BOOTS CATARRH COUGH SYRUP

Active substance: PSEUDOEPHEDRINE HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Boots Catarrh Cough Syrup

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Guaifenesin Ph Eur

100

Pseudoephedrine Hydrochloride BP.

3.

mg/5ml

30

PHARMACEUTICAL FORM
Oral Solution

4.1

4.2

Therapeutic indications
A non-drowsy expectorant and decongestant for the symptomatic relief of
acute productive (chesty) cough, nasal congestion and congestion of mucous
membranes of the upper respiratory tract associated with the common cold.
Posology and method of administration
Adults and children over 12 years
10ml (Two 5ml spoonfuls) four times a day.
Elderly
There is no need for dosage reduction in the elderly.
Children 6-12 years
5ml (One 5ml spoonful) three times a day.
This medicine is contraindicated in children under 6 years of age (see section
4.3).

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 or carers should seek medical attention if the
child's condition deteriorates during treatment.
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.
Should be avoided in patients with prostatic enlargement.

4.4

Concomitant use of other sympathomimetic decongestants.
Monoamine oxidase inhibitors (MAOIs, or within 14 days of stopping
treatment, see section 4.5).
Beta-blockers – (see section 4.5).
Not to be used in children under the age of 6 years.
Special warnings and precautions for use
Guaifenesin
Ask a doctor before use if you suffer from a chronic cough, if you have asthma
or are suffering from an acute asthma attack.
Stop use and ask a healthcare professional if your cough lasts for more than 5
days, comes back, or is accompanied by a fever, rash or persistent headache.
Do not take with a cough suppressant.
Pseudoephedrine
Caution in moderate to severe renal impairment.
If any of the following occur, this medicine should be stopped
Hallucinations
Restlessness
Sleep disturbances
Warning. Do not exceed the stated dose.
If symptoms do not go away talk to your doctor.

4.5

Keep all medicines out of the sight and reach of children.
Interaction with other medicinal products and other forms of interaction
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 product 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 effects of anticholinergic drugs (such as TCAs).

May increase the possibility of arrhythmias in those taking quinidine or
tricyclic antidepressants.

Guaifenesin
If urine is collected within 24 hours of a dose of guaifenesin a metabolite of
guaifenesin may cause a colour interference with laboratory determinations of
urinary 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid
(VMA).
4.6.

Pregnancy and Lactation
The safety of this medicine during pregnancy and lactation has not been
established, but in view of a possible association of foetal abnormalities with
first trimester exposure to pseudoephedrine, the use of the product during
pregnancy should be avoided. The amounts of pseudoephedrine and
guaifenesin secreted into breast milk are considered too small to be harmful.

4.7.

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

4.8

Undesirable effects

Guaifenesin
The following side effects may be associated with the use of guaifenesin:
Gastrointestinal disorders: Nausea, vomiting, gastrointestinal discomfort.
Immune system disorders: Hypersensitivity reactions.
Pseudoephedrine
Cardiovascular disorders: Tachycardia, palpitations, other cardiac
dysrhythmias.
Gastrointestinal disorders: Nausea and/or vomiting, dry mouth.
General disorders and administration site conditions: Irritability.
Immune system disorders: Hypersensitivity reactions, including crosssensitivity that may occur with other sympathomimetics.
Metabolism and nutrition disorders: Anorexia.
Nervous system disorders: Headache, tremor, anxiety, restlessness,
excitability, insomnia, hallucinations (particularly in children) and paranoid
delusions.
Psychiatric disorders: Sleep disturbance.
Renal and urinary disorders: Urinary retention.
Skin and subcutaneous tissue disorders: Skin reactions including rash.
Vascular disorders: Hypertension, impaired circulation to the extremities.

4.9.

Overdose
Symptoms of overdosage include irritability, restlessness, palpitations,
hypertension, difficulty in micturition, nausea, vomiting, thirst and
convulsions. 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.
Convulsions should be controlled with intravenous diazepam.
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 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.
Guaifenesin reduces the viscosity of tenacious sputum and is used as an
expectorant.

5.2.

Pharmacokinetic Properties
Pseudoephedrine is readily and completely absorbed from the gastrointestinal
tract. It is resistant to metabolism by monoamine oxidase 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.
Guaifenesin is readily absorbed from the gastrointestinal tract. It is rapidly
metabolised and excreted in the urine.

5.3.

Pre-clinical Safety Data
There are no preclinical data of relevance to the prescriber which are
additional to that already included.

6

PHARMACEUTICAL PARTICULARS

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Maltitol liquid (E965)
Hyetellose
Glycerol (E422)
Menthol flavour E43525
Acesulfame potassium (E950)
Potassium sorbate (E202)
Citric acid monohydrate
Sodium citrate
Smoke flavour 15852117 (containing ethanol)
Lemon oil
Purified water

6.2.

Incompatibilities
None stated.

6.3.

Shelf Life
24 months.

6.4.

Special Precautions for Storage
Store below 30°C

6

PHARMACEUTICAL PARTICULARS

6.5

Nature and contents of container

120ml amber PET bottle with a child resistant polypropylene cap fitted with an
expanded polyethylene liner.
or
120ml white flint or amber glass bottle with a child resistant polypropylene cap fitted
with an expanded polyethylene liner.
6.6
Special precautions for disposal
Not applicable.

7.

MARKETING AUTHORISATION HOLDER
The Boots Company PLC
1 Thane Road West
Nottingham
NG2 3AA

8.

MARKETING AUTHORISATION NUMBER
PL 00014/0604

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
24/08/2010

10

DATE OF REVISION OF THE TEXT
10/08/2010

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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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