Intuniv 1mg, 2mg, 3mg, 4mg prolonged-release tablets

  • Name:

    Intuniv 1mg, 2mg, 3mg, 4mg prolonged-release tablets

  • Company:
    info
  • Active Ingredients:

    Guanfacine 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: 13/07/20

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Summary of Product Characteristics last updated on medicines.ie: 13/7/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Shire Pharmaceuticals Ireland Limited

Shire Pharmaceuticals Ireland Limited

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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 13 July 2020

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Improved presentation of SmPC
  • Updated inline with QRD template and/or excipient guideline

Free text change information supplied by the pharmaceutical company

Section

Changes (in red)

Throughout

Changed ‘Intuniv’ to ‘guanfacine’

Sections 2, 3, 6.1, 6.5, 8

Added ‘prolonged-release’ to description of product.

Section 3 also moved wording of excipients

4.4 Special warnings and precautions for use

Added:

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

4.7. Effects on ability to drive and use machines

Updated text:

Guanfacine may have a moderate to severe influence on the ability to drive and use machines.

Guanfacine can cause dizziness and somnolence. These effects occur predominantly at the start of treatment and may occur less frequently as treatment continues. Syncope has also been observed. It may have a moderate to severe influence on the ability to drive, use machines or cycling. Patients should be warned of these possible effects and be advised that if affected, they should avoid these activities (see section 4.4).

 

4.8. Undesirable effects

HPRA information – removed address, email address and phone number information

9. Date of first authorization/ renewal of the authorisation

Date of first authorization: 17/09/2015

Date of latest renewal: 25/06/2020

10.         DATE OF REVISION OF THE TEXT

 

 

 

25 June 2020

Updated on 13 July 2020 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 2 July 2019

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Free text change information supplied by the pharmaceutical company

Section 4.5 (Interaction with other medicinal products and other forms of interaction), register a non-clinical study V8953M-SPD503 (Transporter Interaction – OCT1 inhibition).

Updated on 21 February 2018

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 21 February 2018 SPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 7 (Marketing Authorisation Holder), the address has changed

Updated on 20 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 20 February 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 28 June 2017 SPC

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Addition of the undesirable effect of Erectile Dysfunction in section 4.8, with a frequency of “Not known”

Subsequent update to the date of revision of the text. 

Updated on 26 June 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 22 December 2016 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 22 December 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
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

This variation covered a revision to the Product Information in response to a single, well characterized postmarketing case of hypertensive encephalopathy upon abrupt discontinuation of Intuniv (guanfacine hydrochloride) in Canada. The Posology and Method of Administration, Special Warnings and Precautions for Use, and Undesirable Effects sections of the Intuniv SmPC have been updated to include the risk of withdrawal blood pressure, increase/rebound hypertension and heart rate increase, and in very rare cases, hypertensive encephalopathy upon abrupt discontinuation of Intuniv.

Updated on 24 October 2016 SPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Amended (Sections 4.5 & 5.2), to include information on MATE1 and OCT1 inhibition.

Updated on 21 October 2016 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 13 April 2016 SPC

Reasons for updating

  • New SPC for new product
  • New SPC for medicines.ie
  • Addition of joint SPC covering all presentations

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 11 April 2016 PIL

Reasons for updating

  • New PIL for new product
  • New PIL for medicines.ie

Updated on 11 April 2016 PIL

Reasons for updating

  • Correction of spelling/typing errors