Strattera 4 mg/mL oral solution

  • Name:

    Strattera 4 mg/mL oral solution

  • Company:
    info
  • Active Ingredients:

    Atomoxetine hydrochloride

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 31/05/19

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Summary of Product Characteristics last updated on medicines.ie: 12/6/2019

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Eli Lilly and Company (Ireland) Limited

Eli Lilly and Company (Ireland) Limited

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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 12 June 2019 SmPC

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)

Free text change information supplied by the pharmaceutical company

9.         DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07 November 2014

Date of last renewal: 24 May 201903 May 2019

10.       DATE OF REVISION OF THE TEXT

            24 May 201911 June 2019

Updated on 31 May 2019 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 30 May 2019 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 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)

Free text change information supplied by the pharmaceutical company

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

Each mL of oral solution contains atomoxetine hydrochloride equivalent to 4 mg of atomoxetine.

 

For the full list of excipients, see section 6.1.

Excipient with known effect: contains 32.97 mg of sorbitol per mL

Excipient with known effect

Each millilitre contains 32.97 mg of sorbitol, 0.8 mg of sodium benzoate and 2.64 mg of sodium in total.

For the full list of excipients, see section 6.1. 

 

4.4       Special warnings and precautions for use

                        

                        Strattera oral solution contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Sorbitol

This medicinal product contains 32.97 mg sorbitol in each mL. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product.

  

Sodium

This medicinal product contains 2.64 mg of sodium per mL. The maximum dose of 100 mg of atomoxetine is equivalent to 3.3 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.

  

9.         DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07 November 2014

Date of last renewal: 24 May 2019

 

10.       DATE OF REVISION OF THE TEXT

 27 July 201824 May 2019

Updated on 29 August 2018 Ed-Ptnt

Reasons for updating

  • Add New Doc

Updated on 30 July 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 30 July 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 Marketing authorisation holder from Eli Lilly UK (Basingstoke) to Eli Lilly Netherlands

Updated on 22 December 2017 SmPC

Reasons for updating

  • Improved presentation of SPC

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

Free text change information supplied by the pharmaceutical company

 

 

STRATTERA®                                                                                            REPUBLIC OF IRELAND

(atomoxetine)

 

 

 

 

1.             NAME OF THE MEDICINAL PRODUCT

 

STRATTERA* 4 mg/mL oral solution.

 

 

 

 

LEGAL CATEGORY

 

POM.

 

 

STRATTERA is marketed in the Republic of Ireland by:

 

Eli Lilly and Company (Ireland) Limited

Hyde House, 65 Adelaide Road

Dublin 2, Republic of Ireland

 

Telephone: Dublin (01) 661 4377

 

 

 

 

 

*STRATTERA (atomoxetine) is a trademark of Eli Lilly and Company.

 

ST364M (ROI)

Updated on 22 December 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 9 June 2015 SmPC

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)

Free text change information supplied by the pharmaceutical company

Minor formatting changes throughout per QRD template and capsules SPC.

 

 

4.9       Overdose

 

Deleted (strikethrough):

There is limited clinical trial experience with atomoxetine overdose. No fatal overdoses occurred in clinical trials.

 

 

 

10.          DATE OF REVISION OF THE TEXT

 

New date:

 

19 May 2015

Updated on 29 May 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 29 May 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 29 May 2015 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

Updated on 29 May 2015 PIL

Reasons for updating

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