Metrotop 8mg/ml Topical Gel

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Metronidazole

Available from:

Ayrton Saunders (Ireland) Limited

ATC code:

D06BX; D06BX01

INN (International Name):

Metronidazole

Dosage:

8 milligram(s)/millilitre

Pharmaceutical form:

Gel

Therapeutic area:

Other chemotherapeutics; metronidazole

Authorization status:

Not marketed

Authorization date:

1991-04-19

Patient Information leaflet

Ayrton Saunders (Ireland) Limited, 8A Sandyford Business Centre,
Blackthorn Avenue, Sandyford, Dublin 18, Ireland
Ayrton Saunders (Ireland) Limited, 8A Sandyford Business Centre,
Blackthorn Avenue, Sandyford, Dublin 18, Ireland

Summary of Product characteristics

Health Products Regulatory Authority
02 December 2019
CRN009DYN
Page 1 of 3
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.
Health Products Regulatory Authority
02 December 2019
CRN009DYN
Page 2 of 3
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If prolonged therapy is required, the physician should bear in mind
the possibility of peripheral neuropathy or leucopenia.
High oral or parental dosage regimens have been associated with
transient epilepiform seizures. Caution is required with
active disease of the central nervous system. No reports of such
effects have been noted to date with topical use.
Prolonged or repeated course of metronidazole therapy should be
conducted only under conditions of close surveillance for
clinical and biological effects and under specialist direction.
Strong sunlight should be avoided since metronidazole is unstab