Carbex

Carbex

Each 2.8 gram sachet of granules contains:

Each 10ml bottle of Carbex solution contains:

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.

None.

None Known.

No interaction studies have been performed.

Pregnancy

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.

Breast feeding

As simeticone is not absorbed from the gastrointestinal tract it will not appear in human breast milk.

Fertility

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.

Carbex Granules

Povidone

Mannitol

Lemon flavour

Carbex Solution

Methylparaben.

Propylparaben

Saccharin sodium

Orange flavour

Purified Water

None known

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,

Merlin House,

Brunel Road, Theale,

Reading,

RG7 4AB,

United Kingdom

PL 45953/0002

1^st March 2018

1^st July 2021