Buccolam 2.5mg, 5mg, 7.5mg and 10mg oromucosal solution
- Name:
Buccolam 2.5mg, 5mg, 7.5mg and 10mg oromucosal solution
- Company:
Shire Pharmaceuticals Ireland Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/10/20
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Shire Pharmaceuticals Ireland Limited
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 29 October 2020
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Section 4.8 Undesirable effects
Reporting of suspected adverse reactions
Removal of UK reporting instructions.
Section 5.2 Pharmacokinetic properties
Addition of:
Race
Clinical studies have included patients from Japanese and non-Japanese groups, and no differences in the pharmacokinetic profile have been identified on exposure to Buccolam.
No dose adjustment is warranted.
Section 10 Date of revision of the text: 16 October 2020
Updated on 26 October 2020 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
Free text change information supplied by the pharmaceutical company
Update to ADR reporting details to remove UK reporting information.
Updated on 11 August 2020
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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
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Section |
Changes (in red) |
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Tabulated list of adverse reactions
The table below lists the adverse reactions reported to occur when oromucosal midazolam was administered to children in clinical studies and post-marketing experience. The frequency of adverse reactions is classified as follows: Common: ≥ 1/100 to < 1/10 Uncommon: ≥ 1/1,000 to < 1/100 Very rare: < 1/10,000 Not known: cannot be estimated from the available data Addition of new AE: Not known: Angioedema* * ADR identified from post-marketing experience.
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10. DATE OF REVISION OF THE TEXT
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27 July 2020 |
Updated on 11 August 2020 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 4 November 2019
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Updated on 27 October 2018 PIL
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 3 - how to take/use
Updated on 9 February 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 9 February 2018 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 7 November 2016 PIL
Reasons for updating
- Improved presentation of PIL
Updated on 4 October 2016
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 4 October 2016 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 9 - Date of renewal of authorisation
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 4 October 2016 PIL
Reasons for updating
- Change to, or new use for medicine
- Change of contraindications
- Change to side-effects
- Change to date of revision
Updated on 1 March 2016 PIL
Reasons for updating
- Improved electronic presentation
Updated on 9 November 2015 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 9 November 2015 PIL
Reasons for updating
- Change to marketing authorisation holder
Updated on 9 October 2014 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 9 October 2014 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)