Jardiance 10 mg and 25 mg Film-Coated Tablets

  • Name:

    Jardiance 10 mg and 25 mg Film-Coated Tablets

  • Company:
    info
  • Active Ingredients:

    Empagliflozin

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/10/19

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Summary of Product Characteristics last updated on medicines.ie: 21/10/2019

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Boehringer Ingelheim Limited

Boehringer Ingelheim Limited

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1 - 0 of 50 items.Total: Infinity pages

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 21 October 2019 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 21 October 2019 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 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: Update to Diabetic Ketoacidosis section to add information on ketone monitoring in surgical patients as per the PRAC recommendation for SGLT2 inhibitors.

Section 10: Date of revision has been updated.

Editorial update in section 4.8: The Irish AE reporting details have also been updated.

Updated on 26 February 2019 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • 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 - interactions with other medicines, food or drink
  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle

Updated on 26 February 2019 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors
  • Removal of Black Inverted Triangle

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

Free text change information supplied by the pharmaceutical company

  • Title Section: Black triangle removed
  • Section 2, 4.2, 4.4, 4.5, 4.8: Minor content changes including addition of ‘sodium free’ statement to composition, additional detail regarding frequency of hypoglycaemia
  • Sections 2, 4, 5: Minor editorial changes
  • Section 9: updated with details of renewal.
  • Section 10: Date of revision has been updated to 14/02/2019 
     

Updated on 4 February 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to date of revision

Updated on 30 January 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 4.4: Addition of a warning for necrotising fasciitis of the perineum (Fournier’s gangrene)
  • Section 4.8: Addition of necrotising fasciitis of the perineum (Fournier’s gangrene) as an adverse event under the  ‘Not known’ frequency with cross-reference to section 4.4. An additional minor typographical change was also made.
  • Section 10: Date of revision has been updated.
     

Updated on 9 July 2018 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 5 July 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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)

Updated on 30 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 30 January 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

• Sections 4.4: Wording update in the ‘Urinary tract infections’ subsection, where reference to the frequency of complicated UTI cases treated with Empagliflozin compared to placebo has been updated to reflect the reporting of post-marketing cases of complicated UTI with Empagliflozin only.
• Section 4.8: Update to the common side effect ‘Urinary tract infection’ to include reference to pyelonephritis and urosepsis.
• Section 10: Date of revision of the text 

Updated on 17 August 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 17 August 2017 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 9 August 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 8 August 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

·        Sections 4.4: Minor wording update in the ‘Diabetic ketoacidosis’ subsection, where reference to ‘fatal cases’ and ‘clinical trial and post-marketing’ has been added and removed, respectively.

·        Section 4.8: Addition of new side effects, minor editorial changes and update to the UK adverse events reporting details.

·        Section 5.2: Minor update to the mean plasma AUC units. Please refer to the attached tracked version.

·        Section 10: Date of revision of the text has also been aligned with the date of Commission decision, which was 19/07/2017.

Updated on 1 August 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 changes are as follows:

-Sections 5.2: Details regarding the phase 1 PK/PD study in children and adolescents ≥10 to <18 years of age with type 2 diabetes mellitus has been added in the Paediatric population sub-section.

-Section 10: date of revision of the text, has also been aligned with the date of Positive Opinion, which was 22/06/2017.

Updated on 12 May 2017 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Improved presentation of PIL

Updated on 11 May 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 10 May 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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 4.4 (Detail regarding lower limb amputations added)

-Section 4.8 (Adverse drug reaction ‘serum lipids increased’ has moved to common from uncommon)

-Section 5.1 (Clarification in Figure 1 title) and Section 5.1 (ATC code updated)

-Section 10, date of revision of the text

Updated on 6 February 2017 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 - 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

The SPC includes changes resulting from the approval of variation EMEA-H-C-002677-II-0014 to include additional data from a clinical trial (EMPA-REG OUTCOME).

 

The changes are as follows:

- Section 4.1, 4.2, 4.4,4.5, 5.1 (including additional data on cardiovascular outcome).

- Section 4.8 (including new common AE thirst and uncommon AEs Haematocrit increased, Serum lipids increased).

Updated on 1 February 2017 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 - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 15 December 2016 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

The SPC includes changes resulting from the approval of variation EMEA/H/C/002677/WS0926/0017.

The changes are as follows:

 

-Section 4.8 and 5.1 to include data from 1275.9; includes minor editorial change to 4.8.

-Section 10, date of revision of the text is aligned with the date of positive opinion (10 November 2016).

Updated on 21 October 2016 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 5.1 of the SPC has been updated to change the description of sustained efficacy from 52 weeks to 76 weeks (where applicable), other editorial changes have also been made.

Section 10 of the SPC has also been amended to September 2016.

Please note that s
ection 4.8 of the SPC has also been revised to update the AE address details for Ireland.

Updated on 26 August 2016 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 (Hypoglycaemia) and Section 5.1 (In combination with metformin in drug-naïve patients) – additional text added.

Section 10 (Date of revision of the text) of the text is aligned with the date of positive opinion (21 July 2016). Implementation date (based on PO + day 27) is 17 August 2016

Updated on 8 August 2016 PIL

Reasons for updating

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

Updated on 22 July 2016 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
The tabulated list of adverse reactions has been updated to include 'Blood creatinine increased/Glomerular filtration rate decreased" under the class "Investigations".  A description of the adverse reaction has also been added.

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

Updated on 9 May 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 4.4
The following text has been added:

Diabetic ketoacidosis

Rare cases of diabetic ketoacidosis (DKA), including life-threatening cases, have been reported in clinical trials and post-marketing in patients treated with SGLT2 inhibitors, including empagliflozin. In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/l (250 mg/dl). It is not known if DKA is more likely to occur with higher doses of empagliflozin.

The risk of diabetic ketoacidosis must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness. Patients should be assessed for ketoacidosis immediately if these symptoms occur, regardless of blood glucose level.

In patients where DKA is suspected or diagnosed, treatment with empagliflozin should be discontinued immediately.

Treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses. In both cases, treatment with empagliflozin may be restarted once the patient’s condition has stabilised.

Before initiating empagliflozin, factors in the patient history that may predispose to ketoacidosis should be considered.

Patients who may be at higher risk of DKA include patients with a low beta-cell function reserve (e.g. type 2 diabetes patients with low C-peptide or latent autoimmune diabetes in adults (LADA) or patients with a history of pancreatitis), patients with conditions that lead to restricted food intake or severe dehydration, patients for whom insulin doses are reduced and patients with increased insulin requirements due to acute medical illness, surgery or alcohol abuse. SGLT2 inhibitors should be used with caution in these patients.

Restarting SGLT2 inhibitor treatment in patients with previous DKA while on SGLT-2 inhibitor treatment is not recommended, unless another clear precipitating factor is identified and resolved.

The safety and efficacy of empagliflozin in patients with type 1 diabetes have not been established and empagliflozin should not be used for treatment of patients with type 1 diabetes. Limited data from clinical trials suggest that DKA occurs with common frequency when patients with type 1 diabetes are treated with SGLT2 inhibitors.
 
Section 4.8

(Table 1: Adverse reactions reported in placebo controlled studies) – Diabetic ketoacidosis added.as adverse reaction.

Section 10
Date of revision amended.

Updated on 5 May 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 30 November 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 25 November 2015 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • 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 8 - MA number
  • Change to section 10 - Date of revision of the text
  • Change to joint SPC covering all presentations

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

Free text change information supplied by the pharmaceutical company



Section 4.6 Fertility, Pregnancy and Lactation

Pregnancy has been clarified

 

Section 5.1 Pharmacodynamic Properties

Table 7.1 and Patients with high baseline HbA1c have been amended

 

Section 5.3 Preclinical Safety Data

Updated to include additional information for juvenile toxicity study

 

Section 10 Date of Revision of the Text

Updated to align with the date of Positive Opinion (22 October 2015)

 

In addition minor editorial corrections/updates have been made to sections 4.2, 4.4, 5.1 and 5.2


Following a recent update of the European SPC template the two strengths have also been consolidated into one SPC.  As a consequence sections 1, 2, 3 and 8 have been revised.

 

Updated on 12 February 2015 PIL

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 27 January 2015 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic 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

Section 4.5 has been updated in relation to the effects of empagliflozin on other medicinal products.

 

Section 4.8 has been updated to include revised adverse event reporting contact details for Malta and Ireland.

 

Section 5.1 has been updated with changes regarding clinical efficacy and safety data.

 

Section 5.3 has been amended with minor/editorial updates.

 

Section 10 has been updated to January 2015.

 

Updated on 16 December 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder
  • Addition of information on reporting a side effect.

Updated on 1 September 2014 PIL

Reasons for updating

  • New PIL for new product

Updated on 29 August 2014 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