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One-Alpha 0.25 mcg Capsules

  • Name:

    One-Alpha 0.25 mcg Capsules

  • Company:
    info
  • Active Ingredients:

    Alfacalcidol

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 28/10/16

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Summary of Product Characteristics last updated on medicines.ie: 24/11/2017
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LEO Pharma

LEO Pharma

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1 - 0 of 41 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 24 November 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 24 November 2017 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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

- In Section 6.3 the shelf life is extended from two to three years.
- The date of revision is updated.

Updated on 28 October 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 28 October 2016 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 26 September 2016 SmPC

Reasons for updating

  • 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 improve clarity and readability

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

Free text change information supplied by the pharmaceutical company

- In Section 4.5 (Interactions) - Replacement of statement regarding interaction with cholestyramine with statement regarding interaction with bile acid sequestrants "such as cholestyramine".

- In Section 4.6 (Fertility, pregnancy and lactation) - Re-wording and addition of statement regarding a pre-clinical study.

 

- In Section 4.8 (Undesirable effects) - Deletion of list of symptoms of hypercalcaemia. Deletion of frequency number definitions from tabulation.
- Minor clarifications and re-wordings in sections 2, 4.2, 4.4 and 6.6

Updated on 23 September 2016 PIL

Reasons for updating

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

Updated on 22 May 2015 PIL

Reasons for updating

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

Updated on 18 May 2015 SmPC

Reasons for updating

  • 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

In section 4.8, IMB contact details have been replaced with those of HPRA  in "Reporting of suspected adverse reactions"

Updated on 27 January 2014 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

- In Section 4.3 Hypersensitivity is added
- In Section 4.4

A statement regarding monitoring PTH, alkaline phosphatase and the calcium x phosphate product is added

The signs of hypercalcaemia are amended.

A statement regarding the consequences of prolonged hypercalcaemia is added

A recommendation to use a phosphate binding agent in certain patient groups is added

A warning regarding use in patients with granulomatous disease is added

The warning regarding ethanol content is expanded

- Section 4.5 is expanded and rewritten to include statements regarding interactions with thiazide diuretics, vitamin D containing preparations, anticonvulsants, cholestyramine, magnesium-containing preparations and aluminium containing preparations

- In Section 4.6, reference to reproductivity studies in animals is added and statements regarding breast-feeding and fertility are added.

- In section 4.7 dizziness as a possible side effect is added

- Section 4.8 is completely updated and tabulated

- In Section 5.3 statements regarding toxicity, genotoxicity and fertility in animals are added

- Minor wording changes are made to section 2 and 6.6 minor wording changes in line with SmPC guidance are made

- The date of revision is updated

 

Updated on 22 January 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to information about driving or using machinery
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 7 March 2013 PIL

Reasons for updating

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

Updated on 6 March 2013 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


The following warning was added to section 4.4 Special warnings and precautions for use:

Use with caution in patients being treated with thiazide diuretics as they may have an increased risk of developing hypercalcaemia.

Updated on 11 June 2012 PIL

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 8 June 2012 PIL

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 30 August 2011 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 19 August 2009 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 17 June 2009 SmPC

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 20 May 2009 PIL

Reasons for updating

  • Change to date of revision
  • Change to appearance of the medicine

Updated on 14 July 2008 PIL

Reasons for updating

  • Change to improve clarity and readability
  • Change to date of revision
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change of special precautions for disposal

Updated on 19 October 2004 PIL

Reasons for updating

  • New PIL for medicines.ie