Rozex 0.75% gel

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Metronidazole

Boleh didapati daripada:

Galderma (UK) Ltd

Kod ATC:

D06BX01

INN (Nama Antarabangsa):

Metronidazole

Dos:

7.5mg/1gram

Borang farmaseutikal:

Cutaneous gel

Laluan pentadbiran:

Cutaneous

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 13100102; GTIN: 5020465099529 5020465000938

Risalah maklumat

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ROZEX
® 0.75% GEL
(metronidazole)
Your medicine is available using the name Rozex 0.75% Gel
but will be referred to as Rozex throughout this leaflet.
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.
WHAT IS IN THIS LEAFLET
1.
What Rozex is and what it is used for
2.
What you need to know before you use Rozex
3.
How to use Rozex
4.
Possible side effects
5.
How to store Rozex
6.
Contents of the pack and other information
1.
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.
2.
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 stron

Ciri produk

PRODUCT SUMMARY
1.
NAME OF THE MEDICINAL PRODUCT
Not Applicable
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Not Applicable
3.
PHARMACEUTICAL FORM
Not Applicable
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Not Applicable
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Not Applicable
4.3.
CONTRAINDICATIONS
Not Applicable
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Not Applicable
4.5.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Not Applicable
4.6.
PREGNANCY AND LACTATION
Not Applicable
4.7.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Not Applicable
4.8.
UNDESIRABLE EFFECTS
Not Applicable
4.9.
OVERDOSE
Not Applicable
5.
PHARMACOLOGICAL PROPERTIES
5.1.
PHARMACODYNAMIC PROPERTIES
Not Applicable
5.2.
PHARMACOKINETIC PROPERTIES
Not Applicable
5.3.
PRECLINICAL SAFETY DATA
Not Applicable
6.
PHARMACEUTICAL PARTICULARS
6.1.
LIST OF EXCIPIENTS
Not Applicable
6.2.
INCOMPATIBILITIES
Not Applicable
6.3.
SHELF LIFE
Not Applicable
6.4.
SPECIAL PRECAUTIONS FOR STORAGE
Not Applicable
6.5.
NATURE AND CONTENTS OF CONTAINER
Not Applicable
6.6.
INSTRUCTION FOR USE AND HANDLING (, AND DISPOSAL)
Not Applicable
No Data Held
ADMINISTRATIVE DATA
7.
MARKETING AUTHORISATION HOLDER
Not Applicable
8.
MARKETING AUTHORISATION NUMBER
Not Applicable
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Not Applicable
10.
DATE OF REVISION OF THE TEXT
Not Applicable