Metronidazole 0.75% gel

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Metronidazole

Tilgjengelig fra:

CST Pharma Ltd

ATC-kode:

D06BX01

INN (International Name):

Metronidazole

Dosering :

7.5mg/1gram

Legemiddelform:

Cutaneous gel

Administreringsrute:

Cutaneous

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 13100102

Informasjon til brukeren

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor
or pharmacist.
- This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even
if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
Your medicine is called Rozex 0.75% w/w Gel and
will be referred to as Rozex throughout this leaflet.
WHAT IS IN THIS LEAFLET
What Rozex is and what it is used for
What you need to know before you use
Rozex
How to use Rozex
Possible side effects
How to store Rozex
Contents of the pack and other information
WHAT ROZEX IS AND WHAT IT IS USED FOR
•
Your doctor has prescribed this gel for your skin
condition, rosacea.
•
It helps to treat the pimples, pustules (spots) and
redness found with this condition.
•
Rozex contains the active substance
metronidazole. Metronidazole belongs to a group
of medicines called antiprotozoal and antibacterial
agents and has been shown to help to control
infection and inflammation in certain skin
problems, such as rosacea.
WHAT YOU NEED TO KNOW BEFORE YOU USE
ROZEX
DO NOT USE ROZEX
•
If you are allergic to metronidazole or any of the
other ingredients of this medicine (see section 6
for other ingredients). An allergic reaction may
include a rash or itching.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using
Rozex.
•
Do not get the gel in your eyes. If you do so, rinse
thoroughly with large amounts of warm water or
eye wash.
•
If you suffer from any blood disorders do not use
Rozex unless your doctor says you can.
•
This product should not be used in children.
•
Do not go out into strong sunlight (including
sun-bathing) and avoid exposure to ultra-violet
light (eg solariums, sun-lamps) while you are using
this product.

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zyomet 0.75%w/w Gel
Metronidazole 0.75%w/w Gel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Metronidazole 0.75% w/w.
3
PHARMACEUTICAL FORM
Gel for cutaneous use.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Metronidazole Gel is indicated for the treatment of acute inflammatory
exacerbations of acne rosacea.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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 USE
Metronidazole Gel has been reported to cause lacrimation of the eyes,
contact with
eyes and mucous membranes should be avoided.
If eye contact does occur the gel should be washed out carefully with
water.
If irritation does occur the patient should be advised to use
metronidazole less
frequently or to stop temporarily and to seek medical advice if
necessary. The UV
exposure (sunbathing, solarium, sunlamp)