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Gerard Laboratories
Unit 36, Baldoyle Industrial Estate, Grange Road, Baldoyle, Dublin 13,
Telephone: +353 1 832 2250
Fax: +353 1 466 1912
Medical Information Direct Line: +353 1800 272 272
Medical Information e-mail: sales@gerard-laboratories.ie
Summary of Product Characteristics last updated on medicines.ie: 27/09/2006
SPC Atenetic 50/12.5mg & 100/25mg Film - coated Tablets

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 27/09/2006 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   09/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 4.2: Posology for patients with renal failure is added.

Section 4.4: Warning for patients with bronchospasm or asthma is added. Warnings for obstructive airways disease and potassium status are revised.

Section 4.5: Warnings regarding interaction with varapamil/diltiazem and cardiac glycosides have been revised. Interaction with anaesthetic agents is added.

Section 4.6: This section has been entirely updated.

Section 4.8: Udesirable effects are divided per system organ class.

Section 5.1: ATC code and therapeutic group are added.
Updated on 23/08/2006 and displayed until 27/09/2006
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   07/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 1: The trade name has been changed to 'Atenetic 50mg/12.5mg & 100mg/25mg Film-coated Tablets

Section 2: 'Ph. Eur.' designations are deleted. 'For a full list of excipients, see section 6.1' is added.

Section 3: Full pharmaceutical form is Film-coated Tablets. Visual description of the product is added.

Section 6.1: 'Hydroxypropylmethylcellulosed' is revised to 'hypromellose' and 'polyethylene glycol' is revised to 'macrogol'.

Section 6.5: 'Not all pack sizes may be marketed' is added.

Section 6.6: 'No special requirements' has been added.

Section 9: Date of last renewal has been changed to 21st May 2006.

Section 10: Date of revision of the text is July 2006
Updated on 23/03/2006 and displayed until 23/08/2006
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
Updated on 23/09/2004 and displayed until 23/03/2006
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Atenolol
  Chlortalidone