This information is intended for use by health professionals

1. Name of the medicinal product

Conotrane cream

2. Qualitative and quantitative composition

Conotrane cream contains the active substances benzalkonium chloride (0.1% w/w) and dimeticone (22.0% w/w).

Excipient(s) with known effect: cetostearyl alcohol

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Cream

A smooth, white 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

For cutaneous use. The cream should be applied to the affected area(s) several times a day, as necessary or after every napkin change.

4.3 Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.

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

No interaction studies have been performed.

4.6 Fertility, pregnancy and lactation

There are no or limited amount of data from the use of Conotrane in pregnant women. It is unknown whether benzalkonium chloride, dimeticone or their metabolites are excreted in human milk.

4.7 Effects on ability to drive and use machines

Not relevant.

4.8 Undesirable effects

Local hypersensitivity to benzalkonium chloride is rare.

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 at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Not applicable.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antiseptics and disinfectants. ATC code: D08A J01

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 jar with HDPE tamper evident lid.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

None stated.

7. Marketing authorisation holder

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Denmark

8. Marketing authorisation number(s)

PL 05293/0009

9. Date of first authorisation/renewal of the authorisation

Date of first authorisation: 01 July 1998

Date of latest renewal: 16 July 2003

10. Date of revision of the text

01 March 2017