Metrogel 0.75% gel

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Metronidazole

Available from:

Galderma (UK) 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: 5020465200109

Patient Information leaflet

NOTICE RECTO VERSO 147 x 208
PLAN n°09.DRA.2251.R00.2
P24926-2
PMS 432U
DIELINES
Artwork approved by:
Date:
Signature:
_LAUNCHING DEPARTMENT - Z.I. Galderma_
_74540 ALBY-SUR-CHERAN - FRANCE_
This approval applies to WHOLE TEXT, including barcodes,
pre-printed mentions and legal or special labelling constraints.
PLEASE CHECK PROOF CAREFULLY TO ENSURE ALL ELEMENTS ARE CORRECT.
Product code: P24926-2
Product description: METROGEL BIOGLAN
Market: GBR
Article: Leaflet
Flat size: 147x208
Font size: 8 pt
Pharmacode: 887
METROGEL
® 0.75% W/W GEL
PACKAGE LEAFLET: INFORMATION FOR THE USER
METROGEL 0.75% W/W GEL
Metronidazole
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 Metrogel is and what it is used for
2. What you need to know before you use Metrogel
3. How to use Metrogel
4. Possible side effects
5. How to store Metrogel
6. Contents of the pack and other information
1. WHAT METROGEL 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.
•
Metrogel 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 METROGEL
DO NOT USE METROGEL
•
If you are allergic to metronidazole or any of the other ingredients
of this medicine (listed in sectio

Summary of Product characteristics

OBJECT 1
METROGEL
Summary of Product Characteristics Updated 03-Aug-2015 | Galderma
(U.K) Ltd
1. Name of the medicinal product
Metrogel 0.75% w/w Gel
2. Qualitative and quantitative composition
Metronidazole 0.75%.
Excipients with known effect:
Propylene glycol 5% w/w
Hydroxybenzoic acid esters 0.13% w/w
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Aqueous gel for cutaneous use.
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of acute inflammatory exacerbation of rosacea.
For the deodorisation of the smell associated with malodorous
fungating tumours.
4.2 Posology and method of administration
_FOR THE TREATMENT OF ROSACEA: _
Posology
For topical administration only.
The average period of treatment is 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 on 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.
_Older people_: The dosage recommended in the elderly is the same as
that recommended in adults.
_Paediatric population_: Not recommended. Safety and efficacy have not
been established.
Method of administration
Metrogel 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
Metrogel.
_FOR THE DEODORISATION OF MALODOROUS FUNGATING TUMOURS:_
Adults and elderly: Clean the wound thoroughly. Apply the gel over the
complete area and cover with a
non-adherent dressing. Use once or twice daily as necessary.
Paediatric population: Not recommended
4.3 Contraindications
Hypersensitivity to the active substance or to any of