SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Acnemed Clear 0.5% w/w Gel Cepton Medicated Clear Gel

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient: Chlorhexidine Gluconate 0.5%w/w (incorporated as Chlorhexidine Gluconate Solution BP 2.5% V/W.

3    PHARMACEUTICAL FORM

Gel.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

An aid in the treatment of spots and acne.

4.2    Posology and method of administration

For topical use only.

Apply morning and night as follows: wash hands and face

apply a thin coating of the gel to the affected area and work in thoroughly.

4.3    Contraindications

Known hypersensitivity to any of the constituents.

Special warnings and precautions for use

For external use only.

If symptoms persist or skin irritation occurs, consult your doctor or pharmacist.

Avoid contact with eyes.

Keep all medicines out of the reach and sight of children.

Consult your doctor or pharmacist before using this medicinal product if you are pregnant or breast-feeding.

Flammable

4.5    Interaction with other medicinal products and other forms of interaction

There are no known interactions with other medications.

4.6    Fertility, pregnancy and lactation

The product is not contra-indicated during pregnancy and lactation. However, as with all medicines during pregnancy, caution should be exercised. Consult your doctor or pharmacist before use.

4.7 Effects on ability to drive and use machines

The ability to drive or use machines is not affected.

4.8 Undesirable effects

Local irritation, skin rashes and other skin reactions such as contact dermatitis have been reported.

Anaphylactic allergic reactions have been reported.

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 Y ellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Overdose

Accidental ingestion: Chlorhexidine taken orally is poorly absorbed. Systemic effects are unlikely even if large amounts are ingested. Nausea, vomiting, diarrhoea and irritation to the throat and oesophagus may occur. Milk or water can be given to drink. Employ supportive measures as appropriate

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: Dermal Antiseptic Group ATC Code: D08AC02

Chlorhexidine is an effective antiseptic with a wide range of activity against microorganisms, including gram positive and gram negative bacteria, fungi and viruses.

5.2    Pharmacokinetic properties

Because of its cationic nature, chlorhexidine binds strongly to skin, mucosa and tissues and is thus very poorly absorbed and percutaneous absorption, if it occurs at all, is insignificant.

The antiseptic ingredients are in intimate contact with the skin, and as they are in solution, their availability is optimal.

5.3    Preclinical safety data

Not applicable.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Ethanol 96%

Polyoxyethylene hydrogenated castor oil Hydroxyethyl cellulose

Sodium acetate Water

6.2    Incompatibilities

None.

6.3    Shelf life

36 months.

6.4    Special precautions for storage

Store at room temperature.

6.5    Nature and contents of container

Internally lacquered collapsible aluminium tube with HDPE screw cap closure. Pack sizes: 30g

6.6    Special precautions for disposal

Medicines should be kept out of the reach of children.

7    MARKETING AUTHORISATION HOLDER

Boston Healthcare Limited Unit 6, Navigation Court Calder Park Wakefield

West Yorkshire WF2 7BJ United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 39974/0006

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

27/01/2005

03/03/2008

10    DATE OF REVISION OF THE TEXT

24/07/2015