It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.

Bayer Limited

Bayer Limited

Summary of Product Characteristics last updated on medicines.ie: 18/5/2016

Bepantiseptic First Aid Cream

1. NAME OF THE MEDICINAL PRODUCT

Bepantiseptic First Aid Cream

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Phenol 1.20 % w/w

Chlorhexidine Digluconate Solution to give Chlorhexidine Digluconate 0.25 % w/w

Also contains cetostearyl alcohol 10% w/w.

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Cream

A pink, viscous, homogeneous cream

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

In the treatment of minor skin irritations

4.2 Posology and method of administration

Apply as necessary after cleansing for up to 3 days.

4.3 Contraindications

Known hypersensitivity to any of the constituents

4.4 Special warnings and precautions for use

If symptoms persist or the condition worsens, consult your doctor

4.5 Interaction with other medicinal products and other forms of interaction

Chlorhexidine is incompatible with anionic agents.

4.6 Pregnancy and lactation

Although use of this product is not contraindicated during pregnancy and lactation, 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

Spontaneous reports of hypersensitivity reactions (hypersensitivity, anaphylactic reaction, anaphylactic shock) have been made; frequency of these reactions cannot be estimated from the available data.

Rarely irritancy, rashes and other skin conditions may occur.

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

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 gluconate: Antiseptic.

5.2 Pharmacokinetic properties

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

5.3 Preclinical 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

Dimeticone

Methyl salicylate

Sunset yellow (E110)

Ponceau 4R (E124)

Purified 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 25'C.

6.5 Nature and contents of container

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

Or

b) Aluminium laminate tubes for 5g, 30g, 33g or 55g pack sizes consisting of 150μm polyethylene/ 5μm polyacry1ate outer layer, 30μm aluminium and an inner layer of 30 μm polyacrylate/ 60 μm polyethylene, fitted with a HD polyethylene shoulder, an aluminium/EAA/surlyn tamper evident seal, with a polypropylene cap.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements

7. MARKETING AUTHORISATION HOLDER

Bayer Limited

The Atrium

Blackthorn Road

Dublin 18

Ireland

8. MARKETING AUTHORISATION NUMBER(S)

PA 1410/47/1

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 2nd January 1987

Date of last renewal: 2nd January 2007

10. DATE OF REVISION OF THE TEXT

March 2016

It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.