Tyvense 20mg, 30mg, 40mg, 50mg. 60mg & 70mg Capsules, hard

  • Name:

    Tyvense 20mg, 30mg, 40mg, 50mg. 60mg & 70mg Capsules, hard

  • Company:
    info
  • Active Ingredients:

    Lisdexamfetamine dimesylate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 19/11/20

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Summary of Product Characteristics last updated on medicines.ie: 19/11/2020

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Shire Pharmaceuticals Ireland Limited

Shire Pharmaceuticals Ireland Limited

Company Products

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Medicine Name Buccolam 2.5mg, 5mg, 7.5mg and 10mg oromucosal solution Active Ingredients Midazolam Hydrochloride
Medicine Name Cinryze 500 IU powder and solvent for solution for injection Active Ingredients C1 inhibitor (human)
Medicine Name Equasym XL 10, 20 & 30mg Modified Release Capsules Active Ingredients Methylphenidate Hydrochloride
Medicine Name Firazyr 30 mg solution for injection in pre-filled syringe Active Ingredients Icatibant Acetate
Medicine Name Foznol 250mg, 500mg, 750mg & 1000mg Chewable Tablets Active Ingredients Lanthanum Carbonate Hydrate
Medicine Name Intuniv 1mg, 2mg, 3mg, 4mg prolonged-release tablets Active Ingredients Guanfacine hydrochloride
Medicine Name Mezavant XL Active Ingredients Mesalazine
Medicine Name Natpar 25, 50, 75, 100 micrograms/dose powder and solvent for solution for injection in pre filled pen Active Ingredients Parathyroid Hormone
Medicine Name Reminyl Oral Solution Active Ingredients Galantamine Hydrobromide
Medicine Name Reminyl XL 8mg, 16mg and 24 mg prolonged release capsules Active Ingredients Galantamine Hydrobromide
Medicine Name Resolor 1 mg film-coated tablets Active Ingredients Prucalopride Succinate
Medicine Name Resolor 2 mg film-coated tablets Active Ingredients Prucalopride Succinate
Medicine Name Tyvense 20mg, 30mg, 40mg, 50mg. 60mg & 70mg Capsules, hard Active Ingredients Lisdexamfetamine dimesylate
Medicine Name Xagrid 0.5mg hard capsule Active Ingredients Anagrelide hydrochloride
1 - 0 of 14 items.Total: Infinity pages

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 19 November 2020

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

Free text change information supplied by the pharmaceutical company

Section

Changes (in red)

4.4 Special warnings and precautions for use

 

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.

4.8 Adverse events

Addition of the following adverse event:

 

System/Organ Class

Adverse Reaction

Children

(6 to 12 years)

Adolescents

(13 to 17 years)

Adults

Cardiac disorders

QTc prolongation

Frequency not known

Frequency not known

Frequency not known

10 Date of revision of the text

11th November 2020

Updated on 19 November 2020 PIL

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

Reasons for updating

  • Removal of Black Inverted Triangle

Free text change information supplied by the pharmaceutical company

Removal of the black triange 

Updated on 11 December 2019 PIL

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

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

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 6 November 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Company name change or merger

Updated on 5 November 2018

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Company name change or merger

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

Reasons for updating

  • Addition of joint SmPC 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

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 PIL

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 SmPC for new product

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

Updated on 19 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 February 2018 SPC

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 4.8 (undesirable effects), Chest pain has been added to the Tabulated summary of adverse reactions. 
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 PIL

Reasons for updating

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

Updated on 22 November 2016 SPC

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

Update section 4.8 (adverse event) of the SmPC to include dysgeusia as an uncommon adverse reaction with corresponding update to the date of revision of the text.

Updated on 17 November 2016 PIL

Reasons for updating

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

Updated on 28 October 2016 SPC

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

Shire has completed three Elvanse paediatric clinical trials, details of the main results from these studies have been added to section 5.1 of the SPC, and this has required an update in the frequency for some adverse events listed in section 4.8.

Updated on 27 October 2016 PIL

Reasons for updating

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

Updated on 4 August 2016 SPC

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

Section 4.5

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 SPC

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 extend the shelf life from 2 years to 3 years.
To update the date of revision of hte text to April 2015.

Updated on 11 February 2015 SPC

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 4.2 has been updated with guidance on the use of the product in varying degrees of impaired renal function. Also updated to allow administration in yogurt and orange juice.

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 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration

Updated on 9 February 2015 SPC

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 9 February 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 22 July 2014 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Addition of black triangle

Updated on 18 July 2014 SPC

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 1 July 2013 PIL

Reasons for updating

  • New PIL for new product

Updated on 28 June 2013 SPC

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided