Tyvense 20mg, 30mg, 40mg, 50mg. 60mg & 70mg Capsules, hard
*Company:
Takeda Products Ireland LtdStatus:
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 22 December 2023
File name
ie-spc-tyvensecombinedcapsule-clean-indication-upd-app-21-12-2023.pdf
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 4.5 - 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 - how to report a side effect
- Change to section 4.9 - Overdose
- 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 6.4 - Special precautions for storage
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 December 2023
File name
ie-pl-tyvensecombinedcapsule-clean-indication-upd-app-21-12-2023.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 27 July 2023
File name
ie-spc-tyvensecombinedcapsule-clean-app-25-07-2023.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 July 2023
File name
ie-pl-tyvensecombinedcapsule-clean-app-25-07-2023.pdf
Reasons for updating
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 19 June 2023
File name
ie-spc-tyvensecombinedcapsule-clean-leo-update.pdf
Reasons for updating
- 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 19 June 2023
File name
ie-pl-tyvensecombinedcapsule-clean-leo-updates.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 11 August 2022
File name
ie-spc-tyvensecombinedcapsule-CCDS changes-clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 August 2022
File name
ie-pl-tyvensecombinedcapsule--CCDS changes-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 21 June 2022
File name
ie-spc-Tyvense-combined-cap-section 4.9-clean.pdf
Reasons for updating
- Change to section 4.9 - Overdose
- 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 21 June 2022
File name
ie-pl-Tyvense-combined-cap-2nd Manufacturer-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 05 May 2022
File name
ie-spc-Tyvense-combined-cap-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- 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 04 May 2022
File name
ie-pl-Tyvense-combined-cap-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 21 January 2022
File name
ie-pl-tyvensecombinedcapsule-Batch Release_Brexit-clean.pdf
Reasons for updating
- New PIL for new product
File name
176200032_LDX_Child_Leaflet_no_logo_IRE_v4.pdf
Reasons for updating
- Replace File
File name
176200032_LDX_Child_Checklist_2_ongoing monitoring_IRE_v4.pdf
Reasons for updating
- Replace File
File name
176200032_LDX_Child_Checklist_1_before prescribing_IRE_v4.pdf
Reasons for updating
- Replace File
File name
176200032_LDX_Child_Chart_Ongoing_Therapy_IRE_v4.pdf
Reasons for updating
- Replace File
Updated on 10 June 2021
File name
ie-spc-tyvensecombinedcapsule-renewal-clean.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
Patient - Carer Information - Nov 2017.pdf
Reasons for updating
- Add New Doc
File name
Checklist 2_Checklist for ongoing monitoring - Nov 2017.pdf
Reasons for updating
- Add New Doc
File name
Checklist 1_Checklist before prescribing - Nov 2017.pdf
Reasons for updating
- Add New Doc
File name
Chart for ongoing monitoring - Nov 2017.pdf
Reasons for updating
- Add New Doc
Updated on 03 March 2021
File name
ie-spc-tyvensecombinedcapsule-TII-029-clean.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- 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
Under section 4.6 Fertility, pregnancy, and lactation
Pregnancy
Deleted:
There are no adequate and well controlled studies of Tyvense in pregnant women. Dexamfetamine, the active metabolite of lisdexamfetamine, crosses the placenta.
Inserted the following:
Data from a cohort study of in total approximately 5570 pregnancies exposed to amphetamine in the first trimester do not suggest an increased risk of congenital malformation. Data from another cohort study in approximately 3100 pregnancies exposed to amphetamine during the first 20 weeks of pregnancy, suggest an increased risk of preeclampsia, and preterm birth. Newborns exposed to amphetamine during pregnancy may experience withdrawal symptoms.
Section 4.8 Undesirable effects
Added 'Syncope' with frequency of 'uncommon'
Section 10 Date of Revision of the Text: 11-January-2021
Updated on 19 November 2020
File name
ie-spc-tyvense-TIAIN-030-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 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 |
Changes (in red) |
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4.4 Special warnings and precautions for use
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Addition of the following text: Lisdexamfetamine has shown to prolong the QTc interval in some patients. It should be used with caution in patients with prolongation of the QTc interval, in patients treated with drugs affecting the QTc interval, or in patients with relevant pre-existing cardiac disease or electrolyte disturbances. |
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4.8 Adverse events |
Addition of the following adverse event:
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10 Date of revision of the text |
11th November 2020 |
Updated on 19 November 2020
File name
ie-pl-tyvense-TIAIN-030-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 date of revision
Updated on 11 December 2019
File name
ie-spc-tyvense-clean-TIB-025 Dec 19.pdf
Reasons for updating
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Removal of the black triange
Updated on 11 December 2019
File name
ie-pl-tyvense-clean-TIB-025 Nov 2019.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Free text change information supplied by the pharmaceutical company
Removal of Black triangle
Section 2 - addition of sodium excipient warning
Section 4- updated ADR reporting details
Please also note that texts have been combined into one QRD document for all strengths. Grey highlights indicate the differences between texts for the 20, 40, 60mg vs 30, 50, 70mg strengths, as two separate artworks exist , one for the 20, 40, 60mg and another for 30, 50, 70mg strengths.
Section 6- las revised changed from 10/2018 to 11/2019
Updated on 11 December 2019
File name
ie-spc-tyvense-clean-TIB-025 Dec 19.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 4.7 - Effects on ability to drive and use machines
- Change to section 10 - Date of revision of the text
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2 Pre-treatment evaluation has been moved up from under method of administration to under posology and method of administration
The elderly section has been removed
Information from the use in adults section has been removed
The following has been added to the Excipients section "This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’"
Section 4.7- Diplopia has been removed
Section 10- Date of revision has been amended from Oct 2018 to 1st Dec 2019
Updated on 06 November 2018
File name
ie-mockup-pl-tyvense-30mg-50mg-70mg-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Company name change or merger
Updated on 05 November 2018
File name
ie-spc-tyvense-30mg-50mg-70mg-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Company name change or merger
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 7 (Marketing Authorisation Holder): MAH transfer of MAH name and address - from Shire Pharmaceutical Contracts Limited, One Kingdom Street, W2 6BD, London, United Kingdom to Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland
Section 8 (Marketing Authroisation numbers): New numbers due to the MAH transfer
Updated on 16 July 2018
File name
IE-SmPC-Tyvense2030405060 70mg_clean-07_18.docx
Reasons for updating
- Addition of joint SPC covering all presentations
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The Summary of Product Characteristics has been updated to cover all licensed strengths (20, 30, 40, 50, 60 and 70mg capsules). Consequently sections 1, 2, 3, 6.1 8 and 10 have been updated.
Updated on 27 April 2018
File name
IE-SmPC-Tyvense 30 50 70mg - IA022 - 12_17.docx
Reasons for updating
- 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 13 April 2018
File name
IE-PIL-Tyvense 30 50 70mg - IA022 - 12_17_.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 19 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 19 February 2018
File name
PIL_15776_333.pdf
Reasons for updating
- New PIL for new product
Updated on 19 February 2018
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- 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
In section 5.2 (Pharmacokinetic properties), the section on special populations has been clarified concerning administration in children
In section 4.1 (indication) "DSM IV" and "ICD 10" have been replaced by "DSM" and "ICD" respectively
Updated on 19 February 2018
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 22 November 2016
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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
Updated on 17 November 2016
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 28 October 2016
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- 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
Updated on 27 October 2016
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 04 August 2016
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)
Free text change information supplied by the pharmaceutical company
4.5 Interaction with other medicinal products and other forms of interaction
addition of the following wording:
Serotonergic drugs
Serotonin syndrome has rarely occurred in association with the use of amphetamines such as Tyvense, when given in conjunction with serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs). It has also been reported in association with overdose of amphetamines, including Tyvense (see section 4.9).
Updated on 27 April 2015
Reasons for updating
- Change to section 6.3 - Shelf life
- 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
To update the date of revision of hte text to April 2015.
Updated on 11 February 2015
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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
- Change to section 4.9 - Overdose
- 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
Section 4.5 has been updated with clarification text.
Section 4.8 has been updated with Raynaud’s phenomenon.
Section 4.9 has been updated with clarification text.
Section 5.2 with PK study.
Updated on 10 February 2015
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to dosage and administration
Updated on 09 February 2015
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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 4.8 (undesirable effects): Summary of safety profile updated: Very common adverse reactions include decreased appetite, insomnia, dry mouth, headache and weight decreased and upper adnominal pain.
Section 4.8 (undesirable effects): Several updates to the tabulated summary of adverse effects as follows:
- Anorexia deleted as adverse reaction
- Anxiety changed from uncommon to common (adolescents only)
- Psychomotor activity changed from common to uncommon (children only)
- Restlessness changed from uncommon to common (adolescents only)
- Somnolence changed from uncommon to common (adolescents only)
- Dyskinesia changed from frequency not known to uncommon (children only)
- Mydriasis changed from common to uncommon (children only)
- Raynaud’s phenomenon added as adverse reaction
- Constipation added as adverse reaction
- Upper abdominal pain changed from very common to common (children only)
- Hyperhidrosis changed from frequency not known to uncommon (adolescents only)
- Feeling jittery changed from uncommon to common (adolescents only)
Section 10 (date of revision of the text): Date has been updated.
Updated on 09 February 2015
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 22 July 2014
Reasons for updating
- Change to side-effects
- Change to date of revision
- Addition of black triangle
Updated on 18 July 2014
Reasons for updating
- Addition of black triangle
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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
The following sections of the SPC are updated:
Black triangle: Addition of black triangle detailing that the product is subject to additional monitoring and details for how to report adverse reactions have been included in Section 4.8.
Section 4.8 (undesirable effects): Bruxism added as an adverse reaction.
Section 5.1 (pharmacodynamic properties): The results of a recently completed study has been added to this section (See “A double-blind, randomised, active-controlled, dose-optimisation study was conducted in children and adolescents aged 6 to 17 years (n=267) who met DSM-IV criteria for ADHD”).
Section 10: Date of the revision of the text has been updated.
In addition to the changes above, the following amendments were also made:
Section 4.1 (indication): Correction of typographical error: "aged 6 years of age and over"
Section 4.2 (Posology and method of administration): Update to text: “For all patients, either starting treatment for ADHD or switching from another medication, the starting dose is 30 mg taken once daily in the morning."
Section 5.1 (pharmacodynamic properties): The design of Study SPD489-325 has been clarified "dose-titrated" replaced with “dose-optimised”.
Updated on 01 July 2013
Reasons for updating
- New PIL for new product
Updated on 28 June 2013
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)