Jardiance 10 mg and 25 mg Film-Coated Tablets
*Company:
Boehringer Ingelheim LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 22 August 2024
File name
Jardiance NI & IE-MT PIL Annex text - Art61(3)-0087.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - duration of treatment
- Change to section 6 - date of revision
Updated on 21 December 2023
File name
Jardiance NI & IE-MT PIL Annex text - Var-II-0076(Paed).pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Paediatric Indication update Section 1 - what the product is used for, Section 2 - what you need to know - warnings and precautions & Section 6 - date of revision
Updated on 21 December 2023
File name
J2-EU-spc-25.pdf
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 5.2 - 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 following sections of the SmPC have been updated:
· 4.1 Therapeutic indications (Paediatric indication added)
· 4.2 Posology and method of administration (Paediatric info added)
· 4.4 Special warnings and precautions for use (new ‘General’ section added with replicated wording “Empagliflozin should not be used in patients with type 1 diabetes mellitus”)
· 4.5 Interaction with other medicinal products and other forms of interaction (Paediatric info added)
· 4.8 Undesirable effects (Paediatric info added), 5.1 Pharmacodynamic properties (Paediatric info added)
· 5.2 Pharmacokinetic properties (Paediatric info added)
· 10 Date of revision of the SmPC has also been updated to 07/12/2023.
Updated on 03 August 2023
File name
Jardiance NI & IE-MT PIL Annex text - Var-II-0074(CKD).pdf
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 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 03 August 2023
File name
J2-EU-spc-24.pdf
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 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 following sections of the SmPC have been updated:
· Sections 4.1, 4.2, 4.4 & 5.1: New CKD indication and consequential updates
· Sections 4.2 & 4.4: Update to the renal impairment wording
· Sections 4.4 & 4.8: Revision of the ‘ketoacidosis’ warning
· Sections 4.8 & 5.1: Addition of information regarding clinical study EMPA-Kidney
· Section 4.8: Minor editorial update to the Malta AE reporting details
· Section 5.1: Update to the wording in ‘mechanism of action’ section, ‘Heart failure; Empagliflozin in patients with heart failure and reduced ejection fraction’ section and ‘paediatric population’. Other editorial updates are also included
Section 10 - Date of revision of the SmPC has also been updated to 24/07/2023
Updated on 10 August 2022
File name
J2-EU-spc-23.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 (Table 1: Dose adjustment recommendations) – clarification
Section 10 Date of revision of the SmPC has also been updated to 21/07/2022
Updated on 28 June 2022
File name
Jardiance-PIL-Var-0069.pdf
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 date of revision
Updated on 28 June 2022
File name
J2-EU-spc-22 for upload medie.pdf
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
Update to section 4.4 (Special warnings and precautions for use) to clarify detail regarding type 1 diabetes
Section 10 Date of revision of the SmPC has also been updated
Updated on 17 March 2022
File name
Jardiance NI & IE-MT Annex Text HFpEF and PSUSA.pdf
Reasons for updating
- 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 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Updated on 17 March 2022
File name
J2-EU-spc-21 approved.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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
Update to section 4.5 Interactions to add a statement regarding lithium and to section 4.8 to add the AE tubulointerstitial nephritis (frequency very rare)
New indication heart failure (preserved)
Updated on 20 December 2021
File name
Jardiance NI & IE-MT Annex Text IAIN-0064.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 22 November 2021
File name
PIP046090-003 17.11.2021 AMT 108938 cropped.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Update to warnings and precautions, specifically revised information added regarding dosage if you have serious kidney problems. Date of revision updated.
Updated on 09 November 2021
File name
J2-EU-spc-20.pdf
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 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 following sections of the SmPC have been updated:
- Sections 4.2 Posology and method of administration, 4.4 Special warnings and precautions for use and 5.1 Pharmacodynamic properties
- Section 10 Date of revision of the SmPC has also been updated to 22 October 2021
Updated on 06 July 2021
File name
Jardiance NI & IE-MT PIL Annex text - HFrEF .pdf
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 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 05 July 2021
File name
J2-EU-spc-19- medicines.ie.pdf
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 4.1 - 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 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- 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
- Sections 4.1 Therapeutic indications, 4.2 Posology and method of administration, 4.4 Special warnings and precautions for use, 4.8 Undesirable effects and 5.1 Pharmacodynamic properties
- Section 4.8 Undesirable effects – updated AE reporting following Brexit and in line with revised QRD template
- Section 7 Marketing Authorisation Holder – address change
- Section 1, 2, 3, 4, 5, 6.1 Minor / editorial updates
- Section 10 Date of revision of the SmPC has also been updated to 17 June 2021
Updated on 19 October 2020
File name
J2-all-spc-18.pdf
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 – Diabetic ketoacidosis subsection, the information on use of Jardiance in patients with type 1 diabetes has been updated.
- Section 10 Date of revision has been updated.
Updated on 28 July 2020
File name
J2-all-spc-17.pdf
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 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 - 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 – updated to add information regarding pharmacokinetic interactions between empagliflozin and inducers of uridine 5'-diphosphoglucuronosyltransferases (UGT).
- Section 10 Date of revision has been updated.
Updated on 28 April 2020
File name
Jardiance Annex PIL text - Rottendorf manufacturing site.pdf
Reasons for updating
- Change to section 6 - date of revision
- Addition of manufacturer
Updated on 21 October 2019
File name
Jardiance Annex PIL text - Update to Irish AE reporting.pdf
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
File name
J2-all-spc-16-Approved.pdf
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
File name
2019-02-26 PIL Text Renewal for medie and emc.pdf
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
File name
J2-all-spc-15.pdf
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 04 February 2019
File name
EMEA-H-C-3770-IAin-xxx - IA PIL text for eMC and Med.ie.pdf
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
File name
J2-all-spc-14.pdf
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 09 July 2018
File name
CROPPED-PIL09_07_18.PDF
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 05 July 2018
File name
J2-all-spc-13-med-ie.docx
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
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 30 January 2018
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 4.8: 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
File name
PIL_16083_712.pdf
Reasons for updating
- New PIL for new product
Updated on 17 August 2017
Reasons for updating
- Improved presentation of PIL
Updated on 09 August 2017
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 08 August 2017
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 01 August 2017
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
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Improved presentation of PIL
Updated on 11 May 2017
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
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 textUpdated on 06 February 2017
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 01 February 2017
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
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
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 10 of the SPC has also been amended to September 2016.
Please note that section 4.8 of the SPC has also been revised to update the AE address details for Ireland.
Updated on 26 August 2016
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 08 August 2016
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 22 July 2016
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
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 09 May 2016
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
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 05 May 2016
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
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 25 November 2015
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
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 27 January 2015
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
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
- Addition of information on reporting a side effect.
Updated on 01 September 2014
Reasons for updating
- New PIL for new product
Updated on 29 August 2014
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)