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Valdoxan 25mg Film-coated Tablets

*
Pharmacy Only: Prescription

  • Company:

    Servier Laboratories Ireland Ltd

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

  • Active Ingredient(s):

    Agomelatine

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

  • VALDOXAN_Pack_Shot.jpeg

Updated on 29 October 2024

File name

Valdoxan25mg_SmPC_05.2024_clean.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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 29 October 2024

File name

Valdoxan25mg_SmPC_05.2024_clean.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 29 October 2024

File name

Valdoxan25mg_PIL_05.2024_clean.pdf

Reasons for updating

  • Change to section 2 - use in children and adolescents
  • Change to section 6 - date of revision

Updated on 30 November 2021

File name

Valdoxan PIL.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 15 November 2021

File name

Valdoxan PIL.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 24 July 2020

File name

Valdoxan PIL.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - what the product looks like and pack contents
  • Change to date of revision

Updated on 14 January 2019

File name

emea-combined-h-915-bg--R42-Renewal PIL.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to date of revision

Updated on 09 January 2019

File name

Valdoxan PIL.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to date of revision

Updated on 24 October 2018

File name

Valdoxan PIL.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 6 - what the product looks like and pack contents
  • Change due to harmonisation of PIL

Updated on 11 October 2017

File name

PIL_14499_866.pdf

Reasons for updating

  • New PIL for new product

Updated on 11 October 2017

Reasons for updating

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

Updated on 25 September 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 25 September 2017

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

 IN SECTION  6.5 nature and contents of container

IN SECTION      8. marketing authorisation number(s)

 

Updated on 07 December 2016

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.8. Undesirable effects

Addition of : Renal and urinary disorders - Frequency “rare”: Urinary retention*

 

Updated on 07 December 2016

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 30 November 2015

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Older people was changed to Elderly people

Addition of CONFUSION as phychiatric side effect

Updated on 23 November 2015

Reasons for updating

  • Change to improve clarity and readability

Updated on 19 December 2014

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 08 December 2014

Reasons for updating

  • 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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

-In section 4.2, 4.3 and 4.4- New Contraindication in patients ≥75 years$0-In section 4.2 and 4.4 first transaminases test to be performed before starting the treatment$0$0-In section 4.4- Reinforce precautions for patients with risk factors$0

Updated on 08 July 2014

Reasons for updating

  • Change to dosage and administration

Updated on 03 July 2014

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

$0In section 4.2 (Posology andmethod of administration), the following has been added: Patients may experience discontinuation symptoms after cessation from an SSRI/ SNRI antidepressant. The SmPC of the actual SSRI/SNRI should be consulted on how to withdraw the treatment to avoid this. Agomelatine can be started immediately while tapering the dosage of a SSRI//SNRI $0$0In section 5.1 (Pharmacodynamic properties), the paragraph on discontinuation symptoms with SSRIs and SNRIs now specifies paroxetine as the SSRI and venlafaxine as the SNRI. The phrase, "These discontinuation symptoms may be confounded with a lack of early benefit of agomelatine" is now a stand alone sentence (instead of part of the previous sentence).$0$0$0$0$0 $0

Updated on 13 February 2014

Reasons for updating

  • Change to side-effects
  • Change to drug interactions

Updated on 02 December 2013

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 4.8: addition of information on the reporting of suspected adverse reactions

Updated on 25 November 2013

Reasons for updating

  • 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 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company



1.       Posology and Method of administration

                Update of section 4.2 to state that agomelatine should not be used in patients ≥ 75 years.

2.       Contraindication

Update of section 4.3 of the SmPC to add transaminases exceeding 3X upper limit of normal as a contraindication.

3.       Special warnings and precautions for use

Updated section 4.4 of the SmPC with information about exceptional cases of hepatic failure reported with fatal outcome or liver transplantation in patients with hepatic risk factors.

4.       Undesirable effects

                Update section 4.8 of the SmPC

·         to add information about exceptional cases of hepatic failure reported with fatal outcome or liver transplantation in patients with hepatic risk factors

·         to add restless leg syndrome with a frequency uncommon. (Restless Leg Syndrome was identified during our internal signal detection and proposed by Servier in the PSUR 6)
·         to add tinnitus with a frequency uncommon (Tinnitus was requested to be added during the procedure and accepted by Servier)

 

 

 

 

Updated on 01 November 2013

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

$0Update to Section4.2 - Posology and Method of administration:$0$0·         Decision of dose increase has to be balanced with a higher risk oftransaminases elevation. Any dose increase to 50 mg should be made on anindividual patient benefit/risk basis and with strict respect of LFTmonitoring.$0

Updated on 17 September 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 07 August 2013

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

$0The information that has been added is highlighted in blue.$0$0Section 4.2: Posology and method ofadministration$0$0Addition of information to PaediatricPopulation and Elderly patients:$0$0PaediatricPopulation:$0$0“The safety andefficacy of Valdoxan in children from 7 years onwards for treatment of majordepressive episodes have not yet been established. No data are available (see section 4.4). $0$0There is no relevant use of Valdoxan in children from birth to 2 yearsfor treatment of major depressive episodes”.$0$0Elderly Patients:$0$0“The efficacy and safetyof agomelatine (25 to 50mg/day) have been established in elderly depressedpatients (< 75years). No effect is documented in patients ≥75 years (seesection 5.1).No dose adjustment is required in relation to age (see section5.2)”.$0$0 $0$0Section 4.4: Specialwarnings and precautions for use$0$0Addition of:  $0$0Elderly patients$0$0“No effect ofagomelatine is documented in patients ≥75 years, therefore agomelatine shouldnot be used by patients in this age group (see also sections 4.2 and 5.1).” $0$0 $0$0Section 4.6 Fertility, Pregnancy and lactation:$0$0Addition of:$0$0Pregnancy:$0$0“As a precautionarymeasure, it is preferable to avoid the use of Valdoxan duringpregnancy”.$0$0 Breast-feeding:$0$0It is not known whether agomelatine/metabolitesare excreted in human milk.  Availablepharmacodynamic/toxicological data in animals have shown excretion ofagomelatine/metabolites in milk (for details see 5.3). A risk to thenewborns/infants cannot be excluded. A decision must be made whether todiscontinue breast-feeding or to discontinue/abstain from Valdoxan therapytaking into account the benefit of breast feeding for the child and the benefitof therapy for the woman.$0$0 $0$0Section 4.8 Undesirable effects:$0$0Theadverse events have been tabulated, instead of listed, with 3 columns.$0$0Column1: system organ class$0$0Column2: Frequency$0$0Column3: Preferred term$0$0Urticaria, facial oedema and angioedema have been added to skin and subcutaneous disorderlist.$0$0 $0$0Section 5.1:Pharmacodynamic properties$0$0Addition of “Psychoanaleptics”to the Pharmacotherapeutic group.$0$0Additionof information to clinical efficacy and safety regarding:$0$0·A placebo-controlled 8-week trialof agomelatine 25-50mg/day in elderly depressed patients (≥ 65 years).$0$0·The European Medicines Agencydeferring the obligation to submit the results of studies with Valdoxan in oneor more subsets of the paediatric population.$0$0 $0$0Section 5.2: Pharmacokinetic properties$0$0Addition of information regarding apharmacokinetic study in elderly patients (≥ 65 years).$0$0 $0$0Section 5.3 Preclinical Safety data:$0$0Addition of:$0$0“No effect ofagomelatine on juvenile animals behavioural performances, visual andreproductive function were observed. There were mild non dose dependentdecreases in body weight related to the pharmacological properties and someminor effects on male reproductive tract without any impairment on reproductiveperformances”.$0$0 $0$0Section 6.6: Special Precautions fordisposal:$0$0Addition of:$0$0“Any unused medicinalproduct or waste material should be disposed of in accordance with localrequirements”.$0$0 $0$0Section 9: Date ofFirst Authorisation:$0$019/02/2009 changed to:$0$0“Date of first authorisation: 19 February 2009”$0$0 $0$0Section 10:$0$0Date of revision updated to 04/2013.$0$0 $0$0 $0

Updated on 13 November 2012

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

$0$0Section4.2$0$0When increasing the dose, liver function tests should be performed atthe same frequency as when initiating treatment.$0$0Section 4.4$0$0Changes includerenaming of the liver function paragraph, with description of the hepaticadverse reactions observed with agomelatine in the post-marketing setting,inclusion of recommendations to stop the treatment in case of clinical signs orsymptoms of potential liver injury and addition of diabetes as hepatic injuryrisk factor. $0$0Section 4.5$0$0Interactions withrifampicin and smoking included.$0$0Section 4.6 $0$0Update to thepregnancy paragraph.$0$0Section 4.8 $0$0Addition of the following adverse events: jaundice, hepatic failure,vomiting, weight increased and weight decreased. Update to the number ofpatients to patients exposed to agomelatine at therapeutic doses 25/50 mg. Update to thestatement on the frequency of increases in ASAT and/or ALAT> 3 ULN.$0$0Section 5.1 $0$0Update tothe number of patients treated with agomelatine, informationdeleted that agomelatine has a neutral effect on body weight in clinical trials, deleted proposal to add informationon post marketing data on weight increased and weight decreased.$0$0$0$0$0 $0

Updated on 08 November 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation

Updated on 17 April 2012

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

1. Updating of sections 4.2 and 4.4 to include the new recommendation regarding transaminases monitoring:

    A blood sample is now recommended to be performed three weeks after start of treatment.
2.   Updating of section 4.8 : 
    ·         to include new adverse events reported during the post-marketing experience : increased gamma  
          glutamyl transferase (GGT), increased alkaline phosphatase (ALP) and hallucinations
    ·         to update the frequency of the increases in ASAT and/or ALAT and to reword the whole sentence 
    ·         To define frequencies for the added adverse reactions based on post-marketing experience according to the 
          current SmPC guideline, dated September 2009.

Updated on 04 April 2012

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 15 February 2012

Reasons for updating

  • Change to MA holder contact details

Updated on 08 December 2011

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In Section 7: Marketing Authorisation Holder

Change from

LES LABORATOIRES SERVIER

22, rue Garnier

92200 Neuilly-sur-Seine

France

to

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex

France

Updated on 05 September 2011

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

$0$0The following details have been added:$0$04.4 Special warnings and precautions for use$0$0 $0$0-Bipolar disorder/ mania / Hypomania:$0$0Valdoxan should be used with caution in patients with ahistory of bipolar disorder, mania or hypomania and should be discontinued if apatient develops manic symptoms (see section 4.8).$0$0 $0$0-Increased serum transaminases:$0$0Cautionshould be exercised when Valdoxan is administered to patients with pretreatmentelevated transaminases (> the upper limit of the normal ranges and £3 times the upper limit of the normal range), preferably by laboratory testswithin the first 3 weeks of treatment.$0$0 $0$0Caution should be exercised when prescribingValdoxan for patients with hepatic injury risk factors e.g.obesity/overweight/non-alcoholic fatty liver disease, substantial alcoholintake or concomitant medicinal products associated with risk of hepaticinjury.$0$0$0$0 Deleted:$0$0Caution should be exercised when Valdoxan isadministered to patients with obesity/overweight/non-alcoholic fatty liverdisease or to patients who consume substantial quantities of alcohol or aretreated with medicinal products associated with risk of hepatic injury$0$0 $0$04.8  Undesirable effects $0$0 $0$0 $0$0Psychiatricdisorders:$0$0aggression,$0$0Nightmares, abnormal dreams$0$0 $0$0Gastrointestinaldisorders:$0$0Deleted:$0$0upper abdominal pain$0$0

Updated on 05 September 2011

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 09 February 2011

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4 Special warnings and precautions for use

Under "Mania / Hypomania" the reader is referred to Section 4.8 for further information

 

Under "Increased serum transaminases" caution should be exercised when Valdoxan is administered to patients

with obesity/overweight/non-alcoholic fatty liver disease.

 

Section 4.8 Undesirable effects

 

Under "Psychiatric disorders", the following (in red) has been added to the "frequency not known" section:

  • Mania/hypomania. These symptoms may also be due to the underlying disease (see section 4.4),
  • Agitation and
  • related symptoms (as irritability and restlessness)

Under "Skin and subcutaneous tissue disorders" the following has been added:

 

  • Frequency not known : pruritus

 

Section 4.9: Overdose:
The following changes (in red) have been made:

 

There is limited experience with agomelatine overdose. Experience with agomelatine in overdose has indicated

that epigastralgia, somnolence, fatigue, agitation, anxiety, tension, dizziness, cyanosis or malaise have been reported.

 

Updated on 07 February 2011

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about overdose
  • Change to side-effects

Updated on 13 September 2010

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.9 - Overdose

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2- Posology- The words "Valdoxan tablets may be taken with or without food." have been added in.

 


Section 4.6- Fertility- The words "embryofoetal development and pre- and post natal development" have been deleted

                Pregnancy- The words "

 

Reproduction studies in the rat and the rabbit showed no effect of agomelatine on embryofoetal development and pre- and post natal development. (see section 5.3)." have been inserted.

 


Section 4.9- Overdose-    The words "dose up to 2500 mg" have been deleted.

                                            The words "Patients have" have been deleted 

                                            The words "One person having ingested 2450 mg agomelatine," have been inserted.

Updated on 10 September 2010

Reasons for updating

  • Change to side-effects

Updated on 03 December 2009

Reasons for updating

  • New PIL for new product

Updated on 26 November 2009

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided