Zydol SR Tabs 100mg
Last Updated on eMC 21-Mar-2017 View document | Grunenthal Ltd Contact details
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 12-Feb-2015 and displayed until 21-Mar-2017
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 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 4.7 - Effects on ability to drive and use machines
Date of revision of text on the SPC: 13-Feb-2014
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section 2 Qualitative and quantitative composition
- deletion of Zydol SR 100mg prolonged release tablets
Section 4.2 Posology and method of Administration
- Deleted ' for doses not practicable with this strength, other strengths of this medicinal product are available'.
- Editorial changes
Section 4.3 Contrindications
- Changes according current QRD template
Section 4.4 Special warnings and precautions for use
- Editorial changes
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 - Septemebr 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: 02-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):
02/08/2013
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 22-Apr-2010 and displayed until 27-Jan-2011
Reasons for adding or updating:
- Change to section 4.2 - Posology and method of administration
- Change to section 10 date of revision of the text
Date of revision of text on the SPC: 22-Mar-2010
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
- The section 4.2 Renal Insufficiency/Dialysis and Hepatic Insufficiency of the SmPC has been updated for the below reasons:
In patients with renal and/or hepatic insufficiency the elimination of tramadol is delayed. The degree of impaired renal or hepatic function was found to be unsuitable to adequately predict the serum levels of the active ingredient in the individual patient. Therefore, adjusting the dosing interval to the individual patient’s need is recommended for patients with renal or hepatic impairment.
Updated on 06-Mar-2009 and displayed until 22-Apr-2010
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 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 4.7 - 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 6. 5 - Nature and Contents of Container
- Change to section 6. 6 - Instructions for use, handling and disposal
- 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 1Updated to describe dose form.
Section 2
Formatted text and addition of key excipient detail.
Section 3
Updated to describe dose form.
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 6.5
Update of advice.
Section 6.6
Update of advice.
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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