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Grunenthal Ltd
4045 Kingswood Road, Citywest Business Park, Citywest, Co Dublin, Ireland
Telephone: +44 (0)870 351 8960
Medical Information Direct Line: +44 (0)870 351 8960
Medical Information e-mail: medicalinformationie@grunenthal.com
Summary of Product Characteristics last updated on medicines.ie: 19/07/2011
SPC Zydol SR 50mg

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 19/07/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.8 - Undesirable effects
  • 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:   29-Jun-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Section 3, the pharmaceutical form has been revised to state in singular form (from 'Prolonged-release tablets' to 'Prolonged-release tablet'.
Section 4.8, ',' have been removed in the frequencies and replaced with 'to' (format change).
Section 9, the 'Date of last renewal' has been added.
Section 10, the 'Date of revision of the text' has been updated as per the issued PA Schedule.

 
Updated on 09/06/2010 and displayed until 19/07/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-May-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
The SPC sections 2, 3, 4.1, 4.2, 4.3, 4.4, 4.5, 4.8, 5.1, 5.2, 5.3, 6.1, 6.3 and 10     have been harmonised with other EU Zydol SR 50 mg licenses.

SPC section 4.9 Overdose, has been updated to include information about gastrointestinal decontamination with activated charcoal.
Updated on 31/10/2007 and displayed until 09/06/2010
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
  Tramadol Hydrochloride