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Zydol SR 50mg

  • Name:

    Zydol SR 50mg

  • Company:
    info
  • Active Ingredients:

    Tramadol Hydrochloride

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 09/03/20

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 9/3/2020

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Grunenthal Pharma Ltd.

Grunenthal Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Ixprim effervescent tablets Active Ingredients Paracetamol, Tramadol Hydrochloride
Medicine Name Ixprim film coated tablets Active Ingredients Paracetamol, Tramadol Hydrochloride
Medicine Name NEXIUM 20 mg Tablets Active Ingredients Esomeprazole magnesium trihydrate
Medicine Name NEXIUM 40 mg Tablets Active Ingredients Esomeprazole magnesium trihydrate
Medicine Name Nexium I.V. 40mg Powder for solution for injection/infusion Active Ingredients Esomeprazole sodium
Medicine Name Palexia 100 mg film-coated tablets Active Ingredients Tapentadol hydrochloride
Medicine Name Palexia 50 mg film-coated tablets Active Ingredients Tapentadol hydrochloride
Medicine Name Palexia 75 mg film-coated tablets Active Ingredients Tapentadol hydrochloride
Medicine Name Palexia Oral Solution 20 mg/ml Active Ingredients Tapentadol hydrochloride
Medicine Name Palexia Oral Solution 4mg/ml Active Ingredients Tapentadol hydrochloride
Medicine Name Palexia SR 100 mg prolonged-release tablets Active Ingredients Tapentadol hydrochloride
Medicine Name Palexia SR 150 mg prolonged-release tablets Active Ingredients Tapentadol hydrochloride
Medicine Name Palexia SR 200 mg prolonged-release tablets Active Ingredients Tapentadol hydrochloride
Medicine Name Palexia SR 250 mg prolonged-release tablets Active Ingredients Tapentadol hydrochloride
Medicine Name Palexia SR 50 mg prolonged-release tablets Active Ingredients Tapentadol hydrochloride
Medicine Name Qutenza 179mg Cutaneous Patch Active Ingredients Capsaicin
Medicine Name Versatis 700 mg medicated plaster Active Ingredients Lidocaine
Medicine Name Zomig 2.5mg Tablets Active Ingredients Zolmitriptan
Medicine Name Zomig Rapimelt 2.5mg Active Ingredients Zolmitriptan
Medicine Name Zydol 100mg Solution for Injection Active Ingredients Tramadol Hydrochloride
Medicine Name Zydol 50mg caps Active Ingredients Tramadol Hydrochloride
Medicine Name Zydol SR 100mg Active Ingredients Tramadol Hydrochloride
Medicine Name Zydol SR 150mg Active Ingredients Tramadol Hydrochloride
Medicine Name Zydol SR 200mg Prolonged Release Tablets Active Ingredients Tramadol Hydrochloride
Medicine Name Zydol SR 50mg Active Ingredients Tramadol Hydrochloride
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When a pharmaceutical company changes any document, 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 9 March 2020 PIL

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 9 March 2020 SPC

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 PIL

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 SPC

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)

Updated on 18 June 2018

Updated on 29 May 2018 SPC

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 SPC

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 PIL

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 PIL

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 SPC

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 SPC

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 SPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 July 2015 PIL

Reasons for updating

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

Updated on 4 February 2014 SPC

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 4 February 2014 PIL

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 SPC

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 6 September 2013 PIL

Reasons for updating

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

Updated on 19 July 2011 SPC

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 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 15 July 2011 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 10 June 2010 PIL

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 9 June 2010 SPC

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 6 November 2009 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 31 October 2007 SPC

Reasons for updating

  • New SPC for new product

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