Buccolam 2.5mg, 5mg, 7.5mg and 10mg oromucosal solution

  • Name:

    Buccolam 2.5mg, 5mg, 7.5mg and 10mg oromucosal solution

  • Company:
    info
  • Active Ingredients:

    Midazolam Hydrochloride

  • 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

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 29/10/2020

Click on this link to Download PDF directly

Shire Pharmaceuticals Ireland Limited

Shire Pharmaceuticals Ireland Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Buccolam 2.5mg, 5mg, 7.5mg and 10mg oromucosal solution Active Ingredients Midazolam Hydrochloride
Medicine Name Cinryze 500 IU powder and solvent for solution for injection Active Ingredients C1 inhibitor (human)
Medicine Name Equasym XL 10, 20 & 30mg Modified Release Capsules Active Ingredients Methylphenidate Hydrochloride
Medicine Name Firazyr 30 mg solution for injection in pre-filled syringe Active Ingredients Icatibant Acetate
Medicine Name Foznol 250mg, 500mg, 750mg & 1000mg Chewable Tablets Active Ingredients Lanthanum Carbonate Hydrate
Medicine Name Intuniv 1mg, 2mg, 3mg, 4mg prolonged-release tablets Active Ingredients Guanfacine hydrochloride
Medicine Name Mezavant XL Active Ingredients Mesalazine
Medicine Name Natpar 25, 50, 75, 100 micrograms/dose powder and solvent for solution for injection in pre filled pen Active Ingredients Parathyroid Hormone
Medicine Name Reminyl Oral Solution Active Ingredients Galantamine Hydrobromide
Medicine Name Reminyl XL 8mg, 16mg and 24 mg prolonged release capsules Active Ingredients Galantamine Hydrobromide
Medicine Name Resolor 1 mg film-coated tablets Active Ingredients Prucalopride Succinate
Medicine Name Resolor 2 mg film-coated tablets Active Ingredients Prucalopride Succinate
Medicine Name Tyvense 20mg, 30mg, 40mg, 50mg. 60mg & 70mg Capsules, hard Active Ingredients Lisdexamfetamine dimesylate
Medicine Name Xagrid 0.5mg hard capsule Active Ingredients Anagrelide hydrochloride
1 - 0 of 14 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 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

Section

Changes (in red)

    1. Undesirable effects

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.

 

10.         DATE OF REVISION OF THE TEXT

 

 

 

 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

Renewal of SmPC, various edits and reorganisation of text.

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

Change name of MAH

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)

Free text change information supplied by the pharmaceutical company

None provided