BENYLIN Non-Drowsy Dry Coughs, Syrup *

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 October 2020

File name

ie-pl-benylin-nd-dry-2058_1603466517.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 19 November 2019

File name

ie pl benylin non drowsy dry coughs 1991_1574166744.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 3 - overdose, missed or forgotten doses
  • Change to section 6 - date of revision

Updated on 19 November 2019

File name

ie-spc v14 Benylin Non-Drowsy Dry Coughs 1911 _1574166556.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 03 October 2018

File name

ie- PIL Benylin Non-Drowsy Dry Coughs 1822__1538548584.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 03 October 2018

File name

ie-spc v13 Benylin Non-Drowsy Dry Coughs 1822__1538548645.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 15 May 2018

File name

spc.docx

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - 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 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 08 May 2018

File name

ie-pl Benylin ND Dry Coughs April 2018.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • 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 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 13 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

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

4.4 Special warnings and special

precautions for use

Use with caution in patients with hepatic

dysfunction.

Benylin Non Drowsy for Dry Coughs should

only be used under medical supervisions for

persistent or chronic cough such as occurs

with smoking, asthma or emphysema, or

where cough is accompanied by excessive

secretions.

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.

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).

Patients with rare hereditary problems of

fructose intolerance, glucose-galactose

malabsorption or sucrose-isomaltase

insufficiency should not take this product.

If symptoms persist, please consult your

doctor.

Patients who are taking other medication and

/ or under the care of a physician, should

consult their doctor / pharmacist before

taking this product.

Do not exceed the recommended dose

schedule

4.5 Interaction with other medicaments

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.

Dextromethorphan is primarily metabolised

by the cytochrome P450 isoenzyme

CYP2D6, an interaction with quinidine

(CYP2D6 inhibitor) leading to increased

dextromethorphan plasma concentrations has

been described.

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.

5.2. Pharmacokinetics

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 firstpass

(presystemic 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. 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-hydroxymorphinan

via CYP2D6.

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-Nmethylmorphinan),

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.

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

 
23 December 2016









z

Updated on 13 January 2017

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 09 January 2017

File name

PIL_9515_65.pdf

Reasons for updating

  • New PIL for new product

Updated on 09 January 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 26 August 2016

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic 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

Added text has been highlighted in red:

 

5.1 Pharmacodynamics

 

Pharmacotherapeutic group: Cough suppressant

ATC code: R05DA09

Dextromethorphan is the dextrorotatory isomer of 3-methoxy-N-methyl-morphinan. It is a synthetic morphine derivative that, in contrast to its levoisomer, has no significant analgesic, respiratory depressant or physical dependency properties at recommended doses.

Dextromethorphan is a cough suppressant and acts centrally on the cough centre in the medulla oblongata to elevate the threshold for coughing.

The onset of antitussive effects are realised within 15 to 30 minutes of oral administration, lasting for approximately 3 to 6 hours.

The major metabolite of dextromethorphan, dextrorphan, binds with high affinity to σ-receptors to produce its antitussive activity without exhibiting the classic opiate effects that occur from binding into μ- and

 

δ-receptors. Dextrorphan also exhibits binding activity at serotonergic receptors and was shown to enhance serotonin activity by inhibiting the reuptake of serotonin.

Updated on 07 August 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Added to 4.8:

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail:medsafety@hpra.ie.

Updated on 21 July 2015

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 25 March 2014

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

Section 4.3:

Added:

Concurrent use with monoamine oxidase inhibitors (MAOIs), or within 14 days after such treatment (see section 4.5). Benylin Non Drowsy for Dry Cough is contraindicated for children for use in children under 12 years of age.

Section 4.5:

All text replaced with:

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. 

Dextromethorphan is primarily metabolised by the cytochrome P450 isoenzyme CYP2D6, an interaction with quinidine (CYP2D6 inhibitor) leading to increased dextromethorphan plasma concentrations has been described.

'Fertility' added to title of section 4.6.

Section 4.8:

Re-formatted to MedRa format plus additional side effct added:

Post-marketing Data:

Adverse drug reactions (ADRs) identified during post-marketing experience with Dextromethorphan are included in table below. The frequencies are provided according to the following convention:

 

Very common              ³1/10

Common                      ³1/100 and < 1/10

Uncommon                  ³1/1,000 and <1/100

Rare                             ³1/10,000, <1/1,000

Very rare                     <1/10,000

Not known                  (cannot be estimated from the available data)

 

 

Adverse Drug Reactions Identified During Post-Marketing Experience with Dextromethorphan  Frequency Category Estimated from Clinical Trials or Epidemiology Studies

SOC

Frequency category

Adverse Event Preferred Term

 

 

Gastrointestinal Disorders

 

Not known

Abdominal pain

Not known

Diarrhoea

Not known

Nausea

Not known

Vomiting

 

 

Immune System Disorders

 

Not known

Angioedema

Not known

Pruritus

Not known

Rash

Not known

Urticaria

 

 

Nervous System Disorders

 

Not known

Dizziness

Not known

Psychomotor hyperactivity

Not known

Somnolence

 

 

Psychiatric Disorders

 

Not known

Insomnia

 

In rare instances the following adverse events may occur: confusion, bronchoconstriction and dyspnoea.

Section 4.9:

Symptoms of overdose added:

Symptoms of overdose may include:
Eye Disorders
-                      Mydriasis
Nervous System Disorders
-                      CNS depression
-                      CNS excitation
-                      Nystagmus
-                      Serotonin syndrome
Respiratory, Thoracic and Mediastinal Disorders
-         Respiratory depression



Section 5.1, 5.2 and 5.3: Detail added.

Updated on 24 March 2014

Reasons for updating

  • Change to side-effects

Updated on 25 July 2011

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Changed Section 10 - Date of Revision of the Text to November 2010

Updated on 21 July 2011

Reasons for updating

  • Change due to user-testing of patient information

Updated on 13 December 2010

Reasons for updating

  • 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

To update section 4.4 of the SPC to include a warning for patients diabetes mellitus and hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency.

Updated on 08 October 2010

Reasons for updating

  • Change to product name
  • Change to section 6.4 - Special precautions for storage

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Produce namt changed to Benylin Non Drowsy Dry Coughs Syrup, Dextromethorphan hydrobromide 7.5mg/5ml.

Inclusion of a storage condition Keep the bottle tightly closed in order to protect from light and moisture.

Updated on 01 October 2010

Reasons for updating

  • Change due to user-testing of patient information

Updated on 21 September 2009

Reasons for updating

  • Change to dosage and administration

Updated on 15 September 2009

Reasons for updating

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

Section 4.2:

Indication for use in children under 12 removed.

Section 4.3:

Contraindication not to use in children under 12 added.

Section 10:

Changed to June 2009

Updated on 13 November 2008

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

Addition of HDPE plastic cap with PE-Alu-PET wad material.

Updated on 19 May 2008

Reasons for updating

  • Change to marketing authorisation holder

Updated on 11 March 2008

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

Change to the name of the MAH from Pfizer Consumer Healthcare, Pottery Road Dun Laoghaire, Co. Dublin to McNeil Healthcare (Ireland) Limited, Airton Road, Tallaght, Dublin 24

Updated on 30 March 2005

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Supply through pharmacy only

Updated on 30 March 2005

Reasons for updating

  • New PIL for medicines.ie

Updated on 19 August 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only