One-Alpha 1 mcg Capsules

  • Name:

    One-Alpha 1 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: 16/2/2017
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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 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 6.3 the shelf life is changed from two to three years
- In section 10 the date of revision has been updated

Updated on 16 February 2017 SmPC

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 6.3 the shelf life is changed from two to three years
- In section 10 the date of revision has been updated

Updated on 16 February 2017 SmPC

Reasons for updating

  • New SmPC 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 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 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

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

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 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 6.6 - 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 4.3 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

- 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 4.3 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

- 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

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 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 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 17 June 2009 PIL

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

None provided