McNeil Healthcare (Ireland) Ltd

Non-Drowsy SUDAFED Decongestant 30mg/5ml Syrup

Each 5ml of Non-Drowsy SUDAFED Decongestant Syrup contains 30.0 mg Pseudoephedrine Hydrochloride

Excipients: Each 5ml also includes:

Sucrose 3.5 g

Methyl parahydroxybenzoate (E218) 5 mg

Ponceau 4 R (E124) 1.5 mg

For a full list of excipients see section 6.1.

Syrup.

A clear, red liquid with a characteristic raspberry odour and taste.

Non-Drowsy Sudafed Decongestant Syrup is a decongestant of the mucous membranes of the upper respiratory tract, especially the nasal mucosa and sinuses and is indicated for the symptomatic relief of nasal congestion in conditions such as allergic rhinitis, vasomotor rhinitis, the common cold and influenza.

Oral.

Adults and Children over 12 years

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

Children 6-12 years

5 ml syrup every 4-6 hours, up to four times a day.

Maximum daily dose: 20ml.

Use only when simple measures have failed to provide adequate relief.

Use for more than five consecutive days is not recommended.

Children under 6 years

Not recommended. [See Section 4.3]

Use in the Elderly

There have been no specific studies of Non-Drowsy SUDAFED Decongestant Syrup in the elderly. Experience has indicated that normal adult dosage is appropriate.

Hepatic Dysfunction

Caution should be exercised when administering Non-Drowsy SUDAFED Decongestant Syrup to patients with severe hepatic impairment.

Renal Dysfunction

Caution should be exercised when administering Non-Drowsy SUDAFED Decongestant Syrup to patients with moderate to severe renal impairment.

Non-Drowsy SUDAFED Decongestant Syrup is contraindicated in individuals who have previously exhibited hypersensitivity to pseudoephedrine or to any of the excipients listed in Section 6.1

Non-Drowsy SUDAFED Decongestant Syrup is contraindicated in individuals with severe hypertension or coronary artery disease.

Non-Drowsy SUDAFED Decongestant Syrup 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 cause a rise in blood pressure.

Non-Drowsy SUDAFED Decongestant Syrup is contraindicated in patients at risk of developing respiratory failure.

Non-Drowsy SUDAFED Decongestant Syrup is contraindicated in children under 6 years.

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 Non-Drowsy SUDAFED Decongestant Syrup and furazolidone they should not be taken together.

Although pseudoephedrine has virtually no pressor effects in normotensive patients, Non-Drowsy SUDAFED 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 Non-Drowsy SUDAFED Decongestant Syrup on the blood pressure of these patients should be observed before recommending repeated or unsupervised treatment.

As with other sympathomimetic agents, Non-Drowsy SUDAFED Decongestant 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 Non-Drowsy SUDAFED Decongestant Syrup in patients with hepatic and/or renal dysfunction. Caution should be exercised when using the product in the presence of severe hepatic impairment or moderate to severe renal impairment.

Patients with rare hereditary problems of fructose intolerance, glucose – galactose malabsorption or sucrase – isomaltase insuffiency should not take this medicine.

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.

Consult a pharmacist or other healthcare professional before use in children aged 6 to 12 years.

Concomitant use of Non-Drowsy SUDAFED Decongestant Syrup with tricyclic antidepressants, sympathomimetic agents (such as decongestants, appetite suppressants and amphetamine-like psychostimulants) or with monoamine oxidase inhibitors, which interfere with the catabolism of sympathomimetic amines, may cause a rise in blood pressure.

Because of its pseudoephedrine content, Non-Drowsy SUDAFED Decongestant Syrup may partially reverse the hypotensive action of drugs which interfere with sympathetic activity including bretylium, guanethidine, debrisoquine, methyldopa, alpha- and beta-adrenergic blocking agents.

Use with caution in diabetic patients as this product may cause an increase in blood sugar level.

Caution should be exercised during use with halogenated anaesthetic agents as they may provoke or worsen ventricular arrhythmias.

Although pseudoephedrine has been in widespread use for many years without apparent ill consequence, there are no specific data on its use during pregnancy. Caution should therefore be exercised by balancing the potential benefit of treatment to the mother against any possible hazards to the developing foetus.

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.

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 nor alter foetal morphological development and survival. There is no information on the effect of Non-Drowsy SUDAFED Decongestant Syrup on human fertility.

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 – 0.7% of a single dose of pseudoephedrine ingested by a mother will be excreted in the breast milk over 24 hours.

Sudafed Decongestant Syrup has no or negligible influence on the ability to drive and use machines

Serious side effects associated with the use of pseudoephedrine are rare.

Cardiovascular system effects include increased heart rate, tachycardia, palpitations.

Symptoms of central nervous system excitation may occur, including sleep disturbance and, rarely, hallucination.

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 predisposing factor.

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

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.

Pharmacotherapeutic Group: Respiratory System

ATC Code: R01BA02

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.

Pseudoephedrine produces its decongestant effect within 30 minutes which lasts for at least 4 hours.

In healthy adult volunteers, the administration of 60 mg psuedoephedrine resulted in a peak plasma concentration (C_max) of approximately 180 ng/ml occurring at about 2 hours (T_max) post dose. 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 the urine and increased by alkalinization. Pseudoephedrine is partly metabolised in the liver by N-demethylation to norpseudoephedrine, an active metabolite. Excretion is mainly via the urine, 55% to 75% of a dose is excreted unchanged.

The active ingredient of Non-Drowsy SUDAFED Decongestant Syrup is a well-known constituent of medicinal products and its safety is well documented. The results of preclinical studies do not add anything of relevance for therapeutic purposes.

Not applicable

3 years.

Do not store above 25°C. Keep in original container

100 ml amber glass bottles with metal roll on closures or HDPE screw caps, each cap containing a Saran or Steran (PVDC)-lined wad or polyethylene/expanded polyethylene laminated wad.

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

A measuring spoon is supplied with each bottle.

No special requirements.

McNeil Healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland

PA 823/9/1

Date of first authorisation: 23 June 1978

Date of last renewal: 1 April 2009

March 2012