Brintellix 10 mg film-coated tablets
*Company:
Lundbeck (Ireland) LimitedStatus:
No Recent UpdateLegal 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
Updated on 16 January 2024
File name
IE-XI Brintellix FCT_SPC.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 October 2023
File name
IE-XI-MT_Brintellix_5mg_10_mg_15_mg__20_mg_SmPC_-_REG_00079293.pdf
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 4.5 - Interaction with other medicinal products and other forms of interaction
- 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 26 October 2023
File name
IE-XI-MT_Brintellix_10_mg_FCT_PL_-_REG_00124634.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
Updated on 26 October 2023
File name
IE-XI-MT_Brintellix_10_mg_FCT_PL_-_REG_00124634.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
Updated on 26 October 2023
File name
IE-XI-MT_Brintellix_10_mg_FCT_PL_-_REG_00124634.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
Updated on 26 October 2023
File name
IE-XI-MT_Brintellix_10_mg_FCT_PL_-_REG_00124634.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
Updated on 02 August 2023
File name
IE-XI-MT Brintellix 10 mg fct_PIL.pdf
Reasons for updating
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
Updated on 02 August 2023
File name
IE-XI-MT Brintellix FCT_SPC.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 June 2023
File name
XI IE MT Brintellix 5mg 10 mg 15 mg 20 mg SmPC.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 September 2021
File name
XI-IE-MT Brintellix 10 mg FCT PL.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 15 September 2021
File name
XI IE MT Brintellix 5mg 10 mg 15 mg 20 mg SmPC.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 05 August 2021
File name
UK IE MT Brintellix 5mg 10 mg 15 mg 20 mg SmPC-clean.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 10 mg fct PL clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Free text change information supplied by the pharmaceutical company
Hyperprolactinaemia, Headache & Hyperhidrosis
Updated on 31 March 2021
File name
UK IE MT-Brintellix 5 10 15 20mg fct-SmPC.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.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 10 mg FCT PL - REG_00124634.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.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.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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 10 July 2020
File name
GB-IE-MT Brintellix 10 mg fct PIL.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.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.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 03 July 2019
File name
GB-IE-MT Brintellix 10 mg FCT PL_clean.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.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)