SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

CX Powder

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Chlorhexidine Acetate BP 1% w/w

3.    PHARMACEUTICAL FORM

Powder

4. CLINICAL PARTICULARS

4.1.    Therapeutic Indications

General skin disinfection and antisepsis for topical application only.

4.2.    Posology and Method of Administration

Apply lightly to the affected area up to three times daily. The dosage schedule does not require adjustment for adults, children or the elderly. The dosage is as stated for both the clinical indications, vis skin disinfection and antisepsis.

4.3.    Contra-indications

Known hypersensitivity to chlorhexidine.

4.4.    Special Warnings and Precautions for Use

Skin sensitivity to Chlorhexidine salts has occurred occasionally, Chlorhexidine salts are irritant to the conjunctiva and other sensitive tissue.

4.5. Interactions with other Medicaments and other forms of Interaction

None known.

4.6. Pregnancy and Lactation

No special precautions need to be taken when used in pregnancy and lactation.

4.7. Effects on Ability to Drive and Use Machines

None known.

4.8 Undesirable effects

None known.

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, Website: www.mhra.gov.uk/yellowcard.

4.9. Overdose

Not applicable. Ingestion of Chlorhexidine salts should be treated symptomatically, unless gastric lavage is required from other clinical considerations.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic Properties

Chlorhexidine Acetate is an antibacterial substance which is effective against a wide range of gram-positive and gram-negative bacteria. It has limited activity against some viruses and fungi. It is inactive against bacterial spores at room temperature and some strains of pseudomonas and proteus tend to be less susceptible than other bacteria.

Sterilisable Maize Starch BP is an absorbent powder.

5.2.    Pharmacokinetic Properties

Not applicable. The product is for topical application and significant systematic absorption does not occur.

5.3.    Preclinical Safety Data

None stated

6. PHARMACEUTICAL PARTICULARS

6.1.    List of Excipients

Sterilisable Maize Starch BP.

6.2.    Incompatibilities

Not applicable.

6.3.    Shelf Life

2 years

6.4.    Special Precautions for Storage

Store below 25°C. Protect from light.

6.5.    Nature and Contents of Container

CX Powder is packed in LDPE bottles fitted with a nozzle plug and white plastic cap.

Pack size 15g.

6.6. Instruction for Use/Handling

Not applicable.

7    MARKETING AUTHORISATION HOLDER

Ecolab Ltd,

Lotherton Way,

Garforth, Leeds,

LS25 2JY.

8. MARKETING AUTHORISATION NUMBER

PL 04509/0011

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

05/12/2008

10    DATE OF REVISION OF THE TEXT

03/07/2015