Boots Catarrh Cough Syrup

1. Name Of The Medicinal Product

Nirolex Decongestant Syrup or Boots Catarrh Cough Syrup

2. Qualitative And Quantitative Composition

Active ingredient	mg/5ml
Guaifenesin Ph Eur	100
Pseudoephedrine Hydrochloride B.P.	30

3. Pharmaceutical Form

Oral Solution

4. Clinical Particulars

4.1 Therapeutic Indications

A non-drowsy expectorant 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.

4.2 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).

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.

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.

Should be avoided in patients with prostatic enlargement.

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

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.

Keep all medicines out of the sight and reach of children.

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 & 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 cross-sensitivity 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 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included.

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

Do not store above 30°C

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 And Other Handling

Not applicable.

7. Marketing Authorisation Holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

8. Marketing Authorisation Number(S)

PL 00014/0604

9. Date Of First Authorisation/Renewal Of The Authorisation

4 March 1998

10. Date Of Revision Of The Text

July 2010