Boots Dry Cough & Congestion Relief Oral Solution

Oral Solution.

A clear yellow viscous liquid.

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.

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.

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.

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.

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 co-administered 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.

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. Although amounts of pseudoephedrine secreted into breast milk are considered to be too small to be harmful, there is no data on the secretion of dextromethorphan into breast milk and therefore use of this product during lactation should be avoided.

No adverse effects known.

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 cross-sensitivity 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.

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.

Management: 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.

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.

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 3 L/kg bodyweight.

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

Not applicable

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

Not applicable

2 years

None

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

Pack size: 120ml

Not applicable.

The Boots Company PLC

1 Thane Road West

Nottingham

NG2 3AA

Trading as: BCM

PL 00014/0501

1 July 1996

November 2010