Rosiced 0.75% cream

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Metronidazole

Commercializzato da:

Pierre Fabre Dermo-Cosmetique

Codice ATC:

D06BX01

INN (Nome Internazionale):

Metronidazole

Dosaggio:

7.5mg/1gram

Forma farmaceutica:

Cutaneous cream

Via di somministrazione:

Cutaneous

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 13100102; GTIN: 3592619063578

Foglio illustrativo

UK Rosiced 7.5 mg/g cream: PL 20693/0007
Date last approved: 25/03/2015
UK/H/0611/001/1AIN/25
1
PATIENT INFORMATION LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
ROSICED
7.5 MG/G CREAM
Active substance: metronidazole
For adult use
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.

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. Do not pass it on to
others.
It may harm them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side
effects
not listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What ROSICED 7.5mg/g Cream is and what it is used for
2.
Before you use ROSICED 7.5mg/g Cream
3.
How to use ROSICED 7.5mg/g Cream
4.
Possible side effects
5.
How to store ROSICED 7.5mg/g Cream
6.
Further information
1.
WHAT ROSICED 7.5MG/G CREAM IS AND WHAT IT IS USED FOR
ROSICED 7.5mg/g Cream is used to treat inflammation caused by rosacea.
Inflammatory
rosacea is a skin condition that causes redness, papules (pink bumps)
and pustules (pus-filled
spots) on the face.
2.
BEFORE YOU USE ROSICED 7.5MG/G CREAM
DO NOT USE ROSICED 7.5MG/G CREAM
- if you are allergic (hypersensitive) to metronidazole or any of the
other ingredients of
ROSICED 7.5mg/g Cream . All ingredients used in ROSICED 7.5mg/g Cream
are listed in
section 6 of this leaflet. If you are not sure whether you are
allergic, please ask your doctor or
pharmacist.
- if you are in the first 3 months of pregnancy.
If you have any of the following:
- severe liver damage (e.g. cirrhosis of the liver),
- problems affecting blood formation (e.g. anaemia),
- diseases affecting the brain, bone marrow or nerves
UK Rosiced 7.5 mg/g cream: PL 20693/0007
Date last approved: 25/03/2015
UK/H/0611/001/1AIN/25
2
please tell your doctor. In such cases, treatment with ROSICED 7.5mg/g
Cream must be
carefully considered.
TAKE SPECIAL CARE WITH ROSICED 7.

Scheda tecnica

OBJECT 1
ROSICED 7.5MG/G CREAM
Summary of Product Characteristics Updated 10-Sep-2015 | Pierre Fabre
Dermo-Cosmetique
1. Name of the medicinal product
ROSICED 7.5 mg/g Cream
2. Qualitative and quantitative composition
1 g of cream contains 7.5 mg of metronidazole (0.75% m/m)
For excipients, see 6.1.
3. Pharmaceutical form
Cream
Smooth white to off-white cream.
4. Clinical particulars
4.1 Therapeutic indications
For the topical treatment of inflammatory papulo-pustules rosacea
related.
4.2 Posology and method of administration
Cutaneous use
ADULTS AND ELDERLY
Apply and gently rub the cream into the affected skin of the face in a
thin film twice daily for a usual
duration of treatment of 6 to 12 weeks. If necessary, treatment may be
continued (see section 4.4). In the
absence of any clinical improvement therapy should be stopped.
CHILDREN AND ADOLESCENTS
There is no adequate clinical data on efficacy and safety of Rosiced
®
cream in children; therefore
Rosiced
®
cream should not be applied to children.
Areas to be treated should be cleansed before application of the
cream. Patients may use non-
comedogenic and non-astringent cosmetics after application of the
cream.
4.3 Contraindications
ROSICED 7.5 mg/g Cream is contraindicated during the first third of
pregnancy.
ROSICED 7.5 mg/g Cream must not be taken by patients with
hypersensitivity to medicinal products
containing metronidazole or other 5-nitroimidazoles as does ROSICED
7.5 mg/g Cream. Sole exception
is in cases of life-threatening infections and if other medicines are
inefficacious.
ROSICED 7.5 mg/g Cream is contraindicated in patients with
hypersensitivity to any of the excipients.
In patients with severe liver damage, dyshaematopoiesis, and diseases
of the central or peripheral nervous
system a careful risk-benefit assessment is necessary prior to
treatment with ROSICED 7.5 mg/g Cream.
4.4 Special warnings and precautions for use
Avoid contact with the eyes or any mucocutaneous application. If
contact occurs, the cream should be
washed out carefully wit