GERMOLENE ANTISEPTIC CREAM - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Germolene Antiseptic Cream

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Phenol Ph. Eur.                                   ­1.2% w/w

Chlorhexidine digluconate solution B.P.

to give Chlorhexidine digluconate                   ­0.25% w/w

3. PHARMACEUTICAL FORM

Cream for topical administration.

4 CLINICAL PARTICULARS

4.1. Therapeutic Indications

The product will be recommended as an antiseptic (to help prevent secondary infection), local anaesthetic and emollient for minor cuts and grazes, minor burns and scalds and blisters, stings and insect bites, spots and other minor skin conditions, chapped or rough skin.

4.2. Posology and Method of Administration

All age groups:

Thoroughly clean the affected area of skin, apply the cream and rub gently. In the case of cuts or particularly tender areas, rubbing may be avoided by applying on a piece of white lint or gauze.

4.3 Contraindications

Known hypersensitivity to the product or any of its components, especially in those with a history of possible chlorhexidine-related allergic reactions (see sections 4.4 and 4.8).

4.4 Special warnings and precautions for use

Consult your doctor if symptoms persist.

Keep out of the reach of children

For external use only

Replace cap firmly after use

Rare but serious allergic reactions including anaphylaxis have been reported with use of chlorhexidine containing antiseptic products. If symptoms of a serious allergic reaction appear (e.g. wheezing or difficulty breathing, swelling of the face, hives that can quickly progress to more serious symptoms, severe rash, or shock), use must be discontinued immediately and doctor should be consulted.

The product should not be administered to anyone with a potential history of an allergic reaction to a chlorhexidine-containing compound (see sections 4.3 and 4.8).

4.5 Interaction with other medicinal products and other forms of interaction

Chlorhexidine is incompatible with anionic agents.

4.6. Pregnancy and Lactation

The product is not contraindicated during pregnancy and lactation. However, as with all medicines during pregnancy, caution should be exercised.

4.7. Effects on Ability to Drive and Use Machines

None known.

4.8 Undesirable effects

Skin disorders

Frequency not known: Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation, and blisters.

Immune disorders

Frequency not known: Hypersensitivity including anaphylactic shock (see sections 4.3 and 4.4).

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

Repeated Topical Application

Frequently repeated topical application on the same site could theoretically lead to skin irritation. However, since the product is only intended for minor skin trauma, extensive exposure is unlikely.

Accidental or Deliberate Ingestion

The product would only be expected to be harmful if orally ingested in very large quantities. This is unlikely due to the unpleasant taste of the product. In such a case the primary concern would be the phenol intake which can cause nausea, vomiting, diarrhoea and headache.

Treatment

Gastric lavage with water and charcoal. Administration of demulcents such as egg white or milk and supportive measures.

5 PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic Properties

Phenol – antiseptic and local anaesthetic.

Chlorhexidine digluconate – antiseptic.

5.2. Pharmacokinetic Properties

The product has a local action with minimal risk of systemic effects.

5.3. Pre-clinical Safety Data

Preclinical safety data on these active ingredients in the literature have not revealed any pertinent and conclusive findings which are of relevance to the recommended dosage and use of the product.

6 PHARMACEUTICAL PARTICULARS

6.1. List of excipients

Cetostearyl alcohol

Light liquid paraffin

Polyoxyethylene – (21) – stearyl ether

Polyoxyethylene – (2) – stearyl ether

Dimethicone

Methyl salicylate

Sunset yellow (E110)

Ponceau 4R (E124)

Deionised water.

6.2. Incompatibilities

Chlorhexidine is incompatible with anionic agents.

6.3. Shelf life

Three years

6.4. Special precautions for storage

Do not store above 25oC.

6.5. Nature and Contents of Container

a) Flexible aluminium tubes internally lacquered, fitted with an integral nozzle and a polypropylene cap. 5 g, 30 g, 33 g, 55 g or 120 g tubes are contained in boxboard carton.

b) Aluminium laminate tubes for 5g, 20g, 30g, 33g, 35g, 40g or 55g pack sizes consisting of 150pm polyethylene / 5pm polyacrylate outer layer, 30pm aluminium and an inner layer of 30pm polyacrylate / 60pm polyethylene, fitted with a HD polyethylene shoulder, an aluminium/EAA/sur­lyn tamper evident seal, with a polypropylene cap.

6.6. Instruction for use and handling

Not applicable.

Bayer plc

400 South Oak Way

Reading

RG2 6AD

8. MARKETING AUTHORISATION NUMBER

PL 00010/0263

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

21/05/2008