Robitussin Plus

Product Information *

  • Company:

    GlaxoSmithKline Consumer Healthcare (Ireland) Ltd
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Supply through pharmacy only

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 23 February 2021

File name

1541_SmPC_20 339_Robitussin Plus_v3 clean_1614099483.pdf

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 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 23 February 2021

File name

1541_PIL_20 339_Robitussin Plus_v3 clean_1614099420.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 10 December 2020

File name

1541_SmPC_20 028_CLEAN_1607614990.pdf

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:Supply through pharmacy only

Updated on 10 December 2020

File name

1541_PIL_20 028 v1_PAA152536_1607614911.pdf

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 21 August 2020

File name

1711_SmPC_20_286v1 (002)_1598004330.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Supply through pharmacy only

Updated on 21 August 2020

File name

1711_PIL_20_286_medicines ie_1598004228.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 06 August 2020

File name

1711_SmPC_19_122v3_1596736349.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

To update section 4.4 and 4.8 of the SmPC and to update the PIL to implement the PRAC recommendation for Procedure Number PSUSA/00001711/201807,reading Ischemic Colitis Warnings and Side Effects. Also include addition of Aprilia as a Manufacturing Site

Updated on 06 August 2020

File name

1711_PIL_19 122_medicines ie _1596736209.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

To update section 4.4 and 4.8 of the SmPC and to update the PIL to implement the PRAC recommendation for Procedure Number PSUSA/00001711/201807,reading Ischemic Colitis Warnings and Side Effects. Also include addition of Aprilia as a Manufacturing Site.

Updated on 04 November 2019

File name

1711_PIL_19_128_medicines ie_1572886407.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 19 June 2019

File name

1711_SmPC_18_089_v1 clean_1560948914.pdf

Reasons for updating

  • File format updated to PDF

Legal category:Supply through pharmacy only

Updated on 26 June 2018

File name

1711_SmPC_18_089_v1 clean.docx

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 26 June 2018

File name

1711_PIL_18_089_v1 clean.medicines.ie .pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 10 May 2016

File name

PIL_8451_114.pdf

Reasons for updating

  • New PIL for new product

Updated on 10 May 2016

Reasons for updating

  • Correction of spelling/typing errors

Updated on 23 February 2015

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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

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 23 February 2015

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 20 February 2015

Reasons for updating

  • Change of inactive ingredient
  • Change of manufacturer
  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 21 October 2013

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
  • In section 7, Marketing Authorisation Holder address has changed from:
  • 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.

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 18 October 2013

Reasons for updating

  • Change of licence holder
  • Change to date of revision

Updated on 09 March 2013

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use

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 05 March 2013

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 20 November 2012

Reasons for updating

  • Correction of spelling/typing errors

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 September 2012

Reasons for updating

  • Change to section 6.3 - Shelf life

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 November 2011

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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 28 June 2011

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 17 May 2011

Reasons for 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

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 May 2011

Reasons for 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

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 09 May 2011

Reasons for updating

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

Updated on 08 March 2010

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications

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 03 March 2010

Reasons for updating

  • Change of contraindications
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration
  • Change of distributor details

Updated on 28 May 2008

Reasons for updating

  • Addition of manufacturer
  • Change to date of revision
  • Change to dosage and administration
  • Change to warnings or special precautions for use

Updated on 26 March 2008

Reasons for 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

Legal category:Supply 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 15 February 2007

Reasons for updating

  • Change to information about drinking alcohol
  • Change from the BAN of the active substance to the rINN

Updated on 29 January 2007

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category:Supply 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 August 2006

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Updated of Section 6.1 - INNs

Updated on 30 March 2005

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container

Legal category:Supply through pharmacy only

Updated on 30 March 2005

Reasons for updating

  • Change to packaging

Updated on 23 August 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 11 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only