Conotrane Cream

1. Name Of The Medicinal Product

Conotrane Cream.

2. Qualitative And Quantitative Composition

A smooth white cream containing benzalkonium chloride 0.1% w/w and Dimeticone 22.0% w/w.

3. Pharmaceutical Form

Cream for topical administration.

4. Clinical Particulars

4.1 Therapeutic Indications

Conotrane is used for protection of the skin from moisture, irritants, chafing and contamination with bacteria or yeasts.

It may be used in situations such as in the prevention/treatment of napkin rash, the prevention of pressure sores and in the management of incontinence.

4.2 Posology And Method Of Administration

The cream should be applied to the affected area several times a day, as necessary or after every napkin change.

4.3 Contraindications

Known hypersensitivity to benzalkonium chloride.

4.4 Special Warnings And Precautions For Use

Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

Not applicable.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Local hypersensitivity to benzalkonium chloride is rare.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

This is a remedy suitable for both prescription and for self medication. It is a cream for topical application containing dimeticone and benzalkonium chloride. The dimeticone is water repellent allowing transpiration of water vapour from the skin. The benzalkonium chloride is a quaternary ammonium compound, active against bacteria and yeasts.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Cetostearyl alcohol

Macrogol cetostearyl ether

White soft paraffin

Light liquid paraffin

Deionised water

Macrogol 300

Potassium dihydrogen orthophosphate

Geranium SC45

6.2 Incompatibilities

None stated.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

(i) 7 g, 15 g, 50 g and 100 g in white LDPE tubes.

(ii) 500 g white polypropylene pot with screw lid.

6.6 Special Precautions For Disposal And Other Handling

None stated.

Administrative Data

7. Marketing Authorisation Holder

Astellas Pharma Limited

Lovett House

Lovett Road

Staines

TW18 3AZ

United Kingdom

8. Marketing Authorisation Number(S)

PL 0166/0178.

9. Date Of First Authorisation/Renewal Of The Authorisation

1 July 1998 / 16^th July 2003

10. Date Of Revision Of The Text

18 January 2008

11. Legal category

GSL