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Allen & Hanburys Ltd

Allen & Hanburys Ltd
Stonemason's Way, Rathfarnham, Dublin 16,
Telephone: +353 1 495 5000
Fax: +353 1 495 5105
Medical Information Direct Line: +353 1 800 244 255
Medical Information Facsimile: +353 1 495 5242
Summary of Product Characteristics last updated on medicines.ie: 02/09/2010
SPC Becotide 100 Evohaler

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 02/09/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   16-Aug-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Beclometasone dipropionate 100 micrograms per metered dose.

One metered dose contains 100 micrograms Beclometasone Dipropionate

For a full list of excipients, see section 6.1.

 

3.       PHARMACEUTICAL form

 

          Pressurised Inhalation, Solution

Clear and colourless solution in an aluminium canister with a valve

Updated on 14/02/2007 and displayed until 02/09/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   01/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

4.2 Posology and Method of Administration

Using your inhaler:

Remove the mouthpiece cover by gently squeezing the sides of the cover.

Check the inside and outside of the inhaler including the mouthpiece for the presence of loose objects.

Shake the inhaler well to ensure that any loose objects are removed and that the contents of the inhaler are evenly mixed.

Hold the inhaler upright between fingers and thumb with your thumb on the base, below the mouthpiece.

Breathe out as far as is comfortable and then place the mouthpiece in your mouth between your teeth and close your lips around it but do not bite it.

Just after starting to breathe in through your mouth press down on the top of the inhaler to release beclometasone dipropionate while still breathing in steadily and deeply.

While holding your breath, take the inhaler from your mouth and take your finger from the top of the inhaler. Continue holding your breath for as long as is comfortable.

If you are to take further puffs keep the inhaler upright and wait about half a minute before repeating steps 3 to 7.

Replace the mouthpiece cover by firmly pushing and snapping the cap into position.

IMPORTANT:

Do not rush stages 5, 6 and 7. It is important that you start to breathe in as slowly as possible just before operating your inhaler. Practise in front of a mirror for the first few times. If you see "mist" coming from the top of your inhaler or the sides of your mouth you should start again from stage 2.

If your doctor has given you different instructions for using your inhaler, please follow them carefully. Tell your doctor if you have any difficulties.

Updated on 14/07/2005 and displayed until 14/02/2007
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Updated on 22/02/2005 and displayed until 14/07/2005
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
   Beclometasone Dipropionate

Versions

 
02/09/2010 to Current
14/02/2007 to 02/09/2010
14/07/2005 to 14/02/2007
22/02/2005 to 14/07/2005
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Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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