国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
METRONIDAZOLE
Galderma (UK) Ltd
D06BX01
METRONIDAZOLE
0.75 %w/w
Cutaneous Emulsion
Product subject to prescription which may not be renewed (A)
Other chemotherapeutics
Authorised
2000-04-28
PACKAGE LEAFLET: INFORMATION FOR THE USER ROZEX CUTANEOUS EMULSION 0.75% W/W Metronidazole 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 Rozex is and what it is used for 2. Before you use Rozex 3. How to use Rozex 4. Possible side effects 5. How to store Rozex 6. Further information 1. WHAT ROZEX IS AND WHAT IT IS USED FOR • Your doctor has prescribed this emulsion 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 call antiprotozoal and antibacterial agents and has been shown to help to control infection and inflammation in certain skin problems, such as rosacea. 2. BEFORE YOU USE ROZEX DO NOT USE ROZEX • if you are allergic (hypersensitive) to metronidazole or any of the other ingredients of Rozex. Please check by reading the list of ingredients in section 6. If you answer yes, you must inform your doctor before starting treatment. Please seek immediate medical attention if you experience symptoms of an allergic reaction. Signs or symptoms of a severe allergic reaction may include a rash, with or without itching, swelling of the face, eyelids or lips and difficulty in breathing. TAKE SPECIAL CARE WITH ROZEX • 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rozex 0.75% w/w Cutaneous Emulsion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Metronidazole 0.75% w/w. Excipients with known effect: Stearyl Alcohol 2.0%w/w For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous emulsion. A white to beige, bright fluid lotion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the management of acute inflammatory exacerbations of rosacea. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For topical administration only. _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: A thin film of preparation is applied to the affected areas of 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 Rozex cutaneous emulsion. A treatment course of one month is usual, occasionally two months is required. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 1. Contact with eyes and mucous membranes should be avoided. 2. If a reaction suggesting local irritation occurs patients should be directed to use the medication less frequently, discontinue use temporarily and to seek medical advice if necessary. 3. Metronidazole is a nitroimidazole and should be used with caution in patients with evidence of, or history of, blood dyscrasia. 4. Unnecessary and prolonged use of this medication should be avoided. HEALTH PRODUCTS REGULATORY AUTHORITY ______________________________________________________ 完全なドキュメントを読む