RICHMOND ANTISEPTIC CREAM, MEDICAID ANTISEPTIC CREAM - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Medicaid Antiseptic Cream

Richmond Antiseptic Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Cetrimide B.P 0.50% w/w

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

A Water-in-Oil Cream

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the treatment of nappy rash, chapped hands, sunburn, chafing, minor burns, cuts and abrasions.

4.2 Posology and method of administration

No restrictions by age or gender.

Apply liberally to the affected area. Repeat as necessary.

Nappy rash: after normal nappy changing routine, dry baby’s skin without rubbing, apply cream.

First aid use: wash affected area gently, pat dry, and apply to soothe and help prevention infection.

4.3 Contraindications

Hypersensitivity to the active, and any of the listed ingredients.

4.4 Special warnings and precautions for use

Keep all medicines away from children.

If symptoms persist, stop using and consult your doctor

4.5 Interaction with other medicinal products and other forms of interaction

None

4.6 Fertility, Pregnancy and lactation

Although there are no adverse reports for this product in pregnant and lactating mothers, as with all medicines, care should be exercised when administering the product to pregnant or lactating women.

4.7 Effects on ability to drive and use machines

None

4.8 Undesirable effects

Skin irritation has been reported.

Hypersensitivity reactions may develop in certain individuals presenting as a localised contact dermatitis

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

It is unlikely that systemic toxicity will result from the ingestion of Medicaid Antiseptic Cream, although it may give rise to gastrointestinal irritation.

Treatment should be symptomatic.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antiseptic cream

ATC code: D08AJ04

5.2 Pharmacokinetic properties

Not applicable

5.3 Preclinical safety data

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Liquid Paraffin (light)          B.P.

White Soft Paraffin            B.P.

Lanolin (Anhydrous)          B.P.

Cetostearyl Alcohol            B.P.

Glyceryl Monostearate H.S.E

Myristyl Alcohol

H.S.E B.P.

H.S.E

H.S.E

B.P.C

Cetomacrogol 1000

Nipasept

Perfume compound

Deionized Water

6.2 Incompatibilities

None

6.3 Shelf life

60 months.

6.4 Special precautions for storage

None

6.5 Nature and contents of container

White low density polythene tube, lacquered and fitted with a white full skirted polypropylene cap.

Contents: 5, 10, 15, 25, 30, 50, 60, 100 gm

6.6 Special precautions for disposal

No special instructions required.

Boston Healthcare Limited

Unit 6, Navigation Court

Calder Park

Wakefield

West Yorkshire WF2 7BJ

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 39974/0023

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

25/07/1988 / 09/08/2010