BOOTS COUGH AND DECONGESTANT SYRUP 6 YEARS +

Active substance: PSEUDOEPHEDRINE HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Boots Cough and Decongestant Syrup 6 Years +

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Guaifenesin
Pseudoephedrine hydrochloride

3.

% w/v
1.0
0.2

PHARMACEUTICAL FORM
Syrup

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
A combination expectorant and decongestant for the relief of acute productive
(chesty) cough, nasal congestion and congestion of the mucous membranes of the
upper respiratory tract associated with the common cold.

4.2

Posology and method of administration
For oral administration.
Children 6 to 12 years: Two 5ml spoonfuls three or four times a day.
Not more than 4 doses should be given in any 24 hours.
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 all medicines out of the sight and reach of children.

4.3

Contraindications
Hypersensitivity to the active substances or any of the excipients or
intolerance to other sympathomimetics.
Severe renal impairment
Cardiovascular disease including hypertension and peripheral vascular disease.
Diabetes mellitus
Phaeochromocytoma
Hyperthyroidism
Closed angle glaucoma
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.

4.4

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
If any of the following occur, this medicine should be stopped
Hallucinations
Restlessness
Sleep disturbances
Caution in moderate to severe renal impairment.
Pseudoephedrine should be used with caution when administered to patients
taking antihypertensive agents, tricyclic antidepressants, other
sympathomimetic agents such as decongestants, appetite suppressants and
amphetamine-like psycho-stimulants. The effects of a single dose on the
blood pressure of these patients should be observed before recommending
repeated or unsupervised treatment.

Do not give with any other cough and cold medicine.
If symptoms do not go away, talk to your pharmacist or doctor.
4.5

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, diuretics & betablockers): pseudoephedrine may block the hypotensive effects.
Cardiac glycosides: increased risk of dysrhythmias.
Ergot alkaloids (ergotamine & methysergide): increased risk of ergotism.
Appetite suppressants and amphetamine-like psycho-stimulants: risk of
hypertension.
Oxytocin: risk of hypertension.
Enhances effects of anticholinergic drugs (such as TCAs).
Should not be given with other sympathomimetics such as decongestants, and
thyroid hormones. Should not be given to patients undergoing general
anaesthesia as them may induce ventricular arrhythmias.
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
Since the product is intended only for use in children, information on its use in
pregnancy and lactation is not relevant.

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 dysrythmias.
Gastrointestinal disorders: nausea and/or vomiting, dry mouth.
General disorders and administration site conditions: irritability, thirst,
tolerance with dependence has been reported with prolonged administration of
pseudoephedrine-containing preparations.
Immune system disorders: hypersensitivity reactions, including crosssensitivity that may occur with other sympathomimetics.
Musculoskeletal and connective tissue disorders: muscular weakness.
Nervous system disorders: headache, giddiness, 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,
sweating.
Vascular disorders: hypertension.
4.9.

Overdose
Symptoms of overdosage include headache, nausea, vomiting, tachycardia,
urinary retention, hallucinations, coma, tremor, excitement, convulsions,
respiratory depression, hypertension and arrhythmias.
Initial treatment consists of either emesis or gastric lavage, if appropriate.
Otherwise treatment should by symptomatic and supportive, including the
administration of a beta blocker if supraventricular tachycardia supervenes.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic Properties
Pseudoephedrine acts directly on both alpha and to a lesser extent beta
adrenergic receptors. It is believed that the alpha adrenergic effects result
from inhibition of the production of cyclic AMP by inhibition of the enzyme
adenyl cyclase, whereas beta adrenergic effects result from stimulation of
adenyl cyclase activity. Pseudoephedrine also has an indirect effect by
releasing noradrenaline from its storage sites.

Guaifenesin reduces the viscosity of tenacious sputum and is used as an
expectorant.

5.2.

Pharmacokinetic Properties
Pseudoephedrine is absorbed from the gastrointestinal tract. It is resistant to
metabolism by monoamine oxidase and is largely excreted unchanged in the
urine together with small amounts of its hepatic metabolite. It has an
elimination half life of several hours.
Guaifenesin is readily absorbed from the gastrointestinal tract. it is
metabolised and excreted in the urine.

5.3.

Pre-clinical Safety Data
Not applicable.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Maltitol liquid
Hydroxyethyl cellulose
Glycerin
Purified water
Potassium sorbate
Acesulfame K
Sodium citrate
Citric acid monohydrate
Levomenthol
Alcohol 96%
Blackcurrant Flavour QL80001
Vanilla Flavour Mixture QL78307

6.2.

Incompatibilities
None stated.

6.3.

Shelf-Life
24 months.

6.4

Special precautions for storage

6.5.

Nature and Content of Container

Do not store above 25°C.

Amber PET bottle with polypropylene child resistant closure fitted with an
expanded polyethylene liner.
Pack size: 100ml, 125ml, 150ml, 200ml

6.6.

Instructions for Use, Handling and Disposal
Not applicable.

7.

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

8.

MARKETING AUTHORISATION NUMBER(S)
PL 0014/0545

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
31/01/1997 / 21/12/2001

10

DATE OF REVISION OF THE TEXT
03/05/2013

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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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