Strattera 4 mg/mL oral solution

Change to UK Marketing Authorisation Holder only

Changes

Added (underline) deleted (strikethrough)

Strattera^® 4 mg/mL oral solution

Aatomoxetine

2. What you need to know before you take Strattera

Do NOT take Strattera if you:

[…]

Strattera Oral Solution contains sorbitol, sodium, sodium benzoate and propylene glycol

This medicine contains 32.97  mg sorbitol in each mL. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.

This medicine contains 2.64 mg of sodium (main component of cooking/table salt) in each mL. This is equivalent to 3.3 % of the recommended maximum daily dietary intake of sodium for an adult.

This medicine contains 0.8  mg of sodium benzoate in each mL.

This medicine contains 9.8 mg of propylene glycol in each mL.

4.             Possible side effects

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Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Ireland: via HPRA Pharmacovigilance, www.hpra.ie, or the United Kingdom:the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.  By reporting side effects you can help provide more information on the safety of this medicine.

[…]

6.             Contents of the pack and other information

What Strattera 4 mg /mL contains

• The active substance is atomoxetine hydrochloride. Each mL of oral solution contains atomoxetine hydrochloride equivalent to 4 mg of atomoxetine.
• The other ingredients are sodium benzoate (E211), sodium dihydrogen phosphate dihydrate, phosphoric acid, liquid sorbitol (crystallising) E420, xylitol, artificial raspberry flavouring (containing propylene glycol E1520), sucralose, sodium hydroxide, purified water.

[…]

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder is:

United Kingdom

Eli Lilly and Company Limited, Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, UK.

Ireland

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

[…]

This leaflet was last revised in May 2019December 2020

For information about this product, please contact:

Ireland

Eli Lilly and Company (Ireland) Limited

Tel: + 353-(0) 1 661 4377

United Kingdom

Eli Lilly and Company Limited

Tel: + 44-(0) 1256 315000

Detailed information on this medicine is available on the web site of: UK/MHRA, Ireland/HPRA

2.             QUALITATIVE AND QUANTITATIVE COMPOSITION

[…]

Excipients with known effect

Each millilitre contains 32.97 mg of sorbitol (E420), 0.8 mg of sodium benzoate (E211), 9.8 mg propylene glycol (E1520), and 2.64 mg of sodium in total.

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4.4          Special warnings and precautions for use

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Sodium benzoate

This medicinal product contains 0.8 mg of sodium benzoate per mL.

Propylene glycol

This medicinal product contains 9.8 mg of propylene glycol per mL.

6.1          List of excipients

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Artificial raspberry flavouring (containing propylene glycol (E1520))

[…]

10.          DATE OF REVISION OF THE TEXT

09 Dec 202011 June 2019

Detailed information on this medicinal product is available on the website of: Ireland/HPRA

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

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

Transfer of Marketing authorisation holder from Eli Lilly UK (Basingstoke) to Eli Lilly Netherlands

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)

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