TAMBOCOR 10MG/ML INJECTION

  • Name:

    TAMBOCOR 10MG/ML INJECTION

  • Company:
    info
  • Active Ingredients:

    flecainide acetate

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/11/18

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Summary of Product Characteristics last updated on medicines.ie: 7/11/2018

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Mylan IRE Healthcare Limited

Mylan IRE Healthcare Limited

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1 - 0 of 97 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 8 November 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 7 November 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 17 July 2018 SmPC

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 4.2: Information regarding significant hepatic impairment has been added.

In section 4.4: Information regarding ventricular arrhythmias has been added. Information regarding increase in plasma levels have been added.

In section 4.5: Information regarding anti-virals (lopinavir and indinavir), diuretics and anti-coagulants has been changed.

In section 4.6: Information about limit use in pregnancy has been added.

In section 4.8: Convulsion has been changed to seizure. Musculoskeletal and connective tissue disorders with frequency not known has been added.

In section 4.9: Information regarding overdose has been added

In section 10: Date of revision changed.

Updated on 22 December 2014 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 22 December 2014 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 3: the word infusion has been added to the pharmaceutical form

In section 4.2: reference to elderly patients has been changed to older patients

In section 4.3: Additional contraindications have been added

In section 4.4: Additional warnings and precautions have been added

In section 4.5: Additional information regarding Interaction with other medicinal products and other forms of interaction has been added

In section 4.6: This section has been divided into sub-sections. Additional text has been added. Information in relation to New Zealand White rabbits has been removed.

In section 4.8: This entire section has been restricted and divided into system organ class and frequencies. Adverse reaction reporting statement has been added.

In section 4.9: Additional information regarding over dose and treatment has been added.

In section 5.1: Pharmacotherapeutic group has been added and other pharmacodynamic information has been added.

In section 5.2: A correction has been made and additional pharmacokinetic property information has been added.

In section 5.3: Information regarding preclinical data has been removed and replaced by further text

In section 10: date of revision has changed

Updated on 22 December 2014 PIL

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 3: the word infusion has been added to the pharmaceutical form

In section 4.2: reference to elderly patients has been changed to older patients

In section 4.3: Additional contraindications have been added

In section 4.4: Additional warnings and precautions have been added

In section 4.5: Additional information regarding Interaction with other medicinal products and other forms of interaction has been added

In section 4.6: This section has been divided into sub-sections. Additional text has been added. Information in relation to New Zealand White rabbits has been removed.

In section 4.8: This entire section has been restricted and divided into system organ class and frequencies. Adverse reaction reporting statement has been added.

In section 4.9: Additional information regarding over dose and treatment has been added.

In section 5.1: Pharmacotherapeutic group has been added and other pharmacodynamic information has been added.

In section 5.2: A correction has been made and additional pharmacokinetic property information has been added.

In section 5.3: Information regarding preclinical data has been removed and replaced by further text

In section 10: date of revision has changed

Updated on 3 December 2012 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 4.7 - Effects on ability to drive and use machines

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

in section 4.7; the following statement has been added: Driving ability, operation of machinery and work without a secure fit may be affected by adverse reactions such as

dizziness and visual disturbances, if present.

In section 10; the date of revision has been changed to November 2012

Updated on 3 December 2012 PIL

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 4.7 - Effects on ability to drive and use machines

Free text change information supplied by the pharmaceutical company

 

in section 4.7; the following statement has been added: Driving ability, operation of machinery and work without a secure fit may be affected by adverse reactions such as

dizziness and visual disturbances, if present.

In section 10; the date of revision has been changed to November 2012

Updated on 22 February 2012 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 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 1 - Name of medicinal product

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 1; infusion has been added to name
In section 2; quantitative values have been added
In section 4.4; soduoum warning has been added
In section 5.1; ATC code has been added
In section 6.2; additional text added
In section 6.3; do not store above 25 degrees has been added
In section 6.4; additional text has been added
In section 6.6; text for single use only has been added
In section (; date of last renewal has been changed
In section 10; date of revision has been changed

Updated on 22 February 2012 PIL

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 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 1 - Name of medicinal product

Free text change information supplied by the pharmaceutical company

In section 1; infusion has been added to name
In section 2; quantitative values have been added
In section 4.4; soduoum warning has been added
In section 5.1; ATC code has been added
In section 6.2; additional text added
In section 6.3; do not store above 25 degrees has been added
In section 6.4; additional text has been added
In section 6.6; text for single use only has been added
In section (; date of last renewal has been changed
In section 10; date of revision has been changed

Updated on 7 April 2011 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 7; the address of the MAH has changed
In section 10; the date of revision has changed

Updated on 7 April 2011 SmPC

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 7; the address of the MAH has changed
In section 10; the date of revision has changed

Updated on 4 September 2009 SmPC

Reasons for updating

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 7: the name and address of the MAH has changed
In section 8: the marketing authorisation holder has chamged

Updated on 4 September 2009 PIL

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

In section 7: the name and address of the MAH has changed
In section 8: the marketing authorisation holder has chamged

Updated on 20 December 2005 PIL

Reasons for updating

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

Updated on 20 December 2005 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 not be renewed (A)

Updated on 21 November 2005 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 not be renewed (A)

Updated on 21 November 2005 PIL

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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

Updated on 3 August 2004 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 3 August 2004 PIL

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.4 - Special warnings and precautions for use

Updated on 23 June 2003 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 23 June 2003 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 10 June 2003 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 10 June 2003 PIL

Reasons for updating

  • New SPC for new product