BENYLIN DUAL ACTION DRY - PSEUDOEPHEDRINE/DEXTROMETHORPHAN/TRIPROLIDINE

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
PSEUDOEPHEDRINE HYDROCHLORIDE ; DEXTROMETHORPHAN HYDROBROMIDE ; TRIPROLIDINE HYDROCHLORIDE
Available from:
Johnson & Johnson (Ireland) Limited
ATC code:
R01BA52
INN (International Name):
PSEUDOEPHEDRINE HYDROCHLORIDE ; DEXTROMETHORPHAN HYDROBROMIDE ; TRIPROLIDINE HYDROCHLORIDE
Dosage:
30/10/1.25 Milligram
Pharmaceutical form:
Syrup
Prescription type:
Product not subject to medical prescription
Therapeutic area:
pseudoephedrine, combinations
Authorization status:
Marketed
Authorization number:
PA0823/001/002
Authorization date:
1984-03-15

PACKAGE LEAFLET

Benylin

Dual Action Dry Syrup

Pseudoephedrine 30 mg, Dextromethorphan

10 mg, triprolidine 1.25 mg

Cough & Congestion

■ This medicine is used to help relieve symptoms of cold and flu including irritating dry

cough and related congestion symptoms.

■ This medicine is for use by adults and children aged 12 years and over.

Do not use this medicine:

■ There are some people who should not use this medicine. To find out if you are one

of them See Section 2>

■ If you have ever had a bad reaction to any of the ingredients. For the list of

ingredients See Section 6>

Speak to your doctor:

■ If you suffer from any of the conditions mentioned in Section 2. See Section 2>

■ If you are taking any other medicines. See Section 2>

Follow the dosage instructions carefully. These are shown in the tables. See Section 3>

Now read this whole leaflet carefully before you use this medicine. Keep the leaflet: you

might need it again.

Ask your pharmacist if you need more information or advice. Go to see your doctor if your

symptoms worsen or do not improve after a few days.

1 What the medicine is for

Benylin Dual Action Dry is a medicine which is used to help relieve dry coughs and related

congestion symptoms. The liquid contains triprolidine hydrochloride which is an

antihistamine that helps stop sneezing, runny nose and watery eyes, pseudoephedrine

hydrochloride which is a decongestant that unblocks stuffy noses and dextromethorphan

hydrobromide which is an antitussive to help stop coughing.

The medicine is for use in adults and children aged 12 years and over.

2 Before taking this medicine

This medicine is suitable for most people but a few people should not use it. If you are in any

doubt, talk to your doctor or pharmacist.

X Do not use this medicine…

■ If you have ever had a bad reaction to any of the ingredients.

■ If you have high blood pressure or heart disease.

■ If you are taking beta blockers (used to treat high blood pressure).

■ If you are taking, or have taken in the last two weeks, drugs for depression known as

Monoamine Oxidase Inhibitors (MAOIs).

■ If you are taking drugs for depression such as selective serotonin reuptake inhibitors

(SSRIs) such as fluoxetine, paroxetine and sertraline.

■ If you are taking furazolidone (an antibacterial agent).

■ If you have had a cough for a few weeks, or a cough which brings up any blood or a lot of

mucus that may be caused by asthma or other serious breathing difficulties.

■ If you are taking any other cough and cold medicine.

■ If you have diabetes.

■ If you have an overactive thyroid.

■ If you suffer from, or have had closed angle glaucoma (increased pressure in the eye).

■ If you have phaeochromocytoma (rare tumour which affects your heart rate and blood

pressure).

■ If you have severe kidney problems.

■ For children under 12 years old.

If any of these apply to you, get advice from a doctor or pharmacist without using

Benylin Dual Action Dry.

! Talk to your doctor or pharmacist…

■ If you suffer from liver or kidney problems.

■ If you are susceptible to glaucoma (increased pressure in the eye).

■ If you have difficulty breathing (emphysema) or chronic bronchitis.

■ If you suffer from a chronic or persistent cough, if you have asthma, suffer from asthma

attacks or where cough is accompanied by excessive secretions.

■ If you have prostate problems (difficulty with passing water or needing to pass water

often).

■ If you have blocked arteries or veins (occlusive vascular disease).

■ If you are taking alcohol.

■ If your child is prone to developing certain allergic reactions (e.g. atopic reactions) due to

histamine release (a chemical that is released within the body during an allergic reaction).

■ If you have a history of drug abuse.

■ If you have been told by your doctor that you are a slow metabolizer of CYP2D6.

If you experience the following, stop taking the product immediately and contact your

doctor:

A feverish generalised erythema associated with pustules (see section 4)

■ Tell your doctor or pharmacist if you are taking, have recently taken or might take any

other medicines such as:

■ Sedatives (drugs used to treat anxiety and tension).

■ Certain drugs for depression such as selective serotonin reuptake inhibitors

(SSRIs), which includes fluoxetine, paroxetine and sertraline and norepinephrine-

dopamine reuptake inhibitor (NDRI), which include bupropion and tricyclic

antidepressants (used to treat mood disorders).

■ Moclobemide (used to treat mood disorders).

Cardiac glyclosides (drugs used to control heart rhythms or contractions e.g.

digoxin).

Ergot alkaloids (drugs used to treat migraine such as ergotamine and

methsysergide).

Oxytocin (drug used to help contractions during hildbirth).

Hypnotics (sleeping tablets including barbiturates).

Opioid analgesics (drugs used to relieve pain e.g. codeine, tramadol, morphine,

methadone).

Antipsychotics (drugs used to treat mood disorders e.g. haloperidol, thioridazine,

perphenazine).

Antihistamines (drugs used to treat allergies).

Sympathomimetic drugs (stimulants or appetite suppressants and drugs used to treat

congestion and asthma).

Antihypertensives (drugs used to treat high blood pressure such as guanethidine,

methyldopa, adrenergic neuron blockers, beta blockers, debrisoquine, bretylium and

betanidine).

Anti-arrhythmic agents (drugs used to treat irregular heartbeat such as

amiodarone, propafenone, flecainide and quinidine).

Halogenated anaesthetics agents (such as chloroform, cyclopropane, halothane,

enflurane or isoflurane).

Calcimimetic, (drugs to treat secondary hyperparathyroidism, elevated

parathyroid hormone levels such as cinacalcet).

Anti-fungals (terbinafine).

If you are not sure about any of the medicines you are taking, show the bottle or pack to your

pharmacist.

If any of these bullet points apply to you now or in the past, talk to a doctor or pharmacist.

! If you are pregnant or breast-feeding

■ Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant or

breast-feeding.

! Special warnings about this medicine

■ This medicine may cause drowsiness. If affected, do not operate machinery. Avoid

alcoholic drink.

! If any of the following occur this product should be stopped:

■ Hallucinations.

■ Restlessness.

■ Sleep disturbances.

! Some of the ingredients can cause problems

■ Each 5 ml of this medicine contains 2.8 g of sucrose. This should be taken into account in

patients with diabetes mellitus. If you have been told by your doctor that you have an

intolerance to some sugars, contact your doctor before taking this medicine.

■ This medicine contains 5% v/v ethanol (alcohol), which is up to 190 mg per 5 ml, equal to

5 ml beer or 2 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 and epilepsy.

■ Methyl hydroxybenzoate (E218) may cause allergic reactions such as skin rash; this may

happen after a few days.

■ Sodium benzoate (E211) which may irritate the skin, eyes and mucosal surfaces.

■ The colouring in this medicine may cause allergic reactions. These reactions are more

common in people who are allergic to aspirin.

3 How to take this medicine

Check the tables below to see how much medicine to take.

■ For oral use only.

■ Always shake the bottle thoroughly before use.

■ Do not take more than the stated dose shown in the table.

■ Do not overfill the spoon.

There is a double-ended spoon in the pack.

i Adults and Children over 12 years old

Age

Dose

Adults and children over 12 years old

Take two large 5 ml spoonfuls every 4 - 6

hours, up to 4 times a day

■ Do not take more than 4 doses in 24 hours.

■ Leave at least 4 hours between doses.

■ If symptoms persist talk to your doctor or pharmacist.

! If anyone has too much

If anyone has too much contact your doctor or pharmacist immediately.

! If you forget to take the medicine

If you forget to take a dose, take the next dose when needed provided that the last dose was

taken at least 4 hours ago. Do not take a double dose.

4 Possible side-effects

Like all medicines, this medicine can cause side-effects, although not everybody gets them.

If you experience any of the following, stop taking this medicine and talk to your

doctor:

■ Sudden onset of fever, reddening of the skin, or many small pustules (possible symptoms

of Acute Generalized Exanthematous Pustulosis - AGEP) may occur within the first 2 days of

treatment with this medicine (See section 2).

■ A few people have had hallucinations, delusions and fits.

■ Skin rashes that are sometimes itchy.

■ Allergic reactions including skin rashes (which may be severe and include blistering and

peeling of the skin).

■ Swelling of the face, lips mouth, tongue or throat which may cause difficulty in swallowing

or breathing.

■ A few people may find their heartbeat increased or increased awareness of the heartbeat

(palpitations).

■ Shortness of breath.

■ A few men, especially those with prostate problems, may have trouble passing water.

■ Nausea, vomiting and upset stomach.

■ Restlessness or sleep disturbances.

Very common (may affect more than 1 in 10 people)

Headache.

Common (may affect up to 1 in 10 people)

Difficulty sleeping, nervousness or dizziness.

■ Dry mouth, nausea, upset stomach or thicken mucus.

■ Drowsiness.

■ Blurred vision.

■ Difficulty performing tasks.

■ Paradoxical drug reaction (opposite effect than which would normally be expected).

Rare (may affect up to 1 in 1000 people)

Confusion, depression, tremor.

■ Low blood pressure.

■ Blood disorder.

■ Sleep disorder.

■ Liver problems.

■ Unusual movements (extrapyramidal disorder).

Other effects which may occur but it is unknown how often:

Agitation, irritability, feeling anxious, jittery or feelings of extreme happiness.

Pins and needles.

■ Increased blood pressure.

■ Dry throat or nose bleeds (epistaxis).

■ Stomach pain or discomfort, diarrhoea or vomiting.

■ Fatigue.

■ Pain when passing water.

■ This product may potentiate the effects of alcohol and other central nervous system

depressants.

Reporting of side-effects

If you get any side-effects, talk to your doctor, pharmacist or nurse. This includes any

possible side-effects not listed in this leaflet. You can also report side-effects directly via

HPRA Pharmacovigilance, Earlsfort Terrace, IRL-Dublin 2; Tel: +35316764971; Fax:

+35316762517 Website: www.hpra.ie; Email: medsafety@hpra.ie.

By reporting side-effects you can help provide more information on the safety of the

medicine.

5 Storing this medicine

Do not store this product above 25ºC.

Keep this medicine in the outer carton and do not refrigerate.

Keep this medicine tightly closed in the original container.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label after EXP. The

expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist

how to throw away medicines you no longer use. These measures will help protect the

environment.

6 Further Information

What’s in this medicine?

The active ingredients in 5 ml of Benylin Dual Action Dry are:

Triprolidine hydrochloride 1.25 mg, pseudoephedrine hydrochloride 30 mg and

dextromethorphan hydrobromide 10 mg.

Other ingredients are: Sorbitol, sucrose, sodium benzoate (E211), methyl hydroxybenzoate

(E218), Ponceau 4R (E124), alcohol, blackberry flavour, levomenthol, vanillin and purified

water.

What the medicine looks like

Benylin Dual Action Dry is a clear red liquid available in 100 ml bottles.

The Product Authorisation Holder: McNeil Healthcare (Ireland) Ltd., Airton Road, Tallaght,

Dublin 24, Ireland.

The Manufacturer: Famar Orléans, 5 avenue de Concyr, 45071 Orleans, Cedex 2, France

This leaflet was revised June 2018

Benylin is a registered trade mark.

McNeil Healthcare (Ireland) Ltd. logo

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Benylin Dual Action Dry Syrup

Pseudoephedrine 30mg

Dextromethorphan 10mg

Triprolidine 1.25mg

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5 ml of Benylin Dual Action Dry Syrup contains

Pseudoephedrine Hydrochloride 30 mg

Dextromethorphan Hydrobromide 10 mg

Triprolidine Hydrochloride 1.25 mg

Excipients: contains Sorbitol Solution (70%) 1000.0mg, Sucrose 2835.0mg, sodium Benzoate (E211) 5.0mg, Ponceau

4R (E124) 0.8mg and Ethanol (96% v/v) 201.5mg.

For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Syrup

A clear, bright red, blackberry-flavoured syrup.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

BENYLIN Dual Action Dry Syrup is indicated for the relief of dry cough and upper respiratory tract congestion such as

is associated with the common cold and influenza.

4.2 Posology and method of administration

Posology

Adults and Children 12 years and over:

10 ml every 4-6 hours, up to four times a day

Maximum daily dose: 40ml (80mg dextromethorphan, 240mg pseudoephedrine and 10mg triprolidine).

Children under 12 years:

This medicine is contraindicated in children under the age of 12 years. [See section 4.3]

Use in the elderly

There have been no specific studies of Benylin Dual Action Dry Syrup in the elderly. Experience has indicated that

normal adult dosage is appropriate.

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Hepatic Dysfunction

Caution should be exercised when administering Benylin Dual Action Dry Syrup to patients with severe hepatic

impairment.

Renal Dysfunction

Caution should be exercised when administering Benylin Dual Action Dry Syrup to patients with moderate to severe

renal impairment

Method of administration

For oral use.

Do not exceed the stated dose.

4.3 Contraindications

Benylin Dual Action Dry Syrup is contraindicated in individuals with hypersensitivity to dextromethorphan,

pseudoephedrine, triprolidine or to any of the excipients listed in section 6.1.

Benylin Dual Action Dry Syrup is contraindicated in patients who are receiving monoamine oxidase inhibitors or who

have received these within the previous 14 days. There is a risk of serotonin syndrome with dextromethorphan and the

concomitant use of pseudoephedrine and MAOIs may cause a rise in blood pressure or hypertensive crisis (see section

4.5)

Benylin Dual Action Dry Syrup is contraindicated in individuals who are concomitantly taking other sympathomimetic

decongestants.

Benylin Dual Action Dry Syrup is contraindicated in individuals who have diabetes mellitus, phaeochromocytoma,

hyperthyroidism, closed angle glaucoma or severe renal impairment.

Benylin Dual Action Dry Syrup is contraindicated in patients with cardiovascular disease including hypertension and in

those who are taking beta-blockers (see section 4.5).

This product is contraindicated in patients taking selective serotonin reuptake inhibitors. (SSRIs, see section 4.5).

The antibacterial agent, furazolidone, is known to cause a dose-related inhibition of monoamine oxidase.

Therefore

Benylin Dual Action Dry Syrup should not be administered concurrently with furazolidone.

Benylin Dual Action Dry Syrup is contraindicated in patients at risk of developing respiratory failure.

Benylin Dual Action Dry Syrup is contraindicated in children under the age of 12 years.

4.4 Special warnings and precautions for use

Benylin Dual Action Dry Syrup may cause drowsiness. This product should not be used to sedate a child.

If any of the following occur, this product should be stopped:

Hallucinations

Restlessness

Sleep disturbances

Severe Skin reactions

Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) may occur with pseudoephedrine-

containing products. This acute pustular eruption may occur within the first 2 days of treatment, with fever, and

numerous, small, mostly non-follicular pustules arising on a widespread oedematous erythema and mainly localized on

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the skin folds, trunk, and upper extremities. Patients should be carefully monitored. If signs and symptoms such as

pyrexia, erythema, or many small pustules are observed, administration of this medicine should be discontinued and

appropriate measures taken if needed.

Patients with the following conditions should be advised to consult a physician before using this product:

Susceptibility to angle-closure

Urinary retention or prostatic enlargement,

A respiratory condition such as emphysema, chronic bronchitis, or acute or chronic bronchial asthma.

Although pseudoephedrine has virtually no pressor effects in normotensive patients, Benylin Dual Action Dry Syrup

should be used with caution in patients taking tricyclic antidepressants, or other sympathomimetic agents (such as

appetite suppressants and amphetamine-like psychostimulants). The physician or pharmacist should check that

sympathomimetic containing preparations are not simultaneously administered by several routes i.e. orally and

topically (nasal, aural and eye preparations).

Pseudoephedrine may act as a cerebral stimulant giving rise to insomnia, nervousness, hyperpyrexia, tremor and

epileptiform convulsions.

Triprolidine may enhance the sedative effects of central nervous system depressants including alcohol, sedatives and

tranquilisers.

Use of dextromethorphan with alcohol or other CNS depressants may increase the effects on the CNS and cause

toxicity in relatively smaller doses.

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).

While taking this product, patients should be advised to avoid alcoholic drinks and consult a healthcare professional

prior to taking with central nervous system depressants.

Benylin Dual Action Dry Syrup should only be used under medical supervision for persistent or chronic cough such as

occurs with smoking, asthma or emphysema, or where cough is accompanied by excessive secretions.

If symptoms persist or get worse, stop use and 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.

Use with caution in moderate to severe renal impairment or in hepatic impairment.

Use with caution in occlusive vascular disease.

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

This medicine contains 5% v/v ethanol (alcohol), which is up to 190 mg per ml, equal to 5ml beer or 2ml wine per 5

ml. This can be harmful for those suffering from alcoholism. The ethanol content should be taken into account in

pregnant or breastfeeding women, children and high-risk groups such as patients with liver disease and epilepsy.

Methyl hydroxybenzoate (E218) may cause allergic reactions such as skin rash; this may happen after a few days.

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The colouring in this medicine may cause allergic reactions.

Each 5ml of this medicine contains 2.8 g of sucrose per dose. This should be taken into account in patients with

diabetes mellitus.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase

insufficiency should not take this medicine.

Not more than 4 doses should be given in any 24 hours. Do not exceed the stated dose.

Do not take with any other cough and cold medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Triprolidine may enhance the sedative effects of alcohol and other central nervous system depressants including

barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives and antipsychotics.

Concomitant use with sympathomimetic agents such as decongestants, tricyclic antidepressants, appetite suppressants and

amfetamine-like psychostimulants, may cause a rise in blood pressure.

Pseudoephedrine exerts its vasoconstricting properties by stimulating adrenergic receptors and displacing noradrenaline

from neuronal storage sites. Since MAOIs impede the metabolism of sympathomimetic amines and increase the store

of releasable noradrenaline in adrenergic nerve endings, MAOIs may potentiate the pressor effect of pseudoephedrine.

MAOIs and/or RIMAs: Benylin Dual Action Dry Syrup should not to be given to patients treated with MAOIs or

within 14 days of stopping treatment as there is a risk of hypertensive crisis and serotonin syndrome (pyrexia,

hypertension, arrhythmias).

Moclobemide: risk of hypertensive crisis.

Because of its pseudoephedrine content, the product may partially reverse the hypotensive action of antihypertensive drugs

which interfere with sympathetic activity including bretylium, betanidine, guanethidine, debrisoquine, methyldopa,

adrenergic neurone blockers and beta-blockers.

Furazolidone causes a dose-related inhibition of monoamine oxidase. Although there are no reports to date of hypertensive

crisis caused by concurrent use with this product, the combination should be avoided.

Oxytocin: risk of hypertension.

Cardiac glycosides: increased risk of dysrhythmias.

Ergot alkaloids (ergotamine & methysergide): increased risk of ergotism.

Anticholinergic drugs: enhances effects of anticholinergic drugs (such as tricyclic antidepressants and atropine).

Concurrent use with halogenated anaesthetic agents such as chloroform, cyclopropane, halothane, enflurane or

isoflurane may provoke or worsen ventricular arrhythmias.

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

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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.

4.6 Fertility, pregnancy and lactation

This product should not be used during pregnancy or lactation unless the potential benefit of treatment to the mother

outweighs the possible risks to the developing foetus or nursing infant.

Fertility

There is no experience of the effect of Benylin Dual Action Dry Syrup on human fertility.

Pregnancy

There are no adequate and well controlled studies available on the effects of administration of this product in pregnant

women.

Breastfeeding

Pseudoephedrine distributes into and is concentrated in breast milk. In a limited study, three mothers nursing healthy

infants were given an antihistamine-decongestant preparation containing 60mg of pseudoephedrine and 2.5 mg of

triprolidine. Milk concentrations of pseudoephedrine were higher than plasma levels in all three patients, with peak milk

concentrations occurring at 1.0-1.5 hours. The investigators calculated that 1000ml of milk produced during 24 hours

would contain approximately 0.5%-0.7% of the maternal dose. However, following a single-blind, crossover study of a

single dose of pseudoephedrine 60mg vs. placebo conducted in 8 lactating mothers, and assuming maternal intake of 60mg

pseudoephedrine hydrochloride four times daily, the estimated infant dose of pseudoephedrine based on AUC and an

estimated milk production rate of 150 ml/kg/day was 4.3% (95% CI, 3.2, 5.4%; range 2.2 to 6.7%) of the weight-adjusted

maternal dose.

Triprolidine is excreted in breast milk, it has been estimated that approximately 0.06 to 0.2% of a single 2.5 mg dose of

triprolidine ingested by a nursing mother will be excreted in the breast-milk over 24 hours.

It is not known whether dextromethorphan or its metabolites are excreted in breast milk.

4.7 Effects on ability to drive and use machines

The product may act as a cerebral stimulant in children, and occasionally in adults.

Central nervous system depression

or excitation may occur, with symptoms such as drowsiness, sleep disturbance and more rarely, hallucinations.

Patients

receiving it should not drive or operate machinery unless it has been shown that their physical and mental ability remains

unaffected.

4.8 Undesirable effects

Placebo controlled studies with sufficient adverse event data were not available for the combination of

dextromethorphan, pseudoephedrine and triprolidine.

Adverse drug reactions identified during clinical trials and post-marketing experience with dextromethorphan,

pseudoephedrine or the combination of pseudoephedrine and triprolidine or the combination of dextromethorphan and

pseudoephedrine are listed below by System Organ Class (SOC).

The frequencies are defined in accordance with current guidance, as:

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

Not known

(cannot be estimated from the available data)

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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 is listed as ‘Not known’.

System Organ

Class (SOC)

Frequency

Adverse Drug Reaction

(Preferred Term)

Blood and

Lymphatic

System

Disorders

Rare

Blood disorder

Immune System

Disorders

Not known

Rare

Drug hypersensitivity

Hypersensitivity – cross-

sensitivity may occur with other

sympathomimetics

Psychiatric

Disorders

Common

Common

Rare

Rare

Rare

Not known

Not known

Not Known

Not known

Not known

Not known

Not known

Insomnia

Nervousness

Confusional state

Depression

Sleep disorder

Agitation

Anxiety

Delusion

Euphoric mood

Hallucination

Irritability

Restlessness

Nervous System

Disorders

Very Common

Common

Common

Common

Common

Rare

Rare

Rare

Not known

Headache

Dizziness

Paradoxical drug reaction

Psychomotor hyperactivity

Somnolence

Convulsion

Extrapyramidal disorder

Tremor

Paraesthesia

Eye Disorders

Common

Vision blurred

Cardiac

Disorders

Rare

Rare

Not known

Arrhythmia

Palpitations

Tachycardia

Vascular

Disorders

Rare

Not known

Hypotension

Hypertension

Respiratory,

Thoracic and

Mediastinal

Disorders

Common

Not known

Not known

Not known

Not known

Not known

Increased viscosity of bronchial

secretion

Dry Throat

Dyspnoea

Epistaxis

Nasal dryness

Respiratory Depression

Gastrointestinal

Disorders

Common

Common

Common

Dry mouth

Gastrointestinal disorder

Nausea

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*in male patients in whom prostatic enlargement could have been an important predisposing factor.

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.

4.9 Overdose

Symptoms and Signs:

The effects of acute toxicity from Benylin Dual Action Dry Syrup may include drowsiness, lethargy, dizziness, ataxia,

nystagmus, weakness, hypotonicity, respiratory depression, dryness of the skin and mucous membranes, tachycardia,

hypertension, hyperpyrexia, hyperactivity, irritability, convulsions, difficulty with micturition, nausea and vomiting.

Dextromethorphan

It is thought to be of low toxicity, but the effects in overdosage will be potentiated by simultaneous ingestion of alcohol

and psychotropic drugs.

Symptoms: These include nausea, vomiting, dizziness and dysarthria (slurred speech).

Overdose may also result in mydriasis, CNS depression, CNS excitation, nystagmus, somnolence (drowsiness) , mental

confusion, psychotic disorder (psychosis), serotonin syndrome and respiratory depression

Pseudoephedrine

Overdosage may result in:

Metabolism and nutrition disorders: hyperglycaemia, hypokalaemia.

Psychiatric disorders: CNS stimulation, insomnia; irritability, restlessness, anxiety, agitation; confusion, delirium,

hallucinations, psychoses.

Nervous system disorders: convulsions, tremor, intracranial haemorrhage including intracerebral haemorrhage,

drowsiness in children.

Eye disorders: mydriasis.

Not Known

Not Known

Not Known

Abdominal pain

Diarrhoea

Vomiting

Hepatobiliary

Disorders

Rare

Liver disorder

Skin and

Subcutaneous

Tissue Disorders

Not Known

Not Known

Not Known

Not Known

Not Known

Angioedema

Pruritus

Rash

Severe skin reactions, including

acute generalised exanthematous

pustulosis (AGEP)

Urticaria

Renal and Urinary

Disorders

Common

Not Known

Urinary retention*

Dysuria

General Disorders

and Administration

Site Conditions

Not Known

Not Known

Fatigue

Feeling Jittery

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Cardiac disorders: palpitations, tachycardia, reflex bradycardia, supraventricular and ventricular arrhythmias,

dysrhythmias, myocardial infarction.

Vascular disorders: hypertension, hypertensive crisis.

Gastrointestinal disorders: nausea, vomiting, ischaemic bowel infarction.

Musculoskeletal and connective tissue disorders: rhabdomyolysis.

Renal and urinary disorders: acute renal failure, difficulty in micturition

Triprolidine

Overdosage of an H1 receptor antagonist may result in CNS depression, hyperthermia, anticholinergic syndrome

(mydriasis, flushing, fever, dry mouth, urinary retention, decreased bowel sounds), tachycardia, hypotension,

hypertension, nausea, vomiting, agitation, confusion, hallucinations, psychosis, seizures, or dysrhythmias.

Rhabdomyolysis and renal failure may rarely develop in patients with prolonged agitation, coma, or seizures

Management

Treatment of overdose should be symptomatic and supportive:

Necessary measures should be taken to maintain and

support respiration and control convulsions.

Gastric lavage should be performed up to 3 hours after ingestion, if indicated.

Catheterisation of the bladder may be necessary.

If desired, the elimination of pseudoephedrine can be accelerated by acid

diuresis or by dialysis.

Naloxone has been used successfully to reverse central or peripheral opioid effects of dextromethorphan in childrsn

(0.01 mg/kg body weight).

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pseudoephedrine has a direct and indirect sympathomimetic activity and is an orally effective upper respiratory

decongestant.

Pseudoephedrine is substantially less potent than ephedrine in producing both tachycardia and elevation

of systolic blood pressure and considerably less potent in causing stimulation of the central nervous system.

Pseudoephedrine produces its decongestant effect within 30 minutes, persisting for at least 4 hours.

Dextromethorphan has an antitussive action.

It controls coughs by depressing the medullary cough centre. A single

oral dose of 10 - 20 mg dextromethorphan produces its antitussive action within 1 hour and lasts for at least 4 hours.

Triprolidine provides antihistamine activity by antagonising H

-receptors.

After oral administration of a single dose of

2.5 mg triprolidine to adults the onset of action, as determined by the ability to antagonise histamine-induced weals and

flares in the skin, is within 1 to 2 hours.

Peak effects occur at about 3 hours and, although activity declines thereafter,

significant inhibition of histamine-induced weals and flares still occurs 8 hours after the dose.

5.2 Pharmacokinetic properties

After the administration of 2.5 mg triprolidine hydrochloride and 60 mg pseudoephedrine hydrochloride to healthy

adult volunteers, the peak plasma concentration (C

) of triprolidine is approximately 5.5 ng/ml - 6.0 ng/ml occurring

at about 1.5 - 2.0 hours (T

) after drug administration.

Its plasma half-life is approximately 3.2 hours.

The C

pseudoephedrine is approximately 180 ng/ml with T

approximately 1.5 - 2.0 hours after drug administration.

plasma half-life is approximately 5.5 hours (urine pH maintained between 5.0 - 7.0).

The plasma half-life of

pseudoephedrine is increased in subjects with alkaline urine and decreased in subjects with acid urine.

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

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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.

5.3 Preclinical safety data

It has been estimated that 0.5 to 0.7% of a single dose of pseudoephedrine ingested by a mother will be excreted in the

breast milk over 24 hours.

In rats and rabbits, systemic administration of triprolidine up to 75 times the human daily dosage did not produce

teratogenic effects.

Systemic administration of pseudoephedrine up to 50 times the human daily dosage in rats, and up to 35 times the human

daily dosage in rabbits did not produce teratogenic effects.

There is insufficient information available to determine whether dextromethorphan has teratogenic potential.

No studies have been conducted in animals to determine whether pseudoephedrine, dextromethorphan or triprolidine have

the potential to impair fertility.

The active ingredients of BENYLIN Dual Action Dry Syrup are well-known constituents of medicinal products and their

safety profiles are well documented.

The results of pre-clinical studies do not add anything of relevance for therapeutic

purposes.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sorbitol solution (70%)

Sucrose

Sodium benzoate (E211)

Methyl parahydroxybenzoate (E218)

Ponceau 4R (E124)

Ethanol

Blackberry flavour

Levomenthol

Vanillin

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25°C.

Do not refrigerate.

Keep the bottle in the outer carton.

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6.5 Nature and contents of container

Benylin Dual Action Dry Syrup is stored in 30ml, 40ml, 50ml, 100ml and 200ml amber glass bottles closed with metal

roll-on closures or HDPE screw caps fitted with saran - or steran (PVDC)-faced wads.

Alternatively the product is available in amber glass bottles with a three piece plastic child resistant tamper evident

closure fitted with a polyvinylidine chloride (PVDC) faced wad or polyethylene expanded polyethylene laminated wad.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from

such medicinal product and other handling of the product

No special requirements.

7 MARKETING AUTHORISATION HOLDER

McNeil Healthcare (Ireland) Ltd.

Airton Road

Tallaght

Dublin 24

Ireland

8 MARKETING AUTHORISATION NUMBER

PA0823/001/002

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation:

March 1984

Date of last renewal:

March 2009

10 DATE OF REVISION OF THE TEXT

July 2018

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