Sudafed (Pseudoephedrine)

NON-DROWSY SUDAFED CHILDREN'S SYRUP

Sudafed Decongestant Liquid

This product contains -

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.

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.

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.

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 and monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOI treatment

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, this product should be stopped

- Hallucinations

- Restlessness

- Sleep disturbances

Caution in moderate renal impairment

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.

None known

36 months unopened

Store below 25°C.

Protect from light.

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.

Not applicable

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire SL6 3UG

United Kingdom

PL 15513/0023

28 March 1997

30 January 2013