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ADULT MELTUS DRY COUGHS WITH CONGESTION

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Adult Meltus Dry Coughs with Congestion

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION Dextromethorphan hydrobromide BP Pseudoephedrine hydrochloride BP 10.00 mg /5ml 10.00 mg /5ml

3.

PHARMACEUTICAL FORM Oral liquid

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CLINICAL PARTICULARS

4.1

Therapeutic indications
The symptomatic relief of dry painful tickly coughs and catarrh.

4.2.

Posology and Method of Administration Oral 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.

Contra-indications Patients with cardiovascular disease, hypertension, hyperthyroidism, hyperexcitability, phaeochromocytoma, closed angle glaucoma. Use with caution in patients with liver disease and asthma. May increase the difficulty of micturation in patients with prostatic enlargements. Hypersensitivity to any of the ingredients. If also taking monoamine oxidase inhibitors.

4.4.

Special Warnings and Precautions for Use Do not exceed the stated dose. If symptoms persist or worsen, seek medical advice. Keep out of the reach of children. If pregnant or taking regular medication, consult your doctor before taking this product.

4.5.

Interactions with other Medicaments 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
Adult Meltus for Dry Tickly Coughs and Catarrh 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 dependant such that elimination will be increased in subjects 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. 6.1.

PHARMACEUTICAL PARTICULARS List of Excipients Menthol BP, alcohol 96% BP, glycerin BP, sorbitol solution BP, chloroform BP, sodium cyclamate BP, loganbeny flavour 500 195E, sodium saccharin BP, sodium carboxymethylcellulose BP, methylhydroxybenzoate BP, propylhydroxybenzoate 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 25C

6.5.

Nature and Contents of Container 100ml: amber glass bottle with a tamper evident cap with fitted polyclone liner. Packed into a carton enclosing a 5ml spoon with a 2.5ml graduation.

6.6.

Instruction for Use/Handling Not applicable.

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MARKETING AUTHORISATION HOLDER
Cupal Ltd. Venus, 1 Old Park Lane, Trafford Park, Manchester, M41 7HA, UK

8.

MARKETING AUTHORISATION NUMBER(S) PL 0338/5029R

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 31st January 1990/ 19th May 1995

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DATE OF REVISION OF THE TEXT
24/07/2007

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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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