Junior Meltus Dry Coughs with Congestion

1. Name Of The Medicinal Product

Junior Meltus Dry Coughs with Congestion

2. Qualitative And Quantitative Composition

Dextromethorphan Hydrobromide BP 3.5mg/5ml; Pseudoephedrine Hydrochloride BP 10.0mg/5ml.

3. Pharmaceutical Form

Oral solution.

4. Clinical Particulars

4.1 Therapeutic Indications

An oral solution for the symptomatic relief of unproductive coughs accompanied by congestion of the upper respiratory tract.

4.2 Posology And Method Of Administration

To be given four times a day. Do not repeat dosage more frequently than every four hours. Children 6-12 years: Two 5ml spoonfuls. Children 2-5 years: One 5ml spoonful. Adults, the elderly and children over 12 years are recommended to take Adult Meltus Dry Coughs with Congestion. Not to be given to children under two years of age.

4.3 Contraindications

Junior Meltus Dry Coughs with Congestion is contraindicated in patients with a known hypersensitivity to pseudoephedrine or dextromethorphan. Contraindicated in persons under treatment with monoamine oxidase inhibitors or within 2 weeks of stopping such treatment. Contraindicated in patients with severe hypertension or severe coronary artery disease. Junior Meltus Dry Coughs with Congestion should not be administered to patients where the cough is associated with asthma or where the cough is accompanied by excessive secretions. Dextromethorphan, in common with other centrally acting antitussive agents, should not be given to patients in or at risk of developing respiratory failure. Although pseudoephedrine has virtually no pressor effect in patients with normal blood pressure, Junior Meltus Dry Coughs with Congestion should be used with caution in patients taking antihypertensive agents, tricyclic antidepressants, other sympathomimetic agents, such as decongestants, appetite suppressants and amphetamine-like psychostimulants. The effects of a single dose of Junior Meltus Dry Coughs with Congestion on the blood pressure of these patients should be observed before recommending repeated or unsupervised treatment. As with other sympathomimetic agents, caution should be exercised in patients with uncontrolled diabetes, hyperthyroidism, elevated intraocular pressure and prostatic enlargement.

4.4 Special Warnings And Precautions For Use

Keep out of the reach of children. Do not exceed the stated dose. If currently taking any other medicine, consult with a doctor or pharmacist before taking this product. If symptoms persist, consult your doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concomitant use of Junior Meltus Dry Coughs with Congestion with sympathomimetic agents such as decongestants, tricyclic antidepressants, appetite suppressants and amphetamine-like psychostimulants, or with monoamine oxidase inhibitors which interfere with the catabolism of sympathomimetic amines, may occasionally cause a rise in blood pressure. Because of its pseudoephedrine content, the effect of antihypertensive agents which modify sympathetic activity may be partially reversed by Junior Meltus Dry Coughs with Congestion. The antibacterial agent, furazolidine, is known to cause a dose-related inhibition of monoamine oxidase and although there are no reports of a hypertensive crisis having occurred, it should not be administered concurrently with Junior Meltus Dry Coughs with Congestion. The product may potentiate the effects of alcohol and other central nervous system depressants.

4.6 Pregnancy And Lactation

Not applicable.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

In some patients, pseudoephedrine may occasionally cause insomnia. Rarely, sleep disturbance and hallucinations have been reported. Fixed drug eruption due to pseudoephedrine, taking the form of erythematous nummular patches, has been reported as a rare event. Side-effects attributed to dextromethorphan are uncommon; occasionally dizziness, nausea, vomiting or gastrointestinal disturbance may occur.

4.9 Overdose

The effects of acute toxicity from Junior Meltus Dry Coughs with Congestion may include nystagmus, hypertension, irritability, restlessness, tremor, palpitations, visual and auditory hallucinations, convulsions, respiratory depression, difficulty with micturition, nausea and vomiting. Gastric lavage and supportive measures for respiration and circulation should be performed if indicated. Convulsions should be controlled with an anticonvulsant. Catheterisation of the bladder may be necessary. If desired, the elimination of pseudoephedrine can be accelerated by acid diuresis or by dialysis. Naloxone has been used successfully as a specific antagonist to dextromethorphan toxicity in a child.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Cough suppressant; decongestant.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sorbitol Syrup (Non Crystallising) BP; Menthol BP; Chloroform BP; Loganberry Flavour 500195E; Methylhydroxybenzoate BP; Propylhydroxybenzoate BP; Alcohol 96% BP; Glycerin BP; Sodium Saccharin BP; Sodium Cyclamate 1968 BP; Carmellose Sodium BP; Water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months unopened.

6.4 Special Precautions For Storage

Store below 25^oC and avoid prolonged storage at 5^oC or below.

6.5 Nature And Contents Of Container

Amber glass bottle with tamper evident cap with fitted polycone liner packed in an outer carton. Bottle contains 100ml of product.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Cupal Ltd. Venus, 1 Old Park Lane, Trafford Park, Manchester, M41 7HA.

8. Marketing Authorisation Number(S)

PL 0338/0070.

9. Date Of First Authorisation/Renewal Of The Authorisation

11^th October 1991 / 12^th June 2003

10. Date Of Revision Of The Text

April 2006