Conotrane Cream
SUMMARY OF PRODUCT CHARACTERISTICS
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
None stated.
7 MARKETING AUTHORISATION HOLDER
Astellas Pharma Ltd.
2000 Hillswood Drive
Chertsey
Surrey
KT16 0RS
UK
8 MARKETING AUTHORISATION NUMBER
PL 00166/0178
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
01/07/1998 / 16/07/2003
10
DATE OF REVISION OF THE TEXT
09/12/2015