One-Alpha Drops

  • Name:

    One-Alpha Drops

  • 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: 17/05/19

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Summary of Product Characteristics last updated on medicines.ie: 26/4/2019

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LEO Pharma

LEO Pharma

Company Products

Medicine NameActive Ingredients
Medicine Name Dovobet Gel Active Ingredients Betamethasone dipropionate, Calcipotriol monohydrate
Medicine Name Dovobet Ointment Active Ingredients Betamethasone dipropionate, Calcipotriol monohydrate
Medicine Name Dovonex Cream Active Ingredients Calcipotriol hydrate
Medicine Name Dovonex Ointment Active Ingredients Calcipotriol
Medicine Name Dovonex Psoriasis 50 microgram/g ointment Active Ingredients Calcipotriol
Medicine Name Enstilar Cutaneous Foam Active Ingredients Betamethasone dipropionate, Calcipotriol monohydrate
Medicine Name Fucibet Cream Active Ingredients Betamethasone Valerate, Fusidic Acid
Medicine Name Fucibet Lipid Cream Active Ingredients Betamethasone Valerate, Fusidic Acid
Medicine Name Fucidin Cream Active Ingredients Fusidic Acid
Medicine Name Fucidin H Cream Active Ingredients Fusidic Acid Hemihydrate, Hydrocortisone Acetate
Medicine Name Fucidin Ointment Active Ingredients Sodium Fusidate
Medicine Name Fucidin Suspension Active Ingredients Fusidic Acid Hemihydrate
Medicine Name Fucidin Tablets Active Ingredients Sodium Fusidate
Medicine Name innohep 10,000 IU in 0.5 ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 10,000 IU/ml Solution for Injection (Prophylaxis and Haemodialysis) Active Ingredients Tinzaparin sodium
Medicine Name innohep 12,000 IU in 0.6ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 14,000 IU in 0.7 ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 16,000 IU in 0.8ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 18,000 IU in 0.9ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 2,500 IU syringe (Prophylaxis and Haemodialysis) Active Ingredients Tinzaparin sodium
Medicine Name Innohep 20,000 IU/ml Solution for Injection (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 3,500 IU syringe (Prophylaxis and Haemodialysis) Active Ingredients Tinzaparin sodium
Medicine Name innohep 4,500 IU syringe (Prophylaxis and Haemodialysis) Active Ingredients Tinzaparin sodium
Medicine Name innohep 8,000 IU in 0.4ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name Kyntheum 210 mg Solution for Injection Active Ingredients Brodalumab
1 - 0 of 40 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 17 May 2019 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 26 April 2019 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 - what you need to know - warnings and precautions
  • 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
  • Addition of information on alternative format leaflets

Updated on 26 April 2019 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 4.8 - Undesirable effects
  • Change to section 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company

Section 2 Qualitative and Quantitative Composition:

  • Order of excipients changed

Section 4.1 Therapeutic Indications:

  • “Uraemic bone disease” amended to “renal osteodystrophy” (interchangeable terms)
  • Indication in post-menopausal, senile and steroid-induced osteoporosis deleted.
  • The words “Prophylactic and therapeutic use in…” have been deleted in relation to the neonatal hypocalcaemia indication.
  • The words “…and osteomalacia” are added to the “Pseudo-deficiency (D-dependent) rickets” indication.
  • Order of indications changed.

Section 4.2 Posology and method of administration

  • Text added:
    • “Half-drop doses should be rounded up to the next whole number of drops.”
    • “Plasma levels should initially be measured at weekly intervals.  The daily dose of One-Alpha may be increased by increments of 0.25-0.5 microgram.  When the dose is stabilised, measurements may be taken every 2-4 weeks.”
    • “If hypercalcaemia occurs, One-Alpha should be stopped until plasma calcium returns to normal (approximately 1 week) then restarted at half the previous dose.”
    • “Method of administration: One-Alpha Drops should be administered orally, using the integral dropper. One drop = 0.1 microgram.”
  • Deletion and re-ordering of text to align with the revised indications section

Section 4.3 Contraindications

  • Metastatic calcification added

Section 4.4 Special warnings and special precautions for use

  • Text added to the statement about regular monitoring of serum calcium and serum phosphate levels “especially in children, patients with renal impairment and patients receiving high doses.”
  • List of signs of hypercalcaemia amended

Section 4.8 Undesirable effects

  • Frequency of “confusional state” changed from “uncommon to “not known”
  • “Urticaria” added with frequency “not known”
  • Frequency of “renal impairment (including acute renal failure)” changed from “uncommon” to “not known”

Section 6.4 Special Precautions for Storage

  • The statement “Keep the container in the outer carton” added

Updated on 13 October 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 13 October 2016 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 29 September 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 29 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 section 10 - Date of revision of the text
  • 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 26 September 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to information about drinking alcohol
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 20 January 2016 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 10 December 2015 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

- In Section 6.3 (Shelf life) the shelf life after opening has been extended from 28 days to 4 months when stored in a refrigerator

Updated on 7 December 2015 PIL

Reasons for updating

  • Change to storage instructions
  • 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 19 December 2014 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Correction to spelling of "analogues" in Section 4.5

Updated on 3 February 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 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 4.3 ContraindicationsHypersensitivity is added.

- Section 4.4 Special warnings and precautions for use

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 Interactions with other medicinal products and other forms of interaction

This section 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

- Section 4.6 Fertility, pregnancy and lactation

Reference to reproductivity studies in animals is added

Statements regarding breast-feeding and fertility are added

- Section 4.7 Effects on ability to drive and use machines

A statement regarding dizziness as a possible side effects is added

- Section 4.8 Undesirable effects

This section is completely updated and tabulated

- Section 4.9 Overdose

Additional wording regarding hypercalcaemia is added

- Section 5.3 Preclinical Safety Data

Statements regarding toxicity, genotoxicity and fertility in animals are added

- Section 10 Date of Revision of the text is updated

- Section 2, 6.4 and 6.6 are reworded in line with the SmPC guideline

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 31 August 2012 PIL

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 5 March 2012 PIL

Reasons for updating

  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 24 February 2012 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Change to name of manufacturer

Updated on 16 February 2012 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

An in use shelf life of 28 days has been added to the product.

Updated on 18 August 2011 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 24 May 2010 PIL

Reasons for updating

  • Change to improve clarity and readability

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 14 July 2008 PIL

Reasons for updating

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

Updated on 30 August 2007 PIL

Reasons for updating

  • Change of contraindications
  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation
  • Change of trade or active ingredient name

Updated on 30 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie