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Pfizer Consumer Healthcare
9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 (0)1 467 6500
Fax: +353 (0)1 467 6501
Medical Information Direct Line: +353 (0)1 467 6627
Summary of Product Characteristics last updated on medicines.ie: 14/11/2011
SPC Robitussin Chesty Cough

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 14/11/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   22-Sep-2011
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company
6.5 Nature and Contents of Container

PET bottles containing 100ml with PET lined PP/HDPE screw caps.

A clear polypropylene measuring cap is also included.
Updated on 11/05/2011 and displayed until 14/11/2011
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   30-Apr-2011
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company


New Text as follows;

4.1       Therapeutic Indications

Expectorant used as an adjunct in the treatment of productive cough

4.4.      Special Warnings and Precautions for Use

Caution should be exercised in patients with chronic cough as occurs with smoking or chronic lung disease such as asthma or emphysema.

 

A doctor or healthcare professional should be sought if cough lasts more than 5 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.


4.8       Undesirable Effects

 

Immune system disorders

Hypersensitivity

Gastrointestinal disorders

Nausea, vomiting

 

4.9       Overdose

In case of accidentally overdose, discontinue use and seek professional assistance immediately.

The following signs and symptoms may be associated with an overdose of Guaifenesin:

 

Gastrointestinal disorders

Nausea, vomiting

 
Updated on 11/08/2010 and displayed until 11/05/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   30-Jun-2010
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company
7. MARKETING AUTHORISATION HOLDER
Pfizer Consumer Healthcare Ltd,
Ramsgate Road, Sandwich,
Kent, CT13 9NJ,
United Kingdom.

(formally Wyeth Consumer Healthcare)
Updated on 04/03/2010 and displayed until 11/08/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   24-Nov-2009
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company
Section 4.2 the posology for children under 12 has been removed.
Section 4.3 the product is no longer recommended for children under 12 years of age.
Updated on 05/05/2009 and displayed until 04/03/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 10 - Date of revision of the text
Date of revision of text on the SPC:   29-Oct-2008
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company
Section 2 (Qualitative and Quantitive composition), now states the product contains ethanol (103mg/5ml), maltitol (E965) and sorbitol (E420). 

Section 4.4 (Special Warnings and precautions for use) now states; Not more than 4 doses should be given in 24 hours. Do not exceed the stated dose. This product should not be taken with any other cough and cold medicine.          

Section 6.1 (List of excipients) E numbers have been stated after Sodium benzoate (E211) and Maltitol (E965) and Sorbitol (E420).

Section 6.5 (Nature and content of container) removed, glass bottle. which had a shelf life of 5 years (Section 6.3). Not marketed in this type of container.   

Section 10 (Revision of Date) states October 2008.    
Updated on 26/03/2008 and displayed until 05/05/2009
Reasons for adding or updating:
  • 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
Date of revision of text on the SPC:   02/2008
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 4.2, Posology now states, that Patients should be advised to consult a pharmacist/doctor before using in children under 6 years of age.
Section 4.3, Contraindications  now states, not recommended for children under 2 years of age.
Section 4.4, Special Warnings and Precautions states, if symptoms persist for more than 5 days consult a doctor. 
 
Updated on 16/04/2007 and displayed until 26/03/2008
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   02/2007
Legal Category:   general sale

Free-text change information supplied by the pharmaceutical company
Update 6.1 -  Natural cherry flavourings - ethanol, propylene glycol and natural flavorings
Updated on 23/08/2006 and displayed until 16/04/2007
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   08/2006
Legal Category:   general sale

Free-text change information supplied by the pharmaceutical company
Section 10: Include revision date
Updated on 30/03/2005 and displayed until 23/08/2006
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
Updated on 18/08/2004 and displayed until 30/03/2005
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 6.1 - List of excipients
Updated on 11/06/2003 and displayed until 18/08/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Guaifenesin