Adult Meltus Chesty Coughs with Congestion

1. Name Of The Medicinal Product

Adult Meltus Chesty Coughs with Congestion.

2. Qualitative And Quantitative Composition

Guaifenesin 100mg/5ml

Pseudoephedrine Hydrochloride 30mg/5ml

3. Pharmaceutical Form

Oral solution.

4. Clinical Particulars

4.1 Therapeutic Indications

The symptomatic relief of upper respiratory tract disorders accompanied by productive cough which benefit from a combination of a nasal decongestant and an expectorant.

4.2 Posology And Method Of Administration

Oral.

Adults and children aged 12 years and over: Two 5ml spoonfuls three times a day.

The elderly: No specific studies have been carried out on the elderly, but similar products have been widely used in older people. However, it may be advisable to monitor renal and hepatic function and, if there is serious impairment, caution should be exercised.

4.3 Contraindications

The product is contraindicated in patients who have previously shown intolerance to pseudoephedrine or guaifenesin. It is also contraindicated in persons currently being treated with monoamine oxidase inhibitors, and also within two weeks of stopping such treatment. It is also contraindicated in persons with severe hypertension or severe coronary artery disease.

4.4 Special Warnings And Precautions For Use

Although pseudoephedrine has virtually no presser effect in patients with normal blood pressure, Adult Meltus Chesty 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 linctus 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.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The effect of antihypertensive agents which act by modifying sympathetic activity may be partially reversed by Adult Meltus Chesty Coughs with Congestion. Concomitant use of this product with other 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. The antibacterial agent furazolidine is known to cause a dose related inhibition of monoamine oxidase, and although there are reports of hypertensive crises having occurred, it should not be administered concurrently with this product.

4.6 Pregnancy And Lactation

Although pseudoephedrine and guaifenesin have been in widespread use for many years without apparent ill consequence, there are no specific data on their use during pregnancy. Caution should therefore be exercised by balancing the potential benefit of treatment against any possible hazards. Systemic administration of pseudoephedrine, up to 50 times the human dose in rats and up to 35 times the human dose in rabbits, did not produce teratogenic effects.

It has been estimated that approximately 0.5% - 0.7% of a single dose of pseudoephedrine ingested by a mother will be excreted in the breast milk over 24 hours, but the effects of this on breast-fed infants is not known.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Side effects are uncommon. In some patients pseudoephedrine may occasionally cause insomnia. Rarely, sleep disturbances and hallucinations have been reported. A fixed drug eruption to pseudoephedrine, taking the form of erythematous nummular patches, has been reported, but is a rare occurrence. Urinary retention has been reported in male patients in whom prostatic enlargement could have been an important predisposing factor.

4.9 Overdose

As with other sympathomimetic agents, symptoms of overdose include irritability, restlessness, tremor, convulsions, palpitations, hypertension, and difficulty in micturition. 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.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pseudoephedrine has direct and indirect sympathomimetic activity and is an orally effective upper respiratory tract decongestant. Pseudoephedrine is substantially less potent than ephedrine in producing both tachycardia and elevation in systolic blood pressure, and considerably less potent in causing stimulation of the central nervous system. On the basis of widespread and long established clinical use, guaifenesin is recognised as an expectorant in bronchitis.

5.2 Pharmacokinetic Properties

Pseudoephedrine is readily and completely absorbed from the gastrointestinal tract following oral administration, with no presystemic metabolism. It achieves peak plasma concentrations between 1 and 3 hours after oral dosing. It is eliminated largely unchanged in urine (55 -90%) in 24 hours, although there is some metabolism in the liver (<1%) by N-demethylation. It has a plasma half-life of 5-8 hours after oral dosing, but its urinary elimination and hence half-life, is pH dependant, such that elimination will be increased in subjects with acidic urine and decreased in subjects with alkaline urine. It is excreted in breast milk at concentrations consistently higher than those in maternal plasma, and is likely to cross the placenta. The elimination is reduced in renal impairment and with deteriorating renal function in the elderly. Guaifenesin is absorbed from the gastrointestinal tract. It is metabolised and excreted in the urine.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Purified Honey

Sucrose (Granular)

Glycerin

Alcohol 96%

Aniseed Oil

Menthol Crystals

Caramel E150

Glucose Liquid

Purified Water

6.2 Incompatibilities

None stated.

6.3 Shelf Life

24 months unopened.

6.4 Special Precautions For Storage

Store at or below 25^oC.

6.5 Nature And Contents Of Container

Amber glass sirop bottles filled with tamper evident cap with fitted polycone liner in printed cartons containing 100ml of product.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Cupal Ltd

Venus

1 Old Park Lane

Trafford Park

Manchester

M41 7HA

8. Marketing Authorisation Number(S)

PL 00338/0088.

9. Date Of First Authorisation/Renewal Of The Authorisation

23/09/96

10. Date Of Revision Of The Text

January 2007