Germolene Antiseptic Cream
SUMMARY OF PRODUCT 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).
Special warnings and precautions for use
4.4
Consult your doctor if symptoms persist.
Keep out of the reach of children For external use only Replace cap firmly after use
The product contains chlorhexidine. Chlorhexidine is known to induce hypersensitivity, including generalised allergic reactions and anaphylactic shock. The prevalence of chlorhexidine hypersensitivity is not known, but available literature suggests this is likely to be very rare. 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.
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.
7. MARKETING AUTHORISATION HOLDER
Bayer plc
Trading as: Bayer plc; Consumer Care Division Bayer House Strawberry Hill
Newbury Berkshire RG14 1JA United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 00010/0263
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
21/05/2008
10 DATE OF REVISION OF THE TEXT
17/12/2015