SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Sudafed Decongestant Liquid Non-Drowsy Sudafed Children's Syrup

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

This product contains -

Pseudoephedrine Hydrochloride 30.0 mg per 5 ml.

3. PHARMACEUTICAL FORM

Liquid for oral administration.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

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

4.2 Posology and method of administration

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.

This product 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

This product 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 this product in the elderly, experience has indicated that normal adult dosage is appropriate.

Hepatic Dysfunction

Caution should be exercised when administering this product to patients with severe hepatic impairment.

Renal Dysfunction

Caution should be exercised when administering this product to patients with moderate to severe 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.

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.

4.4 Special warnings and precautions for use

Use with caution in occlusive vascular disease

If any of the following occur, this product should be stopped

•    Hallucinations

•    Restlessness

• Sleep disturbances Caution in moderate renal impairment.

4.5 Interaction with other medicinal products and other forms of interaction

•    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): this product 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)

4.6. Pregnancy and Lactation

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 potentital 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.

4.7. Effects on Ability to Drive and Use Machines

None known.

4.8 Undesirable effects

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

4.9 Overdose

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.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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.

Pharmacokinetic Properties

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.

5.3 Preclinical Safety Data

None stated

6. PHARMACEUTICAL PARTICULARS

6.1 List of Excipients

Citric Acid Monohydrate

Sucrose

Glycerol

Methyl Hydroxybenzoate Sodium Benzoate Ponceau 4R, E124

Flavour, Raspberry Essence No. 1NA Purified Water

6.2 Incompatibilities

None known

6.3 Shelf-Life

36 months unopened

6.4 Special Precautions for Storage

Store below 25 °C.

Protect from light.

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 2.5ml measure is supplied with this product.

6.6 Instructions for Use, Handling and Disposal

Not applicable

7 MARKETING AUTHORISATION HOLDER

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

UK

8. MARKETING AUTHORISATION NUMBER

PL 15513/0023

9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION

28 March 1997

10 DATE OF REVISION OF THE TEXT

05/03/2010