One-Alpha 1 mcg Capsules
- Name:
One-Alpha 1 mcg Capsules
- 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: 28/10/16
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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
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 16 February 2017 PIL
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
- In section 10 the date of revision has been updated
Updated on 16 February 2017 SPC
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
- 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
- In section 10 the date of revision has been updated
Updated on 16 February 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 28 October 2016 PIL
Reasons for updating
- New PIL for new product
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 PIL
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
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 18 May 2015 PIL
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
Free text change information supplied by the pharmaceutical company
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 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 6.6 - 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
- 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
- Section 4.9 is reworded slightly
- 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 3 February 2014 PIL
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 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
- 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
- Section 4.9 is reworded slightly
- 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 6 March 2013 PIL
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
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 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 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 17 June 2009 PIL
Reasons for updating
- New individual SPC (was previously included in combined SPC)