Sudafed Decongestant Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sudafed Decongestant Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sudafed Decongestant Tablets contain Pseudoephedrine hydrochloride 60.00mg.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
Reddish-brown, round, biconvex film-coated tablets, with ‘Sudafed’ on one side.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Sudafed Decongestant Tablets 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 conditions such as allergic rhinitis, vasomotor rhinitis, the common cold and influenza.
4.2 Posology and method of administration
For oral use.
Adults and Children over 12 years 1 tablet every 4 - 6 hours up to 4 times a day.
Use in the Elderly
There have been no specific studies of Sudafed Decongestant Tablets in the elderly. Experience has indicated that normal adult dosage is appropriate.
Hepatic Dysfunction
Caution should be exercised when administering Sudafed Decongestant Tablets to patients with severe hepatic impairment.
Renal Dysfunction
Caution should be exercised when administering Sudafed Decongestant Tablets to patients with moderate to severe renal impairment.
4.3 Contraindications
Sudafed Decongestant Tablets is contraindicated in individuals with known hypersensitivity to the product or any of its excipients.
Sudafed Decongestant Tablets is contraindicated in individuals with severe hypertension or coronary artery disease.
Sudafed Decongestant Tablets 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 occasionally cause a rise in blood pressure.
4.4 Special warnings and precautions for use
Although pseudoephedrine has virtually no pressor effects in normotensive patients, Sudafed Decongestant Tablets should be used with caution in patients suffering mild to moderate hypertension. As with other sympathomimetic agents, Sudafed Decongestant Tablets should be used with caution in patients with hypertension, heart disease, diabetes, hyperthyroidism, elevated intraocular pressure and prostatic enlargement.
Caution should be exercised when using the product in the presence of severe hepatic impairment or moderate to severe renal impairment (particularly if accompanied by cardiovascular disease).
This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
The following statements will appear on packs of this product:
Store below 30°C.
Store in the original package.
Warning: Do not exceed the stated dose.
Keep out of the reach and sight of children.
As with all medicines, if you are pregnant or currently taking any other medicine, consult your doctor or pharmacist before taking this product.
If symptoms persist consult your doctor.
Causes no drowsiness.
4.5 Interaction with other medicinal products and other forms of interaction
Concomitant use of Sudafed Decongestant Tablets with tricyclic antidepressants, sympathomimetic agents (such as decongestants, appetite suppressants and amfetamine-like psychostimulants) or with monoamine oxidase inhibitors, which interfere with the catabolism of sympathomimetic amines, may occasionally cause a rise in blood pressure.
Because of its pseudoephedrine content, Sudafed Decongestant Tablets may partially reverse the hypotensive action of drugs which interfere with sympathetic activity including bretylium, betanidine, guanethedine, debrisoquine, methyldopa, alpha- and beta-adrenergic blocking agents.
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 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.
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
Serious adverse effects associated with the use of pseudoephedrine are rare. Symptoms of central nervous system excitation may occur, including sleep disturbances and rarely hallucinations have been reported.
Skin rashes with or without irritation have occasionally been reported. Urinary retention has been reported occasionally in men receiving pseudoephedrine, prostatic enlargement could have been an important predisposing factor.
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
ATC code: R01BA.
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 180mg to man, peak plasma concentrations of 500-900ng/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
The active ingredient of Sudafed Decongestant Tablets is a well-known constituent of medicinal products and its safety is well documented. The results of pre-clinical studies do not add anything of relevance for therapeutic purposes.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose monohydrate Pregelatinised maize starch Cellulose microcrystalline
Magnesium Stearate Silica colloidal
Film Coat:
Opadry OY-S-9473
Opadry OY-S-9473 contains:
Hypromellose
Red iron oxide (E172)
Talc
Polyethylene glycol 400
6.2 Incompatibilities
None known
6.3 Shelf life
3 years
6.4 Special precautions for storage
Store below 30°C.
Store in the original package to protect from moisture.
6.5 Nature and contents of container
12 tablets in PVC/PVDC/Aluminium foil blister packs.
6.6 Special precautions for disposal
Not applicable
7 MARKETING AUTHORISATION HOLDER
McNeil Products Limited Foundation Park Roxborough Way Maidenhead Berkshire SL6 3UG United Kingdom
8 MARKETING AUTHORISATION NUMBER
PL 15513/0024
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
21/03/1997 / 28/07/2004
10
DATE OF REVISION OF THE TEXT
08/02/2010