CHLORHEXIDINE GLUCONATE 1% W/V LOTION, ACNEMED SKIN WASH 1% W/V LOTION, CEPTON MEDICATED SKIN WASH - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Acnemed Skin Wash 1% w/v Lotion

Cepton Medicated Skin Wash

Chlorhexidine Gluconate 1% w/v Lotion

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient: Chlorhexidine Gluconate 1.0%w/v.

3 PHARMACEUTICAL FORM

Lotion

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For daily use in the treatment and prevention of spots and acne.

4.2 Posology and method of administration

Apply morning and night as follows:

Wash hands and face

Wash with undiluted medicated skin wash, then rinse. Repeat

For maximum effect, leave second wash on the skin for one minute before rinsing

4.3 Contraindications

Known hypersensitivity to any of the constituents.

4.4 Special warnings and precautions for use

For external use only.

Frequently repeated topical application on the same site could theoretically lead to skin irritation.

Consult your doctor if symptoms persist.

If skin irritation occurs stop using and talk to your doctor.

Keep out of the eyes and ears.

Treat accidental splashes into the eyes by washing out immediately with water and seek medical advice.

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

4.5 Interaction with other medicinal products and other forms of interaction

Chlorhexidine is incompatible with anionic agents.

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

Rarely local irritation, rashes and other skin reactions such as contact dermatitis may occur.

Anaphylactic allergic reactions have also been reported but are very 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

Accidental ingestion: Chlorhexidine taken orally is poorly absorbed. Systemic effects are unlikely even if large amounts are ingested. However, gastric lavage may be advisable using milk, raw egg, gelatin or mild soap. Employ supportive measures as appropriate.

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.

6.1

Polyoxyethylene polyoxypropylene block co-polymer

Lauryl dimethyl amine oxide

Ponceau 4R (E 124)

Isopropyl alcohol

Perfume

D -gluconolactone

Sodium hydroxide

Water

6.2

None

6.3 Shelf life

3 years

6.4 Special precautions for storage

Store below 25°C.

6.5 Nature and contents of container

High density polyethylene bottle with screw cap closure. Pack sizes: 10ml, 25ml, 50ml, 100ml, 150ml and 250ml.

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 39974/0004