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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Benylin Mucus Cough plus Decongestant Syrup Sudafed Chesty Coughs with Decongestant Liquid

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

This product contains 30 mg pseudoephedrine hydrochloride and 100 mg guaifenesin in each 5 ml.

For excipients see 6.1.

3    PHARMACEUTICAL FORM

A clear orange-red syrup.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

This product is indicated for the symptomatic relief of upper respiratory tract disorders accompanied by productive cough, which are benefited by the combination of a decongestant of the mucous membranes of the upper respiratory tract, especially the nasal mucosa and sinuses, and an expectorant.

4.2    Posology and method of administration Adults and children aged 12 years and over:

Oral. 10 ml syrup every 4 - 6 hours up to 4 times a day.

Maximum daily dose: 40 ml Children under 12 years:

This product is contraindicated in children under the age of 12 years (see section 4.3).

The elderly:

Normal adult dosage is appropriate, [See Pharmacokinetics in the elderly].

Hepatic dysfunction:

Experience with the use of the product suggests normal adult dosage is appropriate, although it may be prudent to exercise caution in the presence of severe hepatic impairment, [See Pharmacokinetics in the elderly].

Renal dysfunction:

Caution should be exercised when administering this product to patients with moderate to severe renal impairment, particularly if accompanied by cardiovascular disease, [See Pharmacokinetics in Renal Impairment].

Do not exceed the stated dose.

Keep out of the reach and sight of children.

4.3 Contraindications

This product is contraindicated in individuals with known hypersensitivity to the product, or any of its components.

This product is contraindicated in individuals with severe hypertension or severe coronary artery disease.

This product is contraindicated in individuals who are taking, or have taken, monoamine oxidase inhibitors within the preceding two weeks. The concomitant use of pseudoephedrine and this type of product may occasionally cause a rise in blood pressure.

Not to be used in children under the age of 12 years.

4.4 Special warnings and precautions for use

Although pseudoephedrine has virtually no pressor effects in normotensive patients, this product should be used with caution in individuals suffering from mild to moderate hypertension, [See Contraindications and interactions with other medicinal products].

As with other sympathomimetic agents, this product should be used with caution in individuals with heart disease, diabetes, hyperthyroidism, elevated intra-ocular pressure or prostatic enlargement.

This product should be not used for persistent or chronic cough, such as occurs with asthma, or emphysema where cough is accompanied by excessive secretions, unless directed by a physician.

Caution should be exercised when using the product in the presence of severe hepatic impairment or renal impairment (particularly if accompanied by cardiovascular disease), [See Pharmacokinetics].

Not more than 4 doses should be given in any 24 hours. Do not exceed the stated dose.

Do not take with any other cough and cold medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Concomitant use of this product with anti-hypertensive agents, tricyclic antidepressants, sympathomimetic agents (such as decongestants, appetite suppressants and amfetamine-like psychostimulants) or with monoamine oxidase inhibitors, which interfere with the catabolism of sympathomimetic amines, may occasionally cause a rise in blood pressure. [See Contraindications].

Because of its pseudoephedrine content, this product may partially reverse the hypotensive action of drugs which interfere with sympathetic activity including bretylium, betanidine, guanethidine, debrisoquine, methyldopa, alpha- and beta- adrenergic blocking agents, [See Special Warnings and Special Precautions for Use].

4.6    Pregnancy and lactation

Insufficient information is available on the effects of administration of this product during human pregnancy. This product, like most medicines, should not be used during pregnancy unless the potential benefit of treatment to the mother outweighs the possible risks to the developing foetus.

Pseudoephedrine is excreted in breast milk in small amounts but the effect of this on breast-fed infants is not known. It has been estimated that approximately 0.5 to 0.7 % of a single 60 mg dose of pseudoephedrine ingested by a nursing mother will be excreted in the breast milk over 24 hours.

Guaifenesin is excreted in breast milk in small amounts with no effect expected on the infant.

4.7    Effects on ability to drive and use machines

No special comment - unlikely to produce an effect.

4.8    Undesirable effects

Serious adverse effects associated with the use of pseudoephedrine are extremely rare. Symptoms of central nervous system excitation may occur, including sleep disturbance and, rarely, hallucinations.

Skin rashes, with or without irritation, have occasionally been reported with pseudoephedrine.

Urinary retention has been reported occasionally in men receiving pseudoephedrine; prostatic enlargement could have been an important factor.

Side effects resulting from guaifenesin administration are very rare.

4.9 Overdose

Symptoms and signs

The effects of acute toxicity from this product may include drowsiness, irritability, restlessness, tremor, palpitations, convulsions, hypertension, difficulty with micturition, gastro-intestinal discomfort, nausea and vomiting.

Treatment

Necessary measures should be taken to maintain and support respiration and control convulsions. Gastric lavage may be undertaken if indicated. Catheterisation of the bladder may be necessary. Acid diuresis can accelerate the elimination of pseudoephedrine, although the potential therapeutic gain of this procedure is now in dispute. The value of dialysis in overdose is not known, although four hours of haemodialysis removed approximately 20 % of the total body load of pseudoephedrine in a combination product containing 60 mg pseudoephedrine and 8 mg acrivastine.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pseudoephedrine has direct and indirect sympathomimetic activity and is an orally effective upper respiratory decongestant. Pseudoephedrine is substantially less potent than ephedrine in producing both tachycardia and elevation of systolic blood pressure and considerably less potent in causing stimulation of the central nervous system.

Pseudoephedrine produces its decongestant effect within 30 minutes, persisting for at least 4 hours.

Guaifenesin is thought to exert its pharmacological action by stimulating receptors in the gastric mucosa. This increases the output from secretory glands of the gastrointestinal system and reflexly increases the flow of fluids

from glands lining the respiratory tract. The result is an increase in volume and decrease in viscosity of bronchial secretions. Other actions may include stimulating vagal nerve endings in bronchial secretory glands and stimulating certain centres in the brain which in mm enhance respiratory fluid flow. Guaifenesin produces its expectorant action within 24 hours.

5.2 Pharmacokinetic properties Absorption

Pseudoephedrine

Pseudoephedrine is well absorbed from the gut following oral administration. After the administration of one 60 mg pseudoephedrine tablet to healthy adult volunteers, the Cmax for pseudoephedrine was approximately 180 ng/ml with tmax occurring at approximately 1.5 - 2.0 hours.

Guaifenesin

Guaifenesin is well absorbed from the gastro-intestinal tract following oral administration, although limited information is available on its pharmacokinetics. After the administration of 600 mg guaifenesin to healthy adult volunteers, the Cmax was approximately 1.4 micrograms/ml, with tmax occurring approximately 15 minutes after drug administration.

Distribution

The apparent volume of distribution of pseudoephedrine (Vd/F) was approximately 2.8 l/kg. No information is available on the distribution of guaifenesin in humans.

Metabolism and elimination

Pseudoephedrine

The t/ was approximately 5.5 hours. Pseudoephedrine is partly metabolised in the liver by N-demethylation to norpseudoephedrine, an active metabolite. Pseudoephedrine and its metabolite are excreted in the urine; 55 % to 90 % of a dose is excreted unchanged. The apparent total body clearance of pseudoephedrine ( Cl/F ) was approximately 6 - 6.5 ml/min/kg. The rate of urinary elimination is accelerated when the urine is acidified. Conversely, as the urine pH increases, the rate of urinary elimination is slowed.

Guaifenesin

Guaifenesin appears to undergo both oxidation and demethylation. Following an oral dose of 600 mg guaifenesin to 3 healthy male volunteers, the t/ was approximately 1 hour and the drug was not detectable in the blood after approximately 8 hours.

Pharmacokinetics in Renal Impairment

Following the administration of a pseudoephedrine-containing product (8 mg acrivastine + 60 mg pseudoephedrine) to patients with varying degrees of renal impairment, the Cmax for pseudoephedrine increased approximately 1.5 fold in patients with moderate to severe renal impairment when compared to the Cmax in healthy volunteers. The tmax was not affected by renal impairment. The t/ increased 3 to 12 fold in patients with mild to severe renal impairment respectively, when compared to the t/ in healthy volunteers.

There have been no specific studies of this product, or guaifenesin in renally impaired patients.

Pharmacokinetics in Hepatic Impairment

There have been no specific studies of this product, guaifenesin or pseudoephedrine in hepatic impairment.

Pharmacokinetics in the Elderly

After the administration of a pseudoephedrine-containing product ( 8 mg acrivastine + 60 mg pseudoephedrine ) to elderly volunteers, the t/ for pseudoephedrine was 1.4 fold that seen in younger healthy volunteers. The apparent Cl/F was 0.8 fold that seen in younger healthy volunteers, and the Vd/F was essentially unchanged.

There have been no specific studies of this product, pseudoephedrine or guaifenesin in the elderly.

5.3 Preclinical safety data

The active ingredients of this product are well known constituents of medicinal products and their safety profiles are well documented. The results of pre-clinical studies do not add anything of relevance for therapeutic purposes.

6.1 List of excipients

Sucrose

Glycerol

Methyl Hydroxybenzoate Propyl Hydroxybenzoate Menthol Ethanol 96 %v/v Wild Cherry flavour Ponceau 4R (E 124) Sunset Yellow (El 10) Purified Water

6.2 Incompatibilities

None known

6.3 Shelf life

36 months

6.4 Special precautions for storage

Do not store above 25°C. Keep container in the outer carton. Do not refrigerate.

6.5 Nature and contents of container

100 ml amber glass bottles with a 2 piece or a 3 piece plastic child resistant, tamper evident closure fitted with a polyvinylidene chloride (PVDC) faced wad.

A spoon with a 5ml and a 2.5ml measure is supplied with this product.

6.6 Special precautions for disposal

None applicable