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This medicinal product is intended for local symptomatic treatment and relief of pain in the following diseases of the middle ear without tympanic perforation: Acute inflammation of the middle ear of viral or bacterial origin, mainly in the initial stage inflammation of the ear drum Barotraumatic otitis . Phenazone has a pronounced anti-inflammatory effect and relieves ear pain. Benzocaine enhances the analgesic effect (pain relief) of phenazone and as a local anesthetic. The product is intended for adults, adolescents and children from 1 month of age. How to use Always use this medicine exactly as described in this leaflet. Check with your doctor or pharmacist if you are not sure. The usual dose is 4 drops 2 to 3 times a day in the ear canal of the patient. Before use warm the ear drops to 37 °C (approximately body temperature). This warming can be done in the palms. The maximum daily dose should not exceed 12 drops / sore ear per day. The recommended treatment time should not exceed 5 days. Warnings and precautions Do not use Earcalm If you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6). If you have perforated or burst ear drum (tympanic perforation) (see Section: Warnings and precautions). If the conditions mentioned in this paragraph occur only during the use of the product, tell your treating physician. The product is not intended for newborns (up to 1 month of age). If you have any doubt, seek advice of your doctor. Warnings and precautions If you have perforated ear drum membrane this medicine may cause side effects in the middle ear. Except ear pain, other common symptoms of perforated ear drum are: vertigo (spinning sensation); hearing change or loss, often with ringing, buzzing, or clicking; fluid or blood draining from the ear. In case of any doubts, as a precautionary measure, it is recommended to visit a doctor to check if your tympanic membrane (ear drum) is intact, before using this medicine. If in doubt, do not hesitate to seek the advice of your doctor or your pharmacist. Side Effects Like all medicines, EARCALM can cause side effects, although not everybody gets them. In rare cases, there is a risk of local reactions such as allergy, irritation, or congestion the ear canal. Storage Information Store below 30°C. Keep in the original pack to protect from light. To be used within 28 days after first opening. Drug Interactions Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. The effects of Earcalm and the effects of other concomitant medications may interfere with each other influence. For Earcalm, interactions are not yet known. Ingredients The active ingredients are Phenazone & Benzocaine Other ingredients : Propylene glycol. Specifications EARCALM is clear, colourless to slightly yellow solution free from particles.
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