R.B.C. Cream 1.8/8/0.5 %w/w

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

ANTAZOLINE HYDROCHLORIDE CALAMINE CETRIMONIUM BROMIDE

Available from:

Co-Pharma Limited

Dosage:

1.8/8/0.5 %w/w

Pharmaceutical form:

Cream

Authorization date:

1996-08-11

Summary of Product characteristics

                                PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
RBC Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 25 g of paste contains 1.8% w/w of Antazoline hydrochloride, 8% of Calamine, 0.5% of Cetrimide.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Cream
A pale pink paste.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of allergic skin disorders such as pruritus, urticaria, insect bites and stings, nettle rash, hives, for the
relief of itching accompanying chicken pox and shingles, for the relief of sunburn and prickly heat.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For external use only.
Apply sparingly 3 to 4 times daily for up to 3 days or as directed by the physician.
4.3 CONTRAINDICATIONS
Eczema, open wounds, symptoms persisting for more than 2-3 days.
Sensitivity to any constituent.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If symptoms persist after 2-3 days, consult a doctor.
Discontinue in case of skin sensitivity.
Do not apply to open wounds or eczema.
For external use only.
Keep all medicines away from children.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
None known.
4.6 PREGNANCY AND LACTATION
No adverse effects known.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 31/07/2006_
_CRN 2026222_
_page number: 1_
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
No or negligible effect.
4.8 UNDESIRABLE EFFECTS
Rare cases of sensitivity have been reported, which subside on application being discontinued.
4.9 OVERDOSE
Not applicable; for external use only.
5 PHARMACOLOGICAL PROPERTIES
5.1 PHARMACODYNAMIC PROPERTIES
Antazoline is a weak antihistamine with local anaesthetic properties.
Cetrimide is an antiseptic.
Ca
                                
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