This information is intended for use by health professionals

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 Contraindications

None

4.4 Special warnings and precautions for use

None

4.5 Interaction with other medicinal products 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
6.1 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 granules 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 polyethylene with a polypropylene closure.

6.6 Special precautions for disposal and other 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).

Administrative Data

7. Marketing authorisation holder

ParaPharm Development Limited,

Merlin House,

Brunel Road, Theale,

Reading,

RG7 4AB,

United Kingdom

8. Marketing authorisation number(s)

PL 45953/0002

9. Date of first authorisation/renewal of the authorisation

1st March 2018

10. Date of revision of the text

March 2018