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This is a text only leaflet, designed for the visually impaired. Please visit our electronic Medicines Compendium (eMC) website to view the original document which may contain images or tables.

To get this leaflet in large print, Braille or as an audio CD, call the RNIB Medicine Information line on 0800 198 5000.

The product code for this leaflet is: PL 00034/5006R

 

Adcortyl in Orabase

Company Details

E. R. Squibb & Sons Limited


Uxbridge Business Park Sanderson RoadUxbridgeMiddlesexUB8 1DH
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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.

ADCORTYL™ IN ORABASE™

PATIENT INFORMATION LEAFLET

ADCORTYL™ IN ORABASE™

(Triamcinolone Acetonide in Oromucosal Paste)

PLEASE READ THIS LEAFLET BEFORE YOU USE YOUR MEDICINE

This leaflet gives a summary of information about Adcortyl in Orabase. If you want to know more, or are not sure about anything, ask your doctor, dentist or pharmacist.

REMEMBER: Keep all medicines OUT OF THE REACH AND SIGHT OF CHILDREN.

IF YOUR SYMPTOMS PERSIST: Consult your doctor or dentist.

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WHAT IS IN ADCORTYL IN ORABASE AND HOW DOES IT WORK?

The product contains triamcinolone acetonide 0.1%w/w, which belongs to a group of medicines called steroids which are used to reduce inflammation. This active ingredient is contained in a paste which will stick to the wet surfaces of the mouth and form a protective film over the affected area.

The orabase paste contains gelatin, liquid paraffin, pectin, polyethylene resin and carmellose sodium.

The product is supplied in 10g tubes.

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WHO SUPPLIES ADCORTYL IN ORABASE?

Product Licence Holder:

E.R. Squibb & Sons Ltd.
Uxbridge Business Park
Sanderson Road
Uxbridge
Middlesex
UB8 1DH
England
Tel:0800 7311736

Product Authorisation Holder:

Bristol-Myers Squibb
Pharmaceuticals Ltd.
Swords
County Dublin
Ireland
Tel:1-800-749-749

Manufacturer:

Bristol-Myers Squibb S.r.l.
Contrada Fontana del Ceraso
03012 Anagni (FR)
Italy
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WHAT IS THE MEDICINE FOR?

This product is for the treatment of mouth ulcers, including those caused by dentures or by injury, sore and inflamed gums, and lichen planus.

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BEFORE TAKING YOUR MEDICINE

SHOULD YOU BE TAKING ADCORTYL IN ORABASE?

NOT if you have any of the following illnesses:

  • Tuberculosis (TB) of the skin,
  • a viral skin infection, especially Varicella (chickenpox), or Herpes simplex (cold sores)
  • any fungal or bacterial infection of the skin (unless the doctor is treating it with antifungals or antibiotics)

and NOT if you have had an allergic reaction to similar medicines or any of the ingredients in this product.

Are there special directions for children?

No, but as for adults, do not use for longer than prescribed by your doctor or dentist.

What if you are pregnant or breast-feeding?

If you are pregnant, may become pregnant or are breast feeding, you should speak to your doctor before using this product.

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USING YOUR MEDICINE

HOW SHOULD I USE ADCORTYL IN ORABASE?

How much should I use?

Just enough to thinly cover the area in your mouth your doctor has told you to treat. Apply at bedtime and two to four times daily, preferably after meals.

How should I use Adcortyl in Orabase?

Remove the cap and pierce the nozzle end of tube with spike in the top of the cap.

Dry the area in your mouth to be treated and smear a small amount of paste on to it using a clean, dry finger. Do not rub in. Use Adcortyl in Orabase after meals, as it will stay in contact with your mouth for longer. Do not eat or drink immediately after applying Adcortyl in Orabase.

How long should I use Adcortyl in Orabase?

Your doctor or dentist will tell you how long to apply the paste. If your symptoms persist after the course of treatment go back and see him/her again. Courses of treatment in children should not exceed 5 days.

What if I miss or forget to apply a dose?

If you miss an application, apply it as soon as possible.

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USING YOUR MEDICINE

Are there any unwanted effects of Adcortyl in Orabase?

Any medicine may cause some unwanted side-effects. After prolonged use there is the possibility of absorption into the body. This may cause side effects, particularly in infants and children or if the product is used under false teeth. If you notice any irritation or other side-effect which you think may be as a result of using this product, stop treatment and consult your doctor.

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LOOKING AFTER YOUR MEDICINE

You will see an ‘EXPIRY DATE’ on the tube and carton of Adcortyl in Orabase. Do not use after this date. Keep all your medicines where children cannot reach or see them. Do not store above 25°C. Do NOT store near a radiator, on a window sill or in the bathroom.

Make sure the cap is tightly closed after use.

DATE OF LAST REVISION: June 2005

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