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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: 23/02/2015
SPC Robitussin Plus

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 23/02/2015 and displayed until Current
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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   31-Dec-2014
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company


In section 2  Sodium has changed from 13.6 mg to 12.6 mg

In section 4.4 the sentence: 'Keep out of the reach of sight and reach of children' has been removed, Sodium has changed from 13.6 mg to 12.6 mg

In section 4.8 reporting information has been updated

in section 10 the date of revision of the text has been changed from October 2013 to December 2014
Updated on 21/10/2013 and displayed until 23/02/2015
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   04-Oct-2013
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

  • In section 7, Marketing Authorisation Holder address has changed from:

Pfizer Consumer Healthcare Ltd,
Ramsgate Road, Sandwich,
Kent, CT13 9NJ,
United Kingdom

to:  

Pfizer Healthcare Ireland,
9 Riverwalk, National Digital Park,
Citywest Business Campus, Dublin 24,
Ireland.

  • In section 8, Marketing Authorisation Number has changed from PA 172/35/1 to PA 0822/171/001.

 

  • In section 10, date has changed from September 2012 to October 2013.
Updated on 09/03/2013 and displayed until 21/10/2013
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   21-Feb-2013
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
2.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Excipients:
Each 5ml contains;
Ethanol (96%) 107 mg

4.4. Special Warnings and Precautions for Use

This medicinal product contains 2.7 % w/v ethanol (alcohol), up to 214 mg per dose (equivalent to approx 2 ml wine per dose). Harmful for those suffering from alcoholism.
Updated on 20/11/2012 and displayed until 09/03/2013
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   15-Nov-2012
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Only typographical revisions made. No change to medical/clinical information.  
Updated on 08/09/2012 and displayed until 20/11/2012
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   31-Aug-2012
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 6.3 Shelf life redued from 36 to 24 months.
Updated on 14/11/2011 and displayed until 08/09/2012
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 pharmacy only

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 17/05/2011 and displayed until 14/11/2011
Reasons for adding or updating:
  • 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   13-May-2011
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company


4.4.      Special Warnings and Precautions for Use

Caution should be exercised in patients with:

- High blood pressure, heart disease, diabetes, thyroid disease, or trouble urinating due to enlarges prostate gland.   

-A chronic cough occurs as occurs with smoking or chronic lung disease such as asthma or emphysema.

It should be used only cautiously in patients with severe hepatic or renal impairment.

A doctor or healthcare professional should be sought if symptoms get worse or last more than 5 days, come back or are accompanied by fever, rash or persistent headaches. These could be signs of a serious condition.
 

Do not exceed recommended dose.

 


4.5       Interactions with other medicaments and other forms of interactions

Do not take this product if you are taking a prescription monoamine oxidase inhibitor (MAOI) or for 14 days after stopping the MAOI drug. 


4.8       Undesirable Effects

The following side effects may be associated with the use of these active ingredients and are listed under their corresponding body system organ class:

 

Immune system disorders

Hypersensitivity

Psychiatric disorders

Agitation, anxiety, excitability, insomnia, irritability, nervousness, restlessness

Nervous system disorders

Dizziness, headache, psychomotor hyperactivity

Cardiac Disorders

Palpitation, tachycardia

Vascular disorders

Hypertension, increased blood pressure

Gastrointestinal disorders

Nausea, vomiting

Skin and subcutaneous tissue disorders

Rash, urticaria

 

4.9       Overdose

The following side effects may be associated with an overdose of these actives ingredients:

 

Gastrointestinal disorders

Nausea, vomiting

 

Cardiac disorders

Bradycardia, palpitation, tachycardia

 

Nervous system disorders

Convulsion, dizziness, tremor

 

Psychiatric disorders

Agitation, anxiety, insomnia, irritability, nervousness, restlessness

 

Vascular disorders

Hypertension, increased blood pressure


10.       Date of (Partial) Revision of the Text

 

13 May 2011
Updated on 10/05/2011 and displayed until 17/05/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   03-May-2011
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Renewal Application R5 - Completed 03 May 2011.
Unlimited validity granted from 29 July 2010.

Changes made during renewal include Section 4.4 on warnings in relation to alcohol and sodium content.    
Updated on 08/03/2010 and displayed until 10/05/2011
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 pharmacy only

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 26/03/2008 and displayed until 08/03/2010
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 29/01/2007 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:   01/2007
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 6.1 now includes following for natural cherry flavour
* contains Ethanol, Propylene Glycol and Natural Cherry Flavour
Updated on 18/08/2006 and displayed until 29/01/2007
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   08/2006
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
Updated of Section 6.1 - INNs
Updated on 30/03/2005 and displayed until 18/08/2006
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
Updated on 11/06/2003 and displayed until 30/03/2005
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Guaifenesin
  Pseudoephedrine Hydrochloride