Robitussin Plus
*Company:
Haleon Ireland LimitedStatus:
No Recent UpdateLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 20 February 2024
File name
ie-working-spc-GDS-update-RobitussinPlus+-230402LD-RFI3-clean.pdf
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
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Safety warning update to align to company core data
Updated on 20 February 2024
File name
ie-working-spc-GDS-update-RobitussinPlus+-230402LD-RFI3-clean.pdf
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
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Safety update to align warnings to company data
Updated on 20 February 2024
File name
ie-working-pil-GDS-update-RobitussinPlus+-230402LD-RFI3-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - duration of treatment
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Safety updates to align to company core data.
Updated on 28 November 2023
File name
ie-spc-robitussin-plus-separation-231122MW-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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
Company name change from GSK to Haleon
Updated on 28 November 2023
File name
ie-spc-robitussin-plus-separation-231122MW-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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
Company name change from GSK to Haleon
Updated on 28 November 2023
File name
ie-PIL-robitussin-plus-separation-231122MW-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Company name change from GSK to Haleon
Updated on 28 November 2023
File name
ie-PIL-robitussin-plus-separation-231122MW-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Company name change from GSK to Haleon
Updated on 26 April 2022
File name
1541_SmPC_20 339_Robitussin Plus_v3 clean.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 23 February 2021
File name
1541_SmPC_20 339_Robitussin Plus_v3 clean.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.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.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.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).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.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.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 .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.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 19 June 2019
File name
1711_SmPC_18_089_v1 clean.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
- New SPC for new product
Legal category:Supply through pharmacy only
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 mgIn 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 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
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
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
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
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
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 4.3 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 4.3, Contraindications now states, Not recommended for children under 2 years of age.
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
* 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 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