Monday, October 10, 2016

Tri-Adcortyl Otic Ointment




The wording of leaflets is regularly updated. This electronic text is the most up-to-date version and may differ from the leaflet in your pack. If you have any questions about the information provided, please ask your doctor or pharmacist.





TRI-ADCORTYL OTIC OINTMENT


Your doctor has prescribed Tri-Adcortyl Otic Ointment for you. This leaflet gives a summary of information about your medicine. If you want to know more, or are not sure about anything, ask your doctor or pharmacist.



REMEMBER: This medicine is for YOU. Only a doctor can prescribe it. Never give it to anyone else. It may harm them even if they have the same symptoms as you.




What Is In Tri-Adcortyl Otic Ointment?


This ointment contains four active ingredients: triamcinolone acetonide which belongs to a group of medicines called steroids which are used to reduce inflammation, nystatin which is a member of a group of medicines called anti-fungal agents, neomycin and gramicidin which are antibiotics.


Each gram of Tri-Adcortyl Otic contains 0.1% of triamcinolone acetonide, nystatin 100,000 units, Neomycin 1625 units (0.25%) and Gramicidin 0.025% and is supplied in tubes of 10g. The other ingredients are: liquid paraffin and polyethylene resin.





Product Licence Holder:



E. R. Squibb & Sons Ltd.

Uxbridge Business Park

Sanderson Road

Uxbridge

Middlesex

UB8 1DH

England

Tel:0800 7311736





Manufacturer:



Bristol-Myers Squibb SpA

Contrada Fontana del Ceraso

03012 Anagni (Fr)

Italy




What Is This Medicine For ?


Tri-Adcortyl Otic ointment is prescribed to treat infection and inflammation of the external ear.




Before Using Your Medicine



Should you be using Tri-Adcortyl Otic ointment?


This ointment has been prescribed to treat the skin problem that you showed your doctor. DO NOT use it on any other skin problems as it may make them worse.



This ointment is NOT for Use in the Eyes



DO NOT use Tri-Adcortyl Otic ointment if you have any of the following skin conditions:


  • Tuberculosis (TB) of the skin;

  • viral infections e.g. cold sores, herpes, chickenpox

  • fungal skin conditions unless a suitable antifungal preparation has also been given

  • acne

  • inflammation around the mouth (perioral dermatitis)

  • a condition called rosacea (flushed, red face)

Tri-Adcortyl Otic ointment should not be used


  • inside the ears of patients with perforated eardrums (holes in eardrums)

  • for long periods of time

  • over large areas of the body

  • in the eyes.

This ointment should not be used if you have had an allergic reaction to any product containing the same ingredients as Tri-Adcortyl Otic ointment.


If Tri-Adcortyl Otic ointment is to be used on the face, or on children, treatment should not be longer than 5 days and the treated area should not be covered with any airtight or waterproof plasters/dressings.


This medicine should not be used in children under one year of age.




What if I am pregnant or breast feeding ?


You should always tell your doctor if you are pregnant, planning to become pregnant or breast feeding and let him decide if it is wise for you to use this medicine.




Do you have problems with your ears or hearing?


Make sure that your doctor knows about any problems you have with your ears before you start using Tri-Adcortyl Otic ointment. Neomycin, which is one of the active ingredients, may be harmful to the ears, particularly if used in large amounts and for long periods of time.





Using Your Medicine



How should I apply Tri-Adcortyl Otic ointment?


This ointment should be applied to the affected area two or occasionally three times daily. In the elderly this ointment should be used sparingly and for short periods of time. If after 7 days little or no improvement occurs then tell your doctor.


If you are using this ointment on burnt skin that has become infected or ulcerated skin, make sure you use a small amount of ointment, as these skin conditions may make it easier for the active ingredient in the ointment to pass through the skin into the blood stream and may increase the possibility of side-effects.




Are there special directions for children?.


As children are more likely to get side effects, they should not normally be treated for longer than 5 days, unless your doctor has told you to to do so.




What if Tri-Adcortyl Otic ointment is swallowed?


If this ointment is swallowed tell your doctor immediately or go to your nearest hospital casualty department.




What happens if you miss an application?


If you forget to use your ointment, apply it as soon as possible. However, if it is nearly time for your next application skip the missed dose and continue as before.




What should you do if you put Tri-Adcortyl Otic ointment on areas of normal or healthy skin?


Remove the ointment with a clean tissue and wash the area with plenty of water.





Undesirable Effects



Are there any unwanted effects of Tri-Adcortyl Otic ointment?


If absorbed into the bloodstream, the active ingredient neomycin can damage the ears or the kidneys.


Check with your doctor if you notice any of the following side effects: blistering, burning, itching, peeling, dryness or other signs of skin irritation not present before using this ointment.


If the ointment is used for a long time additional side effects may occur. Check with your doctor as soon as possible if you notice any of these: acne or oily skin, increased facial hair growth, increased sweating, lightheadedness on standing, reddish purple lines on arms, face, legs, trunk or groin; thinning of skin with easy bruising or wounds that are slow to heal, rashes consisting of slightly raised rounded red patches. It may also cause changes in your body's sugar levels. If you have skin reaction tests, eg. for allergies, the steroid contained in this ointment may affect the result by reducing the reaction. If you notice any other unwanted effect tell your doctor or pharmacist.





Looking After Your Medicine


Do not use your medicine after the expiry date which you will find on both the Ointment tube and box.


Keep all your medicines where children cannot reach them, preferably in a locked cupboard or medicine cabinet. Do not store Tri-Adcortyl Otic ointment above 25°C.


If your doctor decides to stop the ointment, ask your pharmacist to tell you what to do with any you have left.




DATE OF LAST REVISION June 2005





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