Adult Meltus Dry Coughs with Congestion

1. Name Of The Medicinal Product

Adult Meltus Dry Coughs with Congestion.

2. Qualitative And Quantitative Composition

Dextromethorphan Hydrobromide BP 10mg/5ml

Pseudoephedrine Hydrochloride BP 10mg/5ml

For excipients, see 6.1

3. Pharmaceutical Form

Oral liquid.

4. Clinical Particulars

4.1 Therapeutic Indications

Symptomatic relief of dry painful tickly coughs and catarrh.

4.2 Posology And Method Of Administration

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.

4.3 Contraindications

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.

4.4 Special Warnings And Precautions For Use

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.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

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.

4.6 Pregnancy And Lactation

Not to be used by pregnant or lactating women.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

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

4.9 Overdose

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.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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.

5.2 Pharmacokinetic Properties

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.

5.3 Preclinical Safety Data

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

6. Pharmaceutical Particulars

6.1 List Of Excipients

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.

6.2 Incompatibilities

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

6.3 Shelf Life

36 months unopened.

6.4 Special Precautions For Storage

Store below 25^oC.

6.5 Nature And Contents Of Container

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.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Cupal Limited

Tubiton House

Oldham

OL1 3HS

8. Marketing Authorisation Number(S)

PL 0338/5029R.

9. Date Of First Authorisation/Renewal Of The Authorisation

31/01/90 / 26/04/01

10. Date Of Revision Of The Text

29/01/2007