NON-DROWSY SUDAFED DECONGESTANT ELIXIR

NON-DROWSY SUDAFED CHILDREN'S SYRUP*

NON-DROWSY SUDAFED DECONGESTANT ELIXIR contains -

Pseudoephedrine Hydrochloride

30.0 mg per 5 ml

Liquid for oral administration.

For the relief of nasal congestion and congestion of mucous membranes of the upper respiratory tract associated with the common cold.

Oral

Adults and Children aged 12 years and over:

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

Children 6 - 12 years

5 ml elixir every 4-6 hours up to 4 times a day. Not to be used for more than five days without the advice of a doctor. Parents or carers should seek medical attention if the child's condition deteriorates during treatment.

NON-DROWSY SUDAFED DECONGESTANT ELIXIR may be diluted 1:1 (1 in 2) or 1:3 (1 in 4) with syrup BP. These dilutions are stable for 4 weeks if stored at 25°C.

Children under 6 years

NON-DROWSY SUDAFED DECONGESTANT ELIXIR is contraindicated in children under the age of 6 years (see section 4.3).

Use in the Elderly

There have been no specific studies of NON-DROWSY SUDAFED DECONGESTANT ELIXIR in the elderly, experience has indicated that normal adult dosage is appropriate.

Hepatic Dysfunction

Caution should be exercised when administering NON-DROWSY SUDAFED DECONGESTANT ELIXIR to patients with severe hepatic impairment.

Renal Dysfunction

Caution should be exercised when administering NON-DROWSY SUDAFED DECONGESTANT ELIXIR to patients with moderate to severe renal impairment.

Do not exceed the stated dose.

Keep out of the reach and sight of children.

NON-DROWSY SUDAFED DECONGESTANT ELIXIR is contraindicated in individuals with known hypersensitivity to the product or any of its components.

Concomitant use of other sympathomimetic decongestants, beta-blockers (see section 4.5) and monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOI treatment (see section 4.5)

Cardiovascular disease including hypertension

Diabetes mellitus

Phaeochromocytoma

Hyperthyroidism

Closed angle glaucoma

Severe renal impairment

Not to be used in children under the age of 6 years.

Use with caution in occlusive vascular disease

If any of the following occur, NON-DROWSY SUDAFED DECONGESTANT ELIXIR should be stopped

• Hallucinations

• Restlessness

• Sleep disturbances

Caution in moderate renal impairment

• MAOIs and/or RIMAs: Should not be given to patients taking MAOIs or within 14 days of stopping treatment: increased risk of hypertensive crisis

• Moclobemide: risk of hypertensive crisis.

• Antihypertensives (including adrenergic neurone blockers & beta-blockers): NON-DROWSY SUDAFED DECONGESTANT ELIXIR may block the hypotensive effects.

• Cardiac glycosides: increased risk of dysrhythmias

• Ergot alkaloids (ergotamine & methysergide): increased risk of ergotism

• Appetite suppressants and amphetamine-like psychostimulants: risk of hypertension

• Oxytocin – risk of hypertension

• Enhances effects of anticholinergic drugs (such as TCAs)

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 dose in rats and up to 35 times the human daily dosage in rabbits did not produce teratogenic effects. 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.

None known.

Cardiovascular effects

• Tachycardia/palpitations

• Other cardiac dysrhythmias and hypertension

CNS effects

• Irritability

• Anxiety

• Restlessness

• Excitability

• Insomnia

• Hallucinations and paranoid delusion

Skin reactions including rash

Hypersensitivity reactions – cross-sensitivity may occur with other sympathomimetics.

Other reactions

• Nausea and/or vomiting

• Headache

• Urinary retention

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

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.

Psuedoephedrine has direct and indirect sympathlomimetic activity and is an orally effective upper respiratory tract decongestant. Psuedoephedrine 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 is rapidly and completely absorbed after oral administration. After an oral dose of 180 mg to man, peak plasma concentrations of 500-900 ng/ml were obtained about 2 hours post dose. The plasma half life was about 5.5 hours and was increased in subjects with alkaline urine and decreased in subjects with acid urine. The only metabolism was n-demethylation which occurred to a small extent. Excretion was mainly via the urine.

None stated.

Citric Acid Monohydrate

Sucrose

Glycerol

Methyl Hydroxybenzoate

Sodium Benzoate

Ponceau 4R, E124

Flavour, Raspberry Essence No 1NA

Purified Water

None known

36 months unopened

Store below 25°C.

Protect from light.

30 ml and *100 ml amber glass bottles with metal roll on closures or plastic screw caps, each cap containing a PVDC-lined wad or polyethylene/expanded polyethylene laminated wad.

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.

The 30 ml bottle is a sample pack.

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

Not applicable

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire SL6 3UG

United Kingdom

PL 15513/0023

28 March 1997

31 March 2009

* Non-Drowsy Sudafed Decongestant Elixir is an alternative name for this product. Please read Non-Drowsy Sudafed Children's Syrup as an alternative where Non-Drowsy Sudafed Decongestant Elixir appears.