Brintellix 10 mg film-coated tablets
- Name:
Brintellix 10 mg film-coated tablets
- Company:
Lundbeck (Ireland) Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/12/20

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Lundbeck (Ireland) Limited
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Company Products
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 31 March 2021 SPC
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 SPC
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 3 December 2020 PIL
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 3 December 2020 SPC
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 SPC
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 PIL
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 SPC
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 6 March 2020 SPC
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 3 July 2019 PIL
Reasons for updating
- New PIL for new product
Updated on 3 July 2019 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)