SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Crescent Pharma Cetrimide Antiseptic 0.5% w/w Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Cetrimide 0.50 %w/w

Excipients with known effect:

Cetostearyl Alcohol 5.0 % w/w Ethyl parahydroxybenzoate (E214) 0.032 %w/w Propyl parahydroxybenzoate (E216) 0.016 %w/w Methyl parahydroxybenzoate (E218) 0.124 %w/w Butyl parahydroxybenzoate 0.032 %w/w Isobutyl 4-hydroxybenzoate 0.016 %w/w

For the full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Cream

Smooth opaque white cream

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

An antiseptic cream for chapped hands, minor skin abrasions, minor cuts and nappy rash.

4.2    Posology and method of administration

For all ages.

For general use, clean surrounding skin and apply cetrimide cream directly or on a piece of clean lint or gauze.

Hypersensitivity to cetrimide or to any of the excipients listed in section 6.1.

4.4    Special warnings and precautions for use

For external use only.

“Keep all medicines out of reach of children”.

Prolonged and repeated applications of cetrimide are inadvisable as hypersensitivity may occur.

Avoid contact with the eyes.

This medicine may cause local skin reactions (e.g. contact dermatitis) as it contains cetostearyl alcohol.

This medicine may cause allergic reactions (possibly delayed) as it contains E214, E216 and E218.

4.5    Interaction with other medicinal products and other forms of interaction

None.

4.6    Fertility, pregnancy and lactation

No special precautions.

4.7    Effects on ability to drive and use machines

No or negligible influence.

4.8    Undesirable effects

Hypersensitivity reactions may occasionally occur in certain individuals and present as localised contact dermatitis.

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.

Overdosage with Cetrimide Cream is extremely unlikely. The ingestion of very large quantities of cetrimide and other quaternary ammonium compounds can cause nausea, vomiting, dyspnoea, cyanosis, CNS depression (sometimes preceded by excitement and convulsions), hypotension and coma. The fatal dose of quaternary ammonium compounds has been estimated to be 1 to 3 grams (equivalent to 200 - 600 grams of Cetrimide Cream 0.5% w/w).

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

D08A J04 - Antiseptics & Disinfectants Quaternary Ammonium Compounds Contains Cetrimide which is a topical disinfectant.

5.2    Pharmacokinetic properties

Not applicable.

5.3    Preclinical safety data

There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Liquid Paraffin Cetostearyl Alcohol

Phenonip [containing Phenoxyethanol, Methyl parahydroxybenzoate (E218), Ethyl parahydroxybenzoate (E214), Butyl parahydroxybenzoate, Iso butyl 4-hydroxybenzoate, Propyl parahydroxybenzoate (E216)]

Purified Water

6.2 Incompatibilities

Not applicable.

Shelf life

48 months.

6.4 Special precautions for storage

None.

6.5    Nature and contents of container

15g, 30g, 45g, 50g and 60g lacquered aluminium tubes with HDPE cap.

6.6    Special precautions for disposal

Customers are advised that the product is for external use only and to keep all medicines out of the reach of children.

7 MARKETING AUTHORISATION HOLDER

Crescent Pharma Limited Units 3 & 4

Quidhampton Business Units

Polhampton Lane

Overton

Hants

RG25 3ED

8    MARKETING AUTHORISATION NUMBER(S)

PL 20416/0282

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

09/04/2015

10    DATE OF REVISION OF THE TEXT

09/04/2015