One-Alpha Drops
- Name:
One-Alpha Drops
- Company:
LEO Pharma
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/12/20
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LEO Pharma
Company Products
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 15 December 2020 PIL
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 15 December 2020 SPC
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 4.8 – Undesirable effects - how to report a side effect
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
- Section 2. Excipients with known effect updated with quantitative information
- Section 4.4. Excipient warnings updated
- Sectopm 4.8. Updated in line with latest version of Annex V
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 SPC
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 SPC
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 29 September 2016 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
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 SPC
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
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 SPC
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
Updated on 19 December 2014 SPC
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
Updated on 3 February 2014 SPC
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 SPC
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
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 SPC
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
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 SPC
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
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