Benylin Phlegm Cough plus Decongestant Syrup *

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

Children under 12 years:

Benylin Phlegm Cough plus Decongestant Syrup is contra-indicated in individuals who have previously exhibited intolerance to

Although pseudoephedrine has virtually no pressor effects in normotensive patients, Benylin Phlegm Cough plus Decongestant 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 Phlegm Cough plus Decongestant Syrup on the blood pressure of these patients should be observed before recommending repeated or unsupervised treatment.

There have been no specific studies of Benylin Phlegm Cough plus Decongestant Syrup in patients with hepatic and/or renal dysfunction. Caution should be exercised in the presence of severe renal or hepatic impairment.

Benylin Phlegm Cough plus Decongestant Syrup 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.

If cough tends to recur, or is accompanied by a fever, rash, or persistent headache, a physician should be consulted.

This product contains Ponceau 4R (E124) red colouring and sunset yellow (E110) which may cause allergic reactions.

This product contains Methyl Hydroxybenzoate (E 218) and Propyl Hydroxybenzoate (E 216) which may cause allergic reactions (Possibly delayed)

If symptoms persist or get worse, or if new symptoms occur, patients should stop use and consult a physician.

Pseudoephedrine exerts its vasoconstricting properties by stimulating adrenergic receptors and displacing norepinephrine from neuronal storage sites. Since MAOIs impede the metabolism of sympathomimetic amines and increase the store of releasable norepinephrine in adrenergic nervous tissue, MAOIs may potentiate the pressor effect of pseudoephedrine. Acute hypertensive crises have been reported in the medical literature with the concomitant use of MAOIs and sympathomimetic amines.

This product should not be used during pregnancy or lactation unless the potential benefit of treatment to the mother outweighs the possible risks to the developing foetus or nursing infant.

Pregnancy

Breast-feeding

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.

Pseudoephedrine distributes into and is concentrated in breast milk. Up to 0.7% of a single 60 mg dose of pseudoephedrine may be distributed into breast milk over 24 hours. Pseudoephedrine concentrations in milk are from 2 to 3 fold higher than those in plasma. This milk/plasma drug concentration profile suggests low protein binding, although no plasma protein binding data in humans are available. Data from a study of lactating mothers taking 60 mg pseudoephedrine every 6 hours suggests that from 2.2 to 6.7% of the maximum daily dose (240 mg) may be available to the infant from a breastfeeding mother.

Unlikely to produce an effect.It is not known if this product has an effect on the ability to drive or operate machinery.

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.

Placebo-controlled studies with sufficient adverse event data were not available for the combination of guaifenesin and pseudoephedrine.

Adverse drug reactions identified during clinical trials and post-marketing experience with guaifenesin or pseudoephedrine or combination are listed below by System Organ Class (SOC).

The frequencies are defined according to the following convention:

Very common ≥1/10

Common ≥1/100 and < 1/10

Uncommon ≥1/1,000 and <1/100

Rare ≥1/10,000 and <1/1,000

Very rare <1/10,000

Not known (cannot be estimated from the available data).

ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as ‘Not known’

† Adverse events reported by ≥1% of subjects in randomised, placebo-controlled trials with single-ingredient pseudoephedrine.

1

2

3

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the online reporting option (preferred method) accessible from the IMB homepage (www.imb.ie). A downloadable report form is also accessible from the IMB website, which may be completed manually and submitted to the IMB via ‘freepost’ (see details below). Alternatively, the traditional post-paid ‘yellow card’ option may also be used.

FREEPOST

Pharmacovigilance Section

Irish Medicines Board

Kevin O’Malley House

Earlsfort Centre

Earlsfort Terrace

Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail:medsafety@hpra.ie.

Guaifenesin

Somnolence (very rare) may be associated with guaifenesin overdose.

When taken in excess, guaifenesin may cause renal calculi.

Pseudoephedrine

Overdosage may result in nausea, vomiting, sympathomimetic symptoms including central nervous system stimulation, insomnia, tremor, mydriasis, anxiety, agitation, hallucinations, seizures, palpitations, tachycardia, hypertension, and reflex bradycardia.

Other effects may include dysrhythmias, hypertensive crisis, intracerebral haemorrhage, myocardial infarction, psychoses, rhabdomyolysis, hypokalaemia, and ischemic bowel infarction.

Drowsiness has been reported with overdose in children

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.