surlyn.
Part II: 1 x 10ml bottle of Carbex solution. The bottle is high density polyethylene with a high impact polypropylene screw cap.
6.6 Instruction for Use/Handling
Open one sachet of Carbex granules (Part I). Place the granules on the patient’s tongue. Have the patient immediately swallow the complete contents of the 10ml bottle (Part II).
7. MARKETING AUTHORISATION HOLDER
Nordic Pharma Limited 11 Mount Road Feltham TW13 6AR United Kingdom
8. MARKETING AUTHORISATION NUMBER(S)
PL 05827/0011
9. DATE OF FIRST AUTHORISATION/RENEWAL OF
AUTHORISATION
1 October 2002
10 DATE OF REVISION OF THE TEXT
19/08/2013