Boots Pharmaceuticals Dry Cough & Congestion Relief Oral Solution Dextromethorphan Hydrobromide 10 mg/5 mlPseudoephedrine Hydroc

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Dextromethorphan hydrobromide; Pseudoephedrine hydrochloride
Available from:
The Boots Company Plc
ATC code:
R05DA; R05DA20
INN (International Name):
Dextromethorphan hydrobromide; Pseudoephedrine hydrochloride
Dosage:
10 / 30 mg/5ml
Pharmaceutical form:
Oral solution
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Opium alkaloids and derivatives; combinations
Authorization status:
Not marketed
Authorization number:
PA0004/053/001
Authorization date:
1999-11-26

Information for the user

Dry Cough & Congestion Relief Oral Solution

Dextromethorphan Hydrobromide 10 mg/5 ml, Pseudoephedrine

Hydrochloride 30 mg/5 ml

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat minor conditions.

However, you still need to take it carefully to get the best results from it.

Keep this leaflet, you may need to read it again

Ask your pharmacist if you need more information or advice

What this medicine is for

This medicine contains Dextromethorphan, a cough suppressant, which acts to reduce coughing. It

also contains Pseudoephedrine, a decongestant, which acts to relieve a blocked nose.

It can be used to relieve symptoms of dry and tickly coughs, blocked sinuses and catarrh. Dry coughs

do not produce phlegm or mucus on the chest.

For children, simple treatments should be tried first before you give this medicine. Further

information on “Treating coughs and colds in children” is provided at the end of this leaflet.

Before you take this medicine

This medicine can be taken by adults and children of 6 years and over. However, some people should

not take this medicine or should seek the advice of their pharmacist or doctor first.

Do not take:

If you are allergic to any of the ingredients in this medicine (see “What is in this medicine”)

If you are allergic to other decongestants

If you have severe kidney problems

If you have heart or blood vessel disease

If you have high blood pressure (including that due to a tumour near your kidney)

If you have diabetes

If you have an overactive thyroid

If you have raised pressure in the eye (glaucoma)

If you have difficulty breathing

If you have a long-term cough or one which produces lots of phlegm

If you are having an asthma attack

If you have difficulty in passing urine

If you are taking any of these medicines:

Monoamine oxidase inhibitors or moclobemide (for depression), or have taken them in the

last 14 days

Medicines which may cause a dry mouth (e.g. tricyclic antidepressants)

Medicines to reduce your appetite or stimulant medicines

Selective serotonin reuptake inhibitors (for depression)

Medicines called beta-blockers (normally for heart problems)

Other decongestants or medicines containing Pseudoephedrine

Other cough and cold medicines

If you have an intolerance to some sugars, unless your doctor tells you to (this medicine

contains sucrose)

If you are a man with prostate problems

If you are pregnant or breastfeeding

! Talk to your pharmacist or doctor:

If you have other kidney problems (see “Do not take”)

If you have liver problems or angina

If you are treating a child who is prone to allergies

If you are taking any other medicines or are under the care of a doctor (see “If you take other

medicines)

If you intend to treat a child of 6 to 11 years

If you are on a low salt (sodium) diet (each 5 ml spoonful contains 14.78 mg of sodium, which

may be harmful to you)

If you are dependent on alcohol or have epilepsy (this medicine contains alcohol, which may be

harmful to you)

If you develop a feverish generalised erythema associated with pustules, stop taking this medicine

and contact your doctor or seek medical attention immediately. See section 'Possible side effects'.

Sudden abdominal pain or rectal bleeding may occur with this medicine, due to inflammation

of the colon (ischaemic colitis). If you develop these gastro-intestinal symptoms, stop taking

this medicine and contact your doctor or seek medical attention immediately. See 'Possible

side effects' section.

Other important information

If you are going into hospital for an operation tell the doctor that you are taking this medicine.

Driving and using machines: This medicine may make you feel dizzy or drowsy. Do not drive or use

machines until you are sure you are not affected.

Do not drink alcohol (e.g. wine, beer, spirits) whilst taking this medicine. Alcohol increases the risk

of side effects occurring and may make you feel more drowsy.

Information for people with diabetes: Each 5 ml spoonful contains 2.65 g of sucrose.

Information about some of the ingredients in this medicine: Each 5 ml spoonful contains 77.76 mg

alcohol (ethanol) equivalent to 2 ml of beer or 0.8 ml of wine.

If you take other medicines

! This medicine contains Pseudoephedrine. Do not take with any other products that contain this

ingredient.

Before you take this medicine, make sure that you tell your pharmacist about ANY other medicines

you might be using at the same time, particularly the following:

Medicines to treat high blood pressure

Medicines for heart problems (e.g. digoxin)

Ergot alkaloids (for migraine)

Oxytocin (to induce labour and stop excessive bleeding after the birth)

Medicines for allergies

Sedatives or other medicines that make you feel sleepy

Medicines for mental health conditions

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes

medicines prescribed by your doctor and medicine you have bought for yourself, including herbal

and homeopathic remedies.

How to take this medicine

Check the seal is not broken before first use. If it is, do not take the medicine.

Use the measuring spoon provided (the big end measures 5 ml).

Age

How much to take

How often to take

Adults and children of 12 years

and over

Two 5 ml spoonfuls

3 times a day

Children of 6 to 11 years

One 5 ml spoonful

3 times a day

This medicine should be swallowed. (For oral use).

Do not give to children under 6 years.

Do not take more than the amount recommended above.

Do not give this medicine to a child for more than 5 days, unless their doctor tells you to.

If you are treating a child and their symptoms worsen at any time, talk to a pharmacist or doctor.

If symptoms do not go away talk to your doctor.

! If you take too much: Talk to a doctor straight away.

Possible side effects

Most people will not have problems, but some may get some.

! If you get any of these serious side effects, stop taking this medicine. See a doctor at once:

Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)

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. Stop using Dry Cough and Congestion Relief Oral Solution if you

develop these symptoms and contact your doctor or seek medical attention immediately. See

section ‘Before you take this medicine’.

Frequency not known:

Inflammation of the colon due to insufficient blood supply (ischaemic colitis)

! If you get any of these side effects, stop taking this medicine:

Hallucinations

Restlessness

Sleep disturbances

If you get any of the following side effects see your pharmacist or doctor:

Other allergic reactions such as skin rash

Feeling sick, being sick, diarrhoea

Feeling drowsy, dizzy, excited, confused or nervous

Headache, anxiety, feelings of paranoia, irritability, fits, tremors, difficulty sleeping

Fast, slow or irregular heart beat, palpitations and very rarely chest pain

High blood pressure

A very high temperature

Breathing problems

Difficulty in passing urine

Very rarely bowel problems

If any side effect becomes severe, or you notice any side effect not listed here, please tell your

pharmacist or doctor.

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: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie;

E-mail: medsafety@hpra.ie.

By reporting side effects you can help provide more information on the safety of this medicine.

How to store this medicine

This medicine does not require any special storage conditions. Keep this medicine in a safe place out

of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton or on the label edge. After this date return any unused

product to your nearest pharmacy for safe disposal.

What is in this medicine

Each 5 ml of oral solution contains Dextromethorphan Hydrobromide 10 mg, Pseudoephedrine

Hydrochloride 30 mg, which are the active ingredients.

As well as the active ingredients, the solution also contains liquid sugar (containing sucrose) ,

glycerol (E422), purified water, ethanol 96% (alcohol), sodium citrate, citric acid monohydrate,

hydroxyethylcellulose, sodium saccharin, domiphen bromide, quinoline yellow (E104), flavours

(peardrop, peach, levomenthol).

The pack contains 120 ml of clear yellow syrupy liquid.

Who makes this medicine

Manufactured by BCM Ltd Nottingham NG2 3AA UK for the MAH: The Boots Company PLC

Nottingham NG2 3AA, UK

Leaflet prepared June 2019

If you would like any further information about this medicine, please contact The Boots Company

PLC Nottingham NG2 3AA, UK

Treating coughs and colds in children

It’s normal for children to get 8 or more colds in a year, however gradually they build up immunity

and get fewer colds. Most colds will get better within a few days and you may not need to do more

than keep your child comfortable until they get over it. Antibiotics will not help to treat a cold as

they are caused by viruses and not bacteria.

Follow these simple steps, which may help your child overcome their cough or cold:

1. If your child is hot or has a fever: Increase the amount of fluid your child normally drinks. Lower

their temperature with a Paracetamol or Ibuprofen medicine, which is suitable for children.

(Paracetamol is not suitable for children under 2 months. Ibuprofen is not suitable for children under

3 months).

Your pharmacist will be able to help you find a suitable product if in doubt.

2. For coughs: Although it may be distressing to hear your child cough, the coughing itself serves an

important purpose. It helps clear phlegm on the chest or mucus from the nose. Give your child

plenty of lukewarm clear fluids to drink, which may help loosen the phlegm and relax the airways.

3. To help with breathing: Plain saline nose drops, available from your pharmacy, can help babies

with blocked noses who are having trouble feeding.

Other formats

To request a copy of this leaflet in Braille, large print or audio please call:

1890 708091

(ROI only)

and ask for Boots Medical Information

Please be ready to give the following information:

Product Name: Boots Pharmaceuticals Dry Cough & Congestion Relief Oral Solution

Reference Number: 4/53/1

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Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Boots Pharmaceuticals Dry Cough & Congestion Relief Oral Solution Dextromethorphan Hydrobromide 10 mg/5 ml

Pseudoephedrine Hydrochloride 30 mg/5 ml

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredients

per 5 ml

Pseudoephedrine hydrochloride

30 mg

Dextromethorphan hydrobromide

10 mg

Excipients: also contains 2.65g sucrose per 5ml, 77.76mg ethanol 96% per 5ml and 14.78mg sodium per 5ml.

For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Oral Solution

A clear, yellow, viscous liquid.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

For the relief of dry, tickly coughs and the symptoms of nasal congestion associated with blocked sinuses and catarrh.

For children aged 6 to 12 years: For the relief of dry, tickly coughs and the symptoms of nasal congestion associated with

blocked sinuses and catarrh when simple measures have failed.

4.2 Posology and method of administration

For oral administration.

Adults and children 12 years and over: Two 5ml spoonfuls to be taken three times a day.

Elderly: The normal adult dose is appropriate in the elderly.

Children 6-12 years: One 5ml spoonful to be taken three times a day.

This medicine is contraindicated in children under 6 years of age (See section 4.3)

Children of 6-12 years of age: Not to be used for more than 5 days without the advice of a doctor. Parents and carers should

seek medical attention if the child's condition deteriorates during treatment.

Warning: Do not exceed the stated dose.

Keep out of the sight and reach of children.

4.3 Contraindications

Hypersensitivity to the active substances or any of the excipients.

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Severe renal impairment.

Cardiovascular disease including hypertension and ischaemic heart disease.

Diabetes mellitus.

Phaeochromocytoma.

Hyperthyroidism.

Closed angle glaucoma.

Prostatic enlargement (patients with prostatic hypertrophy may have increased difficulty with micturition).

Urinary retention

Patients with chronic or persistent cough such as occurs with smoking, asthma, emphysema, if you are suffering from an acute

asthma attack, or where cough is accompanied by excessive secretions.

Dextromethorphan should not be given to subjects in, or at risk of, developing respiratory failure.

Patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping such treatment (See section 4.5).

Patients taking selective serotonin reuptake inhibitors (SSRIs, See section 4.5).

Beta-blockers – (See section 4.5).

Use in patients who are currently receiving other sympathomimetic drugs (such as other decongestants).

Not to be used in children under the age of 6 years.

4.4 Special warnings and precautions for use

Should be used with caution in patients with liver disease.

Should be used with caution in atopic children due to histamine release.

Do not take with any other cough and cold medicines.

Dextromethorphan

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 and dependence 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.

Serotonin Syndrome

Serotonergic effects, including the development of a potentially life-threatening serotonin syndrome, have been reported for

dextromethorphan with concomitant administration of serotonergic agents, such as selective serotonin re-uptake inhibitors

(SSRIs), drugs which impair metabolism of serotonin (including monoamine oxidase inhibitors (MAOIs)) and CYP2D6 inhibitors.

Serotonin

syndrome

include

mental-status

changes,

autonomic

instability,

neuromuscular

abnormalities,

and/or

gastrointestinal symptoms.

If serotonin syndrome is suspected, treatment with Boots Pharmaceuticals Dry Cough and Congestion Relief Oral Solution

should be discontinued.

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 metabolisers of CYP2D6 or use CYP2D6 inhibitors (see also section 4.5).

Pseudoephedrine

If any of the following occur, this medicine should be stopped

Hallucinations

Restlessness

Sleep disturbances

Caution in moderate to severe renal impairment.

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

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non-follicular pustules arising on a widespread oedematous erythema and mainly localized on 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 Boots Pharmaceuticals Dry Cough & Congestion Relief Oral Solution should be discontinued

and appropriate measures taken if needed.

Ischaemic colitis

Some cases of ischaemic colitis have been reported with pseudoephedrine. Pseudoephedrine should be discontinued and

medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop.

If symptoms persist consult your doctor.

Patients who are taking other medication and/or are under the care of a physician should consult their doctor before taking

this product.

This product should be used with great care in patients suffering from angina and in patients receiving phenothiazines or

tricyclic antidepressants.

This product may act as a cerebral stimulant, giving rise to insomnia, nervousness, hyperpyrexia, tremor and epileptiform

convulsions.

The physician or pharmacist should reassure himself that sympathomimetic containing preparations are not simultaneously

administered by several routes i.e. orally and topically (nasal, aural and eye preparations).

The label and leaflet will have a warning that for Children aged 6 to 12, parents/carers should seek the advice of the pharmacist

or doctor first.

Information related specifically to the excipients in this formulation (See section 6.1)

This medicine contains 2.65 g sucrose per 5 ml spoonful. This should be taken into account by patients with diabetes mellitus.

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

sucrase-isomaltase insufficiency should not take this medicine.

This medicine contains 77.76 mg alcohol per 5 ml dose. Harmful for those suffering from alcoholism. To be taken into account

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

This medicine contains 14.78 mg sodium per 5 ml spoonful. To be taken into consideration by patients on a controlled sodium

diet.

Paediatric population

Serious adverse events may occur in children in case of overdose including neurological disorders. Caregivers should be

advised not to exceed the recommended dose.

4.5 Interaction with other medicinal products and other forms of interactions

Not to be used in patients taking monoamine oxidase inhibitors or within 14 days of stopping treatment as there is a risk of

serotonin syndrome (pyrexia, hypertension, arrhythmias) when MAOIs are taken in combination with dextromethorphan.

Dextromethorphan might exhibit additive CNS depressant effects when co-administered with alcohol, antihistamines,

psychotropics and other CNS depressant drugs.

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, flecaninde 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.

Pseudoephedrine

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MAOIs and/or RIMAs: should not be given to patients treated with MAOIs or within 14 days of stopping treatment: increased

risk of hypertensive crisis.

Moclobemide: risk of hypertensive crisis.

Antihypertensives (including adrenergic neurone blockers & beta-blockers): this medicine may block the hypotensive effects.

Cardiac glycosides: increased risk of dysrhythmias.

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

Appetite suppressants and amphetamine-like psychostimulants: risk of hypertension.

Oxytocin: risk of hypertension.

Enhances the effects on anticholinergic drugs (such as TCAs).

This product should be used with caution in patients receiving guanethidine, reserpine or methyldopa.

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

provoke or worsen ventricular arrhythmias.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no adequate data on the use of pseudoephedrine in pregnant women. Pseudoephedrine should not be used during

pregnancy.

The use of pseudoephedrine during the first trimester of pregnancy has been associated with an increased frequency of

gastroschisis (a developmental defect in the abdominal wall with intestinal herniation) and of small intestinal atresia (congenital

obstruction of small intestine).

Due to the vasoconstrictive properties of pseudoephedrine, it should not be used during the third trimester as it can induce a

reduction in uteroplacental circulation.

Lactation

Pseudoephedrine has been detected in human milk with a small percentage of the maternal dose potentially administered to

the breastfed infant. The use of pseudoephedrine should be avoided during breastfeeding as lactation may be suppressed, and

irritability and disturbed sleep have been reported in breastfed infants.

There is no data available on the secretion of dextromethorphan into breast milk.

4.7 Effects on ability to drive and use machines

Dextromethorphan hydrobromide may cause drowsiness and therefore may influence the ability to drive and operate

machinery.

4.8 Undesirable effects

Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare

(≥1/10,000 to <1/1000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Dextromethorphan

Body System

Undesirable Effect

Frequency

Gastrointestinal disorders

Vomiting, gastrointestinal disturbances (nausea and diarrhoea)

Not known

Nervous system disorders

Drowsiness (occasional), dizziness, convulsions

Not known

Psychiatric disorders

Excitation, mental confusion

Not known

Respiratory, thoracic and mediastinal disorders

Respiratory depression, bronchoconstriction, dyspnoea

Not known

Skin and subcutaneous tissue disorders

Skin reactions including rash

Not known

Pseudoephedrine

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Body System

Undesirable Effect

Frequency

Cardiovascular disorders

Coronary vasospasm leading to myocardial ischaemia

Very rarely

Tachycardia, palpitations, other cardiac dysrhythmias

Not known

Gastrointestinal disorders

Nausea and/or vomiting

Ischaemic colitis

Not known

General disorders and administration site conditions

Irritability

Not known

Immune system disorders

Hypersensitivity reactions, including cross-sensitivity that

may occur with other sympathomimetics

Not known

Nervous system disorders

Headache, tremor, anxiety, restlessness, excitability,

insomnia, hallucinations (particularly in children) and

paranoid delusions

Not known

Psychiatric disorders

Sleep disturbance

Not known

Renal and urinary disorders

Difficulty in micturition including urinary retention

Not known

Skin and subcutaneous tissue disorders

Skin reactions including rash.

Severe skin reactions, including acute generalised

exanthematous pustulosis (AGEP)

Not known

Vascular disorders

Vasopasm associated with ischaemic colitis

Very rarely

Hypertension

Not known

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

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 and signs:

Dextromethorphan overdose may be associated with nausea, vomiting, dystonia, agitation, confusion, somnolence, stupor,

nystagmus, cardiotoxicity (tachycardia, abnormal ECG including QTc prolongation), ataxia, toxic psychosis with visual

hallucinations, hyperexcitability.

In the event of massive overdose the following symptoms may be observed: coma, respiratory depression, convulsions.

Management:

- Activated charcoal can be administered to asymptomatic patients who have ingested overdoses of dextromethorphan within

the preceding hour.

- For patients who have ingested dextromethorphan and are sedated or comatose, naloxone, in the usual doses for treatment

of opioid overdose, can be considered. Benzodiazepines for seizures and benzodiazepines and external cooling measures for

hyperthermia from serotonin syndrome can be used."

Information for children

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

(0.01mg/kg body weight).

Pseudoephedrine

Symptoms: Symptoms of overdosage include abdominal discomfort, excitation, confusion, hallucinations, ataxia, irritability,

restlessness, palpitations, hypertension, difficulty in micturition and thirst.

Management: In severe overdosage gastric lavage and aspiration should be performed. Symptomatic and supportive

measures should be undertaken, particularly with regard to the cardiovascular and respiratory systems. Chlorpromazine may

be used to control marked excitement and hallucinations. Severe hypertension may need to be treated with an

alpha-adrenoreceptor blocking drug, such as phentolamine. A beta-blocker may be required to control cardiac arrhythmias.

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5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pseudoephedrine is a sympathomimetic agent with direct and indirect effects on adrenergic receptors. It has alpha and beta

adrenergic activity and some stimulant effect on the central nervous system.The sympathomimetic effect of pseudoephedrine

produces vasoconstriction which in turn relieves nasal congestion.

Dextromethorphan is a cough suppressant.

5.2 Pharmacokinetic properties

Pseudoephedrine is readily and completely absorbed from the gastrointestinal tract and is largely excreted in the urine

unchanged. It has an elimination half-life of 5 to 8 hours but its urinary elimination and hence half-life, is pH dependent.

Pseudoephedrine is rapidly distributed throughout the body, its volume of distribution being 2 to 3l/kg bodyweight.

Dextromethorphan is well absorbed from the gastrointestinal tract, metabolised in the liver and excreted as both unchanged

drug and demethylated metabolites.

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 predominated in the blood and urine.

5.3 Preclinical safety data

Pseudoephedrine

In a study of a pseudoephedrine/cetirizine combination product, at doses of 160 mg/kg/day in pregnant rats (~7.5 x

therapeutic exposure in humans for pseudoephedrine, and around therapeutic exposure for cetirizine) observations included

decreased pup survival, a small increase in bone deformations, and delay of some development parameters.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium saccharin

Liquid sugar (contains sucrose)

Hydroxyethylcellulose

Glycerol (E422)

Ethanol 96% (alcohol)

Levomenthol

Domiphen bromide

Pear drop flavour C1353 (contains propylene glycol)

Peach flavour 17403109 (contains propylene glycol)

Quinoline yellow (E104)

Sodium citrate

Citric acid monohydrate

Purified water

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6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

An amber PET bottle with a child resistant cap containing a low density polyethylene wad.

A double ended polypropylene spoon with measures of 2.5ml and 5ml will be provided.

Pack sizes: 120ml, 150ml.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

The Boots Company Plc

1 Thane Road West

Nottingham

NG2 3AA

United Kingdom

8 MARKETING AUTHORISATION NUMBER

PA0004/053/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 26

November 1999

Date of last renewal: 26

November 2009

10 DATE OF REVISION OF THE TEXT

February 2020

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