Vokanamet 50 mg/850 mg, 50 mg/1000 mg, 150 mg/850 mg and 150 mg/1000 mg film-coated tablets * Pharmacy Only: Prescription
Company:
Mundipharma Pharmaceuticals Limited - Formerly Napp LaboratoriesStatus:
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
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 18 January 2021
File name
spc_1610987311.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Addition of warnings regarding urinary tract and kidney infections.
Updated on 18 January 2021
File name
pil_1610987269.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Free text change information supplied by the pharmaceutical company
Addition of warnings regarding urinary tract and kidney infections.
Updated on 06 July 2020
File name
pil_1594021952.pdf
Reasons for updating
- Change of distributor details
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Update to local representative details.
Minor editorial updates, including amendment of the product strength from 1000 mg to 1,000 mg.
Updated on 06 July 2020
File name
spc_1594021684.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 2 – Removal of sodium warnings.
Section 4.4 – Amendment to warnings in relation to eGFR. Addition of warning in relation to risk of diabetic ketoacidosis in patients with decreased renal function. Amendment to warning in relation to lower limb amputation following outcome of the CREDENCE study. Addition of sodium warning in line with the updated Annex to the guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’.
Section 4.8 – Amendment to data on patient exposure as a result of the CREDENCE study. Updated data in relation to lower limb amputation and bone fracture following outcome of the CREDENCE study.
Section 5.1 – Update to section on renal endpoints following the CREDENCE study.
Minor editorial changes have been incorporated into this update
Updated on 10 February 2020
File name
pil 10-Feb-20_1581339165.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Addition of photosensitivity and UTI as potential adverse effects
Updated on 10 February 2020
File name
spc 10-Feb-20_1581339136.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.8 - Addition of photosensitivity and UTI as potential adverse effects
Updated on 03 December 2019
File name
spc_1575381092.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
Addition of information on monitoring of patients with diabetic ketoacidosis in section 4.4.
Updated on 06 March 2019
File name
IE Vokanamet PIL 6 March 2019_1551878226.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 section 6 - date of revision
Updated on 06 March 2019
File name
IE Vokanamet-SmPC 6 March 2019_1551878129.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
Texts updated following implementation of product class labelling effect regarding the possible side effect - Fournier’s gangrene
Updated on 11 January 2019
File name
IE Vokanamet PIL 18 Dec 18_1547221290.pdf
Reasons for updating
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Updated on 11 January 2019
File name
IE Vokanamet SPC 18 Dec 18_1547221103.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- Addition 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
Removal of the inverted black triangle following approval of renewal
Updated on 12 September 2018
File name
Vokanamet film-coated tablets PIL UK_1536764082.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 6 - date of revision
Updated on 12 September 2018
File name
Vokanamet film-coated tablets SPC UK_1536763980.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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
4.1 Therapeutic indications
4.4 Special warnings and precautions for use
Lower limb amputations
4.8 Undesirable effects
Summary of the safety profile
Description of selected adverse reactions
5.1 Pharmacodynamic properties
Lower limb amputation
Adverse reactions related to volume depletion
Genital mycotic infections
Bone fracture
Special populations
Renal impairment
Clinical efficacy and safety
Blood pressure
Cardiovascular outcomes
All‑cause mortality
Heart failure requiring hospitalization
Renal Endpoints
Updated on 22 June 2018
File name
Vokanamet SPC.docx
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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
Section 2
‘Each tablet contains less than 1 mmol sodium (23 mg), and is essentially sodium-free.’ This text has been added to ‘Excipient(s) with known effect’ section for all strengths.
‘full’ has been added to ‘For the full list of excipients, see section 6.1’
Section 4.4
This text below has be removed from the section:
‘General
Vokanamet has not been studied in patients with type 1 diabetes and is therefore not recommended for use in these patients.’
Section 5.1
The text in bold has been added to the section and the text in strikethrough has been removed from the section:
‘A total of 10,285 10,501 patients with type 2 diabetes participated in nine ten double blind, controlled clinical efficacy and safety studies conducted to evaluate the effects of Invokana on glycaemic control. The racial distribution was 72% White, 16% Asian, 4 5% Black, and 8% other groups. 16 17% of patients were Hispanic. Approximately 58% of patients were male. Patients had an overall mean age of 59.6 59.5 years (range 21 years to 96 years), with 3,082 3,135 patients ≥ 65 years of age and 510 513 patients ≥ 75 years of age. 58% of patients had a body mass index (BMI) ≥ 30 kg/m2….’
The text below has been added to section 5.1:
‘Furthermore, canagliflozin was studied as triple therapy with metformin and sitagliptin and dosed with a titration regimen, using a starting dose of 100 mg and titrated to 300 mg as early as week 6 in patients requiring additional glycaemic control who had appropriate eGFR and were tolerating canagliflozin 100 mg (table 2). Canagliflozin dosed with a titration regimen produced clinically and statistically significant (p < 0.001) results relative to placebo in glycaemic control, including HbA1c and change from baseline fasting plasma glucose (FPG), and a statistically significant (p < 0.01) improvement in the percentage of patients achieving HbA1c < 7%. In addition, reductions in body weight and systolic blood pressure relative to placebo were observed.’
Within table 2 there has been this change below:
‘Difference from placebo (adjusted mean)
(97.5 95 % CI) ‘
There has been this addition to table 2
There has been an addition to the footnote of table 2:
‘ e Canagliflozin 100 mg titrated to 300 mg
F p<0.01 compared to placebo
G 90.7% of subjects in the canagliflozin untitrated to 300 mg.’
This text and table below have been added to the section:
‘Canagliflozin as initial combination therapy with metformin
Canagliflozin was evaluated in combination with metformin as initial combination therapy in patients with type 2 diabetes failing diet and exercise. Canagliflozin 100 mg and canagliflozin 300 mg in combination with metformin XR resulted in a statistically significant greater improvement in HbA1C compared to their respective canagliflozin doses (100 mg and 300 mg) alone or metformin XR alone (table 4).
Table 4 has been added
Section 10
Revsion date updated
Updated on 22 June 2018
File name
Vokanamet PIL.PDF
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to date of revision
Updated on 02 January 2018
File name
PIL_16468_796.pdf
Reasons for updating
- New PIL for new product
Updated on 02 January 2018
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change in co-marketing arrangement
Updated on 31 May 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 31 May 2017
Reasons for updating
- Change to section 6.3 - Shelf life
- 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
Updated on 08 May 2017
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: Revision to include class labelling text on diabetic ketoacidosis: “Rare cases of diabetic ketoacidosis (DKA), including life-threatening and fatal cases, have been reported in patients treated with SGLT2 inhibitors, including canagliflozin.”
Section 10: Commission Decision of 28 April 2017
Updated on 04 May 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 27 April 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 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 information on lower limb amputations
Section 4.8: addition of “lower limb amputations” as adverse reaction under frequency “uncommon”
Section 10: Commission Decision date of 20 April 2017
Updated on 25 April 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 16 December 2016
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 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
Updated under section 4.2 Posology header
Inserted ‘Adults with normal renal function (GFR ≥ 90 mL/min)’
Updated under ‘Renal Impairment’
Updated under Section 4.3 Contraindications
Added: Any type of acute metabolic acidosis (such as lactic acidosis,
Added: Severe renal failure (GFR < 30 mL/min)
Updated under Section 4.4
Under Lactic acidosis header
Under Renal function header
Under Administration of iodinated contrast agent header
Under Surgery header
Under Section 4.5 Interaction with other medicinal products and other forms of interaction
Updated under ‘METFORMIN’ header
Updated under 5.1 Pharmacodynamic properties
New paragraph ‘Patients with GFR 45 mL/min to < 60 mL/min’
Section 10: Updated Date of Revision
Updated on 15 December 2016
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 4 - possible side effects
- Change to section 6 - date of revision
Updated on 13 October 2016
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
Updated on 31 August 2016
Reasons for updating
- 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
Updated on 30 August 2016
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 06 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
Updated on 04 May 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 22 December 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 22 December 2015
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
Updated on 01 September 2015
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 01 September 2015
Reasons for updating
- New PIL for medicines.ie