Vokanamet 50 mg/850 mg, 50 mg/1000 mg, 150 mg/850 mg and 150 mg/1000 mg film-coated tablets

  • Name:

    Vokanamet 50 mg/850 mg, 50 mg/1000 mg, 150 mg/850 mg and 150 mg/1000 mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Canagliflozin hemihydrate, 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: 10/02/20

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Summary of Product Characteristics last updated on medicines.ie: 10/2/2020

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Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories

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1 - 0 of 31 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 10 February 2020 PIL

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 SmPC

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 3 December 2019 SmPC

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 6 March 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 6 March 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

Texts updated following implementation of product class labelling effect regarding the possible side effect  - Fournier’s gangrene

Updated on 11 January 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle

Updated on 11 January 2019 SmPC

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 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 12 September 2018 SmPC

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 SmPC

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 PIL

Reasons for updating

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

Updated on 2 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 January 2018 PIL

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 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 31 May 2017 SmPC

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

In section 6.3, the shelf-life has been changed from 2 to 3 years.

Updated on 8 May 2017 SmPC

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 4 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 27 April 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 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 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 16 December 2016 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 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 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 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 13 October 2016 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

$0Paediatric population$0A paediatric Phase 1 studyexamined the pharmacokinetics and pharmacodynamics of canagliflozin in childrenand adolescents ≥ 10 to < 18 years of age with type 2diabetes mellitus. The observed pharmacokinetic and pharmacodynamic responseswere consistent with those found in adult subjects.

Updated on 31 August 2016 SmPC

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

Addition of anaphylactic reaction (rare) and angioedema frequency changed from not known to rare. $0Amalgamation of all strengths into one SmPC            $0$0Minor change to section 5.2$0

Updated on 30 August 2016 PIL

Reasons for updating

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

Updated on 6 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: Addition of information regarding Diabetic Ketoacidosis (DKA)$0Section 4.8: Addition of Diabetic Ketoacidosis as a rare side effect$0

Updated on 4 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 22 December 2015 PIL

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 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

Addition of uncommon adverse reaction: Renal failure (mainly in the context of volume depletion)

Updated on 1 September 2015 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 1 September 2015 SmPC

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

None provided