Cordarone X 100 Tablets

  • Name:

    Cordarone X 100 Tablets

  • Company:
    info
  • Active Ingredients:

    Amiodarone Hydrochloride

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/11/19

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Summary of Product Characteristics last updated on medicines.ie: 30/9/2019

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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 21 November 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 30 September 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 30 September 2019 SmPC

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

Anaesthesia (see sections 4.5 and 4.8):

Before surgery, the anaesthetist should be informed that the patient is taking amiodarone. 

Primary Graft Dysfunction post cardiac transplant

In retrospective studies, amiodarone use in the transplant recipient prior to heart transplant has been associated with an increased risk of primary graft dysfunction (PGD).
PGD is a life-threatening complication of heart transplantation that presents as left, right or biventricular dysfunction occurring within the first 24 hours of transplant surgery for which there is no identifiable secondary cause (see Section 4.8). Severe PGD may be irreversible.

For patients who are on the heart transplant waiting list, consideration should be given to use an alternative antiarrhythmic drug as early as possible before transplant.

Section 4.8

Musculoskeletal and Connective Tissue Disorders:

  • Not known
    Lupus like syndrome.
     Injury, poisoning and procedural complications
  • Frequency not known:
    Primary graft dysfunction post cardiac transplant (see Section 4.4)

 

 

 

 

 

Updated on 7 May 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 11 December 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 11 December 2017 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

Section4.8 Undesirable Effects section was updated to include the adverse event of ‘Lupus like syndrome’ under the heading ‘Musculoskeletal and Connective Tissue Disorders’

Updated on 8 December 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 8 December 2017 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 13 June 2017 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 3 May 2017 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 12 January 2017 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

Type II work-sharing variation for the assessment a new adverse event. Procedure Number: NL/H/xxxx/WS/200
Additional New Adverse Event: Lupus Like Syndrome

Updated on 14 June 2016 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 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

variation update

Updated on 26 October 2015 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 4.8

Gastrointestinal disorders:
Common- constipation
Unommon- dry mouth
Not know- pancreatitis/ acute pancreatitis

Updated on 22 October 2015 PIL

Reasons for updating

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

Updated on 17 September 2015 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 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 updated with the following:


Severe bradycardia

Cases of severe, potentially life-threatening bradycardia and heart block have been observed when amiodarone is used in combination with sofosbuvir alone or in combination with another hepatitis C virus (HCV) direct acting antiviral (DAA), such as daclatasvir, simeprevir, or ledipasvir.   Therefore, coadministration of these agents with amiodarone is not recommended.

 

If concomitant use with amiodarone cannot be avoided, it is recommended that patients are closely monitored when initiating sofosbuvir alone or in combination with other DAAs.  Patients who are identified as being at high risk of bradyarrhythmia should be continuously monitored for at least 48 hours in an appropriate clinical setting after initiation of the concomitant treatment with sofosbuvir.

 

Due to the long half-life of amiodarone, appropriate monitoring should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated on sofosbuvir alone or in combination with other direct DAA’s.

 

Patients receiving these hepatitis C medicines with amiodarone, with or without other medicines that lower heart rate, should be warned of the symptoms of bradycardia and heart block and should be advised to seek urgent medical advice if they experience them.

Section 4.5 updated with the following:

 

OTHER DRUG INTERACTIONS WITH CORDARONE

 

Coadministration of amiodarone with sofosbuvir alone or in combination with another HCV direct acting antiviral (such as daclatasvir, simeprevir or ledipasvir) is not recommended as it may lead to serious symptomatic bradycardia.

 

If coadministration cannot be avoided, cardiac monitoring is recommended.

Updated on 30 July 2015 PIL

Reasons for updating

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

Updated on 10 November 2014 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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 updated to include:

Severe bullous reactions

Life threatening or even fatal cutaneous reactions Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN) (see section 4.8).  If symptoms or signs of SJS, TEN (e.g. progressive skin rash often with blisters or mucosal lesions) are present amiodarone treatment should be discontinued immediately.
Section 4.5 updated to add 'e.g. rhabdomyolsis' under CYP P450 3A4 substrates, Statins.

Section 4.8 to add the following:

Under 'Blood and lymphatic system disorders': Neutropenia,  agranulocytosis as Not known.
Under 'Gastrointestinal disorders': Pancreatitis/acute pancreatitis, dry mouth, constipation as Not known.
Under 'Nervous system disorders': Parkinsomism, parosmia as Not known.
New paragraph 'Psychiatric disorders' which includes Confusional state/delirium, hallucination as not known.
Under 'Reproductive system and breast disorders': Libido decreased as not known.
Under 'Skin and subcutaneous tissue disorders, new text after urticaria.
Under 'Immune system disorders': anaphylactic/anaphylactoid reaction including shock as not known
New paragraph 'Metabolism and nutrition disorders'.

Reporting of suspected adverse reactions updated.

Section 4.5 updated to add 'e.g. rhabdomyolsis' under CYP P450 3A4 substrates, Statins.Section 4.8 to add the following:Under 'Blood and lymphatic system disorders': Neutropenia,  agranulocytosis as Not known.Under 'Gastrointestinal disorders': Pancreatitis/acute pancreatitis, dry mouth, constipation as Not known.Under 'Nervous system disorders': Parkinsomism, parosmia as Not known.New paragraph 'Psychiatric disorders' which includes Confusional state/delirium, hallucination as not known.Under 'Reproductive system and breast disorders': Libido decreased as not known.Under 'Skin and subcutaneous tissue disorders, new text after urticaria.Under 'Immune system disorders': anaphylactic/anaphylactoid reaction including shock as not knownNew paragraph 'Metabolism and nutrition disorders'.Reporting of suspected adverse reactions updated.

Section 4.5 updated to add 'e.g. rhabdomyolsis' under CYP P450 3A4 substrates, Statins.Section 4.8 to add the following:Under 'Blood and lymphatic system disorders': Neutropenia,  agranulocytosis as Not known.Under 'Gastrointestinal disorders': Pancreatitis/acute pancreatitis, dry mouth, constipation as Not known.Under 'Nervous system disorders': Parkinsomism, parosmia as Not known.New paragraph 'Psychiatric disorders' which includes Confusional state/delirium, hallucination as not known.Under 'Reproductive system and breast disorders': Libido decreased as not known.Under 'Skin and subcutaneous tissue disorders, new text after urticaria.Under 'Immune system disorders': anaphylactic/anaphylactoid reaction including shock as not knownNew paragraph 'Metabolism and nutrition disorders'.Reporting of suspected adverse reactions updated.

Updated on 5 November 2014 PIL

Reasons for updating

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

Updated on 1 July 2014 SmPC

Reasons for updating

  • 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

Type IA.C.1.z variation following the PRAC decision to implement safety updates to section 5.3 of the SmPC for the amoidarone product range.

Updated on 13 December 2013 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 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

Bulk Type II. I.C.4 variation submitted following a Global Labelling Review for Amiodarone.   The updates reflect safety data presented in CCDS versions 14 & 15 and  relate to sections 4.4, 4.5, 4.8 & 5.2 of the SPC.

Updated on 9 December 2013 PIL

Reasons for updating

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

Updated on 10 September 2013 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

Bulk Type IB variation to update the SPCs in line with Article 45

Updated on 29 August 2013 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

Section 4.2 - new paragraph:

Paediatric population

The safety and efficacy of amiodarone in children has not  been established.

Currently available data are described in sections 5.1 and 5.2.


Section 5.1 new text:

No controlled paediatric studies have been undertaken.

In published studies the safety of amiodarone was evaluated in 1118 paediatric patients with various arrhythmias.  The following doses were used in paediatric clinical trials.

 

Oral

- Loading dose: 10 to 20 mg/kg/day for 7 to 10 days (or 500 mg/m2/day if expressed per square meter)

- Maintenance dose: the minimum effective dosage should be used; according to individual response, it may range between 5 to 10 mg/kg/day (or 250 mg/m2/day if expressed per square meter)

 

            Intravenous

- Loading dose: 5 mg/kg body weight over 20 minutes to 2 hours,

- Maintenance dose: 10 to 15 mg/kg/day from few hours to several days

If needed oral therapy may be initiated concomitantly at the usual loading dose.

Section 5.2 - new paragraph:

No controlled paediatric studies have been undertaken. In the limited published data available in paediatric patients, there were no differences noted compared to adults.






Updated on 23 August 2013 PIL

Reasons for updating

  • Change to, or new use for medicine

Updated on 13 February 2013 SmPC

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

Type IA bulk, category B.II.F.1.a.1, variation to reduce the shelf life of the finished product, as packaged for sale.

Updated on 8 April 2011 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

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

Free text change information supplied by the pharmaceutical company

Section 4.4: Special Warnings and Precautions for use

Section 4.5: Interaction with other medicinal products and other forms of interaction

Updated on 7 April 2011 PIL

Reasons for updating

  • Change to drug interactions

Updated on 21 July 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

Update Section 4.5 - addition of interaction with statins
Update Section 4.8 - addition of urticaria as side effect

Updated on 17 July 2009 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 22 July 2008 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

Update Section 4.4 and 10.

Updated on 22 July 2008 PIL

Reasons for updating

  • Improved electronic presentation
  • Change to warnings or special precautions for use

Updated on 28 February 2008 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

Update Section 4.5 - Interactions and 4.8 undesirable effects

Updated on 6 February 2008 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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

Update
Section 1 - Change in name
2 - Addition of excipients
9 - Date of renewal
10 - Date of revision

Updated on 6 February 2008 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 21 November 2007 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 21 November 2007 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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

Update Section -
3. - Statement regarding scoreline.
10. Revision of text.

Updated on 24 August 2007 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 6 July 2007 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • 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

Update Section 7 Change MA details to sanofi-aventis Ireland Ltd.
Section 8 PA number
Section 10 Date of Revision

Updated on 14 March 2007 SmPC

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

Section 4.4
- Inclusion of reference to use not being recommend in paediatrics.
- Updating of section relating to liver disorders
- Update to section relating to pent amide injection and when it is parenterally administered
- Inclusion or warning regarding combined use with flouroquinolones
- Changing of BAN to INNs for Ciclosporin and Tectrasactride.
 
Section 4.8
- Inclusion of very rare side effect :SIADH

Updated on 18 December 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 28 July 2005 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 26 October 2004 PIL

Reasons for updating

  • New PIL for medicines.ie