SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Ceanel Concentrate

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Cetrimide B.P:    10.0% w/v

Undecenoic Acid B.P:    1.0% v/v

For full list of excipients, see Section 6.1

3 PHARMACEUTICAL FORM

Ceanel Concentrate is a 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 one of the ingredients.

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

None known.

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

None known.

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

Ceanel Concentrate is for external use only. 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

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

Ceanel Concentrate should be stored in a cool, dry place avoiding extremes of temperature i.e. not less than 5°C and not more than 30°C.

6.5 Nature and contents of container

Ceanel Concentrate is available in polyethylene bottles with a screw top containing 150ml and 500ml.

6.6 Special precautions for disposal

No special instructions.

7 MARKETING AUTHORISATION HOLDER

Alliance Pharmaceuticals Limited

Avonbridge House

Bath Road

Chippenham

Wiltshire

SN15 2BB

UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 16853/0141

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

1 January 2004

10 DATE OF REVISION OF THE TEXT

14/10/2016