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RALGEX

Information leaflet

                                                      Irish Medicines Board




                                  Summary of Product Characteristics
 1 NAME OF THE MEDICINAL PRODUCT

 Ralgex Cream

 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

 Ralgex Cream contains:
  Glycol Monosalicylate                10.0 % w/w
  Methyl Nicotinate                     1.0 % w/w
  Capsicum Oleoresin                    0.12 % w/w

 Excipients: Contains
 Methylhydroxybenzoate (E218)              0.20 %w/w
 Butylhydroxybenzoate (E216)               0.10 % w/w
 Emulsifying wax                            9.0 % w/w
 (contains cetostearyl alcohol)

 For a full list of excipients, see section 6.1.


 3 PHARMACEUTICAL FORM

 Cream
 Thick, off-white, homogeneous cream with a characteristic odour.

 4 CLINICAL PARTICULARS

 4.1 Therapeutic Indications

 Symptomatic relief of muscular pain and stiffness, including backache, sciatica, lumbago, fibrositis and rheumatic pain.

 4.2 Posology and method of administration

 Adults and children aged 12 years and over

 After trial use, rub into the skin until absorbed.

 To be applied as required to the affected area. Repeat as necessary up to four times a day.

 Not to be used on children under 12 years except on medical advice.

 The elderly

 The normal adult directions for use can be followed.

 4.3 Contraindications

 Known hypersensitivity to salicylates or to any of the ingredients of the cream. Injuries involving broken skin.




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Date Printed 31/08/2011                               CRN 2104570                                         page number: 1
                                                     Irish Medicines Board




 4.4 Special warnings and precautions for use

 Side effects include local irritation and occasionally allergic reactions. Do not apply near the eyes, mouth or on
 sensitive body areas.

 If symptoms persist or the condition is aggravated, consult the doctor.

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

 4.5 Interaction with other medicinal products and other forms of interaction

 None known.

 4.6 Fertility, pregnancy and lactation

 No evidence of safety of this product has been determined in pregnancy. It is not necessary to contraindicate this
 product in pregnancy and lactation provided caution is exercised and the directions for use are followed. However, as
 with all medicines, the advice of a doctor should be sought before the product is used.

 4.7 Effects on ability to drive and use machines

 None stated.

 4.8 Undesirable effects

 Mild irritations of the skin (reddening, burning sensations and rarely swelling) have been reported, which may become
 more severe. Rashes have also been rarely reported.

 4.9 Overdose

 Overuse would probably cause localised redness, swelling and burning sensations of the skin owing to the counter-
 irritant effect of the product. Rashes may also develop. These should subside on withdrawal of the product, but
 occasionally may require treatment. Where this is indicated, relief would be obtained from gently swabbing the area
 with gauze or white lint soaked in vegetable oil. Rarely the application of a cream or ointment containing corticosteroid
 may be necessary.

 It is most unlikely that even the most excessive use of this product would lead to sufficient percutaneous absorption of
 active ingredients to cause systemic effects.

 In the case of accidental oral ingestion, the advice of a doctor should be sought.

 5 PHARMACOLOGICAL PROPERTIES

 5.1 Pharmacodynamic properties

 Pharmacotherapeutic group: Other topical products for joint and muscular pain, ATC code: M02A.

 Methyl nicotinate has a counter-irritant effect by a rubefacient action. It readily penetrates the cutaneous barrier to
 produce vasodilatation and elevation of skin temperature.

 Capsicum oleoresin has a counter-irritant effect by producing irritation and a transient feeling of warmth.

 Glycol monosalicylate provides the anti-inflammatory and analgesic action.

 Clinical data demonstrate that Ralgex Cream provides rapid warming relief for muscular aches and pains.




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Date Printed 31/08/2011                               CRN 2104570                                         page number: 2
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