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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: 02/11/2009
SPC Zydol 50mg caps

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 02/11/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   19-Oct-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 4.8 Undesirable effects
'Speech disorders' and 'mydriasis' have been added to Nervous system disorders and Eye disorders, respectively. 'CNS symptoms' (i.e. confusion, delusions, depersonalisation, derealisation, paranoia) has been updated with examples in General disorders.  
The frequencies in the section have been re-formatted.
 
Section 10 Date of Revision of the text
Approval date ' October 2009' has been included.
Updated on 24/02/2009 and displayed until 02/11/2009
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

update date to: January 2009
Updated on 04/02/2009 and displayed until 24/02/2009
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   11/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
 
4.9       Overdose  
Advice on how to treat cases of overdose and cases of intoxication with tramadol.
Updated on 26/11/2008 and displayed until 04/02/2009
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 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • 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:   11/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
section 1  clarification as hard capsules
 section 2  clarification as hard capsules
 section 3 clarification that the product is a capsule
 section 5.1 typographic
 section 6.1  clarification of sodium starch glycolate (type A)
 section 9 addition date information
 section 10 data update
Updated on 30/05/2007 and displayed until 26/11/2008
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   04/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 2 – format/harmonisation of text

  Section 4.1 – format/harmonisation of text

  Section 4.2 - – format/harmonisation, change in children age limit

  Section 4.3 - – format/harmonisation of text

  Section 4.4 – format/harmonisation of text

  Section 4.5 – format/harmonisation, INR warning updated, additional information

  Section 4.6 – format/harmonisation of text

  Section 4.7– format/harmonisation of text

  Section 4.8 – format/harmonisation including additions and deletion of adverse reaction details

  Section 4.9 – format/harmonisation with addition advice.

  Section 5.1 – format/harmonisation of text

  Section 5.3 – format/harmonisation of text

  Section 6.6 – format/harmonisation

  Section 10 – updated date of SPC

 
Updated on 24/07/2006 and displayed until 30/05/2007
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   06/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

     Black triangle has been removed as it no longer applies

  • section 4.1  - indication change to state' Management of moderate to severe pain.'
  • section 10 - date of revision
Updated on 06/06/2006 and displayed until 24/07/2006
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5 - Pharmacological properties
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Updated on 03/11/2005 and displayed until 06/06/2006
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
  Tramadol Hydrochloride