Summary of Product Characteristics Updated 02-Jul-2021 | ParaPharm Development Limited
Each 2.8 gram sachet of granules contains:
Each 10ml bottle of Carbex solution contains:
1g in 10ml
For a full list of excipients, see section 6.1.
Separate granules and solution for oral administration.
Gas producing agent for use as an image enhancer in diagnostic procedures of the stomach and upper gastrointestinal tract.
For oral 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. When used in double contrast radiography, the barium should be swallowed thirty seconds after administration of the Carbex solution.
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
No interaction studies have been performed.
Safety in human pregnancy has not been established in animal studies and there is no significant data on human exposure. However as simeticone is not absorbed, it is not anticipated that Carbex will have adverse effects on pregnancy.
As simeticone is not absorbed from the gastrointestinal tract it will not appear in human breast milk.
The effect on human fertility has not been evaluated.
Carbex has no or negligible influence on ability to drive and use machines
No known effects.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
No cases of overdose have been reported. Theoretically, constipation may occur. Treat with fluids and keep under observation.
Sodium bicarbonate and citric acid react to produce carbon dioxide in the gastrointestinal tract. Simeticone is present to prevent excessive bubble formation during the release of gas.
Simeticone is not absorbed from the gastrointestinal tract.
There are no pre-clinical data of relevance to the prescriber which are additional to those already included in other sections of the SPC.
Shelf life of granules and solution (unopened): 36 months
Do not store above 25° C.
Carbex is supplied as a pack containing sufficient for one patient treatment.
The outer package (cardboard carton) contains the following:
Granules: 1 x 2.8g sachets of Carbex granules. The sachet is composed of paper/polyethylene/aluminium foil/surlyn.
Solution: 1 x 10ml bottle of Carbex solution. The bottle is polyethylene with a polypropylene closure.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
ParaPharm Development Limited,
Brunel Road, Theale,
1st March 2018
1st July 2021
Building 1410, Arlington Business Park, Theale, Reading, RG7 4SA, UK
+44 (0)118 2810151
+44 (0)1183 217 100