BENYLIN Non-Drowsy Dry Coughs, Syrup
*Company:
KenvueStatus:
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 29 April 2024
File name
ie-pil-benylin-non-drowsy-dry-coughs-2441.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 29 April 2024
File name
ie-spc v16 Benylin Non-Drowsy Dry Coughs-2441.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 14 March 2022
File name
ie-pl-benylin-nd-dry-2099.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - excipient warnings
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 6 - what the product contains
Updated on 14 March 2022
File name
ie-spc v15-Benylin Non-Drowsy Dry Coughs-2099.pdf
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 4.6 - Pregnancy and lactation
- Change to section 4.9 - Overdose
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 23 October 2020
File name
ie-pl-benylin-nd-dry-2058.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.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 .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_.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_.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
- New SPC for new product
Legal category:Supply through pharmacy only
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
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 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
|
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
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
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
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
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
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
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