Kapake 30mg/500mg Tablets

  • Name:

    Kapake 30mg/500mg Tablets

  • Company:
    info
  • Active Ingredients:

    Codeine Phosphate, Paracetamol DC

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 09/09/19

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 9/9/2019

Click on this link to Download PDF directly

Galen Pharma Ireland Limited

Galen Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Erdotin 300mg Capsules Active Ingredients Erdosteine
Medicine Name Kapake 15mg/500mg Tablets Active Ingredients Codeine Phosphate Hemihydrate, Paracetamol
Medicine Name Kapake 30mg/500mg Tablets Active Ingredients Codeine Phosphate, Paracetamol DC
Medicine Name Laxido Orange, powder for oral solution Active Ingredients Macrogol 3350, Potassium Chloride, Sodium Chloride, Sodium Hydrogen Carbonate
Medicine Name Laxido Paediatric Plain, 6.9 g sachet, powder for oral solution. Active Ingredients Macrogol 3350, Potassium Chloride, Sodium Chloride, Sodium Hydrogen Carbonate
Medicine Name PENTHROX 3mL inhalation vapour, liquid Active Ingredients Methoxyflurane
Medicine Name THORENS 10 000 I.U. /ml oral drops, solution Active Ingredients Colecalciferol (Vitamin D3)
Medicine Name THORENS 25 000 I.U. /2.5 ml oral solution Active Ingredients Colecalciferol (Vitamin D3)
Medicine Name Tramake 100mg Tablets Active Ingredients Tramadol Hydrochloride
Medicine Name Tramake 50mg Tablets Active Ingredients Tramadol Hydrochloride
1 - 0 of 10 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 9 September 2019 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Sections 4.4, 4.5 and 10 of the SPC were updated to incorporate warnings relating to the interaction between benzodiazepines/benzodiazepine like products and opioids and the serious risks associated with their combined use including sedation, respiratory depression, coma and death, in line with CMDh advice. 

Updated on 9 September 2019 PIL

Reasons for updating

  • Change to Section 1 - what the product is

Free text change information supplied by the pharmaceutical company

The description of pharmacotherapeutic group within Section 1 of the PIL was updated.

Updated on 23 May 2019 PIL

Reasons for updating

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

Updated on 25 April 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 25 April 2019 SmPC

Reasons for updating

  • 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 13 February 2019 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • 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 11 February 2019 PIL

Reasons for updating

  • Addition of manufacturer
  • Change to date of revision

Updated on 19 July 2018 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 19 July 2018 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 4.6 - Pregnancy and lactation
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • 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

  • Update the Summary of Product Characteristics (SPC) in line with the current EU product information requirements (QRD template). 
  • Update the Pharmacotherapeutic group and ATC code within section 5.1 of the SPC to the new code for combinations of codeine and paracetamol

Updated on 18 July 2018 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 18 July 2018 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 4.6 - Pregnancy and lactation
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • 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

Updates have been made in line with the current EU product information requirements (QRD template).

 

Updated on 11 August 2015 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)

Free text change information supplied by the pharmaceutical company

Section 4.5 ‘Interaction with other medicinal products’ with regards to Monoamine Oxidase Inhibitors (MAOIs). 

Updated on 11 August 2015 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 11 August 2015 PIL

Reasons for updating

  • Change to date of revision

Updated on 11 August 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 14 August 2014 SmPC

Reasons for updating

  • SPC retired pending re-submission
  • 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
  • Very rare cases of serious skin reactions added.
  • Change in name of the Irish Medicines Board to the Health Products Regulatory Agency (HPRA) and wording on reporting suspected adverse reactions to the HPRA.

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

Free text change information supplied by the pharmaceutical company

In section 4.8 (undesirable effects)
  • Very rare cases of serious skin reactions added.
  • Change in name of the Irish Medicines Board to the Health Products Regulatory Agency (HPRA) and wording on reporting suspected adverse reactions to the HPRA.

Updated on 8 August 2014 PIL

Reasons for updating

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

Updated on 12 November 2013 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • PIL retired pending re-submission
  • Change to warnings or special precautions for use

Updated on 4 May 2011 PIL

Reasons for updating

  • Change to date of revision
  • Change due to user-testing of patient information

Updated on 21 February 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 25 June 2010 SmPC

Reasons for updating

  • New SPC for medicines.ie
  • SPC retired pending re-submission

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 20 October 2009 PIL

Reasons for updating

  • Change to date of revision

Updated on 27 January 2009 PIL

Reasons for updating

  • Change to date of revision

Updated on 25 July 2008 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 7 March 2008 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 7 March 2008 PIL

Reasons for updating

  • Change to information about pregnancy or lactation