Adult Meltus Dry Coughs with Congestion.

Dextromethorphan Hydrobromide BP 10mg/5ml

Pseudoephedrine Hydrochloride BP 10mg/5ml

For excipients, see 6.1

Oral liquid.

Symptomatic relief of dry painful tickly coughs and catarrh.

Oral Use.

Adults, the elderly and children over 12 years of age: One or two 5ml spoonfuls to be taken four times a day.

Not to be given to children under 12 years of age.

Patients with cardiovascular disease, hypertension, hyperthyroidism, hyperexcitability, phaechromocytoma, closed angle glaucoma. Use with caution in patients with liver disease and asthma. May increase the difficulty of micturition in patients with prostatic enlargements. Hypersensitivity to any of the ingredients or if also taking monoamine oxidase inhibitors.

Do not exceed the stated dose.

If symptoms persist of worsen, seek medical advice.

Keep out of reach of children.

If pregnant or taking regular medication, consult your doctor before taking this product.

Mono-amine oxidase inhibitors. The activity of the pseudoephedrine content is diminished by guanethidine, reserpine and methyldopa and may be diminished or enhanced by tricyclic antidepressants; it may diminish the effects of guanethidine and may increase the possibility of arrhythmias in digitalised patients.

Use with caution in patients with diabetes.

Not to be used by pregnant or lactating women.

None known.

Large doses may cause giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness, tremors, anxiety, restlessness and insomnia.

Management of overdose generally involves supportive and symptomatic therapy, and in cases of severe overdose, aspiration followed by gastric lavage may be used to empty the stomach. Treatment of dextromethorphan hydrobromide overdose is by the specific antidote, naloxone.

Pharmacotherapeutic group: Dextromethorphan, ATC code: R05DA09

Adult Meltus Dry Coughs with Congestion contains dextromethorphan hydrobromide and pseudoephedrine hydrochloride to provide cough suppression and bronchodilation in cases of dry irritating coughs.

Pseudoephedrine is readily and completely absorbed from the gastrointestinal tract following oral administration with no presystemic metabolism, achieving peak plasma concentrations between one and three hours after oral dosing. It has a plasma half-life of 5 to 8 hours following oral dosing but its urinary elimination and hence its half-life is pH dependent such that elimination will be increased in patients with acidic urine and decreased in subjects with alkaline urine.

Dextromethorphan is well absorbed following oral administration but is subject to extensive presystemic metabolism in the liver. The main metabolite is dextrorphan. Dextromethorphan is extensively biotransformed in the liver with about 50% of the dose excreted in the urine over 24 hours. Less than 1% of a dose being excreted in the faeces. About 8% of the dose is excreted as unchanged drug in the urine within 6 hours.

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

Menthol BP

Alcohol 96% BP

Glycerin BP

Sorbitol Solution BP

Chloroform BP

Sodium Cyclamate BP

Loganberry Flavour 500 195E

Sodium Saccharin BP

Sodium Carboxymethylcellulose BP

Methyl Hydroxybenzoate BP

Propyl Hydroxybenzoate BP

Water.

Mono-amine oxidase inhibitors (MAOIs). Antihypertensive therapy. Chloroform, cyclopropane, halothane and other halogenated anaesthetics.

36 months unopened.

Store below 25^oC.

100ml: Amber glass bottles with tamper evident cap with fitted polycone liner packed into a carton enclosing a 5ml spoon with a 2.5ml graduation.

Not applicable.

Cupal Limited

Tubiton House

Oldham

OL1 3HS

PL 0338/5029R.

31/01/90 / 26/04/01

29/01/2007