Galvus 50mg tablets *

  • Company:

    Novartis Ireland Limited
  • Status:

    No Recent Update
  • Legal 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 30 July 2021

File name

Galvus_REG PIL_PF21-0166_PF 21-0184_IPHA_1627654634.pdf

Reasons for updating

  • Change to MA holder contact details

Updated on 06 July 2021

File name

Galvus_REG PIL_PF21-0166_21.06.2021_Clean_1625567092.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose

Updated on 06 July 2021

File name

Galvus_REG SPC_PF21-0166_June 2021_IPHA_1625566999.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Updated on 05 July 2021

File name

Galvus REG PIL PF21-089 clean IPHA_1625478532.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

New manufacturer responsible for batch release

Updated on 04 November 2020

File name

Galvus REG PIL PF20-219 clean IPHA_1604504428.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

Sodium statement added

Updated on 04 November 2020

File name

Galvus REG SPC PF20-219 October 2020_clean IPHA_1604504056.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

Sodium statement added

Updated on 05 February 2020

File name

Galvus REG PIL PF20-021 IPHA_1580891763.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 28 November 2019

File name

Galvus REG PIL PF18-073_1574955568.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 02 April 2019

File name

Galvus_REG_SmPC_50mg_Tab_PF18-0073_clean IPHA_1554199828.pdf

Reasons for updating

  • File format updated to PDF

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

Updated on 23 October 2018

File name

Galvus REG PIL_1119553-A18-R91_P01_LFT_IPHA_1540208114.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 14 May 2018

File name

Galvus_REG_SmPC_50mg_Tab_PF18-0073_clean.docx

Reasons for updating

  • 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)

Updated on 26 July 2017

File name

PIL_14276_291.pdf

Reasons for updating

  • New PIL for new product

Updated on 26 July 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect

Updated on 06 June 2017

Reasons for updating

  • New SPC for new product

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

Updated on 06 June 2017

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

updated section 5.1 of SmPC, subsection ‘cardiovascular risk’, with results from a new meta-analysis evaluating the cardiovascular safety of vildagliptin

Updated on 27 March 2017

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 - in Table 6 "Post marketing adverse reactions", revised "bullous skin lesions" to "Exfoliative and bullous skin lesions, including bullous pemphigoid"

Updated on 13 January 2016

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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

Free text change information supplied by the pharmaceutical company

Section 4.5 Added:
"ACE inhibitors

There may be an increased risk of angioedema in patients concomitantly taking ACE-inhibitors.”

Updated on 17 August 2015

Reasons for updating

  • Change to side-effects

Updated on 25 June 2015

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 - added myalgia as a side effect with unknown frequency.

Updated on 12 February 2015

Reasons for updating

  • Change to MA holder contact details

Updated on 10 December 2014

Reasons for updating

  • Change to MA holder contact details

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

Free text change information supplied by the pharmaceutical company

Change in MAH address

Updated on 30 July 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Addition of information on reporting a side effect.

Updated on 11 June 2014

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

Update the warning for pancreatitis in the SPC for Galvus & Eucreas following a request from EMA to harmonize all the labels across all DPP-4 inhibitors and GLP-1 agonists products. 

Updated on 11 October 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions

Updated on 13 August 2013

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 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

Section 4.2 paediatric population reworded
Sections 4.4 and 5.2 have been updated as a result of study CLAF237A23118 (VIVIDD) which examined safety and efficacy in CHF patients NYHA class
Section 4.8 has been updated with instructions to healthcare professional to report adverse events to the IMB. Inclusion of this information is a requirement of the new PV legislation.

Updated on 16 January 2013

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 13 November 2012

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 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

SPC changes all related to approval of two new indication (Section 4.1):

·         As triple oral therapy in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycemic control

·         Vildagliptin is also indicated for use in combination with insulin (with or without metformin) when diet and exercise plus a stable dose of insulin do not provide adequate glycaemic control.

Section 4.4 updated with new warning related to the use with sulphonylureas:

·         Hypoglycaemia:

Sulphonylureas are known to cause hypoglycaemia. Patients receiving vildagliptin in combination with a sulphonylurea may be at risk for hypoglycaemia. Therefore, a lower dose of sulphonylurea may be considered to reduce the risk of hypoglycaemia.

 

 

 

Section 4.8 updated with the following new adverse reactions:

·         Taken in combination with metformin and a sulphonylurea: Hypoglocemia, dizziness, tremor, hyperhidrosis, Asthenia

·         Taken in combination with insulin: Decreased blood glucose, headache, chills, nausea, gastro-oesophageal reflux disease, diarrhoea, flatulence

Section 5.1: Updated with additional clinical data

 

 

 

Updated on 13 September 2012

Reasons for updating

  • Change to side-effects
  • Change to improve clarity and readability

Updated on 08 August 2012

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

Section 4.4: “Furthermore, there have been post-marketing reports of bullous and exfoliative skin lesions.”

Section 4.8: Post-marketing adverse drug reaction added with an unknown frequency: “bullous or exfoliative skin lesions”

Also many editorial changes to SPC as a result of renewal.

Updated on 11 April 2012

Reasons for updating

  • Changes to therapeutic indications

Updated on 09 February 2012

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 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Sections 4.1 and 4.2 have been updated to include the new monotherapy indication.

Section 4.4 has been updated by Removing the precaution of use in patients with CHF NYHA class I and II.

Section 5.1 has been updated to include to reflect the PIP waiver decision with no reference to the grounds of the waiver in the SmPC.

Updated on 03 January 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to dosage and administration

Updated on 08 December 2011

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

Section 4.2 Replaced:
"The use of Galvus is not recommended in patients with moderate or severe renal impairment or in haemodialysis patients with end-stage renal disease (ESRD)."
with:
"In patients with moderate or severe renal impairment or with end-stage renal disease (ESRD), the recommended dose of Galvus is 50 mg once daily."

Section 4.4 Replaced:
"There is limited experience in patients with moderate to severe renal impairment or in patients with ESRD on haemodialysis. Therefore, the use of Galvus is not recommended in these patients."
with:

"There is limited experience in patients with ESRD on haemodialysis. Therefore Galvus should be used with caution in these patients (see also section 5.2)."

Also ins ection 4.4, inserted:

"Pancreatitis

In post-marketing experience there have been spontaneously reported adverse reactions of acute pancreatitis. Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain.

 

Resolution of pancreatitis has been observed after discontinuation of vildagliptin. If pancreatitis is suspected, vildagliptin and other potentially suspect medicinal products should be discontinued."

Section 4.8 added:

·                Cases of abnormal liver function tests and cases of hepatitis, reversible upon discontinuation of the medicinal product, have been reported (see also section 4.4).

·                Frequency not known: urticaria, pancreatitis.

Section 5.1 added:

"A 24-week, multi-centre, randomised, double-blind, placebo-controlled trial was conducted to evaluate the treatment effect of vildagliptin 50 mg once daily compared to placebo in 515 patients with type 2 diabetes and moderate renal impairment (N=294) or severe renal impairment (N=221). 68.8% and 80.5% of the patients with moderate and severe renal impairment respectively were treated with insulin (mean daily dose of 56 units and 51.6 units respectively) at baseline. In patients with moderate renal impairment vildagliptin significantly decreased HbA1c compared with placebo (difference of ‑0.53%) from a mean baseline of 7.9%. In patients with severe renal impairment, vildagliptin significantly decreased HbA1c compared with placebo (difference of ‑0.56%) from a mean baseline of 7.7%."

Section 5.2 added:

"A multiple-dose, open-label trial was conducted to evaluate the pharmacokinetics of the lower therapeutic dose of vildagliptin (50 mg once daily) in patients with varying degrees of chronic renal impairment defined by creatinine clearance (mild: 50 to <80 ml/min, moderate: 30 to <50 ml/min and severe: <30 ml/min) compared to normal healthy control subjects.

 

Vildagliptin AUC increased on average 1.4, 1.7 and 2-fold in patients with mild, moderate and severe renal impairment, respectively, compared to normal healthy subjects. AUC of the metabolites LAY151 and BQS867 increased on average about 1.5, 3 and 7-fold in patients with mild, moderate and severe renal impairment, respectively. Limited data from patients with end stage renal disease (ESRD) indicate that vildagliptin exposure is similar to that in patients with severe renal impairment. LAY151 concentrations were approximately 2‑3-fold higher than in patients with severe renal impairment.

 

Vildagliptin was removed by haemodialysis to a limited extent (3% over a 3‑4 hour haemodialysis session starting 4 hours post dose)."

 

Updated on 06 October 2011

Reasons for updating

  • Change to section 6.3 - Shelf life

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 was increased from 2years to 3 years.

Updated on 16 March 2011

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • 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

4.2 update to reflect safety and efficacy data in patients <75 years
4.6 and 4.8: formatting changes

Updated on 23 November 2010

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

4.8: Post marketing experience, addition of pancreatitis

5.1 Additional clinical data

Updated on 22 September 2010

Reasons for updating

  • Change to side-effects

Updated on 28 October 2009

Reasons for updating

  • Change to side-effects

Updated on 15 September 2009

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Changes to Section 4.8:

 

"During post-marketing experience the following additional adverse drug reaction has been reported (frequency not known): urticaria"

"Clinical trials of up to 2 years’ duration did not show any additional safety signals or unforeseen risks with vildagliptin monotherapy"

"Clinical trials of up to more than 2 years’ duration did not show any additional safety signals or unforeseen risks when vildagliptin was added on to metformin"


Changes to Section 5.1: Results from 2 year clinical trial included.

 

Updated on 05 May 2009

Reasons for updating

  • New PIL for new product

Updated on 05 May 2009

Reasons for updating

  • New SPC for new product

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