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Forest Laboratories UK Limited
Riverbridge House, Anchor Boulevard, Crossways Business Park, Dartford, Kent, DA2 6SL, UK
Telephone: +44 (0)1322 421 800
Fax: +44 (0)1322 291 306
Medical Information e-mail: medinfo@forest-labs.co.uk
Summary of Product Characteristics last updated on medicines.ie: 05/05/2010
SPC Effico Tonic

When a pharmaceutical company changes an SPC or PIL, 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 05/05/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Mar-2010
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company
Section 2 - The quanlitative and quantitative declaration has changed due to the removal of ponceau 4R (E124), it should now read:

Each 5ml oral solution contains:

Thiamine hydrochloride             0.18mg
Caffeine                                  20.20mg
Nicotinamide                           2.10mg
Compound Gentian Infusion      0.31ml

Excipients: Each 5ml dose contains ethanol 90mg and sucrose 2g.

For a full list of excipients, see section 6.1.

Section 3 - Pharmaceutical Form has changed due to the removal of the colours ponceau 4R (E124) and quinoline yellow (E014), see below the amended text:

Oral solution
Clear colourless/light straw coloured slightly viscous oral solution.

Section 4.4 Special warnings and precautions for use has changed due to the removal of the colours thus there is no need for the warnings. This section should now read:

None Stated.

Section 6.1 - List of Excipients has changed due to the deletion of the colourings, this section should now read;

Ethanol 96%
Sodium Benzoate (E211)
Citric Acid (E330)
Hydrocholoride Acid
Sucrose
H & R Summer Fruit Flavour 288234
Purified water

Section 6.3 - Shelf-life has changed due to the addition of a new PET bottle, this section should now read:

Clear colourless glass bottle: 3 years
Orange polyethylene terephthalate (PET) bottle: 2 years

Section 6.5 - Nature and contents of container has changed due to the addition of the new PET bottle, this section should now read:

Clear, colourless glass bottle with food grade polypropylene tamper-evident cap, pigmented with titanium dioxide containing 200ml, 250ml, 300ml or 500ml, or orange polyethylene terephthalate (PET) bottle with food grade polpropylene tamper-evident cap pigmented with titanium dioxide containing 300ml or 500ml.

Not all pack sizes may be marketed.

Section 7 - Marketing Authorisation Holder has been updated with a new address:

Forest Laboratories Uk Ltd.
Riverbridge House
Anchor Boulevard
Crossways Business Park
Dartford
Kent
DA2 6SL.

Section 10 - Date of revision of text needs to be updated to:

March 2010.
Updated on 21/08/2008 and displayed until 05/05/2010
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   11/2007
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 1
The name has changed from 'Effico Tonic' to 'Effico Tonic, Oral Solution'.
 
Section 2
This section has been expanded to include information on the excipients ethanol, sucrose and ponceau 4R.
 
Section 6.1
The 'E numbers' of the relevant excipients have been included.
Updated on 21/07/2004 and displayed until 21/08/2008
Reasons for adding or updating:
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
Updated on 29/10/2003 and displayed until 21/07/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 17/06/2003 and displayed until 29/10/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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