Dysport

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/05/19

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Summary of Product Characteristics last updated on medicines.ie: 4/3/2019

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Ipsen Pharmaceuticals Ltd

Ipsen Pharmaceuticals Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Cabometyx Tablets Active Ingredients Cabozantinib
Medicine Name Decapeptyl (triptorelin) 3-month Active Ingredients triptorelin pamoate
Medicine Name Decapeptyl (triptorelin) SR Active Ingredients triptorelin acetate
Medicine Name Decapeptyl 6 Month 22.5mg Active Ingredients triptorelin pamoate
Medicine Name Dysport Active Ingredients Clostridium botulinum type A toxin-haemagglutinin complex
Medicine Name Hexvix 85 mg powder and solvent for solution for intravesical use Active Ingredients Hexaminolevulinate Hydrochloride
Medicine Name INCRELEX Active Ingredients Mecasermin
Medicine Name Mucodyne 375mg Capsules- Discontinued Active Ingredients Carbocisteine
Medicine Name NutropinAq Active Ingredients Somatropin
Medicine Name Salvacyl 11.25 mg powder and solvent for prolonged-release suspension for injection Active Ingredients Triptorelin embonate
Medicine Name Somatuline Autogel 60 mg, 90 mg and 120 mg solution for injection in a pre-filled syringe Active Ingredients Lanreotide acetate
Medicine Name Somatuline LA 30mg Active Ingredients Lanreotide acetate
Medicine Name Xermelo 250 mg film-coated tablets Active Ingredients Telotristat ethyl
1 - 0 of 13 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 2 May 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 4 March 2019 PIL

Reasons for updating

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

Updated on 4 March 2019 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

Change in frequency category of 'pain in extremity' for Adult Upper Limb.

Updated on 16 November 2018 PIL

Reasons for updating

  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents

Updated on 9 November 2018 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 7 August 2018 PIL

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 7 August 2018 SmPC

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)

Free text change information supplied by the pharmaceutical company

Transfer of ownership from Ipsen Biopharm Limited to Ipsen Pharma

Updated on 12 May 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 7 August 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 7 August 2017 SmPC

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 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Update of Adult Upper Limb indication and addition of Adult Lower Limb indication

Updated on 31 July 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 31 July 2017 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 8 May 2017 SmPC

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 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Clinical and non-clinical update for existing Paediatric Lower Limb indication.

Updated on 2 May 2017 PIL

Reasons for updating

  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors
  • Change to section 2 - what you need to know - warnings and precautions

Updated on 7 February 2017 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 to ADR section 4.8

Updated on 2 February 2017 PIL

Reasons for updating

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

Updated on 14 April 2016 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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)

Free text change information supplied by the pharmaceutical company

Type II Clinical Variation Relating to Adult Upper Limb (AUL) Spasticity Indication and CCSI update.

 

Changes to sections of the SmPC:

(main change - 4.1 detailed below addition of AUL)

 

4.1          Therapeutic indications

Dysport is indicated for focal spasticity including  the:

-              Symptomatic treatment of focal spasticity affecting the upper limbs (fingers, wrist and elbow) in adults

-              Treatment of dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients, two years of age or older.

 

Dysport is also indicated for the following treatments:

-              Spasmodic torticollis.

-              Blepharospasm.

-              Hemifacial spasm.

-              Persistent severe primary hyperhidrosis of the axillae, which interferes with the activities of daily living and is resistant to topical treatment.

Updated on 14 April 2016 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to how the medicine works
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration
  • Changes to therapeutic indications
  • Correction of spelling/typing errors

Updated on 17 February 2016 SmPC

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 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: 
General: rewording of AEs under skin and subcutaneous tissue disorders, general disorders
Paediatric leg spasicity due to cerebral palsy: rewording of AEs in injury and poisoning sections
Spasmodic torticollis: rewording of AEs under eye disorders and addition of nausea as uncommon AE under GI disorders
Blepharospasm and hemifacial spasm: rewording of AEs under nervous system and eye disorders

Addition of reporting side effects wording to section 4.8.

Updated on 17 February 2016 PIL

Reasons for updating

  • Change to side-effects
  • Addition of information on reporting a side effect.

Updated on 25 July 2014 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

shelf-life reconstitution change variation rapp 9746. 

Updated on 23 July 2014 PIL

Reasons for updating

  • Change to storage instructions

Updated on 7 May 2014 SmPC

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

Changes have been made to a paragraph of section 4.4 of the SmPC as follows: 

 

Very rare cases of death, occasionally in a context of dysphagia, pneumopathy (including but not limited to dyspnoea, respiratory failure, respiratory arrest) and/or in patients with significant asthenia have been reported after treatment with botulinum toxin A or B. Patients with disorders resulting in defective neuro-muscular transmission, difficulty in swallowing or breathing are more at risk of experiencing these effects. In these patients, treatment must be administered under the control of a specialist and only if the benefit of treatment outweighs the risk.

Updated on 22 April 2014 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 27 February 2014 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

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

Free text change information supplied by the pharmaceutical company

The change to the SPC is change in Marketing Authorisation Holder and Number. 

Updated on 9 October 2013 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 22 August 2013 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 29 July 2013 SmPC

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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

$0CRN 2091872  C.I.4. Changes to 4.2, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.3 and 6.5 of SPC$0$0$0$0CRN 2092132  C.I.4 To update the Summary of Product Characteristics in accordance with the Company Core Safety Information version 5$0$0CRN 2113934 C.I.3.A Changes to the SPC sections 4.2, 4.3, 4.4, 4.6, 4.8 & 6.6Incorporation of change in MAH address and contact details. Addition of PA no to the vial.$0

Updated on 9 March 2012 SmPC

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 6.1 - List of excipients

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

Free text change information supplied by the pharmaceutical company

Minor changes to format section 4.2, 4.8$0Minor change to wording: section 4.4, 4.6 (heading title)$0$0Major change to section 6.1$0

Updated on 22 September 2011 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product

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

Free text change information supplied by the pharmaceutical company

Changed to read Dysport 500 units powder for solution for injection

Updated on 27 May 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 26 May 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 16 July 2009 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
  • Change to section 4 - Clinical particulars
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

4.1 New indication - Persistent sever primary hyperhidrosis of the axillae, which interferes with the activities of daily living and is resistant to topical treatment

4.2 Axillary Hyperhidrosis - Posology and method of administration

4.4 Special Warnings and precautions for use - Primary Axillary Hyperhidrosis

4.8 Undesirable effects - Axillary Hyperhidrosis

10. Date of approval / revision of SPC

Updated on 8 July 2009 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to dosage and administration
  • Changes to therapeutic indications
  • Change to date of revision

Updated on 27 August 2008 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 February 2008 SmPC

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

Changes to Undesirable Effects, approved by IMB January 2008.

Updated on 21 February 2008 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 13 September 2007 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Change to Shelf Life from 15 to 24 months

Updated on 23 August 2006 SmPC

Reasons for updating

  • 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

Change to Date of Partial Revision of Text
Correction of Spelling/Typing Errors

Updated on 19 May 2005 SmPC

Reasons for updating

  • 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 16 August 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 30 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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