Synjardy film coated tablets

  • Name:

    Synjardy film coated tablets

  • Company:
    info
  • Active Ingredients:

    Empagliflozin, Metformin Hydrochloride

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/06/20

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Summary of Product Characteristics last updated on medicines.ie: 28/7/2020

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Boehringer Ingelheim Limited

Boehringer Ingelheim Limited

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1 - 0 of 47 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 28 July 2020 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 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 - updated to include the statement ‘The tablets should be swallowed whole with water.’

Section 4.4 - updated to add information regarding the interference with the 1,5-anhydroglucitol assay used to monitor glycaemic control in patients taking SGLT2 inhibitors.

Section 4.5 – in the last line of the paragraph relating to the effect of UGT induction, reference to ‘empagliflozin’ has been replaced by ‘Synjardy’

Section 10 Date of revision has been updated.

Updated on 4 June 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 6 updated to add a new manufacturer (Patheon France). Date of revision updated.

Updated on 17 April 2020 PIL

Reasons for updating

  • 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 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle

Updated on 16 April 2020 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 4.8 - Undesirable effects
  • 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
  • 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

Updates to the SmPC concern the removal of the Black Triangle, editorial changes to Sections 4.2, 4.3, 4.4, 4.5, 4.8, 4.9 and the deletion of ‘ongoing’ from the Lower limb amputation warning in section 4.4.

Additionally, Section 9 has been updated to give the date of renewal and Section 10 Date of revision has been updated.

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 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 section 6 - 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.
  • 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 31 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

• Section 4.4: The following statement in the ‘Renal function’ subsection has been reinstated as it was deleted in error as part of a previous variation application.
‘Due to the mechanism of action, decreased renal function will result in reduced glycaemic efficacy of empagliflozin’
• 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 31 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 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 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

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 5.1: Minor wording update in the ‘Clinical efficacy and safety’ subsection with regards to the referenced clinical studies.

·        Section 10: Date of revision of the text has also been aligned with the date of Commission decision, which was 19/07/2017. Final texts were available on 01/08/2017.

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 31 July 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 10 July 2017 SmPC

Reasons for updating

  • 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

The changes are as follows:
-Sections 4.5: Information on interaction of metformin with ionic cation transporters has been added.
-Section 10 date of revision of the text, has also been aligned with the date of Positive Opinion, which was 22/06/17

Updated on 5 July 2017 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 7 June 2017 PIL

Reasons for updating

  • Change to other sources of information section
  • 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 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 4.5 - 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

The changes are as follows:

-Section 4.4: updated with detail regarding lower limb amputations.

-Sections 4.5 and 5.1: additional changes outside of the scope of EMEA/H/A-20/1442/C/3770/0022, were included in line with CD text within Sections 4.5 (regarding cationic medicinal products) and 5.1 (regarding Clinical efficacy and safety). Detail previously removed in EMEA-H-A-31-1432-C-003370-0013 and EMEA-H-C-003770-II-0015 has been reintroduced.

-Section 10 revision date updated

Updated on 17 March 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
  • 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 additional data from a clinical trial (EMPA-REG OUTCOME).

 

The changes are as follows:

- Section 4.1, 4.2, 4.4, 4.5

- Section 4.8 (including new common AE thirst and uncommon AEs Haematocrit increased, Serum lipids increased), 5.1 (including additional data on cardiovascular outcome).

- Section 10, date of revision of the text is aligned with the date Commission Decision: 03Mar17. Text available 13Mar17.

Updated on 16 March 2017 PIL

Reasons for updating

  • 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 - date of revision

Updated on 13 January 2017 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 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

This follows an Article 31 referral to review metformin containing medicines and align patient information between EU countries with information on use in patients with moderate renal impairment with the focus on lactic acidosis.

 

The changes are as follows:

 

-Section 4.2 (Posology and method of administration), 4.3 (Contraindications) has been updated regarding renal function / impairment and lactic acidosis.

-Section 4.4 (Special warnings and precautions for use) has been updated. Detail regarding administration of iodinated contrast agent and surgery have been amended.

-Section 4.5 (Interaction with other medicinal products and other forms of interaction) has been updated. The section covering metformin has been substantially rewritten including concomitant use, alcohol, cationic substances, iodinated contrast agents and combination requiring precautions for use.

-Section 4.8 and 5.1 contains editorial changes to table numbers.

Updated on 13 January 2017 PIL

Reasons for updating

  • 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 - dose and frequency
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - manufacturer

Updated on 13 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/003770/II/WS0926/0016.

 

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 25 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 (Empagliflozin in combination with metformin in drug-naïve patients) – additional text added.

Section 10, date of revision 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 5 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, Undesirable effects, 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

Updated on 20 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 12 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 Special warnings and precautions for use –the following text has been added to the section.:

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 SGLT2 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 of the text has been updated.

Updated on 27 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 4.3 - 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 4.9 - 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 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 4.3 has been updated regarding disease which may cause tissue hypoxia (includes decompressed heart failure).

 

Section 4.4 has been updated with information on lactic acidosis - additional cautionary information relating to situations where renal function may become impaired; update to clarify when precaution should be taken and when the product is contraindicated in patients with reduced renal function and those with heart failure; update to information on use of iodinated contrast agent as this can lead to renal failure (consequential update to sections 4.5 and 4.6).

 

Section 5.3 has been updated to include additional information for juvenile toxicity study.

 

Section 6.5 has been updated to include a new pack size (90 x 1 tablets).

 

Section 8 has been updated to include a new pack size (90 x 1 tablets).

 

Section 8 has been updated to include the following new licence numbers:

- Synjardy 5 mg/850 mg (EU/1/15/1003/037)

- Synjardy 5 mg/1000 mg (EU/1/15/1003/038)
- Synjardy 12.5 mg/850 mg (EU/1/15/1003/039)
- Synjardy 12.5 mg/1000 mg (EU/1/15/1003/040)

 

Section 10 has been 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, 4.9, 5.1 and 5.2.

Following a recent update of the European SPC template, the four strengths have also been consolidated into one SPC.  As a consequence sections 1, 2, 3, 6.1 and 8 have been revised.

Updated on 19 November 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about overdose
  • Change to date of revision
  • Introduction of new pack/pack size

Updated on 2 September 2015 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

Updated on 1 September 2015 PIL

Reasons for updating

  • New PIL for new product