Zydol 100mg Solution for Injection
- Name:
Zydol 100mg Solution for Injection
- Company:
Grunenthal Pharma Ltd.
- Active Ingredients:
- 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

XPIL
Package leaflet: Information for the user
Package leaflet: Information for the user
1. What ZYDOL is and what it is used for
1. What ZYDOL is and what it is used for
2. What you need to know before you take ZYDOL
2. What you need to know before you take ZYDOL
3. HOW TO USE ZYDOL
3. HOW TO USE ZYDOL
4. POSSIBLE SIDE EFFECTS
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ZYDOL
5. HOW TO STORE ZYDOL
6. Contents of the pack and other information
6. Contents of the pack and other information
Click on this link to Download PDF directly
Grunenthal Pharma Ltd.

Company Products
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 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 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
Infomration added on sleep-related breathing disorders
Updated on 5 July 2019 SPC
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 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 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 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
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 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
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 SPC
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 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 24 April 2014 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
Updated on 17 April 2014 PIL
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 4 February 2014 SPC
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 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 SPC
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 SPC
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 SPC
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 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 SPC
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
The frequencies in the section have been re-formatted.
Updated on 24 February 2009 SPC
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 SPC
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
10. DATE OF REVISION OF THE TEXT
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 SPC
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
Updated on 31 May 2007 PIL
Reasons for updating
- Change due to harmonisation of patient information leaflet
Updated on 31 May 2007 SPC
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 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 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 24 July 2006 SPC
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 7 June 2006 SPC
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 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)