RALGEX

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

GLYCOL MONOSALICYLATE ; METHYL NICOTINATE ; CAPSICUM OLEORESIN

Available from:

GR Lane Health Products Ltd

ATC code:

M02AX

INN (International Name):

GLYCOL MONOSALICYLATE ; METHYL NICOTINATE ; CAPSICUM OLEORESIN

Dosage:

10/1/0.12% %v/v

Pharmaceutical form:

Cream

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Other topical products for joint and muscular pain

Authorization status:

Not Marketed

Authorization date:

1992-06-16

Summary of Product characteristics

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
Method of administration: for external application to the skin
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, salicylic acid (or other
NSAIDs) or to any of the ingredients of the cream.
Injuries involving broken or inflamed skin.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This product contains glycol salicylate and so should be used with
caution in patients at
increased risk of developing salicylate adverse effects.
Glycol Monosalicylate
10.0
% w/w
Methyl Nicotinate
1.0
% w/w
Capsicum Oleoresin
0.12 % w/w
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