Tyvense 30mg, 50mg & 70mg Capsules, hard

  • Name:

    Tyvense 30mg, 50mg & 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: 06/11/18

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Summary of Product Characteristics last updated on medicines.ie: 5/11/2018
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Shire Pharmaceuticals Ireland Limited

Shire Pharmaceuticals Ireland Limited

Address: Shire Pharmaceuticals Ireland Limited, Block 2, Miesian Plaza, 50-58 Baggot St, Dublin 2, Ireland

Medical Information E-mail: medinfoEMEA@shire.com

Customer Care direct line: 01800837470

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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, 40mg & 60mg Capsules, hard Active Ingredients Lisdexamfetamine dimesylate
Medicine Name Tyvense 30mg, 50mg & 70mg Capsules, hard Active Ingredients Lisdexamfetamine dimesylate
Medicine Name Xagrid 0.5mg hard capsule Active Ingredients Anagrelide hydrochloride
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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 6 November 2018 PIL

Reasons for updating

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

Updated on 5 November 2018 SmPC

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 SmPC

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 SmPC

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 SmPC

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 SmPC

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

  • New PIL for new product

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 SmPC

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 SmPC

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 SmPC

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 SmPC

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 SmPC

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 SmPC

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 SmPC

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 SmPC

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