McNeil Healthcare (Ireland) Ltd

Benylin Dual Action Chesty Syrup

Pseudoephedrine Hydrochloride 30mg/5ml

Guaifenesin 100mg/5ml

Each 5ml of syrup contains 30mg Pseudoephedrine hydrochloride and 100 mg Guaifenesin

Excipients: Also includes Sucrose 3g per 5ml, Sunset yellow (E110) 0.25mg per 5ml, Ponceau 4R (E124) 0.25mg per 5ml. Methyl hydroxybenzoate (E218) 5.0mg per 5ml, Propyl hydroxybenzoate (E216) 0.5mg per 5ml and ethanol (96%) 0.25ml per 5ml.

Syrup

A clear orange-red, cherry-flavoured syrup

Benylin Dual Action Chesty Syrup is indicated for the symptomatic relief of upper respiratory tract disorders accompanied by productive cough which benefits from a combination of a nasal decongestant and an expectorant.

For oral administration

Adults and children over 12 years:

10 ml every 4-6 hours, up to four times a day

Children under 12 years:

Not recommended (see section 4.3)

The Elderly:

There have been no specific studies of Benylin Dual Action Chesty Syrup in the elderly. Experience has indicated that normal adult dosage is appropriate, although it may be advisable to monitor renal and/or hepatic function. If there is serious impairment then caution should be exercised.

Benylin Dual Action Chesty Syrup is contra-indicated in individuals who have previously exhibited intolerance to it or to any of its constituents.

Benylin Dual Action Chesty Syrup is contra-indicated in patients 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.

Benylin Dual Action Chesty Syrup is contra-indicated in patients with severe hypertension or severe coronary artery disease.

The antibacterial agent furazolidone is known to cause a dose-related inhibition of monoamine oxidase. Although there are no reports of hypertensive crises caused by the concurrent administration of Benylin Dual Action Chesty and furazolidone, they should not be taken together.

Benylin Dual Action Chesty Syrup is contraindicated for use in children under 12 years.

Although pseudoephedrine has virtually no pressor effects in normotensive patients, Benylin Dual Action Chesty Syrup should be used with caution in patients taking antihypertensive agents, tricyclic antidepressants or other sympathomimetic agents, such as decongestants, appetite suppressants and amphetamine-like psychostimulants. The effects of a single dose of Benylin Dual Action Chesty on the blood pressure of these patients should be observed before recommending repeated or unsupervised treatment.

As with other sympathomimetic agents, Benylin Dual Action Chesty Syrup should be used with caution in patients with hypertension, heart disease, diabetes, hyperthyroidism, elevated intraocular pressure and prostatic enlargement.

There have been no specific studies of Benylin Dual Action Chesty Syrup in patients with hepatic and/or renal dysfunction. Caution should be exercised in the presence of severe renal or hepatic impairment.

Benylin Dual Action Chesty should not be used for persistent or chronic cough such as occurs with smoking, asthma or emphysema or where cough is accompanied by excessive secretions unless directed by a physician.

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

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

Do not take with any other cough and cold medicine.

Concomitant use of Benylin Dual Action Chesty Syrup 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.

Because of its pseudoephedrine content, Benylin Dual Action Chesty Syrup may partially reverse the hypotensive action of drugs which interfere with sympathetic activity including bretylium, bethanidine, guanethidine, debrisoquine, methyldopa, alpha- and beta-adrenergic blocking agents.

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 preganancy. Caution should, therefore, be exercised by balancing the potential benefit of treatment to the mother against any possible hazards 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 0.5 to 0.7% of a single dose of pseudoephedrine ingested by a mother will excrete in the breast milk over 24 hours.

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

Unlikely to produce an effect.

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

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

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

Symptoms and signs

The effects of acute toxicity from Benylin Dual Action Chesty Syrup may include gastro-intestinal discomfort, nausea, vomiting, irritability, restlessness, tremor, convulsions, palpitations, hypertension, and difficulty with mictufition.

Treatment

Necessary measures should be taken to maintain and support respiration and control convulsions. Gastric lavage should be performed if indicated. Catheterisation of the bladder may be necessary. If desired, the elimination of pseudoephedrine can be accelerated by acid diuresis or by dialysis.

ATC code: R01BA52 (Pseudoephedrine, combinations)

Pseudoephedrine has direct and indirect sympathomimetic activity and is an orally effective upper respiratory decongestant. Pseudoephedrine is substantially less potent than ephedfine in producing both tachycardia and elevation of systolic blood pressure and considerably less potent in causing stimulation of the central nervous system. Guaifenesin has an expectorant action. It is thought to reduce sputum viscosity by increasing the volume and water content of the bronchial secretion, thereby facilitating the expectoration of sputum.

Pseudoephedrine produces its decongestant effect within 30 minutes, persisting for a least 4 hours. Guaifenesin produces its expectorant action within 24 hours.

In healthy adult volunteers, the administration of 60 mg pseudoephedrine resulted in a peak plasma concentration (Cmax) of approximately 180 ng/ml occurring at about 2 hours (Tmax) after drug administration. The plasma half-life was approximately 5.5 hours (urine pH maintained between 5.0-7.0). The plasma half-life of pseudoephedrine is markedly decreased by acidification of urine and increased by alkalinisation. After the administration of 600 mg guaifenesin in healthy adult volunteers the Cmax was approximately 1.4 microgram/ml with Tmax about 15 minutes after drug administration. Guaifenesin had a plasma half-life of approximately 1 hour and was not detectable in the blood after 8 hours.

Mutagenicity

The results of a wide range of tests indicate that pseudoephedrine does not pose a mutagenic risk to man.

Carcinogenicity

There is insufficient information available to determine whether pseudoephedrine or guaifenesin have carcinogenic potential.

Teratogenicity

Systemic administration of pseudoephedrine up to 50 times the human daily dosage in rats and up to 35 times the human daily dosage in rabbits, did not produce teratogenic effects.

There is insufficient information available to determine whether guaifenesin has teratogenic potential.

Fertility

Systemic administration of pseudoephedrine in rats, up to 7 times the human daily dosage in females and 35 times the human daily dosage in males, did not impair fertility or alter foetal morphological development and survival.

There is insufficient information to determine whether guaifenesin has the potential to impair fertility.

Sucrose

Glycerol

Methyl Hydroxybenzoate (E218)

Propyl Hydroxybenzoate (E216)

Ethanol

Levomenthol

Ponceau 4R (E 124)

Sunset Yellow (El 10)

Wild Cherry flavour (contains ethanol)

Purified water

None known

3 years

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

100 ml amber glass bottles closed with metal roll-on closures or HDPE screw caps fitted with saran or steran (PVDC) faced wads or 3 piece plastic child resistant, tamper evident closure fitted with a PVDC faced wad or polyethylene/expanded polyethylene laminated wad. A double headed 2.5ml/5ml spoon is provided for administration.

No special requirements

McNeil Healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland

PA 823/43/1

First date of authorisation: 7^th April 1997

Last date of authorisation: 7^th April 2007

July 2009