Metrotop 8mg/ml Topical Gel

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Metronidazole

Available from:

Ayrton Saunders Ltd

ATC code:

D06BX; D06BX01

INN (International Name):

Metronidazole

Dosage:

8 milligram(s)/millilitre

Pharmaceutical form:

Gel

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other chemotherapeutics; metronidazole

Authorization status:

Not marketed

Authorization date:

1991-04-19

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Metrotop 8mg/ml Topical Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains metronidazole 0.8%w/v (equivalent to 8mg/ml)
Also contains 0.02%w/v benzalkonium chloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gel.
A sterile, clear, colourless gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an adjunct in the management of fungating tumours.
For the topical treatment of acute inflammatory exacerbations of
rosacea.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
TUMOURS
Following adequate cleansing, a liberal application of the gel should
cover the area and in turn be covered with a
loosely packed paraffin gauze and bandage as indicated.
ACNE ROSACEA
The gel should be applied twice daily to the affected areas.
The usual duration of treatment is 1 month, but up to 2
months may be required in some cases.
Contact with the eyes should be avoided.
Elderly:
instructions apply as for other adults with care.
Children:
not recommended.
For topical administration.
4.3 CONTRAINDICATIONS
o
Use in patients with disease of the peripheral nervous system.
o
Use in patients known to be hypersensitive to metronidazole or other
constituents.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
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If prolonged therapy is required, the physician should bear