Land: Storbritannien
Språk: engelska
Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)
Metronidazole
Pierre Fabre Dermo-Cosmetique
D06BX01
Metronidazole
7.5mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13100102; GTIN: 3592619063578
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. Läs hela dokumentet
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 Läs hela dokumentet