CHILBLAIN CREAM - Summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Chilblain Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Methyl Nicotinate 1.00 % W/W

For excipients, see 6.1.

3 PHARMACEUTICAL FORM

Rubificient Cream

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the symptomatic relief of pain associated with chilblains.

4.2 Posology and method of administration

For Adults, Elderly and Children.

Gently bathe affected parts in water. Dry carefully. Apply cream sparingly morning and night and more frequently if required

4.3 Contraindications

Hypersensitivity to the product.

4.4 Special warnings and precautions for use

If symptoms deteriorate or do not improve within 5 days a physician should be consulted.

Caution is advised in diabetic patients and those with poor circulation.

For external use only.

Keep out of the reach and sight of children.

Wash hands thoroughly after use and avoid touching sensitive areas of the body.

If you have sensitive skin, apply cream to a small area of skin to test whether you are allergic to the product before fully applying it.

4.5 Interaction with other medicinal products and other forms of interaction Not known.

4.6 Fertility, Pregnancy and lactation

As with all medicines avoid in early pregnancy and lactation.

4.7 Effects on ability to drive and use machines Not applicable, none-reported.

4.8 Undesirable effects

Temporary reddening of the skin may occur where applied.

4.9 Overdose

In the unlikely case of accidental ingestion treat symptomatically.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Methyl Nicotinate is a “vasodilator” and is used in concentrations of 1% in ointments and creams for topical application as a rubificient for the relief of pam in chilblains.

5.2 Pharmacokinetic properties Not relevant.

5.3 Preclinical safety data

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sebase, Emulsifying wax, Liquid paraffin, Euxyl Kl00, Water

6.2 Incompatibilities

None stated.

6.3 Shelf life

36 months.

6.4 Special precautions for storage

Do not store above 25°C and do not freeze.

6.5 Nature and contents of container

15g printed collapsible aluminium tube.

6.6 Special precautions for disposal

No special requirements, but always wash hands after using product

7 MARKETING AUTHORISATION HOLDER

Optima Consumer Health Ltd

Concept house,

Brackenbeck Road,

Bradford,

BD7 2LW, UK

8 MARKETING AUTHORISATION NUMBER(S)

PL 40575/0001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

21/05/2008