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Nordic Pharma Limited

1650 Arlington Business Park, Reading , Berkshire , RG7 4SA
Telephone: +44 (0) 118 929 8233
Fax: +44 (0) 118 929 8234
E-mail: nordic@professionalinformation.co.uk
Medical Information Direct Line: +44 (0) 800 121 8924
Customer Care direct line: +44 (0) 118 929 8236
Medical Information Fax: +44 (0) 44 1748 828801

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Summary of Product Characteristics last updated on the eMC: 11/07/2011
SPC Carbex


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1. NAME OF THE MEDICINAL PRODUCT

Carbex


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredients

Each 2.8 sachet of granules contains:

Sodium Bicarbonate EP

1.26g

Simethicone

0.042g

Each 10ml sachet of Carbex solution contains:

Citric Acid EP 1g in 10ml


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3. PHARMACEUTICAL FORM

Separate granules and solution for oral administration


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

Gas producing agent for double contrast radiography of the gastrointestinal tract. Carbex is given orally.


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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.


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4.3 Contraindications

None


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4.4 Special warnings and precautions for use

None


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4.5 Interaction with other medicinal products and other forms of interaction

None Known


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4.6 Pregnancy and lactation

No known effect


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4.7 Effects on ability to drive and use machines

No known effects


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4.8 Undesirable effects

No known effect


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4.9 Overdose

Not applicable


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5. PHARMACOLOGICAL PROPERTIES

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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.


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5.2 Pharmacokinetic properties

Not applicable


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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.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Carbex Granules

Povidone BP

Mannitol EP

Lemon Flavour

Carbex Solution

Methylparabens EP

Propylparabens EP

Saccharin Sodium BP

Orange Flavour

Purified Water


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6.2 Incompatibilities

None known


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6.3 Shelf life

Shelf life of granules and solution (unopened): 36 months


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6.4 Special precautions for storage

Do not store above 25° C.


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6.5 Nature and contents of container

Carbex is supplied as a bulk outer containing sufficient for 10 patient treatments. The outer contains the following:

Part 1: 10 x 2.8g sachets of Carbex granules. The sachet is composed of paper/polyethylene/aluminium foil/surlyn.

Part II: 10 x 10ml sachets of Carbex solution. The sachet is composed of paper/polyethylene/aluminium foil/surlyn.


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6.6 Special precautions for disposal and other handling

Pour the contents (10ml) of one sachet of Carbex solution (Part II) into a suitable cup. Open one sachet of Carbex granules (Part I). Place the granules on the patient's tongue. Have the patient immediately swallow the measured solution.


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7. MARKETING AUTHORISATION HOLDER

Nordic Pharma Limited

Abbey House

1650 Arlington Business Park

Theale

Reading

Berkshire

RG7 4SA

United Kingdom


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8. MARKETING AUTHORISATION NUMBER(S)

PL 05827/0011


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

1st October 2002


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10. DATE OF REVISION OF THE TEXT

August 2003



More information about this product

  • Patient Information Leaflets (PILs):

    Carbex

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/21962/SPC/


Active Ingredients/Generics

 
  citric acid
  sodium bicarbonate
  simeticone