Galvus 50mg tablets
- Name:
Galvus 50mg tablets
- Company:
Novartis Ireland Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/11/20
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Novartis Ireland Limited
Company Products
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 4 November 2020 PIL
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 4 November 2020 SPC
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 5 February 2020 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 28 November 2019 PIL
Reasons for updating
- Improved presentation of PIL
Updated on 2 April 2019 SPC
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 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 14 May 2018 SPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 26 July 2017 PIL
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 6 June 2017 SPC
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 on 6 June 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 27 March 2017 SPC
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
Updated on 13 January 2016 SPC
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
"ACE inhibitors
There may be an increased risk of angioedema in patients concomitantly taking ACE-inhibitors.”
Updated on 17 August 2015 PIL
Reasons for updating
- Change to side-effects
Updated on 25 June 2015 SPC
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
Updated on 12 February 2015 PIL
Reasons for updating
- Change to MA holder contact details
Updated on 10 December 2014 SPC
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
Updated on 30 July 2014 PIL
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 SPC
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 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
Updated on 13 August 2013 SPC
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 PIL
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 SPC
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 PIL
Reasons for updating
- Change to side-effects
- Change to improve clarity and readability
Updated on 8 August 2012 SPC
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 PIL
Reasons for updating
- Changes to therapeutic indications
Updated on 9 February 2012 SPC
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 3 January 2012 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to dosage and administration
Updated on 8 December 2011 SPC
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
"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:
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 6 October 2011 SPC
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
Updated on 16 March 2011 SPC
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
4.6 and 4.8: formatting changes
Updated on 23 November 2010 SPC
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
5.1 Additional clinical data
Updated on 22 September 2010 PIL
Reasons for updating
- Change to side-effects
Updated on 28 October 2009 PIL
Reasons for updating
- Change to side-effects
Updated on 15 September 2009 SPC
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 5 May 2009 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 5 May 2009 PIL
Reasons for updating
- New PIL for new product