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Zydol 50mg caps

*
Pharmacy Only: Prescription

  • Company:

    Grunenthal Pharma Ltd.

  • Status:

    No Recent Update

  • 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-CAPS-50MG-[Left].jpeg

Updated on 09 October 2024

File name

ie-spc-2242-5-1-50mg-caps-v23-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

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

Updated on 09 October 2024

File name

ie-pl-capsules-v21-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
  • Change to section 6 - date of revision

Updated on 31 May 2024

File name

ie-pl-capsules-v21-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-2242-5-1-50mg-caps-v23-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 31 January 2023

File name

ie-spc-2242-5-1-50mg-caps-v22-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-pl-capsules-v20-ipha 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 4 - possible side effects

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-2242-5-1-50mg-caps-v22-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 09 March 2020

File name

ie-pl-capsules-v15-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 on sleep-related breathing disorders

Updated on 09 March 2020

File name

ie-spc-2242-5-1-50mg-caps-v17-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 on sleep-related breathing disorder added

Updated on 08 October 2019

File name

ie-pl-capsules-v14-clean-ipha.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Section 2:

- text added on the concomitant use of Zydol and benzodiazepines

- information added on the sodium content

Section 6:

- updated text on the alternative formats of the leaflet

- update to date of reveision of text

Updated on 08 October 2019

File name

ie-spc-2242-5-1-50mg-caps-v16d2-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 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: Special Warning and precautions for use

- Text added on the concomitant use of Zydol and sedating medicinal products such as benzodiazepines or related substances.

- Information added on the sodium content.

 

Section 4.5: Interactions with other medicinal products and other forms of interactions

- Text added on the concomitant use of opioids with sedating medicinal products such as benzodiazepines or related substances.

 

 

Updated on 05 July 2019

File name

ie-spc-2242-5-1-50mg-caps-ipha.pdf

Reasons for updating

  • File format updated to PDF

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

File name

ie-pl-capsules-v13-ipha.pdf

Updated on 05 June 2018

File name

ie-spc-1189-1-1-50mg-caps-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

Change to marketing authorisation holder and number

Updated on 05 June 2018

File name

ie-pl-capsules-v13-ipha.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number

Updated on 25 May 2018

File name

ie-spc-1189-1-1-50mg-caps-v14-clean.docx

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation

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

Updated on 18 May 2018

File name

ie-pl-capsules-v12-clean-ipha.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 - date of revision

Updated on 13 May 2018

File name

ie-pl-capsules-v12-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 3 - how to take/use
  • 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 14 July 2015

File name

PIL_11146_376.pdf

Reasons for updating

  • New PIL for new product

Updated on 14 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 - IMB details changed to HPRA details

Updated on 14 July 2015

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 11 August 2014

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • 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:
Capsule shell changes from green/yellow to yellow/yellow. Description in section 3 changed accordingly

Section 6.1:
Update to list of excioients due to deletion of logo on capsule shell and change in capsule shell colour. Indio carmine, Capsugel ink 1007 black, shellac, soya lecithin, black iron oxide and antifoam DC 1510 deleted.

Updated on 11 August 2014

Reasons for updating

  • Change to date of revision
  • Change to appearance of the medicine

Updated on 10 June 2014

Reasons for 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 4.8 – Undesirable effects - how to report a side effect
  • 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

 Section 3 – Pharmaceutical Form

Rewording of text


Section 4.2- Posology and method of administration

Further details added on dosing and dosing interval

Changes in line with current QRD template

 

Section 4.3 – Contraindications

Changes in line with current QRD template

 

Section 4.4 – Special warning and precautions for use

Editorial changes

 

Section 4.5 – Interaction with other medicinal products and other forms of interaction

Deletion of text on combination with mixed agonist/antagonist

 

Section 4.6 – Pregnancy and lactation

Deletion of ‘ teratogenic effects were not observed’

Addition of ‘Post marketing surveillance does not suggest an effect of tramadol on fertility. Animal studies did not show an effect of tramadol on fertility.’

 

Section 4.7 – ffects on ability to drive and use machine

Editorial changes

 

Section 4.8 -Undesirable effects

-          The frequency of ‘speech disorders’ changed from ‘unknown’ to ‘Rare’

-          Delirium added as a ‘rare’ adverse effect

-          The frequency of ‘mydriasis’ changed from ‘unknown’ to ‘Rare’

-          Miosis added as a ‘rare’ adverse effect

-          change to address for reporting adverse reactions to IMB included.

 

Section 4.9 – overdose

Editorial changes

 

 

 

Updated on 10 June 2014

Reasons for updating

  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to dosage and administration
  • Addition of information on reporting a side effect.

Updated on 24 April 2014

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 - Adverse event reporting. IMB address details updated

Updated on 17 April 2014

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 12 February 2014

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • 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 6.4
Do not store above 30oC has been changed to Do not store above 25oC

Section 10
06 February 2014

Updated on 12 February 2014

Reasons for updating

  • Change to storage instructions

Updated on 04 February 2014

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 – 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 1 - formatting changes

Section 2 - aligning to current QRD template

Section 4.2 - formatting changes

Section 4.3 - aligning to current QRD template

Section 4.4 - formatting changes

Section 4.5 - formatting changes

Section 4.6 - aligning to current QRD template

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 03 December 2013

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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)

Free text change information supplied by the pharmaceutical company

Pharmacovigilance working Party recommended changes from July 2012

Section 4.2 (Posology and method of administration)

Geriatric Elderly patients
Editorial changes to text

Patients with renal insufficiency/dialysis and hepatic impairment insufficiency

Rewording of text to state ‘In patients with renal and/or hepatic insufficiency the elimination of tramadol is delayed.  In these patients prolongation of the dosage intervals should be carefully considered according to the patient’s requirements.’

Text on initial dosing this this patient population and text relation to dialysis deleted.

 

Section 4.5 (Interaction with other medicinal products and other forms of interaction)

Text on tramadol induced convulsion in relation to use with SSRIs, SNRIs, TCAs, antipsychotics andother seizure threshold-lowering products modified according to pharmacovigilance Working Party recommendations.

Symptoms of serotonin syndrome added as Spontaneous clonus, Inducible or ocular clonus with agitation or diaphoresis, Tremor and hyperreflexia, Hypertonia and body temperature > 38˚C and inducible ocular clonus.

 

 

Updated on 27 November 2013

Reasons for updating

  • Change to drug interactions
  • Change to date of revision
  • Change to dosage and administration

Updated on 06 September 2013

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.1 - List of excipients

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

Free text change information supplied by the pharmaceutical company

Section 3: Pharmaceutical form

-          Updated to align with Zydol dossier

 

Section 4.2: Posology and method of administration

-          Text reformatted for clarity

 

Section 4.8: Undesirable effects

-          Undesirable effects further separated according to area of body affected.

 

Section 6.1: List of excipients

-          Updated according to Zydol dossier

Updated on 03 September 2013

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Improved electronic presentation

Updated on 08 July 2011

Reasons for updating

  • Improved electronic presentation

Updated on 06 November 2009

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 02 November 2009

Reasons for updating

  • 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)

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 February 2009

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)

Free text change information supplied by the pharmaceutical company

update date to: January 2009

Updated on 04 February 2009

Reasons for updating

  • Change to section 4.9 - Overdose

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

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 27 November 2008

Reasons for updating

  • Change of trade or active ingredient name
  • Correction of spelling/typing errors
  • Change to date of revision
  • Change to name of manufacturer

Updated on 26 November 2008

Reasons for 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

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

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 31 May 2007

Reasons for updating

  • Change due to harmonisation of patient information leaflet

Updated on 30 May 2007

Reasons for 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

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

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 July 2006

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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

     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 24 July 2006

Reasons for updating

  • New PIL for medicines.ie

Updated on 06 June 2006

Reasons for 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

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

Updated on 03 November 2005

Reasons for updating

  • New SPC for new product

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