Skip to content
SPC Logo

Benylin Dry Coughs 7.5mg / 5ml Syrup

Last Updated on eMC 16-Jan-2017 View document  | McNeil Products Ltd Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 16-Jan-2017 and displayed until Current

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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 04-Jan-2017

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Text that has been highlighted and underlines has been added, text that has been struck through has been removed:

 

4.4 Special Warnings and Precautions for Use

 

This product should not be administered to patients with chronic or persistent cough, such as occurs with asthma, or where cough is accompanied by excessive secretions, unless directed by a physician.

There have been no specific studies of this product in renal or hepatic dysfunction. Due to the extensive hepatic metabolism of dextromethorphan, caution should be exercised in the presence of hepatic impairment.

Cases of dextromethorphan abuse have been reported. Caution is particularly recommended for adolescents and young adults as well as in patients with a history of drug abuse or psychoactive substances.

This product should not be taken with any other cough and cold medicine.

Use of dextromethorphan with alcohol or other CNS depressants may increase the effects on the CNS and cause toxicity in relatively smaller doses.

Dextromethorphan is metabolised by hepatic cytochrome P450 2D6. The activity of this enzyme is genetically determined. About 10% of the general population are poor metabolisers of CYP2D6. Poor metabolisers and patients with concomitant use of CYP2D6 inhibitors may experience exaggerated and/or prolonged effects of dextromethorphan. Caution should therefore be exercised in patients who are slow metabolizers of CYP2D6 or use CYP2D6 inhibitors (see also section 4.5).

This product should be used with caution in atopic children due to histamine release.

 

 

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This product contains 6.0 vol % ethanol (alcohol), i.e. up to 240 mg per 5ml equivalent to approximately 6 ml beer, 2.5 ml wine per 5 ml. This can be harmful for those suffering from alcoholism. The ethanol content should be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.

4.5 Interactions with other medicinal products and other forms of Interaction

Dextromethorphan should not be used concurrently in patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping treatment with MAOIs as there is a risk of serotonin syndrome (e.g. hyperpyrexia, hallucinations, gross excitation or coma).

CYP2D6 inhibitors

Dextromethorphan is metabolized by CYP2D6 and has an extensive first-pass metabolism. Concomitant use of potent CYP2D6 enzyme inhibitors can increase the dextromethorphan concentrations in the body to levels multifold higher than normal. This increases the patient's risk for toxic effects of dextromethorphan (agitation, confusion, tremor, insomnia, diarrhoea and respiratory depression) and development of serotonin syndrome. Potent CYP2D6 enzyme inhibitors include fluoxetine, paroxetine, quinidine and terbinafine. In concomitant use with quinidine, plasma concentrations of dextromethorphan have increased up to 20-fold, which has increased the CNS adverse effects of the agent. Amiodarone, flecainide and propafenone, sertraline, bupropion, methadone,

 

 

cinacalcet, haloperidol, perphenazine and thioridazine also have similar effects on the metabolism of dextromethorphan. If concomitant use of CYP2D6 inhibitors and dextromethorphan is necessary, the patient should be monitored and the dextromethorphan dose may need to be reduced.

Dextromethorphan is primarily metabolised by the cytochrome P450 isoenzyme CYP2D6; the possibility of interactions with inhibitors of this enzyme, including amiodarone, haloperidol, propafenone, quinidine, SSRIs, and thioridazine, should be borne in mind.

Dextromethorphan might exhibit additive CNS depressant effects when co-administered with alcohol, antihistamines, psychotropics, and other CNS depressant drugs.

5. PHARMACOLOGICAL PROPERTIES

5.2. Pharmacokinetic properties

Absorption

Dextromethorphan is rapidly absorbed from the gastrointestinal tract with peak plasma concentrations reached in approximately 2 to 2.5 hours. The low plasma levels of dextromethorphan suggest low oral bioavailability secondary to extensive first-pass (pre-systemic metabolism) in the liver. The maximum clinical effects occur 5 to 6 hours after ingestion of dextromethorphan.

Distribution

Dextromethorphan is widely distributed in the human body. Dextromethorphan and its active metabolite, dextrorphan, are actively taken up and concentrated in brain tissue. It is not known if dextromethorphan or dextrorphan are excreted in breast milk or cross the placenta.

 

Metabolism

Dextromethorphan undergoes rapid and extensive first-pass metabolism in the liver after oral administration.

Genetically controlled O-demethylation (CYD2D6) is the main determinant of dextromethorphan pharmacokinetics in human volunteers.

 

It appears that there are distinct phenotypes for this oxidation process resulting in highly variable pharmacokinetics between subjects. Unmetabolised dextromethorphan, together with the three demethylated morphinan metabolites dextrorphan (also known as 3-hydroxy-N-methylmorphinan), 3- hydroxymorphinan and 3-methoxymorphinan have been identified as conjugated products in the urine.

Dextrorphan, which also has antitussive action, is the main metabolite. In some individuals metabolism proceeds more slowly and unchanged dextromethorphan predominates in the blood and urine.

As the hepatic metabolism of dextromethorphan is genetically determined, individuals vary in their ability to metabolise dextromethorphan and have been classified as either poor or extensive metabolisers. Dextromethorphan undergoes O-demethylation via CYP2D6 to dextrorphan; N-demethylation to 3- methoxymorphinan via CYP3A4/3A5; which is further metabolised to 3-hydroxy-morphinan via CYP2D6.

Excretion

Dextromethorphan is primarily excreted via the kidney as unchanged parent drug and its active metabolite, dextrorphan. Dextrorphan and 3-hydroxy-morphinan are further metabolised by glucuronidation and are eliminated via the kidneys.

 

The elimination half-life of the parent compound is between 1.4 to 3.9 hours; dextrorphan is between 3.4 to 5.6 hours. The half-life of dextromethorphan in poor metabolisers is extremely prolonged, in the range of 45 hours.

10 Date of Revision of the Text

04 May 2016

04 January 2017






Updated on 11-May-2016 and displayed until 16-Jan-2017

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 04-May-2016

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 2 Removed text “BENYLIN DRY COUGHS 7.5mg/5ml Syrup contains - Dextromethorphan hydrobromide Ph Eur 7.5 mg in each 5 ml”

Added text “Each 5 ml contains:

Dextromethorphan hydrobromide 7.5 mg

Each 5ml also contains:

Sucrose 1.6g

Liquid glucose 2.38g

Sorbitol 325mg

Ethanol 240mg

For the full list of excipients, see section 6.1.”

 

Section 4.1 replaced “BENYLIN DRY COUGHS 7.5mg/5ml Syrup” with “this product” and replaced “persistent, dry, irritating” with “an unproductive”

 

Section 4.2 added “Posology” as a title and removed “oral”

Replaced “BENYLIN DRY COUGHS 7.5mg/5ml Syrup” with “this product”

Added text “Method of Administration

For oral use

Opportunity taken to align with SPC QRD template”

 

Section 4.3 Replaced “BENYLIN DRY COUGHS 7.5mg/5ml Syrup” with “this product” twice

Replaced “product” with “active substance” added “to” and replaced “its components” with “the excipients”

Removed text “The concomitant use of a dextromethorphan-containing product and monoamine oxidase inhibitors, can occasionally result in symptoms such as hyperpyrexia, hallucinations, gross excitation or coma”

 

Added text “This product is contraindicated in patients taking serotonin reuptake

inhibitors (SSRIs, see section 4.5).”

 

Section 4.4 Replaced “BENYLIN DRY COUGHS 7.5mg/5ml Syrup” with “this product” twice

Added text “This product should not be taken with any other cough and cold medicine.

Use of dextromethorphan with alcohol or other CNS depressants may increase the effects on the CNS and cause toxicity in relatively smaller doses.

This product should be used with caution in atopic children due to histamine release.

Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This product contains 6.0 vol % ethanol (alcohol), i.e. up to 240 mg per 5ml equivalent to approximately 6 ml beer, 2.5 ml wine per 5 ml. This can be harmful for those suffering from alcoholism. The ethanol content should be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy”

 

Section 4.5 removed text “The concomitant use of a dextromethorphan-containing product and monoamine oxidase inhibitors can occasionally result in symptoms such as”

Added text “Dextromethorphan should not be used concurrently in patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping treatment with MAOIs as there is a risk of serotonin syndrome (e.g.”

“Dextromethorphan is primarily metabolised by the cytochrome P450 isoenzyme CYP2D6,”

“the possibility of interactions with inhibitors of this enzyme, including amiodarone, haloperidol, propafenone, quinidine, SSRIs, and thioridazine, should be borne in mind.

Dextromethorphan might exhibit additive CNS depressant effects when co-administered with alcohol, antihistamines, psychotropics, and other CNS depressant drugs.”

 

Section 4.6 removed text “Although dextromethorphan has been in widespread use for many years without apparent ill consequence, there is insufficient information on the effects of administration during human pregnancy.”

Added text “There are no adequate and well-controlled studies in pregnant women. Dextromethorphan should not be used during pregnancy or lactation unless the potential benefit of treatment to the mother outweighs the possible risk to the developing foetus or nursing infant.”

Removed text “BENYLIN DRY COUGHS 7.5mg/5ml Syrup should therefore only be used when the potential benefit of treatment to the mother exceeds any possible hazards to the developing foetus or suckling infant”

 

Section 4.8 replaced “Side effects attributed to dextromethorphan are uncommon; occasionally dizziness, nausea, vomiting, or gastro-intestinal disturbance may occur” with “Adverse drug reactions (ADRs) identified during clinical trials and post marketing experience with dextromethorphan are included in the table below by System Organ Class (SOC).

The frequencies are provided according to the following convention:

Very common ≥1/10

Common ≥1/100 and < 1/10

Uncommon ≥1/1,000 and <1/100

Rare ≥1/10,000 and <1/1,000

Very rare <1/10,000, including isolated reports

Not known (cannot be estimated from the available data)

ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as ‘Not known’.

Body System (SOC)

Frequency

Adverse Drug Reaction (Preferred Term)

Immune System Disorders

Not known

Not known

Not known

Not known

Angioedema

Pruritus

Rash

Urticaria

 

Psychiatric Disorders

Not known

Insomnia

Nervous System Disorders

Not known

Not known

 

Not known

Dizziness

Psychomotor hyperactivity

Somnolence

 

Gastrointestinal Disorders

Not known

Not known

Not known

 

Not known

Not known

Abdominal pain

Diarrhoea

Gastrointestinal disturbance

Nausea

Vomiting

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card scheme at: www.mhra.gov.uk/yellowcard

 

Section 4.9 removed text “The effects of acute toxicity from BENYLIN DRY COUGHS

7.5mg/5ml Syrup overdose may include drowsiness, lethargy, nystagmus, ataxia, respiratory depression, nausea, vomiting, hyperactivity”

Added text “Dextromethorphan is thought to be of low toxicity, but the effects in

overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.

Symptoms of overdose may include: mydriasis, nausea and vomiting,

CNS depression, excitation, lethargy, nystagmus, psychomotor hyperactivity, serotonin syndrome, somnolence (drowsiness), dizziness, dysarthria (slurred speech), mental confusion, psychotic disorder (psychosis), and respiratory depression”

Replaced “as a specific antagonist to dextromethorphan toxicity in children” with “o reverse central or peripheral opioid effects of dextromethorphan in children (0.01mg/kg body weight)”

 

Section 5.1 added text “Pharmacotherapeutic Group: Cough Suppressant, Opium alkaloids and derivatives

ATC Code: R05DA09”

 

Section 6.6 removed text “Not applicable” and added text “No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements”

 

Section 7 corrected address to say “Berkshire” rather than “Bershire”

 

Section 10 replaced date with “04 May 2016”

Updated on 08-Jul-2015 and displayed until 11-May-2016

Reasons for adding or updating:

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 30-Jun-2015

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 5.1, 5.2 and 5.3 to update in line with the Core Safety Information and QRD template

Section 10 - Revision text date 30th June 2015

Updated on 19-Jan-2015 and displayed until 08-Jul-2015

Reasons for adding or updating:

  • Change from joint to individual SPC

Date of revision of text on the SPC: 11-Jul-2014

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 1 - name change on the licence.
It was Benylin Dry Coughs (Non-Drowsy) now name change to
Benyling Dry Coughs 7.5mg/5ml Syrup

Updated on 07-Aug-2014 and displayed until 19-Jan-2015

Reasons for adding or updating:

  • Correction of spelling/typing errors
  • Product/presentation discontinued

Date of revision of text on the SPC: 11-Jul-2014

Legal Category:P

Black Triangle (CHM): NO

Updated on 21-Jul-2014 and displayed until 07-Aug-2014

Reasons for adding or updating:

  • Change to section 1 - Name of the medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 11-Jul-2014

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 1, 2, 4.1, 4.2, 4.3, 4.4, 4.6, 4.9  to remove 'Non Drowsy' from the product name

Section 4.7 to add the following text below

' This medicines can impair cognitive function and can affect a patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988.
When taking this medicine, patients should be told:

  • The medicine is likely to affect your ability to drive
  • Do not drive until you know how the medicine affects you
  • It is an offence to drive while under the influence of this medicine
  • However, you would not be committing an offence (called 'statutory defence') if:

                - The medicine has been taken to treat a medical or dental problem and
                - You have taken it according to the information provided with the medicine and
                -    It was not affecting your ability to drive safely,

Details regarding a new driving offence concerning driving after drugs have been taken  in the UK may be found here: https://www.gov.uk/drug-driving-law'

Section 10: date of revision text - 11th July 2014


     

Updated on 21-May-2014 and displayed until 21-Jul-2014

Reasons for adding or updating:

  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 24-Apr-2014

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 4.7 - to add the following the text
'

This medicine can impair cognitive function and can affect a patient’s ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When taking this medicine, patients should be told:

•      The medicine is likely to affect your             ability to drive

•      Do not drive until you know how the             medicine affects you

•      It is an offence to drive while under the        influence of this medicine

•      However, you would not be committing                       an offence (called ‘statutory defence’) if:

             o   The medicine has been taken to                               treat a medical or dental problem and

o   You have taken it according to the information provided with the  medicine and

o   It was not affecting your ability to drive safely.

 

Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here:  https://www.gov.uk/drug-driving-law

In section 10 - revision date text: 24/04/2014

Updated on 17-Mar-2010 and displayed until 21-May-2014

Reasons for adding or updating:

  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 05-Mar-2010

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Change to section 6.5

 

(1) To register an alternative child resistant cap for the currently approved amber glass bottles. The proposed cap is a 2-piece plastic child-resistant cap. The wad material (polyterephthalate ethylene faced aluminium/expanded polyethylene laminated wad) in contact with the product remains unchanged.

(2) To register the removal from the licence of the following pack sizes/packaging: pack size – 30 ml; caps - ROPP aluminium and HDPE plastic; wads fitted in caps - polyester faced wad and polyethylene/expanded polyethylene laminated wad.

Updated on 12-May-2009 and displayed until 17-Mar-2010

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • 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 4.8 - Undesirable Effects

Date of revision of text on the SPC: 04-Apr-2009

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Update to Childrens Cough and Cold medicinal products as requested by the MHRA:

http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/Safetywarningsandmessagesformedicines/CON038908

Updated on 21-Aug-2008 and displayed until 12-May-2009

Reasons for adding or updating:

  • Change to section 6. 5 - Nature and Contents of Container

Date of revision of text on the SPC: 13-Aug-2008

Legal Category:P

Black Triangle (CHM): NO

Updated on 03-Apr-2008 and displayed until 21-Aug-2008

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

Date of revision of text on the SPC: 01-Mar-2008

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to MA as a result of integration

Updated on 12-Jun-2007 and displayed until 03-Apr-2008

Reasons for adding or updating:

  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-Apr-2007

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 10: change to date of revision of text

Updated on 28-Sep-2004 and displayed until 12-Jun-2007

Reasons for adding or updating:

  • Improved Electronic Presentation

Updated on 19-Sep-2002 and displayed until 28-Sep-2004

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text

Updated on 29-Aug-2001 and displayed until 19-Sep-2002

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Company contact details

McNeil Products Ltd

Company image
Address

Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG

Medical Information e-mail
Medical Information Direct Line

01344 864042

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

dextromethorphan hydrobromide

Legal categories

P - Pharmacy

This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Continue