ROSAC METRONIDAZOLE GEL

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

METRONIDAZOLE

Fáanlegur frá:

Stiefel Laboratories (U.K.) Ltd.

Skammtar:

0.75 %w/w

Lyfjaform:

Cutaneous Gel

Leyfisdagur:

1996-01-08

Vara einkenni

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rosac
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Metronidazole 0.75 % w/w
3 PHARMACEUTICAL FORM
Gel for cutaneous use.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
Rosac is indicated for the treatment acne rosacea
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
Apply to the affected skin of the face in a thin
film twice daily for eight to nine weeks. Thereafter,
further applications 
may be necessary Adults depending on the severity
of the condition.
Elderly patients
As detailed for adults.
Paediatric use
Not recommended.
4.3 CONTRAINDICATIONS
Patients with known hypersensitivity to any
of the ingredients should not use this product.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Avoid contact with
the eyes; if eye contact does occur the gel should be washed
out carefully with water.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION 
There is evidence to suggest that systemic absorption
of metronidazole after topical application
is negligible. A small 
number of patients taking oral metronidazole and
alcohol concomitantly have experienced a disulfiram-like reaction.
4.6 PREGNANCY AND LACTATION
The safety of Rosac in human pregnancy and lactation has not been
established. Animal studies have shown no 
evidence of teratogenicity or embryo toxicity. It is recommended
that the use of Rosac during pregnancy and lactation 
is avoided.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 01/12/2005_
_CRN 2017406_
_page number: 1_
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None.
4.8 UNDESIRABLE EFFECTS
Dryness or irritation of the skin may be experienced by
some patients after application.
4.9 OVERDOSE
Not applicable.
5 PHARMACOLOGICAL PROPERTIE