BOOTS DRY COUGH & CONGESTION RELIEF ORAL SOLUTION

Active substance: PSEUDOEPHEDRINE HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE MEDICINAL PRODUCT
Almus Dry Cough Linctus with Decongestant
Boots Dry Cough & Congestion Relief Oral Solution

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Pseudoephedrine hydrochloride
Dextromethorphan hydrobromide

3

Mg/5ml
30.0
10.0

PHARMACEUTICAL FORM
Oral Solution.
A clear, yellow, viscous liquid.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Cough suppressant for the relief of acute non-productive cough associated
with upper respiratory tract infection. Decongestant for the relief of catarrh
and blocked sinuses associated with nasal congestion and congestion of
mucous membranes of the upper respiratory tract associated with the common
cold.

4.2

Posology and method of administration

Adults and children over 12 years: 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.
Severe renal impairment
Cardiovascular disease including hypertension and peripheral vascular disease
Diabetes mellitus
Phaeochromocytoma
Hyperthyroidism
Closed angle glaucoma
Prostatic enlargement
Patients with chronic or persistent cough such as occurs with asthma, 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).
Concomitant use of other sympathomimetic decongestants.
Not to be used in children under the age of 6 years.

4.4

Special warnings and precautions for use
Dextromethorphan
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.

Use of dextromethorphan with alcohol or other CNS depressants may increase
the effects on the CNS and cause toxicity in relatively smaller doses.
Pseudoephedrine
If any of the following occur, this medicine should be stopped
Hallucinations
Restlessness
Sleep
disturbances
Caution in moderate to severe renal impairment.
If symptoms persist consult your doctor.
4.5

Interaction with other medicinal products and other forms of interaction

Dextromethorphan
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 is primarily metabolised by the cytochrome P450
isoenzyme CYP2D6; the possibility of interactions with inhibitors of this
enzyme, including amiodarone, haloperidol, propafenone, quinidine, SSRIs,
and thioridazine, should be borne in mind.
Dextromethorphan might exhibit additive CNS depressant effects when coadministered with alcohol, antihistamines, psychotropics, and other CNS
depressant drugs.

Pseudoephedrine
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 of anticholinergic drugs (such as TCAs).
There is an increased risk of arrhythmias if given to patients receiving
anticholinergic drugs such as tricyclic antidepressants.
Concomitant use with sympathomimetic agents such as decongestants,
tricyclic antidepressants, may occasionally cause a rise in blood pressure.

4.6.

Pregnancy and Lactation
In view of a possible as sociation of foetal abnor malities with first trimester
exposure to pseudoephed rine, the use o f the prod uct during pre gnancy should
be avoided. Althoug h amount s of pseudoeph edrine secr eted into b reast milk
are considered to be too sma ll to be harmful, there is no da ta on the secretion
of dextromethorphan into breast milk a nd therefore use of this product du ring
lactation should be avoided.

4.7.

Effects on Ability to Drive and Use Machines
No adverse effects known.

4.8

Undesirable effects
Dextromethorphan
The following side effects may be associated with the use of
dextromethorphan:
Gastrointestinal disorders: vomiting, gastrointestinal disturbances (nausea and
diarrhoea).
Nervous system disorders: drowsiness (occasional), dizziness, convulsions.
Psychiatric disorders: excitation, mental confusion.
Respiratory, thoracic and mediastinal disorders: respiratory depression.
Skin and subcutaneous tissue disorders: skin reactions including rash.

Pseudoephedrine
Cardiovascular disorders: tachycardia, palpitations, other cardiac
dysrhythmias.
Gastrointestinal disorders: nausea and/or vomiting.
General disorders and administration site conditions: irritability.
Immune system disorders: hypersensitivity reactions, including crosssensitivity that may occur with other sympathomimetics.
Nervous system disorders: headache, tremor, anxiety, restlessness, excitability,
insomnia, hallucinations (particularly in children) and paranoid delusions.
Psychiatric disorders: sleep disturbance.
Renal and urinary disorders: difficulty in micturition including urinary
retention.
Skin and subcutaneous tissue disorders: skin reactions including rash.
Vascular disorders: hypertension.
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: These include nausea and vomiting, CNS depression, dizziness,
dysarthria (slurred speech), nystagmus, somnolence (drowsiness), excitation,
mental confusion, psychotic disorder (psychosis), and respiratory depression,
convulsions.
Mana

gement: Treatment of overdose should be symptomatic and supportive.
Gastric lavage may be of use. Convulsions should be controlled with
intravenous diazepam. The specific narcotic antagonist naloxone can be used
to reverse the effects of dextromethorphan.
Information for children
Naloxone has been used successfully to reverse contral 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.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic Properties
Pseudoephedrine is a s ympathomimetic agent wi th direct and indirect eff ects
on adrene rgic r eceptors. It has alpha and b eta a drenergic act ivity and s ome
stimulant effect on the central nervous system. The sympathomimetic effect of
pseudoephedrine produc es va soconstriction whi ch in turn reliev es na sal
congestion.
Dextromethorphan is a cough suppressant.

5.2.

Pharmacokinetic Properties
Pseudoephedrine is re adily and completely absorbed from th e gastrointestinal
tract and is largely excreted in the urine unchanged. It has an elimination half-

life of 5 to 8 hou rs bu t its urina ry elimination a nd h ence ha lf-life is pH
dependent.
Pseudoephedrine is rapi dly distributed throughout the bod y, its volume of
distribution being 2 to 3 L/kg bodyweight.
Dextromethorphan is we ll a bsorbed from the
g astrointestinal tra ct,
metabolised i n t he l iver and ex creted as both unchan ged d rug and
demethylated metabolites.

5.3.

Pre-clinical Safety Data
Not applicable.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Sodium saccharin
Liquid sugar
Hydroxyethylcellulose
Glycerin
Alcohol 96%
Levomenthol
Domiphen bromide
Pear drop flavour C1353
Peach flavour 17403109
Quinoline yellow 14031
Sodium citrate
Citric acid monohydrate
Purified water

6.2.

Incompatibilities
Not applicable.

6.3.

Shelf-Life
2 years.

6.4.

Special Precautions for Storage
None.

6.5

Nature and contents of container
An amber PET bottle with a child resistant plastic cap containing a low density
polyethylene wad.
Pack size: 120ml

6.6.

Instructions for Use/Handling
Not applicable.

7.

MARKETING AUTHORISATON HOLDER
The Boots Company PLC
1 Thane Road West
Nottingham
NG2 3AA
Trading as: BCM

8.

MARKETING AUTHORISATION NUMBER(S)
PL 0014/0501

9.
DATE OF FIRST AUTHORISATION / RENEWAL OF
AUTHORISATION
01 July 1996

10

DATE OF REVISION OF THE TEXT
27/11/2010

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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