Metrosa 0.75% gel

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Metronidazole

Available from:

Beaumont Pharma Ltd

ATC code:

D06BX01

INN (International Name):

Metronidazole

Dosage:

7.5mg/1gram

Pharmaceutical form:

Cutaneous gel

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13100102; GTIN: 4048882321284 4048882321024

Patient Information leaflet

UK/0820/001/IB/018 UK METROSA 0.75% GEL
METROSA® 0.75% GEL
Metronidazole
PACKAGE LEAFLET: INFORMATION FOR THE USER
1. WHAT METROSA 0.75% GEL IS
AND WHAT IT IS USED FOR
Metrosa 0.75% Gel is an antiinflammatory gel
to be applied on the skin.
Metrosa 0.75% Gel is used for the treatment
of rosacea (redness in the face, sometimes
together with additional pustules) when
the condition suddenly gets worse, and the
inflammation becomes troublesome.
1 g Metrosa 0.75% Gel contains 7.5 mg
Metronidazole as active substance.
Metronidazole acts against some of the fungi
and other organisms that can affect the skin,
and also, in patients suffering from rosacea,
it can relieve the condition by acting against
the inflammation which happens when the
condition becomes troublesome.
2. BEFORE YOU USE METROSA 0.75% GEL
DO NOT USE METROSA 0.75% GEL
if you are hypersensitive (allergic) to
Metronidazole, propylene glycol or any of the
other ingredients listed below (see 6. Further
Information; What Metrosa 0.75% Gel contains).
TAKE SPECIAL CARE WITH METROSA 0.75% GEL
Do not let the gel come into contact with the
eyes and mucous membranes. If eye-contact
should occur, wash the gel carefully out of the
eyes with warm water.
If irritation does occur you should use Metrosa
0.75% Gel less frequently or stop temporarily. If
necessary seek medical advice, please.
Do not go out into strong sunlight
(sunbathing), or use UV lamps (solarium,
sunlamps) while you are using this product.
Avoid prolonged and unnecessary use of
this medicine. You shouldn`t exceed the
recommended duration of therapy. If required,
the therapy could be recommended again and
be repeated. However you should consider
that an interval of 6 weeks in between has to
be kept.
Use Metrosa 0.75% Gel with care if you suffer
or suffered in the past from blood disorders
(blood dyscrasia).
USE IN CHILDREN AND ADOLESCENTS
Metrosa 0.75% Gel should not be used in
children and adolescents.
USING OTHER MEDICINES
Interaction with systemic medication is unlikely
because absorption (ability to

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Metrosa 0.75% Gel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of gel contains 7.5 mg Metronidazole.
Excipient with known effect:
30 mg propylene glycol / gram Gel
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gel.
A smooth clear to turbid colourless to faintly yellow gel.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the topical treatment of Rosacea (inflammatory papulopustules
rosacea
related).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric population_
Not recommended as clinical trials have not been undertaken.
Method of administration_ _
Cutaneous use.
Apply a thin film of the gel to the affected facial areas twice daily
for four
weeks. Treatment may be continued for a further four weeks if
necessary.
Metronidazole should be applied in a thin layer to the affected areas
of the
skin twice daily, morning and evening. Areas to be treated should be
washed
with a mild cleanser before application. Patients may use non
comedogenic
and non astringent cosmetics after application of metronidazole. The
dosage
does not need to be adjusted for elderly patients. Metronidazole is
not
recommended for use in children due to a lack of data on safety and
efficacy.
The average period of treatment varies according countries. It is
usually of
three to four months. The recommended duration of treatment should not
be
exceeded. However, if a clear benefit has been demonstrated continued
therapy for a further three to four months period may be considered by
the
prescribing physician depending upon the severity of the condition. In
clinical
studies, topical metronidazole therapy for rosacea has been continued
for up to
2 years. In the absence of a clear clinical improvement, therapy
should be
stopped.
4.3
CONTRAINDICATIONS
Topical metronidazole therapy is contraindicated in individuals with a
history
of hypersensitivity to metronidazole or other ingredients of the
formulation.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR US