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Boehringer Ingelheim Limited

The Crescent Building, , Northwood, Santry, Dublin 9,
Telephone: +353 1 295 9620
Fax: : +353 1 816 3642
Medical Information e-mail: Medinfo@dbl.boehringer-ingelheim.com
Summary of Product Characteristics last updated on medicines.ie: 10/07/2017
SPC Synjardy film coated tablets

When a pharmaceutical company changes an SPC or PIL, 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 10/07/2017 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   22-Jun-2017
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 10/05/2017 and displayed until 10/07/2017
Reasons for adding or 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
Date of revision of text on the SPC:   20-Apr-2017
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 17/03/2017 and displayed until 10/05/2017
Reasons for adding or 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
Date of revision of text on the SPC:   03-Mar-2017
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 13/01/2017 and displayed until 17/03/2017
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   12-Dec-2016
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 13/12/2016 and displayed until 13/01/2017
Reasons for adding or 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
Date of revision of text on the SPC:   10-Nov-2016
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 25/08/2016 and displayed until 13/12/2016
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   17-Aug-2016
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 05/08/2016 and displayed until 25/08/2016
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   15-Jul-2016
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 12/05/2016 and displayed until 05/08/2016
Reasons for adding or 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
Date of revision of text on the SPC:   28-Apr-2016
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 27/11/2015 and displayed until 12/05/2016
Reasons for adding or 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
Date of revision of text on the SPC:   22-Oct-2015
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 02/09/2015 and displayed until 27/11/2015
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Metformin Hydrochloride
   Empagliflozin