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Zydol SR 50mg

*
Pharmacy Only: Prescription

  • Company:

    Grunenthal Pharma Ltd.

  • Status:

    Updated

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Tramadol Hydrochloride

    *Additional information is available within the SPC or upon request to the company

  • ZYDOL-SR-50MG-[Left].jpeg

Updated on 12 November 2024

File name

ie-spc-2242-5-6-sr50mg-tabs-v17-clean.pdf

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 11 November 2024

File name

ie-spc-2242-5-6-sr50mg-tabs-v17-clean.pdf

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 20 September 2024

File name

ie_uk-leaflet-zydol-sr50mg-tablets-v4-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - how to take/use
  • Change to section 5 - how to store or dispose

Updated on 20 September 2024

File name

ie-spc-2242-5-6-sr50mg-tabs-v17-clean.pdf

Reasons for 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 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 31 May 2024

File name

ie_uk-leaflet-zydol-sr50mg-tablets-v4-clean IPHA.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - how to take/use
  • Change to section 5 - how to store or dispose

Free text change information supplied by the pharmaceutical company

Do and tell Type IA(IN) variation change that was implemented on 31st May 2024. PSUSA outcome PSUSA/00003002/202306 

Updated on 31 May 2024

File name

ie-spc-2242-5-6-sr50mg-tabs-v17-clean IPHA.pdf

Reasons for 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 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Do and tell Type IA(IN) variation change that was implemented on 31st May 2024. PSUSA outcome PSUSA/00003002/202306 

Updated on 11 January 2024

File name

ie_uk-leaflet-zydol-sr50mg-tablets-v3.0 ipha.pdf

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 31 January 2023

File name

ie-spc-2242-5-6-sr50mg-tabs-v16-ipha clean.pdf

Reasons for updating

  • Document format updated

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 21 February 2022

File name

ie-spc-2242-5-6-sr50mg-tabs-v16-ipha clean.pdf

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Approval of End of Procedure of two work-sharing procedures as outlined below;

  1. DE/H/XXXX/WS/964 - Grouped Type II and Type IB variations.

Change 1: Type II - to update product information following CCDS update with additions of 3 ADRs and working adaptation of section 5.3 (pre-clinical safety data) with impact on the wording in section 4.6 (fertility).

Change 2: Type IB unforseen - to implementation PSUSA/00003002/202005 outcome.

  1. DE/H/xxxx/WS/1000 – Type IB PRAC change - to implement the PRAC change recommendation on signals based on EMA/PRAC/2050777/2021; EPITT no 19635 (dated 31st May 2021) into the product information (SmPC and PIL).

 

Updated on 21 February 2022

File name

ie-spc-2242-5-6-sr50mg-tabs-v16-ipha clean.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Approval of End of Procedure of two work-sharing procedures as outlined below;

  1. DE/H/XXXX/WS/964 - Grouped Type II and Type IB variations.

Change 1: Type II - to update product information following CCDS update with additions of 3 ADRs and working adaptation of section 5.3 (pre-clinical safety data) with impact on the wording in section 4.6 (fertility).

Change 2: Type IB unforseen - to implementation PSUSA/00003002/202005 outcome.

  1. DE/H/xxxx/WS/1000 – Type IB PRAC change - to implement the PRAC change recommendation on signals based on EMA/PRAC/2050777/2021; EPITT no 19635 (dated 31st May 2021) into the product information (SmPC and PIL).

 

Updated on 07 February 2022

File name

ie_uk-leaflet-zydol-sr50mg-pr-tablets-v2.0 ipha.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Individual PILs superseded by joint PIL

Free text change information supplied by the pharmaceutical company

Joint PIL for Ireland and UK has been approved by both HPRA and MHRA. The 2 safety changes that have been approved in the 2 worksharing procedures DE/H/xxxx/964 and 1000 are also updated in this joint PIL approval impacting warnings and precautions and possible side effects. 

Updated on 09 March 2020

File name

m1-3-1-leaflet-2242-5-6-sr50mg-tablets-v12-ipha.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Free text change information supplied by the pharmaceutical company

Information added on sleep related breathing disorders

Updated on 09 March 2020

File name

ie-spc-2242-5-6-sr50mg-tabs-v11-ipha.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Information added on sleep-related breathing disorders

Updated on 25 February 2019

File name

m1-3-1-leaflet-2242-5-6-sr50mg-tablets-v11-ipha.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 25 February 2019

File name

ie-spc-2242-5-6-sr50mg-tabs-v10-ipha.pdf

Reasons for updating

  • 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 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

File name

m1-3-1-leaflet-2242-5-6-sr50mg-tablets-v10-no-header.pdf

Updated on 29 May 2018

File name

ie-spc-2242-5-6-sr50mg-tabs-v9-ipha.docx

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to marketing authorisation holder and PA number

Updated on 25 May 2018

File name

ie-spc-1189-1-9-sr50mg-tabs-v8-clean.docx

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4

-          Updated text on dependence and treatment discontinuation

-          Text added on CYP2D6 metabolism

-          Text added on available information on the use in post-operative children

-          Text added on the use in children with compromised respiratory function

Section 4.6

-          Update to breast-feeding section

 

Section 4.8

-          Update on how to report adverse events to the MHRA

 

Section 5.2

-          Deleted ’Up to now, clinically relevant interactions have not been reported'

Section 7 : MA holder changed to Grunenthal Pharma Ltd

Section 8: MA number changed to PA 2242/5/6

Section 10: Date of revision as 01 May 2018

 

Updated on 18 May 2018

File name

m1-3-1-leaflet-2242-5-6-sr50mg-tablets-v10-no-header.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 10 May 2018

File name

m1-3-1-leaflet-1189-1-9-sr50mg-tablets-v9-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 19 October 2016

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 19 October 2016

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.2 Posology and method of administration:
Reference to section 5.1 included

Section 5.1 Pharmacodynamic properties:
Information about paediatric population added

Section 5.2 Pharmacokinetic properties:
Information about paediatric population added

Updated on 21 July 2015

File name

PIL_14473_722.pdf

Reasons for updating

  • New PIL for new product

Updated on 21 July 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8:

Details of adverse event reporting changed from IMB to HPRA.

Updated on 21 July 2015

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 04 February 2014

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company


Section 2 - formatting changes

Section 4.8 - addition of hypoglycaemia is a side effect with unknown frequency
- reporting of side effect

Section 10 - September 2013

Updated on 04 February 2014

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 12 September 2013

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.9 - Overdose
  • 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 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

-          Editorial changes to sections 1,2, 4.2, 4.3, 4.4, 4.7, 4.9, 5.2, 5.3, 6.1, 6.3, 6.6, 10.

-          Section 4.5

o   Added information on Serotonin-norepinehphrine reuptake inhibitors (SNRIs) induced convulsions can be increased by tramadol.  

o   Added Symptoms/signs of serotonin syndrome

-          Section 4.6

o   Statement on fertility included

-          Section 4.8

o   Included adverse reaction relating to : Immune system disorders, investigations, vascular disorders, metabolism disorders

o   Updates to adverse reactions relating to: cardiac disorders, nervous system disorders, psychiatric disorders, Eye disorders, respiratory, thoracic and mediastinal disorders, gastro intestinal disorders, skin disorders, hepatobiliary disorders, renal disorders and general disorders

Updated on 06 September 2013

Reasons for updating

  • Change of contraindications
  • Change to side-effects
  • Change to date of revision
  • Improved electronic presentation

Updated on 19 July 2011

Reasons for 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

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 15 July 2011

Reasons for updating

  • Change to improve clarity and readability

Updated on 15 July 2011

Reasons for updating

  • Improved electronic presentation

Updated on 10 June 2010

Reasons for updating

  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to further information section
  • Change to appearance of the medicine
  • Change to dosage and administration

Updated on 09 June 2010

Reasons for 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

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 06 November 2009

Reasons for updating

  • New PIL for medicines.ie

Updated on 31 October 2007

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)