Product Summary

1.    Tradename of the Medical Product

Vesagex Antiseptic Cream.

2.    Qualitative and Quantitative Composition

Cetrimide BP 1.0% w/w For excipients, see 6.1.

3.    Pharmaceutical Form

A White opaque cream

Clinical Particulars

4.1. Therapeutic Indications

As an antiseptic cream for cuts and abrasions, minor skin disorders, dry and cracked skin, minor burns and nappy rash.

4.2    Posology and method of administration

For external use only

For all ages and all listed indications; apply liberally as required

First aid: gently wash and dry the affected area, then apply the cream to soothe

and help prevent infection.

Nappy rash: when changing the nappy, gently wash and dry the baby’s skin and then apply the cream.

4.3.    Contra-indications

For cutaneous use only.

Hypersensitivity to any of the ingredients.

4.4    Special warnings and precautions for use

Keep out of reach and sight of children

Not for use around the eyes or ears.

If symptoms persist, discontinue use and consult your doctor.

Contains chlorocresol - may cause allergic reactions

Contains cetostearyl alcohol - may cause local skin reactions (eg contact dermatitis)

4.5. Interactions with other Medicaments and other forms of Interaction

Not applicable.

4.6. Pregnancy and Lactation

None stated.

4.7. Effects on ability to drive and use machines

No or negligible influence.

4.8    Undesirable effects

Excessive dryness of the skin may occur in patients who become hypersensitive to cetrimide.

Hypersensitivity may occur, presenting as localised contact dermatitis. Discontinue use.

4.9    Overdose

Ingestion may cause nausea and vomiting. Toxic symptoms include dyspnoea and cyanosis, possibly leading to asphyxia. Depression of the central nervous system, hypotension and coma may also occur.

Treatment of poisoning is symptomatic. Demulcents may be given if necessary but emesis and lavage should be avoided.

5.    Pharmacological Properties

5.1.    Pharmacodynamic Properties

D08A J04 - Antiseptics and disinfectants, quaternary ammonium compounds

Cetrimide is a quaternary ammonium disinfectant with properties and uses typical of cationic surfactants. These surfactants dissociate in aqueous solution into a relatively large and complex cation, which is responsible for the surface activity, and a smaller inactive cation. It has bactericidal activity against Gram-positive and, at higher concentrations, against some Gramnegative organisms.

5.2. Pharmacokinetic Properties

Vesagex Antiseptic Cream is intended for cutaneous use only.

5.3. Preclinical safety data

No data of relevance which is additional to that already included in other sections of the SPC.

Pharmaceutical Particulars

6.1.    List of Excipients

Chlorocresol Liquid Paraffin Cetostearyl alcohol Glycerol Verbena Oil Purified Water

6.2.    Incompatibilities

Not applicable, cutaneous preparation.

6.3.    Shelf Life

36 months.

6.4.    Special precautions for storage

Do not store above 25°C.

6.5.    Nature and Contents of Container

Pack size 500g

pack size 15g, 30g and 60g

Not all packed sizes may be marketed

6.6. Instruction for Use/Handling

Not applicable.

7.    MARKETING AUTHORISATION HOLDER

Strides Shasun (UK) Ltd Unit 4 Metro Centre Tolpits Lane Watford Hertfordshire WD18 9SS

Trading as: Co-pharma

8.    Marketing Authorization Number

PL 13606/0079

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

14/07/2006

10 DATE OF REVISION OF THE TEXT

18/05/2016