NovoNorm 0.5 mg, 1 mg and 2 mg tablets

  • Name:

    NovoNorm 0.5 mg, 1 mg and 2 mg tablets

  • Company:
    info
  • Active Ingredients:

    Repaglinide

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/12/15

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 10/6/2016
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Novo Nordisk Limited

Novo Nordisk Limited

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1 - 0 of 40 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 June 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 10 June 2016 SmPC

Reasons for updating

  • 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

4.5          Interaction with other medicinal products and other forms of interaction

In an interaction study with healthy volunteers, co-administration of clopidogrel (300 mg loading dose), a CYP2C8 inhibitor, increased repaglinide exposure (AUC0–∞) 5.1-fold and continued administration (75 mg daily dose) increased repaglinide exposure (AUC0–∞) 3.9-fold. A small, significant decrease in blood glucose values was observed.  Since the safety profile of the co-treatment has not been established in these patients, the concomitant use of clopidogrel and repaglinide should be avoided. If concomitant use is necessary, careful monitoring of blood glucose and close clinical monitoring should be performed (see section 4.4).

 

10.       DATE OF REVISION OF THE TEXT

11/201505/2016

Updated on 9 December 2015 SmPC

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • 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

4.5      Interaction with other medicinal products and other forms of interaction

The following substances may enhance and/or prolong the hypoglycaemic effect of repaglinide: Gemfibrozil, clarithromycin, itraconazole, ketokonazole, trimethoprim, ciclosporin, deferasirox, clopidogrel, other antidiabetic substances, monoamine oxidase inhibitors (MAOI), non selective beta blocking substances, angiotensin converting enzyme (ACE)-inhibitors, salicylates, NSAIDs, octreotide, alcohol, and anabolic steroids.

In an interaction study with healthy volunteers, co-administration of clopidogrel (300 mg loading dose), a CYP2C8 inhibitor, increased repaglinide exposure (AUC0–∞) 5.1-fold and continued administration (75 mg daily dose) increased repaglinide exposure (AUC0–∞) 3.9-fold. A small, significant decrease in blood glucose values was observed.

 

9.      DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 17 August 1998

Date of last renewal: 17 August23 July 2008

 

10.    DATE OF REVISION OF THE TEXT

01/201511/2015

Updated on 8 December 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 8 December 2015 PIL

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 13 February 2015 PIL

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 10 February 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

EMA Quality Review of Documents (QRD) update

Including formatting changes.

 

4.2      Posology and method of administration

Renal Impairment

Repaglinide is added: “not affected by renal disorders” (see section 5.2).

Text deleted: primarily excreted via the bile and excretion is therefore not affected by renal disorder.

 

4.8      Undesirable effects

 

Reporting of suspected adverse reactions

Updated on 3 August 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 14 May 2012 SmPC

Reasons for updating

  • 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 4.5 Interaction with other medicinal products and other forms of interaction

 

Sentence added:

 

In an interaction study with healthy volunteers, co-administration of deferasirox (30 mg/kg/day, 4 days), a moderate inhibitor of CYP2C8 and CYP3A4, and repaglinide (single dose, 0.5 mg) resulted in an increase in repaglinide systemic exposure (AUC) to 2.3-fold (90% CI [2.03-2.63]) of control, a 1.6-fold (90% CI [1.42-1.84]) increase in Cmax, and a small, significant decrease in blood glucose values. Since the interaction has not been established with dosages higher than 0.5 mg for repaglinide, the concomitant use of deferasirox with repaglinide should be avoided. If the combination appears necessary, careful clinical and blood glucose monitoring should be performed (see section 4.4).

 

Section 10.DATE OF REVISION OF THE TEXT

 

04/2012

Updated on 10 February 2010 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 27 January 2010 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 23 January 2009 SmPC

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

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

Free text change information supplied by the pharmaceutical company

4.5   Interaction with other medicinal products and other forms of interaction

Additional information:

Based on in vitro data, repaglinide appears to be a substrate for active hepatic uptake (organic anion transporting protein OATP1B1). Drugs that inhibit OATP1B1 may likewise have the potential to increase plasma concentrations of repaglinide, as has been shown for ciclosporin (see below).
 
Additional information ciclosporin added after trimethoprim:

The following substances may enhance and/or prolong the hypoglycaemic effect of repaglinide: Gemfibrozil, clarithromycin, itraconazole, ketokonazole, trimethoprim, ciclosporin, other antidiabetic agents, monoamine oxidase inhibitors (MAOI), non selective beta blocking agents, angiotensin converting enzyme (ACE)-inhibitors, salicylates, NSAIDs, octreotide, alcohol, and anabolic steroids.

Additional information:

In a study conducted in healthy volunteers, the concomitant administration of repaglinide (a single dose of 0.25 mg) and ciclosporin (repeated dose at 100 mg) increased repaglinide AUC and Cmax about 2.5-fold and 1.8-fold respectively. Since the interaction has not been established with dosages higher than 0.25 mg for repaglinide, the concomitant use of ciclosporin with repaglinide should be avoided. If the combination appears necessary, careful clinical and blood glucose monitoring should be performed (see section 4.4).

4.8     Undesirable effects

Additional information: (e.g. anaphylactic reaction)

Immune system disorders

Very rare: Allergy

Generalised hypersensitivity reactions (e.g. anaphylactic reaction), or immunological reactions such as vasculitis.

 

Additional information: Interactions with other medicinal products may increase the risk of hypoglycaemia (see section 4.5).

Metabolism and nutrition disorders

Common: Hypoglycaemia

Not known: Hypoglycaemic coma and hypoglycaemic unconsciousness

As with other hypoglycaemic agents, hypoglycaemic reactions have been observed after administration of repaglinide. These reactions are mostly mild and easily handled through intake of carbohydrates. If severe, requiring third party assistance, infusion of glucose may be necessary. The occurrence of such reactions depends, as for every diabetes therapy, on individual factors, such as dietary habits, dosage, exercise and stress (see section 4.4). Interactions with other medicinal products may increase the risk of hypoglycaemia (see section 4.5). During post marketing experience, cases of hypoglycaemia have been reported in patients treated with repaglinide in combination with metformin or thiazolidinedione.

Updated on 22 January 2009 PIL

Reasons for updating

  • New PIL for new product

Updated on 14 August 2008 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • 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

4.2 Posology and method of administration

Comment added regarding the time of dose with regards to mealtimes. Also, a statement that children under age 18 should not use Repaglinide.

4.3 Contraindications

Pregnancy and lactation, and children <12 years of age have been removed from the list of contraindications.

4.4 Special warnings and precautions for use

General

Comment about no trials of combination therapy have been performed, has been removed, and a statement has been added regarding the latest from combination therapy trials.

Concomitant use

Comment regarding the safety profile has been removed, in addition to the paragraph containing the concomitant administration of particular drugs. A comment had been added advising the use of caution when receiving drugs which influence Repaglinide metabolism.

Specific patient groups

A comment has been added regarding careful dose titration in debilitated or malnourished patients.

4.8 Undesirable effects

Frequency definition has been amended.

Immune system disorders - frequency added.

Metabolism and nutrition disorders

Hypoglycaemia amended from rare to common.

Added - Not known: Hypoglycaemia coma and hypoglycaemia unconsciousness.

Gastro-intestinal disorders

Abdominal pain - amended from rare to common

Diarrhoea deleted from very rare.

Added - Not known: Nausea.

Skin and subcutaneous tissue disorders

Deleted - Not known: Hypersensitivity

Erythema added to the hypersensitivity reactions, and generalised comment removed.

Hepato-biliary disorders

Added - Very rare: Hepatic function abnormal (comment also added about very rare cases, and the last sentence about severe hepatic dysfunction has been removed)

4.9 Overdose

In the last sentence the i.v was amended to capitals.

6.5 Nature and contents of container

360 blister pack quantity has been removed.

8. MA numbers

Numbers have been updated

9. Date of first authorisation/renewal of the authorisation

Renewal date amended to 23 July2008

10. Date of revisions of text

Amended to 07-2008.

Updated on 24 August 2007 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

A number of editorial changes have been made together with a warning of an increased incidence of acute coronary syndrome.

2. Qualitative and quantitative composition

Editorial change – “a full list of” added to read “For a full list of excipients, see 6.1.”

4.2 Posology and method of administration

Editorial change – “Please be referred to section 4.4.” now reads “See section 4.4.”.

4.3 Contraindications

“Interaction with other medicinal products and other forms of interaction” has been removed.

4.4 Special warnings and precautions for use

“The use of repaglinide might be associated with an increased incidence of acute coronary syndrome (e.g. myocardial infarction) (see section 4.8 and 5.1).”, statement has been added.

4.8 Undesirable effects

“Based on the experience with repaglinide and with other hypoglycaemic agents the following adverse events have been seen: …”, “side effects” has been replaced with “adverse events”.

The following statement has been added.

“Cardiac disorders

Rare: Cardiovascular disease

Type 2 diabetes is associated with an increased risk for cardiovascular disease.  In one epidemiological study, a higher incidence of acute coronary syndrome was reported in the repaglinide group.  However, the causality of the relationship remains uncertain (see sections 4.4. and 5.1).”

Heading “Liver disorders” replaced with “Hepato-biliary disorders”.

5.1 Pharmacodynamic properties

The following statement has been added:

“One epidemiological study suggested an increased risk of acute coronary syndrome in repaglinide treated patients as compared to sulfonylurea treated patients (see section 4.4 and 4.8).”

5.3 Preclinical safety data

Editorial change, “Pre-clinical data revealed no special…”, replaced with “Non-clinical data revealed no special…”.

 

 

Updated on 3 August 2005 SmPC

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 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • 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 2004 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 17 September 2003 SmPC

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

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

Updated on 18 August 2003 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 23 July 2003 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Correction of spelling/typing errors
  • Change to section 8 - MA number

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

Updated on 30 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie
  • Change to section 4.3 - Contraindications
  • 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)