Zydol 50mg/ml Solution for Injection
Last Updated on eMC 21-Mar-2017 View document | Grunenthal Ltd Contact details
Versions
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 21-Mar-2017 and displayed until Current
Reasons for adding or 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
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 07-Jul-2016
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section 4.2: Posology and method of adminstration
- Reference is made to section 5.1
Section 5.1: Pharmacodynamic properties
- Information on use of tramadol in paediatric population is included
Section 5.2: Pharmacokinetic properties
- Information on pharmacokinetics in paediatric population is included
Section 10: Date of revision of the text
- 7 July 2016
Updated on 09-Aug-2016 and displayed until 21-Mar-2017
Reasons for adding or updating:
- Change to section 1 - Name of the medicinal product
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 07-Jul-2016
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
- In Section 1 - product strength included as part of the name of the medicinal product (in line with the QRD template)
- In section 10 - date of revision of the text
Updated on 12-Feb-2015 and displayed until 09-Aug-2016
Reasons for adding or updating:
- Change to section 4.7 - Effects on ability to drive and use machines
Date of revision of text on the SPC: 12-Aug-2014
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section 4.7Addition of drug driving warning inline with MHRA directions
Updated on 20-Aug-2014 and displayed until 12-Feb-2015
Reasons for adding or updating:
- Change to section 4.6 - Fertility, pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- 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 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 07-Feb-2014
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section 4.2 Posology and method of Administration
- Editorial changes
- total daily dose changed from 600mg to 400mg
Section 4.3 Contrindications
- Editorial changes
Section 4.4 Special warnings and precautions for use
- Editorial changes
- upper daily dose limit changed from 600mg to 400mg
Section 4.5 Interactions
- deletion of text on combined adminstration with mixed agoinists/antagonists
Section 4.6 Fertility, pregnancy and lactation
- deletion of ' teratogenic effects were not observed'
- Added ' Fertility - 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 - Effects on ability to drive and use machines
- Editorial changes
Section 4.8 Undesirable effects
- Frequency of Speech disorders changed to Rare
- Frequency of Mydriasis changed to Rare
- Delirium added as a Rare adverse reaction
- Miosis added as a Rare adverse reaction
Updated on 31-Jan-2014 and displayed until 20-Aug-2014
Reasons for adding or updating:
- Change to section 1 - Name of the 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 - Fertility, 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
Date of revision of text on the SPC: 01-Sep-2013
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section 1 - formatting changes
Section 2 - Editorial changes/ align to current QRD template
Section 4.2 - Editorial changes/ align to current QRD template
Section 4.3 - Editorial changes/ align to current QRD template
Section 4.4 - formatting changes
Section 4.5 - formatting changes
Section 4.6 - align to current QRD template
Section 4.8 - addition of hypoglycaemia as a side effect of unknown frequency
- Details on reporting side effects
Section 10 - Spetemebr 2013
Updated on 05-Nov-2013 and displayed until 31-Jan-2014
Reasons for adding or 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
Date of revision of text on the SPC: 27-Aug-2013
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
In Section 4.2 (posology and method of administration):
- wording change for administration in geriatric patients to state 'A dose adjustment is not usually necessary in patients up to 75 years without clinically manifest hepatic or renal insufficiency. In elderly patients over 75 years elimination may be prolonged. Therefore, if necessary the dosage interval is to be extended according to the patient’s requirements.'
- wording change for administration in patients with renal insufficiency/dialysis and hepatic insufficiency 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.'
In section 4.5 (Interaction with other medicinal products and other forms of interaction):
added 'Tramadol can induce convulsions and increase the potential for selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, antipsychotics and other seizure threshold-lowering medicinal product (such as bupropion, mirtazapine, tehrahydrocannabinol) to cause convulsions.'
symptoms of serotonin syndrome are given as 'spontaneous clonus, inducible or ocular clonus with agitation or diaphoresis, tremor and hyperreflexia and hypertonia and body temperature >38oC and inducible ocular clonus.'
In section 10 (date of revision):
08/2013
Updated on 27-Jan-2011 and displayed until 05-Nov-2013
Reasons for adding or updating:
- Change to section 4.8 - Undesirable Effects
- Change to section 4.9 - Overdose
- Change to section 10 date of revision of the text
Date of revision of text on the SPC: 20-Jan-2011
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Updated on 29-Jun-2010 and displayed until 27-Jan-2011
Reasons for adding or updating:
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6. 5 - Nature and Contents of Container
- Change to section 10 date of revision of the text
Date of revision of text on the SPC: 01-Jun-2010
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
In sections 2 and 6.5, the packsize 50 mg per ml has been deleted.In section 10, the date of revision has been updated.
Updated on 17-Mar-2009 and displayed until 29-Jun-2010
Reasons for adding or updating:
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 9 - Date of first Authorisation/renewal of the Authorisation
- Change to section 10 date of revision of the text
Date of revision of text on the SPC: 05-Mar-2009
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section 9 - updated to 05/03/09
Section 10 - updated to 05/03/09
Updated on 06-Mar-2009 and displayed until 17-Mar-2009
Reasons for adding or 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 5.2 - Pharmacokinetic Properties
- Change to section 5.3 - Preclinical Safety Data
- Change to section 7 - Marketing Authorisation Holder
- Change to section 10 date of revision of the text
Date of revision of text on the SPC: 27-Feb-2009
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section 2formatted text
Section 4.1
Harmonised text for product range to “Treatment of moderate to severe pain.”
Section 4.2
Additional advice on administration.
Section 4.3
Formatted text and inclusion of contraindicated “for use in narcotic withdrawal treatment.”
Section 4.4
Reorganisation and update of advice on use particular groups of patients.
Section 4.5
Reorganisation and update of advice.
Section 4.6
Additional advice on breast-feeding.
Section 4.7
Reorganisation and update of advice.
Section 4.8
Reorganisation and update of advice. Addition of fatigue, dysuria, dyspnoea, involuntary muscle contractions, abnormal coordination, syncope.
Section 4.9
Reorganisation and update of advice.
Section 5.1
Reorganisation and update of advice.
Section 5.2
Reorganisation and update of advice.
Section 5.3
Reorganisation and update of advice.
Section 7
Format
Section 10
Update to reflect approval date.
Updated on 26-Jul-2005 and displayed until 06-Mar-2009
Reasons for adding or updating:
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Grunenthal Ltd
Units 1 and 2 Stokenchurch Business Park, Ibstone Road, Stokenchurch, Buckinghamshire, HP14 3FE, UK
+44 (0)870 351 8960
+44 (0)1494 486298
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