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LUSTRAL 50mg film coated tablets

*
Pharmacy Only: Prescription

  • Company:

    Upjohn EESV

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Sertraline Hydrochloride

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

Updated on 03 April 2023

File name

Patient Information Leaflet - IE - Lustral FCT.pdf

Reasons for updating

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

Updated on 26 September 2022

File name

Reg PIL LU 67_1 IE 50mg & 100mg IE - clean.pdf

Reasons for updating

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

Updated on 26 September 2022

File name

Reg SPC LU 68_1 50mg IE- clean.pdf

Reasons for updating

  • 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)

Updated on 15 September 2022

File name

Reg PIL LU 66_2 IE 50mg 100mg IE - clean.pdf

Reasons for updating

  • Change to name of medicinal product

Updated on 15 September 2022

File name

Reg PIL LU 66_2 IE 50mg 100mg IE - clean.pdf

Reasons for updating

  • Change to name of medicinal product

Updated on 05 August 2022

File name

DEC202209291-V_Reg SPC LU 67_1 50mg IE - clean.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

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Updates to opioids in section 4.4 and 4.5 of the Summary of Product Characteristics (SmPC).

Updated on 05 August 2022

File name

DEC202209291-V_Reg PIL LU 65_1 IE 50mg 100mg IE - clean.pdf

Reasons for updating

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

Updated on 20 July 2022

File name

DEC202208473-V_Reg SPC LU 66_1 50mg IE - clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Updates to section 4.4 and 5.1 of the Summary of Product Characteristics (SmPC) to include information from SPRITES study.

Updated on 20 July 2022

File name

DEC202208473-V_Reg PIL LU 64_1 IE 50mg 100mg IE - clean.pdf

Reasons for updating

  • Change to section 3 - use in children/adolescents
  • Change to section 6 - date of revision

Updated on 15 June 2021

File name

DEC202107404-V_Reg SPC LU 64_0 50mg IE - clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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

Updated on 15 June 2021

File name

DEC202107404-V_Reg PIL LU 62_0 IE 50mg & 100mg IE - clean.pdf

Reasons for updating

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

Updated on 19 March 2021

File name

DEC202103959-V_Reg SPC LU 62_2 50mg IE - Clean.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

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

Updated on 19 March 2021

File name

DEC202103959-V_Reg PIL LU 61_1 IE 50mg & 100mg IE -Clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 20 January 2021

File name

DEC202101041-V_Reg SPC LU 60_2 50mg IE - Clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

Updated on 20 January 2021

File name

DEC202101041-V_Reg PIL LU 58_1 IE 50mg & 100mg IE - clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 09 October 2020

File name

DEC202048631-V_Reg SPC LU 59_0 50mg IE -Clean.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.1 - List of excipients

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

Updated on 08 October 2020

File name

DEC202048631-V_Reg SPC LU 59_0 50mg IE -Clean.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6 - Pharmaceutical particulars

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

Updated on 08 October 2020

File name

DEC202048631-V_Reg PIL LU 57_0 IE 50mg & 100mg IE -Clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 12 November 2019

File name

DEC201962657_Reg SPC LU 55_0 50mg IE clean.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 12 November 2019

File name

DEC201962657_Reg PIL LU 53_0 IE 50mg & 100mg IE 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 09 October 2019

File name

Reg SPC LU 53_0 50mg IE.pdf

Reasons for updating

  • Previous version of SPC reinstated

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

Updated on 09 October 2019

File name

Reg PIL LU 51_0 IE 50mg & 100mg IE.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Updated on 14 August 2019

File name

DEC201943666_Reg PIL LU 52_1 IE 50mg & 100mg IE.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 14 August 2019

File name

DEC201943666_Reg SPC LU 54_2 50mg IE.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)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: The following text is added to Section 4.4 –

Sexual dysfunction

Selective serotonin reuptake inhibitors (SSRIs) may cause symptoms of sexual dysfunction (see section 4.8). There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs.

In section 4.8, Undesirable Effects, a note to see section 4.4 is added against ‘sexual dysfunction’ and ‘female sexual dysfunction’.

Note that another Type IA PRAC update (to add maculopathy UK IE LU 252; SCC Decision Form DEC201943674) was submitted simultaneously. Changes corresponding to this submission are also included in this SPC-see below

In section 4.8, Undesirable Effects, ‘maculopathy’ is added against Eye disorders, under Frequency not known.

Updated on 30 November 2018

File name

Reg PIL LU 51_0 IE 50mg 100mg IE-clean.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Updated on 30 November 2018

File name

Reg SPC LU 53_0 50mg IE-clean.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Section 6.5 – updated to include ‘Tablets are packed in Aluminium/PVC blister strips containing 30x1’.

Updated on 28 November 2018

File name

Reg SPC LU 52_1 50mg IE.pdf

Reasons for updating

  • Improved presentation of SPC

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

Free text change information supplied by the pharmaceutical company

Improved presentation of SPC uploaded

Updated on 28 November 2018

File name

Reg SPC LU 52_1 50mg IE.pdf

Reasons for updating

  • Improved presentation of SPC

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

Free text change information supplied by the pharmaceutical company

Improved presentation of SPC uploaded

Updated on 28 August 2018

File name

Reg_SPC_LU_52_1_50mg_IE_cl.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
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.4 – updated regarding QTc

Sections 4.4, 4.5, 4.8 and 4.9 - updated to include corresponding cross-references to section 5.1.

Section 5.1 - new subsection entitled “Cardiac Electrophysiology” included to add results from QTc study A051104.

Updated on 24 April 2018

File name

Reg_PIL_LU_50_0_IE_50mg_&_100mg_IE_cl.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 23 April 2018

File name

Reg_SPC_LU_52_1_50mg_IE_cl.docx

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
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Type II variation to update sections 4.4, 4.5, 4.8, 4.9, 5.1 of SPC in line with CDS regarding QTc study results (WS 250)

Updated on 05 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 05 February 2018

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 4.6 - Pregnancy and lactation
  • 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

The SPC has been updated as follows:

·         Section 4.8 - frequency of Adverse Drug Reactions (ADR)  amended and ADR Rhabdomyolysis added

·         Sections 4.4 and 4.5 - updated to include amphetamine in the list of other serotonergic drugs in relation to concomitant use with Sertraline.  Section 4.6 – editorial change

Updated on 05 February 2018

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

·         Section 4.8 - frequency of Adverse Drug Reactions (ADR)  amended and ADR Rhabdomyolysis added

·         Sections 4.4 and 4.5 - updated to include amphetamine in the list of other serotonergic drugs in relation to concomitant use with Sertraline.  Section 4.6 – editorial change

Updated on 02 February 2018

File name

PIL_8720_712.pdf

Reasons for updating

  • New PIL for new product

Updated on 04 September 2017

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

Section 4.8 – ADR ‘trismus’ added

Updated on 04 September 2017

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Section 4.8 – ADR ‘trismus’ added

Updated on 23 November 2015

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

The SPC has been updated as follows:

Section 4.5 updated to include the interaction of sertraline and NMBAs

Updated on 23 November 2015

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

The SPC has been updated as follows:

Section 4.5 updated to include the interaction of sertraline and NMBAs

Updated on 01 April 2015

Reasons for updating

  • Change to section 3 - Pharmaceutical form

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

Free text change information supplied by the pharmaceutical company

Section 3 - codes ‘LTL’ and ‘SER’ removed from tablet description

Updated on 01 April 2015

Reasons for updating

  • Change to section 3 - Pharmaceutical form

Free text change information supplied by the pharmaceutical company

Section 3 - codes ‘LTL’ and ‘SER’ removed from tablet description

Updated on 22 January 2015

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation

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

Free text change information supplied by the pharmaceutical company

Sections 2, 3, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.2, 6.1: updated in line with QRD/minor editorial changes; Section 9: renewal date updated

Updated on 22 January 2015

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation

Free text change information supplied by the pharmaceutical company

Sections 2, 3, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.2, 6.1: updated in line with QRD/minor editorial changes; Section 9: renewal date updated

Updated on 09 December 2014

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
  • Change to section 4.9 - Overdose

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Sections 4.4, 4.5, 4.8 and 4.9: updated with addition of safety language on the risk of QTc prolongation and Torsade de Pointes (TdP) events. Section 2: Editorial change

Updated on 09 December 2014

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
  • Change to section 4.9 - Overdose

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Sections 4.4, 4.5, 4.8 and 4.9: updated with addition of safety language on the risk of QTc prolongation and Torsade de Pointes (TdP) events. Section 2: Editorial change

Updated on 09 September 2014

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.3 - Preclinical safety data
  • Improved electronic presentation

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

Free text change information supplied by the pharmaceutical company

Section 4.4 Special Warning and precautions for use - Use in children and adolescents under 18 years of age subsection updated to include information regarding growth retardation and development.

Section  5.3 Preclinical safety date – New subsection and paragraph added: Juvenile animal studies

Entire SPC minor editorial changes to section headings to align with QRD version 9

Updated on 09 September 2014

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.3 - Preclinical safety data
  • Improved electronic presentation

Free text change information supplied by the pharmaceutical company

Section 4.4 Special Warning and precautions for use - Use in children and adolescents under 18 years of age subsection updated to include information regarding growth retardation and development.

Section  5.3 Preclinical safety date – New subsection and paragraph added: Juvenile animal studies

Entire SPC minor editorial changes to section headings to align with QRD version 9

Updated on 20 March 2014

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

Update to section 4.8

Updated on 20 March 2014

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Update to section 4.8

Updated on 17 December 2013

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

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

Free text change information supplied by the pharmaceutical company

Updates to section 4.4 & 4.5

Updated on 17 December 2013

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

Free text change information supplied by the pharmaceutical company

Updates to section 4.4 & 4.5

Updated on 31 July 2013

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
  • Change to section 4.9 - Overdose

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

Free text change information supplied by the pharmaceutical company

Section 4.4       Special warnings and precautions for use – Addition of methylene blue as an example of MAOI
Section 4.5       Interaction with other medicinal products and other forms of interaction - Addition of methylene blue as an example of MAOI
Section 4.5       Interaction with other medicinal products and other forms of interaction - Addition of examples of CYP3A4 inducers and its interaction with grapefruit juice
Section 4.5       Interaction with other medicinal products and other forms of interaction - Addition of examples of CYP2C19 inhibitors
Section 4.8       Undesirable effects – Addition of the following adverse events to Table 1 under the column ‘Frequency not Known’ “Pupils Unequal, Interstitial Lung Disease”
Section 4.8       Undesirable effects – Removal of the following adverse events from Table 1 under the column ‘Rare’ Section ‘General Disorders and Administration Site Conditions’ “Injection Site Fibrosis, Unevaluable Event”
Section 4.9       Overdose – Toxicity paragraph updated

Updated on 31 July 2013

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
  • Change to section 4.9 - Overdose

Free text change information supplied by the pharmaceutical company

Section 4.4       Special warnings and precautions for use – Addition of methylene blue as an example of MAOI
Section 4.5       Interaction with other medicinal products and other forms of interaction - Addition of methylene blue as an example of MAOI
Section 4.5       Interaction with other medicinal products and other forms of interaction - Addition of examples of CYP3A4 inducers and its interaction with grapefruit juice
Section 4.5       Interaction with other medicinal products and other forms of interaction - Addition of examples of CYP2C19 inhibitors
Section 4.8       Undesirable effects – Addition of the following adverse events to Table 1 under the column ‘Frequency not Known’ “Pupils Unequal, Interstitial Lung Disease”
Section 4.8       Undesirable effects – Removal of the following adverse events from Table 1 under the column ‘Rare’ Section ‘General Disorders and Administration Site Conditions’ “Injection Site Fibrosis, Unevaluable Event”
Section 4.9       Overdose – Toxicity paragraph updated

Updated on 19 October 2012

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

Section 4.6       Fertility, pregnancy and lactation – Section heading amended and Fertility subsection added to include effects on animal fertility and effects on human fertility and sperm
Section 5.3       Preclinical safety data – Effects on animal data fertility added to include rodents and non-rodents

Updated on 19 October 2012

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data

Free text change information supplied by the pharmaceutical company

Section 4.6       Fertility, pregnancy and lactation – Section heading amended and Fertility subsection added to include effects on animal fertility and effects on human fertility and sperm
Section 5.3       Preclinical safety data – Effects on animal data fertility added to include rodents and non-rodents

Updated on 03 October 2012

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)

Free text change information supplied by the pharmaceutical company

Section 4.4 -Special Warnings and Precautions for Use – Angle-Closure Glaucoma added
Section 4.8 -Undesirable Effects -  Nervous system Disorders: Dystonia and Cerebrovascular Spasm (including reversible cerebral vasoconstriction syndrome and Call-Fleming syndrome) added

Updated on 03 October 2012

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Section 4.4 -Special Warnings and Precautions for Use – Angle-Closure Glaucoma added
Section 4.8 -Undesirable Effects -  Nervous system Disorders: Dystonia and Cerebrovascular Spasm (including reversible cerebral vasoconstriction syndrome and Call-Fleming syndrome) added

Updated on 09 August 2012

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

Section 4.4       Special warnings and precautions for use - Interference with urine screening tests for benzodiazepines added  

Updated on 09 August 2012

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Free text change information supplied by the pharmaceutical company

Section 4.4       Special warnings and precautions for use - Interference with urine screening tests for benzodiazepines added  

Updated on 06 June 2012

Reasons for updating

  • Change to section 3 - Pharmaceutical form

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 tablet can be divided into equal doses" & deletion of "The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses".

Updated on 06 June 2012

Reasons for updating

  • Change to section 3 - Pharmaceutical form

Free text change information supplied by the pharmaceutical company

Addition of: " The tablet can be divided into equal doses" & deletion of "The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses".

Updated on 19 December 2011

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)

Free text change information supplied by the pharmaceutical company

Section 4.4 Special warnings and precautions for use – Diabetes subsection updated

Section 4.5 Interaction with other medicinal products and other forms of interaction – Caution is advised with the use of fentanyl in general anaesthesia

Section 4.8 Undesirable effects - Metabolism and Nutrition Disorders (frequency not known) diabetes mellitus, hyperglycaemia added

Updated on 19 December 2011

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

Free text change information supplied by the pharmaceutical company

Section 4.4 Special warnings and precautions for use – Diabetes subsection updated

Section 4.5 Interaction with other medicinal products and other forms of interaction – Caution is advised with the use of fentanyl in general anaesthesia

Section 4.8 Undesirable effects - Metabolism and Nutrition Disorders (frequency not known) diabetes mellitus, hyperglycaemia added

Updated on 17 October 2011

Reasons for updating

  • Change to section 4.9 - Overdose
  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

Section 4.9    Overdose
Section 6.5    Nature and Contents of Container

Updated on 17 October 2011

Reasons for updating

  • Change to section 4.9 - Overdose
  • Change to section 6.5 - Nature and contents of container

Free text change information supplied by the pharmaceutical company

Section 4.9    Overdose
Section 6.5    Nature and Contents of Container

Updated on 12 August 2011

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company

Section 3 Pharmaceutical Form – For 50 mg (only) Tablet Description of score line function added
Section 6.1 List of Excipients updated to include Film-coating components and the inclusion of additional E numbers
Section 6.4 Storage conditions harmonised to: Do not store above 30°C

Updated on 12 August 2011

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage

Free text change information supplied by the pharmaceutical company

Section 3 Pharmaceutical Form – For 50 mg (only) Tablet Description of score line function added
Section 6.1 List of Excipients updated to include Film-coating components and the inclusion of additional E numbers
Section 6.4 Storage conditions harmonised to: Do not store above 30°C

Updated on 08 June 2011

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 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

Update to section 4.4, 4.5 and 5.2 of the SPC to update interactions and pharmacodynamics including effect of grapefruit juice.

Updated on 08 June 2011

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 5.2 - Pharmacokinetic properties

Free text change information supplied by the pharmaceutical company

Update to section 4.4, 4.5 and 5.2 of the SPC to update interactions and pharmacodynamics including effect of grapefruit juice.

Updated on 28 June 2010

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 4.6 - Pregnancy and lactation
  • 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

Section 4.4 – Update regarding Seretonin Syndrome or Neuroleptic malignant syndrome.

Section 4.5 – Minor changes regarding Monoamine Oxidase Inhibitors

Section 4.6 – Update to include information on persistent pulmonary hypertension in the newborn (PPHN)

Section 4.8 – Update to side effects

Updated on 28 June 2010

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Section 4.4 – Update regarding Seretonin Syndrome or Neuroleptic malignant syndrome.

Section 4.5 – Minor changes regarding Monoamine Oxidase Inhibitors

Section 4.6 – Update to include information on persistent pulmonary hypertension in the newborn (PPHN)

Section 4.8 – Update to side effects

Updated on 13 April 2010

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)

Free text change information supplied by the pharmaceutical company

Section 4.4 and 4.8 to include Serotonin Syndrome and Neuroleptic Malignant Syndrome

Updated on 13 April 2010

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Section 4.4 and 4.8 to include Serotonin Syndrome and Neuroleptic Malignant Syndrome

Updated on 26 February 2010

Reasons for updating

  • Change to section 4 - Clinical particulars
  • Change to section 5 - Pharmacological properties

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

Free text change information supplied by the pharmaceutical company



SPC has been harmonised across the EU and as such all sections have been updated in line with EU Article 30 referral.

Updated on 26 February 2010

Reasons for updating

  • Change to section 4 - Clinical particulars
  • Change to section 5 - Pharmacological properties

Free text change information supplied by the pharmaceutical company



SPC has been harmonised across the EU and as such all sections have been updated in line with EU Article 30 referral.

Updated on 03 October 2008

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

Section 4.4 – Warnings updated with MAOIs and Other Serotonergic drugs. Section also updated with additional information on Abnormal Bleeding/Haemorrhage and Hyponatremia.

Updated on 03 October 2008

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Free text change information supplied by the pharmaceutical company

Section 4.4 – Warnings updated with MAOIs and Other Serotonergic drugs. Section also updated with additional information on Abnormal Bleeding/Haemorrhage and Hyponatremia.

Updated on 19 June 2008

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

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

Free text change information supplied by the pharmaceutical company

Update to section 4.6 (pregnancy and lactation) in line with changes made to the CDS.

Updated on 19 June 2008

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

Free text change information supplied by the pharmaceutical company

Update to section 4.6 (pregnancy and lactation) in line with changes made to the CDS.

Updated on 28 April 2008

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)

Free text change information supplied by the pharmaceutical company

 

4.4 – addition of information on suicide/suicidal thoughts or clinical worsening

4.8 – addition of suicidality

Updated on 28 April 2008

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

 

4.4 – addition of information on suicide/suicidal thoughts or clinical worsening

4.8 – addition of suicidality

Updated on 12 February 2007

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • 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

 

Section 3 - administrative changes made as part of a renewal

 

Section 6.1 - administrative changes made as part of a renewal

 

Section 6.2 - administrative changes made as part of a renewal

 

Section 6.4 - administrative changes made as part of a renewal

 

Section 6.6 - administrative changes made as part of a renewal

 

Section 9 - administrative changes made as part of a renewal

 

Section 10 - administrative changes made as part of a renewal

Updated on 12 February 2007

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

 

Section 3 - administrative changes made as part of a renewal

 

Section 6.1 - administrative changes made as part of a renewal

 

Section 6.2 - administrative changes made as part of a renewal

 

Section 6.4 - administrative changes made as part of a renewal

 

Section 6.6 - administrative changes made as part of a renewal

 

Section 9 - administrative changes made as part of a renewal

 

Section 10 - administrative changes made as part of a renewal

Updated on 25 January 2006

Reasons for updating

  • Change to section 3 - Pharmaceutical form

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

Updated on 25 January 2006

Reasons for updating

  • Change to section 3 - Pharmaceutical form

Updated on 17 October 2005

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 5.1 - Pharmacodynamic properties
  • 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 17 October 2005

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Updated on 29 July 2004

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

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

Updated on 29 July 2004

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Updated on 19 January 2004

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

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

Updated on 19 January 2004

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

Updated on 18 August 2003

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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)

Updated on 18 August 2003

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Updated on 27 June 2003

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 27 June 2003

Reasons for updating

  • New SPC for medicines.ie