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Ralgex Cream

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Document: leaflet MAH BRAND 2_PL 01074-0244 change

Common Technical Document    Ralgex Heat Rub Cream

Module 1 - Administrative and Prescribing Information Module 1.3 - Product Information

Text to appear on the Patient Information Leaflet Ralgex Heat Rub Cream

Glycol Monosalicylate 10% w/w, Methyl Nicotinate 1% w/w and Capsicum Oleoresin 0.12% w/w

PATIENT INFORMATION LEAFLET

Please read this leaflet carefully before using Ralgex Cream.

•    Keep this leaflet, you may wish to read it again.

•    Ask your pharmacist if you need more information or advice.

What is this cream used for?

This cream provides rapid warming relief for muscular pain and stiffness, including backache sciatica, lumbago, fibrositis and rheumatic pain.

Before using this cream Do not use...

•    If you are allergic to salicylates (e.g. aspirin), salicylic acid (or other non steroidal anti-inflammatory drugs) or to any of other ingredient in this product. See ‘What this cream contains' for the full list of ingredients.

•    On broken or inflamed skin.

Take special care.

•    Some people experience stronger effects with Ralgex Cream than others. The product should be tried on a small area first.

•    Do not apply near the eyes or mouth, or on sensitive body areas (such as lips, bottom and genitals).

•    Day-to-day variation may occur in the sensitivity of the skin, which is more sensitive after a hot bath or in hot weather.

•Do not apply to large areas of the body.

Important information about some of the ingredients.

•    This cream contains methyl hydroxybenzoate (E218) which may cause allergic reactions (possible delayed) and emulsifying wax of which cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).

If you are pregnant or breast feeding.

•    Speak to your doctor or pharmacist before using

How to use this cream

Adults, the elderly and children 12 years and over:

•    After trial use, rub into the skin until absorb

•    To be applied as required to the affected are

•    Repeat as necessary up to four times a day.

Common Technical Document    Ralgex Heat Rub Cream

Module 1 - Administrative and Prescribing Information Module 1.3 - Product Information

Children under 12 years:

Not to be used on children under 12 years unless your doctor tells you to.

If you accidentally swallow the cream...

The cream is for external use only - do not put it in your mouth or swallow. If it is swallowed accidentally, contact your doctor or pharmacist.

Possible side effects

As with all medicines, this cream can have side effects in some people.

•    Irritation of the skin, including reddening, burning sensations and, rarely, swelling, have been reported.

•    Rarely, rashes may occur.

If you feel you are reacting badly to this medicine in any way stop using the cream and tell your doctor or pharmacist.

How to store this cream

•    Keep out of the sight and reach of children.

•    Do not store above 25°C.

•    Do not use after the expiry date shown on the tube or carton.

•    If you find that you still have this medicine after its expiry date, return it to your local pharmacist who will dispose of it properly.

What this cream contains

Ralgex Cream contains 10% by weight of the active ingredient glycol monosalicylate, 1% by weight of the active ingredient methyl nicotinate and 0.12% by weight of the active ingredient capsicum oleoresin.

Glycol monosalicylate is a topical analgesic and anti-inflammatory agent, which provides pain relief. Methyl nicotinate and capsicum oleoresin are warming agents, assisting in the relief of muscular pain.

It also contains emulsifying wax, glycerol monostearate and polyoxyethylene stearate, oleyl alcohol, dimeticone, methylhydroxybenzoate (E218), butylhydroxybenzoate, perfume and deionised water

The cream comes in a tube containing 40g or 100g.

Marketing Authorisation Holder:

G R Lane Health Products Ltd. Sisson Road, Gloucester GL2 0GR UK

Manufactured by SSL International plc, Whitehouse Industrial Park, Traynor Way, Peterlee, Co Durham, SR8 2RU, UK or Wrafton Laboratories Limited, Wrafton, Braunton, EX33 2DL, UK.

D ate of preparation: July 2013.

Trafford Park, Manchester, M41 7HA, UK Ralgex is a trade mark of the SSL Group.

January 2015 - LB