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

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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

Reasons for adding or updating:

• Change to section 4.7 - Effects on ability to drive and use machines
• Change to section 10 - Date of revision of the text

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 4.7
Addition of drug driving warning inline with MHRA directions

Reasons for adding or updating:

• 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
• Change to section 4.8 - Undesirable effects
• Change to section 4.9 - Overdose
• Change to section 6.1 - List of excipients
• 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
- Frequency of dosing changed from ' not more frequently than 4 hourly' to '4-6 hoursly intervals'
- 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

Section 4.9 Overdose
added 'or prolonged-release formulation to the following 'In case of intoxication orally, gastrointestinal decontamination with activated charcoal or by gastric lavage is only recommended within 2 hours after tramadol intake. Gastrointestinal decontamination at a later time point may be useful in case of intoxication with exceptionally large quantities or prolonged-release formulation.'

Section 6.1 List of Excipients
- Editorial changes

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

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 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 >38^oC and inducible ocular clonus.'

In section 10 (date of revision):

August 2013

 

Reasons for adding or updating:

• Change to section 3 - Pharmaceutical form
• Change to section 6.1 - List of excipients
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 01-Apr-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 3:  Pharmaceutical Form (capsule description changed from green-pale yellow to yellow-yellow)

Section 6.1:  List of Excipients (indigo carmine deleted)

Section 10:  Date of Revision of the Text (changed to April 2013)

Reasons for adding or updating:

• Change to section 3 - Pharmaceutical form
• Change to section 6.1 - List of Excipients
• Change to section 10 date of revision of the text

Date of revision of text on the SPC: 27-Jan-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In Section 3: Deletion of wording about company logo on the capsule shell.
In Section 6.1: Excipients for Logo printing ink has been deleted.
In Section 10: Date of revision has been updated to the date when the text was revised during submission to the MHRA.

Reasons for adding or updating:

• Change to section 6. 4 - Special Precautions for Storage

Date of revision of text on the SPC: 01-Jan-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In 6.4, Storage condition has been reivsed from 30C to 25C.

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:



Reasons for adding or updating:

• Change to section 4.6 - Pregnancy and Lactation
• Change to section 4.9 - Overdose
• 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: 06-Mar-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



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 6.1 - List of Excipients
• 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: 27-Feb-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 2
formatted 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 6.1
Reorganisation and update of advice.

Section 6.5
Update of advice.

Section 10
Update to reflect approval date.

Reasons for adding or updating:

• Change to section 3 - pharmaceutical form
• Change to section 10 (date of (partial) revision of the text

Date of revision of text on the SPC: 01-Nov-2005

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Reasons for adding or updating:

• Change to section 3 - pharmaceutical form
• Change to section 10 (date of (partial) revision of the text
• Pending awaiting re-submission
• Pending awaiting re-submission

Date of revision of text on the SPC: 01-Nov-2005

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Reasons for adding or updating:

• Change to section 6. 5 - Nature and Contents of Container

Reasons for adding or updating:

• New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC