Updated on 30/04/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 13-Apr-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 and 4.5
Addition of wording related to concomitant treatments and bleeding risk along with editorial changes.
Section 7
Addition of Binger Str. 173
Section 10
Date revised to 04/2012
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Updated on 01/03/2012 and displayed until 30/04/2012
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6. 3 - Shelf Life
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 09-Feb-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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4.3 Contraindications
Minor amendment has been made to this section.
4.8 Undesirable effects
Additional side effect - Haemoptysis has been added with Uncommon frequencies.
Hepatic function abnormal/Liver function Test abnormal - frequencies have changed from “Uncommon” to “Common”.
Bloody discharge – frequencies have changed from “Uncommon” to “Rare”
Incision site haemorrhage – frequencies have changed from “Rare” to “Uncommon”
Wound drainage – frequencies have changed from “Uncommon” to “Rare”
5.1 Pharmacodynamic properties
Addition of “see section 4.2 for information on paediatric use” added to last paragraph under Paediatric population.
6.3 Shelf life
The shelf life has been changed from 2 years to 3 years.
The use by date once bottle is opened has been changed from within 30 days to 4 months.
9 Date of first authorisation/renewal of the authorisation
Minor update of the section
10 Date of revision
Date updated to 02/2012
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Updated on 20/12/2011 and displayed until 01/03/2012
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 28-Nov-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.2
To include recommendations to assess renal function in patients being considered for or already being treated with Pradaxa.
Section 4.3
Added a cross reference to section 4.2 for the contra-indication “patients with severe renal impairment (CrCL <30 ml/min)”
Section 10
Date updated to 11/2011
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Updated on 18/08/2011 and displayed until 20/12/2011
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 5.3 - Preclinical Safety Data
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Change to section 6. 3 - Shelf Life
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Aug-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Tables renumbered following inclusion of new tables early in SPC.
Section 4.2
Major update, including inclusion of paragraphs on hepatic impairment, weight, gender and missed dose, paragraph on paediatric population moved.
Section 4.3
Concomitant treatment with cyclosporine, itraconazole and tacrolimus added.
Section 4.4
Paragraph on 'hepatic impairment' amended. Major update to Paragraph on haemorrhagic risk. Paragraph on 'Spinal anaesthesia/epidural anaesthesia/lumbar puncture' deleted.
Section 4.5
Major updates including re-wording of several paragraphs and Anticoagulants and antiplatelet aggregation agents paragraph amended. Paragraphs added on Clopidogrel, ASA, NSAIDs, and LMWH.
Paragraph on P-gp inhibitors updated. Cyclosporine, itraconazole and tacrolimus added to contraindicated, paragraph on P-gp inducers updated.
Section 4.6
Lactation amended to Breast-feeding, paragraph added to fertility.
Section 4.8
Information previously included in Table 1 now in Table 4, paragraph included on definition of major bleeding events.
Section 4.9
Information on overdose re-written.
Section 5.1
'If the dTT is used, dabigatran concentrations above 200 ng/ml, measured at trough after150 mg twice daily dosing (10 16 hours after the previous dose), are associated with an increased risk of bleeding (see sections 4.4 and 4.9)' added; 'More that 99% of efficacy and safety data were generated in Caucasians' deleted and replaced wtih 'No clinically relevant ethnic differences among Caucasians, African American, Hispanic, Japanese or Chinese patients were observed.'
Minor changes to paragraph on 'Clinical trials in Venous Thromboembolism (VTE) prophylaxis following major joiunt replacement surgery'.
Section 5.2
Editorial changes, inclusion of Table 8 'Half life of total dabigatran in healthy subjects and subjects with impaired renal function', amendment of paragraphs on Elderly patients, Body weight, Gender, and Ethinic origin.
Section 5.3
' Carcinogenicity studies have not yet been completed with dabigatran' deleted and 'In lifetime toxicology studies in rats and mice, there was no evidence for a tumorigenic potential of dabigatran up to maximum doses of 200 mg/kg.' added.
Section 6.3
Shelf life amended from 3 years to 2 years.
Section 10
Date of revision amended.
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Updated on 16/02/2011 and displayed until 18/08/2011
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 21-Jan-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Sections 5.1 has been updated to include further pharmacokinetic data
Sections 4.2, 4.5, 4.8 and 5.2 have been updated to make other editorial changes
Section 10 Date of revision of the text has also been updated.
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Updated on 25/01/2011 and displayed until 16/02/2011
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 20-Dec-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Sections 4.2, 4.3, 4.4, 4.5 and 5.2 have been updated to include additional information regarding P-glycoprotein interactions
As part of this update section 4.3 has been revised to add concomitant treatment with systemic ketoconazole as a contraindication and to remove concomitant treatment with quinidine as a contraindication. Information regarding quinidine is now included in other sections of the SPC.
Section 10:
Date of revision of the text has also been updated.
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Updated on 22/11/2010 and displayed until 25/01/2011
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 25-Oct-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Section 4.8 has been updated.
Section 10 has been updated to 25 October 2010
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Updated on 15/09/2010 and displayed until 22/11/2010
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 26-Aug-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Section 4.4
Addition of a statement regarding activated partial thromboplastin time (aPTT) test in. Other minor changes to the SPCs have been made regarding formatting/punctuation.
Section 10
Date has been revised to 26 August 2010
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Updated on 15/07/2010 and displayed until 15/09/2010
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Jul-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Section 4.2
- update to add a sub-heading 'Adults'; to add a statement regarding the Paediatric population; to update patient to patients in the sub-section relating to amiodarone and verapamil and to add a statement advising patients not to open the capsules with a cross reference to section 5.2
Section 4.5
- typographical corrections have been made to sub-section Transporter interactions
Section 4.6
- update to include the new heading Fertility, pregnancy and lactation and to include a statement regarding fertility.
Section 5.1
- update to add a statement regarding the Paediatric population
Section 5.2
- update sub-section absorption to include information regarding the capsule formulation and not opening the capsule with a cross reference back to section 4.2
- typographical correction to sub-section Ethnic origin
Section 8
- deletion of the Legal category sub heading/information and inclusion of a statement referring to the EMA website.
Section 10 – date has been revised to 1 July 2010
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Updated on 25/11/2009 and displayed until 15/07/2010
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 28-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| To add information regarding verapamil to sections 4.2, 4.4 and 4.5.
To add information regarding clarithromycin to section 4.5.
Section 10 date has been revised to 28 October 2009.
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Updated on 22/04/2009 and displayed until 25/11/2009
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 25-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Section 4.8 Undesirable Effects
The following text has been inserted as a new third paragraph
Although rare in frequency in clinical trials, major or severe bleeding may occur and, regardless of location, may lead to disabling, life-threatening or even fatal outcomes.
Section 10 Date of Revision of the Text
The date has been updated from 26th February 2009 to 25th March 2009.
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Updated on 25/03/2009 and displayed until 22/04/2009
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 26-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Pradaxa 75 mg Hard Capsules changes
Section 5.1 Pharmacodynamic Properties
The bracketed figure in Table 6 of this section (row Number of MBE N(%), column Enoxaparin 40 mg) has been changed from 1.8 to 1.6.
Section 6.5 Nature and Contents of Container
The first sentence of this section has been amended from :
Cartons containing 1, 3, or 6 blister strips (10 x 1, 30 x 1, or 60 x 1 hard capsules) in perforated aluminium unit dose blisters.
to:
Cartons containing 1, 3, or 6 blister strips (10 x 1, 30 x 1, 60 x 1) in perforated aluminium unit dose blisters.
i.e. removal of the words or and hard capsules.
Section 10 Date of Revision of the Text
The date has been updated from 10th June 2008 to 26th February 2009.
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Updated on 16/09/2008 and displayed until 25/03/2009
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 10-Jun-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Pradaxa 75 mg Hard Capsules changes
Section 6.3 – Shelf-life:
This section has been amended to 3 years (as opposed to the original 2 years).
Section 6.5 – Nature and contents of container:
The first paragraph of this section has been amended to read:
“Cartons containing 1, 3, or 6 blister strips (10 x 1, 30 x 1, or 60 x 1 hard capsules) in perforated aluminium unit dose blisters. The blister consists of an aluminium lidding foil coated with polyvinylchloride-polyvinylacetate copolymer-acrylate (PVCAC acrylate) in contact with the product and an aluminium bottom foil with polyvinylchloride (PVC) in contact with the product.”
Section 10 – Date of revision of the text:
The date has been updated to 10th June 2008.
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Updated on 16/04/2008 and displayed until 16/09/2008
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Reasons for adding or updating:
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