Updated on 04/01/2017 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 5.2 - Pharmacokinetic properties
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Change to section 10 - Date of revision of the text
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| Date of revision of text on the SPC: 23-Dec-2016 |
| Legal Category: Supply through pharmacy only |
Free-text change information supplied by the pharmaceutical company
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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.
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Updated on 10/04/2015 and displayed until 04/01/2017
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to Section 4.8 – Undesirable effects - how to report a side effect
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Change to section 4.9 - Overdose
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Change to section 10 - Date of revision of the text
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| Date of revision of text on the SPC: 31-Aug-2014 |
| Legal Category: Supply through pharmacy only |
Free-text change information supplied by the pharmaceutical company
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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.
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Updated on 09/03/2013 and displayed until 10/04/2015
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Change to section 7 - Marketing authorisation holder
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Change to section 8 - MA number
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| Date of revision of text on the SPC: 22-Feb-2013 |
| Legal Category: Supply through pharmacy only |
Free-text change information supplied by the pharmaceutical company
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New PA Holder: PHI, Citywest, Dublin 24.
New PA Number 822/172/1
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Updated on 25/02/2013 and displayed until 09/03/2013
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.4 - Special warnings and precautions for use
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| Date of revision of text on the SPC: 12-Feb-2013 |
| Legal Category: Supply through pharmacy only |
Free-text change information supplied by the pharmaceutical company
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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.
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Updated on 20/11/2012 and displayed until 25/02/2013
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Reasons for adding or updating:
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Correction of spelling/typing errors
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| 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
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| Only typographical revisions made. No change to medical/pharmaceutical information.
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Updated on 07/08/2012 and displayed until 20/11/2012
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.7 - Effects on ability to drive and use machines
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Change to section 4.8 - Undesirable effects
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Change to section 5.1 - Pharmacodynamic properties
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| Date of revision of text on the SPC: 20-Jul-2012 |
| Legal Category: Supply through pharmacy only |
Free-text change information supplied by the pharmaceutical company
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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
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Updated on 14/11/2011 and displayed until 07/08/2012
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Reasons for adding or updating:
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Change to section 6.5 - Nature and contents of container
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| 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
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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.
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Updated on 24/05/2011 and displayed until 14/11/2011
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.4 - Special warnings and precautions for use
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Change to section 6.3 - Shelf life
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Change to section 6.5 - Nature and contents of container
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Change to section 9 - Date of renewal of authorisation
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Change to section 10 - Date of revision of the text
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| Date of revision of text on the SPC: 20-May-2011 |
| Legal Category: Supply through pharmacy only |
Free-text change information supplied by the pharmaceutical company
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2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of liquid contains;
Active ingredient:
Dextromethorphan Hydrobromide 7.5 mg
Excipients:
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Ethanol (96%)
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101 mg
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Sodium
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10.8 mg
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Amaranth
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0.165 mg
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Liquid Maltitol
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242 mg
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Sorbitol Solution 70%
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1.454 g
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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.
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Updated on 11/08/2010 and displayed until 24/05/2011
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Reasons for adding or updating:
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Change to section 7 - Marketing authorisation holder
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| Date of revision of text on the SPC: 30-Jun-2010 |
| Legal Category: Supply through pharmacy only |
Free-text change information supplied by the pharmaceutical company
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7. MARKETING AUTHORISATION HOLDER
Pfizer Consumer Healthcare Ltd,
Ramsgate Road, Sandwich,
Kent, CT13 9NJ,
United Kingdom.
(formally Wyeth Consumer Healthcare)
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Updated on 08/03/2010 and displayed until 11/08/2010
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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| 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
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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
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Updated on 12/01/2007 and displayed until 08/03/2010
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for use
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Change to section 10 - Date of revision of the text
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| Date of revision of text on the SPC: 12/2006 |
| Legal Category: retail sale through pharmacy only |
Free-text change information supplied by the pharmaceutical company
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| Update of section 4.4 (C2030281)
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Updated on 23/08/2006 and displayed until 12/01/2007
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Reasons for adding or updating:
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Change to section 6.1 - List of excipients
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| 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
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| Section 6.1: Remove referecence to BP1968
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Updated on 01/02/2006 and displayed until 23/08/2006
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.6 - Pregnancy and lactation
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Change to section 4.8 - Undesirable effects
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Updated on 30/03/2005 and displayed until 01/02/2006
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Reasons for adding or updating:
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Change to section 6.3 - Shelf life
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Change to section 6.5 - Nature and contents of container
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Updated on 13/06/2003 and displayed until 30/03/2005
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