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Kapake 15mg/500mg Tablets

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/06/19

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Summary of Product Characteristics last updated on medicines.ie: 10/6/2019

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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 Thorens 25 000 IU capsules, hard Active Ingredients Colecalciferol (Vitamin D3)
Medicine Name Tramake 100mg Tablets Active Ingredients Tramadol Hydrochloride
Medicine Name Tramake 50mg Tablets Active Ingredients Tramadol Hydrochloride
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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 10 June 2019 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 10 June 2019 SPC

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 5.1 - Pharmacodynamic properties
  • 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 25 April 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 25 April 2019 SPC

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 11 February 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Addition of manufacturer

Updated on 3 September 2018 SPC

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation

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

Free text change information supplied by the pharmaceutical company

Section 9 of the SmPC was updated to add in the date of last renewal.

Updated on 17 August 2018 SPC

Reasons for updating

  • File format updated to PDF

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

Updated on 27 February 2018 SPC

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 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

.

Updated on 27 February 2018 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 26 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 26 February 2018 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 26 October 2015 SPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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

The following sections of the SPC have been updated:

4.3 Contraindications (minor administrative update to incorporate a cross-referral to section 4.5)

4.5 Interactions

Updated on 23 October 2015 PIL

Reasons for updating

  • Change of contraindications
  • Change to drug interactions
  • Change to date of revision

Updated on 28 May 2015 SPC

Reasons for updating

  • New SPC for medicines.ie

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 26 May 2015 PIL

Reasons for updating

  • New PIL for medicines.ie