Product Description

Do not use Tropex: - If you have a perforated (burst) ear drum - If you are allergic to phenazone or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before using Tropex. If improvement does not occur within 24 hours consult your doctor. If there is an infection present consult your doctor.

Other medicines and Tropex

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Tropex is unlikely to interfere with other medicines; however, accidental swallowing of Tropex may affect the metabolism of medicines broken down by liver enzymes. Little absorption is expected from topical application into the ear canal.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines No effect on ability to drive or use machines is to be expected.

Tropex contains methyl parahydroxybenzoate. May cause allergic reactions (possibly delayed).

How to take Tropex

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Tropex is for auricular use (administer the product into the ear). Usually 4-6 drops should be introduced into the ear 3-4 times daily according to the severity of the inflammation. You should check with your doctor or pharmacist if you are not sure. In case of accidental oral intake If you swallow small amounts of Tropex it will usually not cause any problem. However, for safety reasons, you should contact your doctor or pharmacist. If you forget to use Tropex Use the ear drops as soon as you remember then continue on as before. If you have any further questions on the use of this product contact your doctor or pharmacist

Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Phenazone may give rise to skin eruptions and hypersensitivity (allergic) reactions. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie . By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Tropex Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on both the label of the bottle and the outer carton after EXP. The expiry date refers to the last day of the month. Store Tropex in the original container. Do not store above 25°C. Do not refrigerate. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment. 6. Contents of the pack and other information What Tropex contains - The active substance is phenazone 5.0% w/v (50mg/ml). - The other ingredients are methyl parahydroxybenzoate (E218) and glycerol. What Tropex looks like and contents of the pack Tropex Ear Drops is a clear colourless solution. Tropex Ear Drops is available in a 10ml amber glass bottle equipped with dropper cap. Marketing Authorisation Holder and Manufacturer Rowa Pharmaceuticals Ltd., Bantry, Co. Cork, Ireland

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