Pradaxa 150 mg hard capsules

  • Name:

    Pradaxa 150 mg hard capsules

  • Company:
    info
  • Active Ingredients:

    Dabigatran etexilate mesilate

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 01/07/20

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Summary of Product Characteristics last updated on medicines.ie: 30/6/2020

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Boehringer Ingelheim Limited

Boehringer Ingelheim Limited

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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 17 August 2020 Ed-HCP

Reasons for updating

  • Replace document

Updated on 1 July 2020 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 30 June 2020 SmPC

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

 

  • Section 4.8: Updated to add ‘Neutropenia’ and ‘Agranulocytosis’ as Adverse reactions (Frequency: Not known) for all strengths, including addition of information regarding reporting of Neutropenia and Agranulocytosis under the section ‘Description of selected adverse reactions’.
  • Section 10: Date of revision has been updated

Updated on 19 February 2020 Ed-HCP

Reasons for updating

  • Replace document

Updated on 9 January 2020 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 9 January 2020 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

·         Section 4.3: Updated to add concomitant treatment of fixed-dose combination of glecaprevir/pibrentasvir (P-gp inhibitor) as a contraindication.

·         Section 4.5: Updated to add information regarding interaction of dabigatran etexilate and fixed-dose combination of glecaprevir/pibrentasvir (P-gp inhibitor).

·         Section 4.8: Updated to add ‘alopecia’ as an Adverse reaction (Frequency: Not known) + minor editorial update regarding description wording of Table 10. The Irish AE reporting details have also been updated.

·         Section 10Date of revision has been updated to 16 December 2019  

Updated on 29 July 2019 Ed-HCP

Reasons for updating

  • Replace document

Updated on 29 July 2019 Ed-Both

Reasons for updating

  • Add New Doc

Updated on 20 May 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 20 May 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4: To include warning regarding thromboembolic risk in patients with antiphospholipid syndrome.

Section 10: Date of revision has been updated to May 2019

Updated on 7 May 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 3 May 2019 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

  • Sections 4.2, 4.4, 4.8, 4.9, 5.1 & 5.2: Editorial updates.
  • Section 5.1: To include wording regarding Medicare study (Graham et al)
  • Section 10 updated

Updated on 20 August 2018 Ed-HCP

Reasons for updating

  • Replace document

Updated on 4 July 2018 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 3 July 2018 PIL

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 26 June 2018 SmPC

Reasons for 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 19 June 2018 Ed-HCP

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

Pradaxa (dabigatran etexilate) Prescriber Guide:

- Stroke prevention in atrial fibrillation

- Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (DVT/PE) 

Updated on 16 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 February 2018 PIL

Reasons for updating

  • Correction of spelling/typing errors
  • Improved presentation of PIL

Updated on 5 February 2018 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • 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 - interactions with other medicines, food or drink
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 1 February 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 1 February 2018 SmPC

Reasons for updating

  • 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 4.8 - 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 6.3 - 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Renewal: EMEA/H/C/000829/R/105. Sections 3, 4.1, 4.6, 4.9, 5.1, 5.2, 5.3, 6.1, 6.3, 6.5, 6.6,  – minor rewording/editorial changes

Main changes:

4.2 - dose recommendation and duration of treatment information now tabulated (subsequent table numbers updated).  Duplicated statements/information removed. New section ‘Discontinuation of Pradaxa’. Other editorial changes.;

4.3- inclusion of the wording ‘with the following strong P-gp inhibitors’ in the contraindications ‘Concomitant treatment with the following strong P-gp inhibitors: systemic ketoconazole, cyclosporine, itraconazole and dronedarone (see section 4.5)’;

4.4 - mainly editorial changes.  P-gp information in the table expanded;

4.5 - information tabulated.  Some changes to figures e.g. percentages replaced by ‘x- fold’ or percentages deleted/other text changes; 

4.8 - patient numbers per study/indication now included in a table; new text re: bleeding reactions; major bleeding definitions removed;

10 – Date of revision updated

Updated on 6 November 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Sections 4.2 (Posology and method of administration), 4.4 (Special warnings and precautions for use) and 5.1 (Pharmacodynamic properties) have been updated to include information regarding Catheter ablation for atrial fibrillation.

Section 4.8 (Undesirable effects) has been updated to include revised details for AE reporting in the UK.

Section 9 (Date of first authorisation/renewal of the authorisation) has been updated to include a revised date.

Section 10 (Date of revision of the text) includes the date of approval - 19 October 2017. 

Updated on 31 July 2017 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 21 June 2017 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change of capsule colour including removal of sunset yellow -  Sections 2 - Qualitative and Quantitative Composition, 3 – Pharmaceutical Form, 4.4 – Special warnings and precautions and 6.1 – List of excipients have been updated

Updated on 4 April 2017 SmPC

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPCs have been updated in section 5.2 to include information from study 1160.173 to assess dabigatran PK in NVAF patients dosed with 75mg bid with severe renal impairment (EMA/H/C/00829/II/097).
The date of revision of the text in the SPCs has been updated to 02 February 2017 (date of positive opinion).

Updated on 11 March 2016 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 8 March 2016 SmPC

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Deletion of the statement ‘Any unused product or waste material should be disposed of in accordance with local requirements.’ from Section 6.6 Special precautions for disposal and other handling.  The internal reference number of the SPCs has been updated but the date of the SPC is unchanged.

Updated on 2 March 2016 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company



SPC Sections 4.4 (special warnings and precautions for use) and 4.9 (Overdose) have been updated to include information relating to the reversal agent Praxbind  and to provide more information on surgery and interventions (section 4.4.).

Please also note that some editorial changes have been made to sections 2, 4.2 and 5.1.

Section 10 has been updated to 28 January 2016

Updated on 16 February 2016 PIL

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability

Updated on 20 January 2016 SmPC

Reasons for updating

  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Sections 6.5 Nature and content of container and 6.6 Special precautions for disposal and other handling have been updated.

Section 10 has been updated to 17 December 2015

Updated on 27 October 2015 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

SPC Section 5.1 Pharmacodynamic Properties; pharmacodynamics effects section has been updated.

 

 

Section 10 has been updated to 20 October 2015

Updated on 2 September 2015 SmPC

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

SPC Section 5.2 Pharmacokinetic Properties, last paragraph of the ‘Absorption’  subsection. Details of this change are given below with the change highlighted in red.

 

‘The oral bioavailability may be increased by 75 % after a single dose and 37 % at steady state compared to the reference capsule formulation when the pellets are taken without the Hydroxypropylmethylcellulose (HPMC) capsule shell. Hence, the integrity of the HPMC capsules should always be preserved in clinical use to avoid unintentionally increased bioavailability of dabigatran etexilate. Therefore, patients should be advised not to open the capsules and taking the pellets alone (e.g. sprinkled over food or into beverages) (see section 4.2).’

 

Section 10 has been updated to 07/2015

Updated on 13 February 2015 PIL

Reasons for updating

  • Change of inactive ingredient
  • Change to side-effects
  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 30 January 2015 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Sections 4.8 and 5.1: updates to efficacy and safety data

 

Headings were added to all tables (sections 4.4 and 4.8).

 

Section 4.8 has been updated to include the new contact details for AE reporting for Malta and in section 6.1 to revise the information on the printing ink used

 

Section 10 has been updated to 12/2014

Updated on 5 November 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8 has also been updated to include the new details for the Irish Health authority (HPRA formerly IMB).  Other minor editorial/formatting changes have also been made. 

 

Section 5.1 correction of typographical error thrombine to thrombin; to include safety information from the RELY-ABLE study

 

Section 10 has been updated to 09/2014

Updated on 17 July 2014 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Change to dosage and administration

Updated on 15 July 2014 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.1 Therapeutic indications

 

Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent

DVT and PE in adults

 

4.2 Posology and method of administration

 

Extensive changes throughout section 4.2

 

4.4 Special warnings and precautions for use

 

Numerous changes throughout section 4.4

 

4.5 Interaction with other medicinal products and other forms of interaction

 

Patients with NVAF concomitantly receiving dabigatran etexilate and verapamil, the dose of Pradaxa

should be reduced to 220 mg taken as one 110 mg capsule twice daily (see section 4.2).Close clinical

surveillance is recommended when dabigatran etexilate is combined with verapamil and particularly in

the occurrence of bleeding, notably in patients having a mild to moderate renal impairment.

 

4.8 Undesirable effects

 

Extensive changes throughout section 4.8

 

5.1 Pharmacodynamic properties

 

Extensive changes throughout section 5.1

 

 

5.2 Pharmacokinetic properties

 

The median CrClL in the RE-COVER study was 100.4 mL/min. 21.7 % of patients had mild renal

impairment (CrCL > 50 - < 80 mL/min) and 4.5% of patients had a moderate renal impairment (CrCL

between 30 and 50 mL/min). Patients with mild and moderate renal impairment had at steady state an

average 1.8-fold and 3.6-fold higher pre-dose dabigatran plasma concentrations compared with

patients with CrClL > 80 mL/min, respectively. Similar values for CrClL were found in RE-COVER

II.

 

The median CrCL in the RE-MEDY and RE-SONATE studies were 99.0 mL/min and 99.7 mL/min,

respectively. 22.9 % and 22.5 % of the patients had a CrClL > 50-< 80 mL/min, and 4.1 % and 4.8 %

had a CrClL between 30 and 50 mL/min in in the RE-MEDY and RE-SONATE studies.

 

5.3 Preclinical safety data

 

Dabigatran, the active moiety of dabigatran etexilate mesilate, is persistent in the environment.

 

 

10. DATE OF REVISION OF THE TEXT

Updated to June 2014

Updated on 12 June 2014 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

  • Section 4.2

The paragraph under Switching (SPAF) Parenteral anticoagulants to Pradaxa has been updated:

 

Discontinue the parenteral anticoagulant and start dDabigatran etexilate should be given 0‑2 hours prior to the time that the next dose of the alternate therapy would be due, or at the time of discontinuation in case of continuous treatment (e.g. intravenous Unfractionated Heparin (UFH)) (see section 4.5).

 

 

  • Section 4.3

Concomitant treatment with any other anticoagulants e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin etc), heparin derivatives (fondaparinux etc), oral anticoagulants (warfarin, rivaroxaban, apixaban etc) except under specific the circumstances of switching anticoagulant therapy to or from Pradaxa (see section 4.2) or when UFH is given at doses necessary to maintain an open central venous or arterial catheter (see section 4.5)

 

 

  • Section 4.5

Addition of the following paragraph:

Concomitant administration of a loading dose of 180 mg ticagrelor and 110 mg dabigatran etexilate (in steady state) increased the dabigatran AUCτ,ss and Cmax,ss by 1.49-fold and 1.65-fold (+49% and

65%), respectively, compared with dabigatran etexilate given alone. When a loading dose of 180 mg

ticagrelor was given 2 hours after 110 mg dabigatran etexilate (in steady state), the increase of

dabigatran AUCτ,ss and Cmax,ss was reduced to 1.27-fold and 1.23-fold (+27% and 23%),

respectively, compared with dabigatran etexilate given alone. This staggered intake is the

recommended administration for start of ticagrelor with a loading dose.

 

Concomitant administration of 90 mg ticagrelor BID (maintenance dose) with 110 mg dabigatran

etexilate increased the adjusted dabigatran AUCτ,ss and Cmax,ss 1.26-fold and 1.29-fold,

respectively, compared with dabigatran etexilate given alone.

 

 

  • Section 10 Date of revision of the text has also been updated to 05/2014

 

Updated on 29 January 2014 PIL

Reasons for updating

  • Change of contraindications
  • Change to drug interactions
  • Change to date of revision

Updated on 28 January 2014 SmPC

Reasons for updating

  • 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 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.1 – Therapeutic indications
Numerous changes to this section.

Section 4.2 – Posology and method of administration
The words “nonvalvular atrial fibrillation” have been removed and replaced with NVAF.

Section 4.3 – Contraindications
Tacrolimus has been removed from the 2nd last bullet point

Section 4.4 Special warnings and precautions
The words “nonvalvular atrial fibrillation” have been removed and replaced with NVAF.

Section 4.5 – Interactions
The following statement has been added under Transporter interactions; P-gp inhibitors:
“Concomitant treatment with tacrolimus is not recommended”

“posaconazole” has been added into the sentence:
“Caution should be exercised with mild to moderate P gp inhibitors (e.g. amiodarone, posaconazole, quinidine, verapamil and ticagrelor) (see sections 4.2 and 4.4).”

Tacrolimus has been removed from the “Ticagrelor” section:
“The following potent P gp inhibitors have not been clinically studied but from in vitro results a similar effect as with ketoconazole may be expected:
Itraconazole and cyclosporine, which are contra indicated (see section 4.3).”

The following paragraphs have been added into the “Ticagrelor” section:
“Tacrolimus has been found in vitro to have a similar level of inhibitory effect on P-gp as that seen with itraconazole and cyclosporine. Dabigatran etexilate has not been clinically studied together with tacrolimus. However, limited clinical data with another P-gp substrate (everolimus) suggest that the inhibition of P-gp with tacrolimus is weaker than that observed with strong P-gp inhibitors. Based on these data concomitant treatment with tacrolimus is not recommended.

Posaconazole also inhibits P-gp to some extent but has not been clinically studied. Caution should be exercised when Pradaxa is co-administered with posaconazole.”

The following statement has been deleted from the “Ticagrelor” section:
“Neither clinical nor in vitro test results are available for posaconazole which is not recommended for concomitant treatment with Pradaxa.”

Section 5.1 Pharmacodynamic properties
The words “nonvalvular atrial fibrillation” have been removed and replaced with NVAF.

Section 10 – date of revision
Updated to 12/2013

Updated on 22 October 2013 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2 Method of administration information,
Section 4.8 inclusion of a reference to oesophageal ulcer plus inclusion of information relating to reporting of suspected adverse reactions.
Section 10 Date of revision has been revised to 09/2013.

Updated on 16 October 2013 PIL

Reasons for updating

  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration
  • Addition of information on reporting a side effect.

Updated on 4 September 2013 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.4 Special warnings and precautions for use
The header has changed to “Postoperative phase”

Addition of sentence:
“Dabigatran etexilate should be restarted after the invasive procedure or surgical intervention as soon as possible provided the clinical situation allows and adequate haemostasis has been established.”

Removal of sentence:
“Resume treatment after complete haemostasis is achieved.”

10. Date of revision
Updated to 08/2013

Updated on 5 August 2013 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.3 Contraindications
Revision of the contraindication section

10. Date of revision
has also been updated

Updated on 24 June 2013 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 11 June 2013 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

section 4.8 (undesirable effects)
Revision of the calculation method of the approved side effects frequencies. In addition, the term ‘genitourological haemorrhage’ has been changed to ‘genitourological haemorrhage, including haematuria’.

section 4.4 (special warnings and precautions for use)
Addition of a warning regarding the increase of dabigatran exposure with concomitant intake of ticagrelor

section 4.5 (interaction with other medicinal products and other forms of interaction)
Inclusion of the data for ticagrelor

section 4.2 (posology and method of administration), 4.4, 4.5 and 5.2 (pharmacokinetic properties)
Updates regarding P-gp related wording.

section 10 (date of revision of the text)
Updated to 04/2013

Updated on 1 March 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about overdose
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to how the medicine works
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration

Updated on 14 February 2013 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to section 4.8 – anaphylactic reaction and angioedema added as rare adverse reactions; frequency for bronchospasm for 150 mg twice daily changed from very rare to not known; frequency for genitourological haemorrhage for 110 mg twice daily changed from uncommon to common; traumatic haemorrhage added as an uncommon adverse reaction; plus editorial changes (side effects re-ordered).

Update to section 4.3 – addition of prosthetic heart valves contraindication with cross-reference to section 5.1; plus editorial changes
Update to section 4.4 – deletion of sub-section relating to prosthetic heart valves; plus editorial changes
Update to section 5.1 – addition of a new sub-section ‘Clinical trials for the prevention of thromboembolism in patients with prosthetic heart valves’; plus editorial changes

Minor updates to sections 2, 3, 4.2, 4.5, 4.6, 4.7, 4.9, 5.2, 6.1, 6.4, 6.5, 9 and 10. These section updates also include some format changes e.g. in vitro now in italics.

Updated on 21 September 2012 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The contraindication regarding concomitant treatment with dronedarone has been added resulting in changes to sections 4.3, 4.5 and 5.2.

An additional new pack (white blister) (section 6.5) and the relevant new marketing authorisation number (section 8) has also been added.

Section 10 has also been updated.

Updated on 20 September 2012 PIL

Reasons for updating

  • Change of contraindications
  • Change to drug interactions
  • Change to date of revision
  • Change to MA holder contact details
  • Introduction of new pack/pack size

Updated on 22 August 2012 SmPC

Reasons for updating

  • 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 4.9 - Overdose
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4
The following statement was added:
‘Patients with prosthetic heart valves

The safety and efficacy of Pradaxa has not been studied in patients with prosthetic heart valves. Therefore, use of Pradaxa is not recommended in these patients.’

Plus a minor editorial change, removal of underlining.

Section 4.5

Minor editorial change - paragraph spacing and font.

Section 4.9
Correction of a minor spelling mistake.

Section 6.5
Addition of '...and a multipack containing 2 packs of 50 x 1 hard capsules (100 hard capsules) ...'

Section 8
Addition of MA number for new pack size EU/1/08/442/016.

Section 10
Date of revision of text amended to 07/2012 from 06/2012.

Updated on 2 August 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to date of revision

Updated on 23 July 2012 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.9 - Overdose
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

4.2 (posology and method of administration), has been updated to include further information on renal testing.
4.3 (contraindications) has been updated
4.4 (special warnings and precautions), further information has been included regarding factors which may increase the haemorrhagic risk
4.5 (interactions) - has been updated.
4.9 (overdose) - additional paragraph has been added to this section.
5.1 (pharmacodynamic properties – Addition of information regarding concomitant use of ASA or clopidogrel in the RELY study.
5.2 (pharmacokinetic properties - minor editorial update only) have been revised.
10 (date of revision of the text) has also been updated

Updated on 19 June 2012 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The addition of/revision of wording regarding anticoagulant tests have been made to sections
4.2 Posology and method of administration
4.4 Special warnings and precautions for use
4.8 Undesirable effects
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties

The addition of wording regarding haemodialysis have been made to sections
4.9 Overdose
5.2 Pharmacokinetic properties

Section 10 Date of revision of the text has also been updated

Updated on 1 May 2012 SmPC

Reasons for updating

  • 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 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

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

Updated on 30 April 2012 PIL

Reasons for updating

  • Change to drug interactions
  • Change to date of revision
  • Change to MA holder contact details
  • Correction of spelling/typing errors

Updated on 12 March 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration

Updated on 2 March 2012 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 9 - Date of renewal of authorisation

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.3 Contraindications
Minor amendment has been made to this section.

4.8 Undesirable effects
Hepatic function abnormal/Liver function Test abnormal - frequencies have changed from “Uncommon” to “Common”.

Incision site haemorrhage – frequencies have changed from “Rare” to “Uncommon”

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

Updated on 20 December 2011 SmPC

Reasons for 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 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

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 4.4
Minor changes to 3rd paragraph under “haemorrhagic risk”.

Section 10
Date updated to 11/2011

Updated on 26 August 2011 PIL

Reasons for updating

  • New PIL for new product

Updated on 26 August 2011 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided