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Zydol 100mg Solution for Injection

  • Name:

    Zydol 100mg Solution for Injection

  • 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: 18/06/18

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 5/7/2019

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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 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 100mg, 150mg, 200mg Tablets 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
1 - 0 of 23 items.Total: Infinity pages

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 5 July 2019 SmPC

Reasons for updating

  • File format updated to PDF

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

Updated on 18 June 2018

Updated on 15 June 2018

Updated on 5 June 2018 PIL

Reasons for updating

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

Updated on 29 May 2018 SmPC

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 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 8 and 9 : Update to marketing authorisation holder and number 

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 - date of revision

Updated on 13 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 - date of revision

Updated on 19 October 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 19 October 2016 SmPC

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 added

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 14 July 2015 SmPC

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 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 6 June 2014 PIL

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 6 June 2014 SmPC

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 4.7 - 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 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • 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 1 – Name of medicinal product

Editorial changes

 

Section 2 – Qualitative and quantitative composition

Editorial changes

 

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

 

Section 6.1 – List of excipients

Editorial changes

 

Section 6.2 Incompatibilities

Re-wording of text

 

Section 6.3 – Shelf life

Editorial changes

 

Section 6.5 – Nature and contents of container

Re-wording of text

 

Section 6.6 – Special precautions for disposal

Re-wording of text

 

Updated on 24 April 2014 SmPC

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 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 4 February 2014 SmPC

Reasons for updating

  • 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
  • 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

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 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 27 November 2013 SmPC

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 PIL

Reasons for updating

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

Updated on 6 September 2013 SmPC

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 3 September 2013 PIL

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 10 June 2010 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects
  • Change to dosage and administration

Updated on 25 May 2010 SmPC

Reasons for updating

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

In Section 4.2, the dosage in Children above the age of 1 year has been updated with supporting data.
In Section 10, the approval date has been updated.

Updated on 21 May 2010 PIL

Reasons for updating

  • Change to, or new use for medicine

Updated on 6 November 2009 PIL

Reasons for updating

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

Updated on 2 November 2009 SmPC

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.
 
2. Section 10 Date of Revision of the text
Approval date ' October 2009' has been included.

Updated on 24 February 2009 SmPC

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 4 February 2009 SmPC

Reasons for updating

  • 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

4.9       Overdose  
Advice on how to treat cases of overdose and cases of intoxication with tramadol.

10.       DATE OF REVISION OF THE TEXT

 Date updated to November 2008

Updated on 27 November 2008 PIL

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 SmPC

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 4.6 - Pregnancy and lactation
  • Change to section 7 - Marketing authorisation holder
  • 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 of 100 mg / 2 ml
 section 2  clarification of 100 mg / 2 ml
 section 3 clarification that the product is a Solution for injection
 section 4.6 typographic
 section 7 formatting
 section 9 addition date information
 section 10 data update

Updated on 31 May 2007 PIL

Reasons for updating

  • Change due to harmonisation of patient information leaflet

Updated on 31 May 2007 SmPC

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 5.3 - 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
  • Change to section 5.1 - Pharmacodynamic properties

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 and additional information on excipients

  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 SmPC

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

 

          section 4.1  - indication change to state' Management of moderate to severe pain.'

          section 10 - date of revision

Updated on 24 July 2006 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 7 June 2006 SmPC

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 4 - Clinical particulars
  • Change to section 5 - Pharmacological properties
  • Change to section 6 - Pharmaceutical particulars
  • 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 3 November 2005 SmPC

Reasons for updating

  • New SPC for new product

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