Intuniv 1mg, 2mg, 3mg, 4mg prolonged-release tablets
*Company:
Takeda Products Ireland LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 27 January 2023
File name
Intuniv-IE-NI-SPC-block change-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 January 2023
File name
Intuniv-IE-NI-SPC-block change-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 24 October 2022
File name
Intuniv-IE-NI-SPC-Type 1B-RMP update-clean.pdf
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)
Updated on 24 October 2022
File name
Intuniv-IE-NI-PIL-addition of LRs (T1B RMP)-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Addition of local representatives
File name
176200401_Intuniv_Checklist 2_Ongoing_Therapy_Ireland v06.pdf
Reasons for updating
- Replace File
File name
176200401_Intuniv_HCP Guide-edited in PDF_APO_July2022_V03.pdf
Reasons for updating
- Replace File
File name
176200401_Intuniv_Checklist 3_Discontinuation_Ireland v06.pdf
Reasons for updating
- Replace File
File name
176200401_Intuniv_Checklist 1_Before_Prescribing_Ireland v06.pdf
Reasons for updating
- Replace File
File name
176200401_Intuniv_Chart_1_Ongoing_Monitoring_Ireland v06.pdf
Reasons for updating
- Replace File
File name
Checklist 2 - for ongoing monitoring - Nov 2017.pdf
Reasons for updating
- Add New Doc
Updated on 07 January 2022
File name
Intuniv-IE-NI-PIL-PSUR-Dec 2021-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 07 January 2022
File name
Intuniv-IE-SPC-PSUR-Dec 2021-clean (002).pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 19 November 2021
File name
Intuniv-IE-PIL-MIA-November 2021-clean.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
Addition of Takeda Pharmaceuticals International AG Ireland Branch as an additional site responsible for batch release
Updated on 04 October 2021
File name
Intuniv-IE-SPC-MAT_Sept 2021-clean.pdf
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
Transfer of Marketing Authorisation from Shire Pharmaceuticals Ireland Limited, Ireland to Takeda Pharmaceuticals International AG Ireland Branch
File name
HCP RMM guide - Nov 2017.pdf
Reasons for updating
- Add New Doc
File name
Checklist 3_Checklist for discontinuation - Nov 2017.pdf
Reasons for updating
- Add New Doc
File name
Checklist 1_Checklist for use prior to initiation - Nov 2017.pdf
Reasons for updating
- Add New Doc
File name
Chart 1_Chart for ongoing monitoring - Nov 2017.pdf
Reasons for updating
- Add New Doc
Updated on 13 July 2020
File name
Intuniv-UK-IE-SPC-Renewal-25 June 2020-Clean.pdf
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 SPC
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may not be renewed (A)
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.
|
|
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 02 July 2019
File name
UK_IE-Intuniv-SmPC-S 4.5 amended-June19-Clean.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may not be renewed (A)
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 SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 February 2018
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
Updated on 20 February 2018
File name
PIL_16692_862.pdf
Reasons for updating
- New PIL for new product
Updated on 20 February 2018
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
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
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 22 December 2016
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 22 December 2016
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 24 October 2016
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
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
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
Updated on 11 April 2016
Reasons for updating
- New PIL for new product
- New PIL for medicines.ie
Updated on 11 April 2016
Reasons for updating
- Correction of spelling/typing errors