Almogran 12.5 mg Film-coated tablet
- Name:
Almogran 12.5 mg Film-coated tablet
- Company:
Almirall Limited
- 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: 20/01/20
(Click to Download)XPIL
Package leaflet: Information for the user
Package leaflet: Information for the user
1. What Almogran is and what it is used for
1. What Almogran is and what it is used for
2. What you need to know before you take Almogran
2. What you need to know before you take Almogran
3. How to take Almogran
3. How to take Almogran
4. Possible side effects
4. Possible side effects
5. How to store Almogran
5. How to store Almogran
6. Contents of the pack and other information
6. Contents of the pack and other information
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Almirall Limited
Company Products
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| Medicine Name Almogran 12.5 mg Film-coated tablet | Active Ingredients Almotriptan D, L-hydrogen malate |
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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 21 January 2020 SmPC
Reasons for updating
- 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
Date of revision Feb 2016
Updated on 20 January 2020 PIL
Reasons for updating
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Date of revision updated to Jan 2019
Updated on 20 July 2015 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 20 July 2015 SmPC
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 6.1 - List of excipients
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 3 - replacement of description of printed blue A with engraved A.
Section 6.1 - removal of printing inks for blue A.
Updated on 16 July 2015 PIL
Reasons for updating
- New PIL for new product
Updated on 16 July 2015 PIL
Reasons for updating
- Change of inactive ingredient
- Change to appearance of the medicine
Updated on 14 July 2015 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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
Addition of side effect with frequency unknown: intestinal ischemia.
Update of name of Competent Authority in Ireland to HPRA.
Updated on 9 July 2015 PIL
Reasons for updating
- Change to side-effects
Updated on 12 May 2015 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Adddition of AEs with frequency not known.
Immune system disorders:
hypersensitivity reactions including angioedema, anaphalactic reactions
Eye disorders
Visual impairment, vision blurred. However visual disorders occure dureint a migraine attach.
Section 4.9
Deletion of: No case of overdose has been reported.
Updated on 8 May 2015 PIL
Reasons for updating
- Change to name of manufacturer
Updated on 25 September 2012 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 4.8 - Undesirable effects
- 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
Serotonin syndrome warning - section 4.4
Clarification of SSRI interaction - section 4.5
QRD template change to heading in section 4.6
Adverse events tabulated in section 4.8
Date of revision 02/2012
Updated on 18 September 2012 PIL
Reasons for updating
- Change of trade or active ingredient name
- Change of inactive ingredient
- Change to warnings or special precautions for use
Updated on 3 June 2011 SmPC
Reasons for updating
- 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 4.8 - Undesirable effects
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 the potential interaction with serotonin noradrenaline reuptake inhibitors (SNRI's) has been added
In section 4.8 the addition of seizure, category frequency not known
Updated on 2 June 2011 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
- Change to name of manufacturer
Updated on 28 March 2011 PIL
Reasons for updating
- Improved electronic presentation
Updated on 3 July 2009 SmPC
Reasons for updating
- Addition of separate SPCs covering individual presentations
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 26 March 2009 PIL
Reasons for updating
- New PIL for medicines.ie