Robitussin Dry Cough *
Pharmacy Only: Non-prescription

Updated on 23 February 2021

File name

1551_SmPC_Dry Cough_20 338 v 3_clean_1614099189.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 4.8 – Undesirable effects - how to report a side effect
  • 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

1551_PIL_Dry Cough_20 338 v3_clean_1614099013.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 10 December 2020

File name

1551_PIL_20 027 v1_PAA152653_1607614656.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 10 December 2020

File name

1551_SmPC_20 027 v 1_CLEAN_1607614301.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 07 October 2020

File name

1721_Robi Dry Cough_SmPC_19_149_v1_CLEAN_1602064238.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Supply through pharmacy only

Updated on 06 August 2020

File name

1721_SmPC_19_136_CLEAN_1596736595.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

To update sections 4.4 and 4.9 of the SmPC in line with PRAC recommendation,

Consequentially, sections 2 and 3 of the PIL have been amended to align with

these changes. Regarding warning in usue with Serotonin Syndrome and Overdose symptoms &  management. Also include addition of Aprilia as a Manufacturing Site

Updated on 06 August 2020

File name

1721_PIL_19 136_medicines ie_1596736545.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

To update sections 4.4 and 4.9 of the SmPC in line with PRAC recommendation,

Consequentially, sections 2 and 3 of the PIL have been amended to align with

these changes. Regarding warning in use with Serotonin Syndrome and Overdose symptoms & management. Also include addition of Aprilia as a Manufacturing Site

Updated on 04 November 2019

File name

1721_19 127_PIL_ medicines ie_1572883942.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 04 January 2017

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 04 January 2017

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 5.2 - Pharmacokinetic properties
  • 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

As a result of the recent PSUR assessment for dextromethorphan, the following PRAC recommended wording has been added to the SPC.

In section 4.4 (Special warnings and special precautions for use): text has been added for drug abuse and slow metabolizers of CYP2D6.

In section 4.5 (Interactions with other medicinal products and other forms of interaction): text has been added and amended regarding CYP2D6 inhibitors and toxicity.
 
In section 5.2 (Pharmacokinetic properties): text has been added and amended regarding CYP2D6 and metabolism.

The revision date in section 10 has been updated as per approval.

Updated on 03 January 2017

File name

PIL_8452_719.pdf

Reasons for updating

  • New PIL for new product

Updated on 03 January 2017

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 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 10 April 2015

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 – Undesirable effects - how to report a side effect
  • 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

In section 2, 'sodium 10.8mg' was removed

In section 4.3, the following text was modified to give:
 Use in patients taking a prescription monoamine oxidase inhibitor (MAOI), a selective serotonin reuptake inhibitor (SSRI), or for 2 weeks after stopping the medication.

In section 4.4, the sentence 'Patients with rare hereditary problems of fructose intolerance should not take this medicine'
Also in 4.4, the following text was added:

If symptoms persist for more than 7 days, you have a recurrent cough or is accompanied by fever, rash or persistent headaches, consult your doctor or pharmacist. These could be signs of a serious condition.

Keep out of the sight and reach of children. (sight and reach swapped round)

In section 4.5, the following text was modified to give:

MAOI or SSRI

Do not give to patients taking a a prescription monoamine oxidase inhibitor (MAOI), a selective serotonin reuptake inhibitor (SSRI), or for 2 weeks after stopping the medication.
In section 4.8, the reporting information was added.

In section 4.9, the following text was added:

These include nausea and vomiting, CNS depression, dizziness, dysarthria (slurred speech), myoclonus, nystagmus, somnolence (drowsiness), tremor, excitation, mental confusion, psychotic disorder (psychosis), and respiratory depression.
This replaced 'excitation, confusion and respiratory depression may occur after overdosage.'



In section 10, the date was revised from Feb 2013 to Aug 2014.

Updated on 02 April 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions
  • Change to date of revision
  • Addition of information on reporting a side effect.
  • Removal/change of distributor

Updated on 09 March 2013

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

New PA Holder: PHI, Citywest, Dublin 24. 
New PA Number 822/172/1   

Updated on 06 March 2013

Reasons for updating

  • Change to further information section
  • Change to marketing authorisation holder

Updated on 25 February 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. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5 ml of liquid contains;

Active ingredient:
Dextromethorphan Hydrobromide 7.5 mg
Excipients:
Ethanol (96%) 98 mg
Sodium 10.8 mg
Amaranth 0.165 mg
Liquid Maltitol 242 mg
Sorbitol Solution 70% 1.454 g

For a full list of ingredients, see 6.1

4.4 Special Warnings and Special Precautions for Use


This medicinal product contains 2.5% v/v ethanol (alcohol), up to 196 mg per dose, (equivalent to approx 1.6 ml wine per dose). Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women and high-risk groups such as patients with liver disease, or epilepsy.
This product contains amaranth (E123) which may cause allergic reactions.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Updated on 18 February 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/pharmaceutical information.     

Updated on 07 August 2012

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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.2 Posology

Taken orally
Adults and children over 12 years: 10 ml 3 to 4 times daily
Children under 12 years: Do not use
Due to the extensive hepatic metabolism of dextromethorphan, caution should be exercised in the presence of hepatic impairment.

Section 4.3 Contra-indications
Use in children under 12 years of age.
Use in patients taking a prescription monoamine oxidase inhibitor (MAOI) or for 14 days after stopping the MAOI drug.
Hypersensitivity to the active substance or to any of the excipients.

Section 4.4 Special Warnings
Robitussin Dry Cough should only be used under medical supervision for persistent or chronic cough such as occurs with smoking, asthma or emphysema, or where the cough is accompanied by excessive secretions.

If the product is abused by patients they may become dependant on it.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Patients who are taking other medication and/or are under the care of a physician, should consult their doctor before taking the product.
There have been no specific studies of Robitussin Dry Cough in renal or hepatic dysfunction. Due to the extensive hepatic metabolism of dextromethorphan, caution should be exercised in the presence of hepatic impairment.
Do not exceed the recommended dose.
If symptoms persist for more than 7 days or you have a recurrent cough, consult your doctor or pharmacist.
This product contains 2.1 % w/v per 5 ml of ethanol (96%) which should be taken into consideration for those suffering from alcoholism, those who are pregnant or breastfeeding or high risk groups such as patients suffering from liver disease or epilepsy.
This product contains amaranth (E123) which may cause allergic reactions.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Section 4.5 Interactions
Anti-depressants
Fluoxetine / Paroxetine: Hallucinations and serotonin syndrome may occur.
Use with caution in patients receiving monoamine oxidase inhibitors, or within two weeks of stopping treatment.
Anti-arrhtyhmics
Quinodine and Amiodarone can increase the concentration of Dextromethorphan.
Anti-bacterials
Linezolid: Serotonin like symptoms have occurred when Dextromethorphan has been taken with Linezolid.
MAOI drugs
Concomitant use of dextromethorphan with an MAOI drug can result in serotonin syndrome, with symptoms including hypertension, hyperpyrexia, arrhythmia or myoclonus. The pharmacological mechanism for the interaction may be that of 1) dextromethorphan blocking the neuronal reuptake of serotonin, and 2) MAOI drug decreasing the breakdown of serotonin.
Keep out of the reach and sight of children.

Section 4.7 Driving and using machinery
Dextromethorphan hydrobromide has no or negligible influence on the ability to drive and use machines.

Section 4.8 Undesirable effects
The following side effects may be associated with the use of dextromethorphan:
Immune system disorders
Hypersensitivity reactions
Nervous system disorders
Dizziness
Gastrointestinal disorders
Gastrointestinal upset

Section 5.1 Pharmacodynamic propoerties
Dextromethorphan hydrobromide is a cough suppressant, which has a central action on the cough centre in the medulla. It has no analgesic properties and little sedative activity.
ATC code: R05DA09

 

Updated on 20 July 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Change to dosage and administration

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 24 May 2011

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







2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each 5 ml of liquid contains;

 

Active ingredient:

Dextromethorphan Hydrobromide     7.5 mg

Excipients:

Ethanol (96%)

101 mg

Sodium

10.8 mg

Amaranth

0.165 mg

Liquid Maltitol

242 mg

Sorbitol Solution 70%

1.454 g

 

For a full list of ingredients, see 6.1


4.4       Special Warnings and Special Precautions for Use

This product contains 2.1 % w/v per 5 ml of ethanol (96%) which should be taken into consideration for those suffering from alcoholism, those who are pregnant or breastfeeding or high risk groups such as patients suffering from liver disease or epilepsy. 

This product contains amaranth (E123) which may cause allergic reactions.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

6.3       Shelf Life

 

PET Bottles: 3 years

 

 

6.5       Nature and Contents of Containers

 

PET bottles containing 100ml with PVdC lined PP child resistant screw caps

 

A clear polypropylene measuring cup is also included.

Updated on 24 May 2011

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 11 August 2010

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Supply through pharmacy only

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 09 August 2010

Reasons for updating

  • Change to marketing authorisation holder

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

  • Change to date of revision
  • Addition of manufacturer

Updated on 15 February 2007

Reasons for updating

  • Change due to user-testing of patient information

Updated on 12 January 2007

Reasons for updating

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

Update of section 4.4 (C2030281)

Updated on 23 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

Section 6.1: Remove referecence to BP1968

Updated on 01 February 2006

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Legal category:Supply through pharmacy only

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 13 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only