Brintellix 15 mg film-coated tablets *

  • Company:

    Lundbeck (Ireland) Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

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 15 September 2021

File name

XI IE MT Brintellix 5mg 10 mg 15 mg 20 mg SmPC_1631701857.pdf

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 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

Interaction with buprenorphine/opioid

Updated on 15 September 2021

File name

IE Brintellix 15 mg PIL_1631701802.pdf

Reasons for updating

  • 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 6 - date of revision

Free text change information supplied by the pharmaceutical company

Interaction with buprenorphine/opioid

Updated on 05 August 2021

File name

UK IE MT Brintellix 5mg 10 mg 15 mg 20 mg SmPC-clean_1628161499.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Hyperprolactinaemia, Headache & Hyperhidrosis

Updated on 05 August 2021

File name

GB-IE-MT Brintellix 15 mg fct clean_1628161422.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 31 March 2021

File name

UK IE MT-Brintellix 5 10 15 20mg fct-SmPC_1617182432.pdf

Reasons for updating

  • Other

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

Free text change information supplied by the pharmaceutical company

The previous version ommited information regarding warnings updated on glaucoma, feelings of aggression, anger, agitation and irritablity, contains sodium, false positives for methadone in urinalysis. Mydrasis, insomnia, agitation, and agression are added to adverse events. All these information were approved in July 2020 and have been placed back in the following sections:

  • 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

Updated on 12 March 2021

File name

UK IE MT Brintellix 5mg 10 mg 15 mg 20 mg SmPC_1615535466.pdf

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Editorial correction on section 4.2 Paediatric Population

[...]7-118 years[...] to [...]7-11 years[...]

Updated on 03 December 2020

File name

GB-IE-MT Brintellix 15 mg FCT PL - REG_00124635_1606987807.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects

Updated on 03 December 2020

File name

UK IE MT Brintellix 5mg 10 mg 15 mg 20 mg SmPC - REG_00079293_1606987761.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

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

Updated on 10 July 2020

File name

GB-IE-MT Brintellix 5-10-15-20 mg fct SPC_1594384225.pdf

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 - how to report a side effect

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

Updated on 10 July 2020

File name

GB-IE-MT Brintellix 15 mg fct PIL_1594384138.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - how to report a side effect

Updated on 10 March 2020

File name

REG_00079293_GB.MT.IE SPC Hepatic clean_1583845147.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

•    The purpose of the first Type II variation is to update the SmPC, section 4.8 and 5.1 to include clinically relevant information for the prescriber and patient describing vortioxetine’s superior (comparative) effect on treatment-emergent sexual dysfunction (TESD) based on the outcome of 2 prospective clinical studies (Studies 318 and 4001).

•    The purpose of the second Type II variation is to update the SmPC, section 4.4 and 5.2 to reflect the outcome of Study 401 that investigated PK, safety, and tolerability in subjects with severe hepatic impairment, as requested by the EMA during the Renewal assessment. In addition, adjustments are also proposed for renal impairment (although there is no new data on renal impairment) to align the wording between hepatic and renal impairment.

Updated on 06 March 2020

File name

GB-IE-MT Brintellix SPC_clean_1583490121.pdf

Reasons for updating

  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

•    The purpose of the first Type II variation is to update the SmPC, section 4.8 and 5.1 to include clinically relevant information for the prescriber and patient describing vortioxetine’s superior (comparative) effect on treatment-emergent sexual dysfunction (TESD) based on the outcome of 2 prospective clinical studies (Studies 318 and 4001).

•    The purpose of the second Type II variation is to update the SmPC, section 4.4 and 5.2 to reflect the outcome of Study 401 that investigated PK, safety, and tolerability in subjects with severe hepatic impairment, as requested by the EMA during the Renewal assessment. In addition, adjustments are also proposed for renal impairment (although there is no new data on renal impairment) to align the wording between hepatic and renal impairment.
 

Updated on 03 July 2019

File name

GB-IE-MT Brintellix 15 mg FCT PL_clean_1562154174.pdf

Reasons for updating

  • New PIL for new product

Updated on 03 July 2019

File name

1-3-1 IE Brintellix 5mg, 10 mg, 15 mg & 20 mg SPC_clean_1562154187.pdf

Reasons for updating

  • New SPC for new product

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