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METROSA 0.75% GEL

Transcript

UK/0820/001/IB/018 UK Metrosa 0.75% Gel

Package leaflet: Information for the user

Metrosa® 0.75% Gel 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 Metrosa 0.75% Gel is and what it is used for 2. Before you use Metrosa 0.75% Gel 3. How to use Metrosa 0.75% Gel 4. Possible side effects 5. How to store Metrosa 0.75% Gel 6. Further information

1. What Metrosa 0.75% Gel is and what it is used for Metrosa 0.75% Gel is an antiinflammatory gel to be applied on the skin. Metrosa 0.75% Gel is used for the treatment of rosacea (redness in the face, sometimes together with additional pustules) when the condition suddenly gets worse, and the inflammation becomes troublesome. 1 g Metrosa 0.75% Gel contains 7.5 mg Metronidazole as active substance. Metronidazole acts against some of the fungi and other organisms that can affect the skin, and also, in patients suffering from rosacea, it can relieve the condition by acting against the inflammation which happens when the condition becomes troublesome.

2. Before you use Metrosa 0.75% Gel Do not use Metrosa 0.75% Gel if you are hypersensitive (allergic) to Metronidazole, propylene glycol or any of the other ingredients listed below (see 6. Further Information; What Metrosa 0.75% Gel contains). Take special care with Metrosa 0.75% Gel Do not let the gel come into contact with the eyes and mucous membranes. If eye-contact should occur, wash the gel carefully out of the eyes with warm water. If irritation does occur you should use Metrosa 0.75% Gel less frequently or stop temporarily. If necessary seek medical advice, please. Do not go out into strong sunlight (sunbathing), or use UV lamps (solarium, sunlamps) while you are using this product. Avoid prolonged and unnecessary use of

this medicine. You shouldn`t exceed the recommended duration of therapy. If required, the therapy could be recommended again and be repeated. However you should consider that an interval of 6 weeks in between has to be kept. Use Metrosa 0.75% Gel with care if you suffer or suffered in the past from blood disorders (blood dyscrasia). Use in children and adolescents Metrosa 0.75% Gel should not be used in children and adolescents. Using other medicines Interaction with systemic medication is unlikely because absorption (ability to get through the skin into the body) of metronidazole following cutaneous application of Metrosa 0.75% Gel is low. Nevertheless, it should be mentioned that reactions called disulfiram-like reactions have been reported in a small number of patients taking metronidazole and alcohol concomitantly. These reactions can include nausea, vomiting, flushing of the skin, an accelerated heart rate and shortness of breath. Using Metrosa 0.75% Gel could interfere with drugs used to thin the blood (anticoagulants) such as warfarin and coumarin. Contact your doctor for advice if you are taking medicines to thin your blood, or if you suffer for any other blood disorders. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Using Metrosa 0.75% Gel with food and drink Food and meals can be consumed with only one exception: It is best not to take alcohol while using the gel, as there is a very small possibility of a reaction that might make you feel sick or nauseous. Pregnancy and breast-feeding Metrosa 0.75% Gel should be used in pregnancy only if it is clearly needed and recommended by your doctor. Please ask for medical advice. You should ask your doctor for advice if you are breast-feeding whether to discontinue nursing or the drug. Driving and using machines You are allowed to drive and use machines since there are no effects known on the ability to drive. Important information about some of the ingredients of Metrosa 0.75% Gel Propylene glycol may cause skin irritation. Should this occur, stop using the medicine and consult your doctor.

UK/0820/001/IB/018 UK Metrosa 0.75% Gel

3. How to use Metrosa 0.75% Gel Metrosa 0.75% Gel gel is for cutaneous use only. Unless your doctor has told you differently, apply a 2 – 3 cm line of gel to the affected areas and rub it gently into the skin. Use the gel twice each day, for up to four weeks. Always use Metrosa 0.75% Gel exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. If you use more Metrosa 0.75% Gel than you should If you apply too much of the gel, simply wipe off the excess with a clean tissue or remove by washing with warm water. The gel is for use on the skin only. If you, or anyone else, should accidentally swallow a quantity of the gel, tell your doctor at once, or go to the nearest hospital casualty department. If you forget to use Metrosa 0.75% Gel If you forget to use the gel, then use it as soon as you remember, unless the next application is due within about two or three hours, in which case omit the forgotten dose. If you stop using Metrosa 0.75% Gel If you stop using the gel, contact your doctor or pharmacist. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects Like all medicines, Metrosa 0.75% Gel can cause side effects, although not everybody gets them. The evaluation of side effects is based on the following frequencies: Very common:

More than one patient in 10

1 to 10 patients in 100

1 to 10 patients in 1,000

1 to 10 patients in 10,000

Less than 1 patient in 10,000

Significant side effects, signs to look out for and what to do if you are affected: If you are affected by any of the side effects listed below, stop using Metrosa 0.75% Gel and consult your doctor as quickly as possible. Common: Skin and subcutaneous tissue disorders Contact dermatitis (skin reaction resulting from exposure to allergens), dry skin, erythema (abnormal redness and inflammation of the skin), pruritus (itching), rash (inflammation of the skin with reddening), skin discomfort (burning and stinging), skin irritation, worsening of rosacea (chronic skin condition involving inflammation of the cheeks, nose, chin, forehead or eyelids). General disorders Pain. Uncommon: Nervous System disorders Hypoaesthesia (decreased sensation to normal or painful skin stimulation), paraesthesia (an

abnormal or inappropriate sensation in an organ). Other possible side effects Rare: Gastrointestinal disorders Metallic taste, nausea 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.

5. How to store Metrosa 0.75% Gel Keep out of the reach and sight of children. Do not use Metrosa 0.75% Gel after the expiry date which is stated on the tube. The expiry date refers to the last day of that month. Do not refrigerate or freeze the gel. Use within 3 months of first opening.

6. Further information What Metrosa 0.75% Gel contains – The active substance is Metronidazole 1 g of gel contains 7.5 mg Metronidazole – The other ingredients are phenoxyethanol (Ph. Eur.), propylene glycol, hypromellose (E 464) and purified water. What Metrosa 0.75% Gel looks like and contents of the pack It is made available as a collapsible aluminium tube containing 25 g, 30 g, 40 g or 50 g of the gel (not all pack sizes will be market at time). Marketing Authorisation Holder and Manufacturer Dr. August Wolff GmbH & Co. KG Arzneimittel Sudbrackstra?e 56, 33611 Bielefeld, GERMANY Phone: +49 521 8808-05 Fax: +49 521 8808-334 E-Mail: info@wolff-arzneimittel. de For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: m & a pharmachem ltd Allenby Laboratories, Wigan Road, Westhoughton, Bolton BL5 2AL Telephone 01942 816184 This medicinal product is authorised in the Member States of the EEA under the following names: Estonia. Metrosa 7,5 mg/g geel Germany. MetroGalen 7,5 mg/g Gel Hungary. Metrosa 7,5 mg/g gel Latvia. Metrosa 7,5 mg/g gels Lithuania. Metrosa 7,5 mg/g gelis Austria, Belgium. Nidazea 7,5 mg/g Gel The Netherlands. Metrosa 7,5 mg/g, gel United Kingdom. Metrosa 0.75% Gel This leaflet was last revised in 10/2014

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.