Summary of Product Characteristics (SmPC) - Ceanel concentrate
1 NAME OF THE MEDICINAL PRODUCT
Ceanel Concentrate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Cetrimide 10.0% w/v
Undecenoic Acid 1.0% v/v
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Shampoo
Clear, viscous, golden-yellow coloured liquid.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
As an adjunct in the management psoriasis of the scalp, seborrhoeic dermatitis, dandruff, psoriasis of the trunk and limbs.
4.2 Posology and method of administration
For topical use only.
Adults, Children and the Elderly:
Scalp Conditions
Wet the scalp and hair with warm water. Protect the eyes with a towel to avoid discomfort. Apply 1/2 -1 teaspoonful of Ceanel to the wetted scalp. Then apply a small amount of water and work up into a lather. Rinse and repeat. Finally rinse the hair and scalp thoroughly. Use three times in the first week and twice weekly thereafter.
Other areas of the body.
Wet the area to be treated with warm water; apply sufficient Ceanel Concentrate by gentle massage to cover the wetted area. Allow to remain in contact for two minutes. Remove the Ceanel by thorough rinsing with warm water. Use as required.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1
4.4 Special warnings and precautions for use
In common with other shampoos, it is suggested that the eyes be closed during treatment to avoid discomfort or that they may be protected with a towel.
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 is inadequate evidence of safety in human pregnancy, but it has been in wide use for many years without apparent ill consequence. As with other medicaments it may be used during pregnancy if the anticipated benefits outweigh the risks. No problems are anticipated during lactation.
4.7 Effects on ability to drive and use machines
Not applicable.
4.8 Undesirable effects
Skin irritation may occasionally occur and hypersensitivity reactions may develop in certain individuals.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
Following accidental ingestion, nausea and vomiting may occur as well as respiratory problems and hypotension. Treatment is supportive and symptomatic avoiding gastric lavage
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other dermatological preparations, medicated shampoos
ATC Code: D11AC
Cetrimide is particularly active against Gram-positive organisms. This feature combined with the fungicidal properties of undecenoic acid makes Ceanel Concentrate particularly effective in the treatment of dermatological conditions, Ceanel Concentrate is effective in removing debris and scale in seborrhoea capitis and psoriasis of the scalp.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
None stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Phenylethyl Alcohol,
Poly Oxy Propylene Stearyl Ether,
`Purified Water BP.
Ninol CDX:
N,N-Bis(hydroxyethyl)octanamide
Diethanolamine
Lauric acid
6.2 Incompatibilities
None known
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
Ceanel Concentrate is available in polyethylene bottles with a screw top.
Pack sizes: 150ml and 500ml. Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
Derma UK Ltd
The Toffee Factory
Lower Steenbergs Yard, Quayside
Ouseburn, Walker Rd
Newcastle upon Tyne
Tyne and Wear NE1 2DF
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 19876/0015
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
1 January 2004
10 DATE OF REVISION OF THE TEXT
23/03/2021