Sudafed Decongestant Liquid
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.
5.2
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