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RALGEX

Main information

  • Trade name:
  • RALGEX Cream 10/1/0.12% %v/v
  • Available from:
  • SSL International plc
  • Dosage:
  • 10/1/0.12% %v/v
  • Pharmaceutical form:
  • Cream
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
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Documents

Localization

  • Available in:
  • RALGEX Cream 10/1/0.12% %v/v
    Ireland
  • Language:
  • English

Other information

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Status

  • Source:
  • IMB
  • Authorization date:
  • 28-07-2006
  • Last update:
  • 09-08-2016

Summary of Product characteristics

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Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Ralgex Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Ralgex Cream contains:

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

Glycol Monosalicylate 10.0 % w/w

Methyl Nicotinate 1.0 % w/w

Irish Medicines Board

______________________________________________________________________________________________________________________

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

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.

Irish Medicines Board

______________________________________________________________________________________________________________________

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

5.2 Pharmacokinetic properties

Glycol monosalicylate and methyl nicotinate are readily absorbed percutaneously.

5.3 Preclinical safety data

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Emulsifying Wax (contains cetostearyl alcohol)

Glycerol monostearate with polyoxyethylene stearate

Oleyl Alcohol

Dimeticone

Methylhydroxybenzoate (E218)

Butylhydroxybenzoate (E216)

Goliath perfume SE 83.0502

Neutralaire D7

Deionised water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Two years.

6.4 Special precautions for storage

Store below 25°C.

6.5 Nature and contents of container

Flexible aluminium tubes (containing 5 g, 15g, 40g, 44g, 80g, 88g, 100g or 110g of product), internally lacquered and

having a white polypropylene screw cap. The tubes may be contained in a boxboard carton.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from

such medicinal product and other handling of the product

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 31/08/2011 CRN 2104570 page number: 3

7 MARKETING AUTHORISATION HOLDER

SSL International Plc

Venus

1 Old Park Lane

Trafford Park

Manchester

M41 7HA

United Kingdom

8 MARKETING AUTHORISATION NUMBER

PA 1138/12/1

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 16 June 1992

Date of last renewal: 16 June 2007

10 DATE OF REVISION OF THE TEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 31/08/2011 CRN 2104570 page number: 4

There are no safety alerts related to this product.

There are no news related to this product.

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