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BOOTS DECONGESTANT TABLETS
Active substance(s): PSEUDOEPHEDRINE HYDROCHLORIDE
QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient Pseudoephedrine hydrochloride
PHARMACEUTICAL FORM Tablets
CLINICAL PARTICULARS Therapeutic Indications For the relief of nasal and sinus congestion without causing drowsiness. For oral administration.
Posology and Method of Administration Adults and children over 12 years: One tablet if necessary, up to four times daily at intervals of not less than 4 hours. Children under 12 years: Not recommended. Elderly: There is no need for dosage reduction in the elderly.
Contra-Indications Hypersensitivity to any of the ingredients. Avoid in patients with cardiovascular disease, hypertension, severe renal impairment, diabetes mellitus, closed angle glaucoma, hyperthyroidism, prostatic enlargement and phaeochromocytoma.
Special Warnings and Special Precautions for Use If symptoms do not go away talk to your doctor. Keep all medicines out of the reach of children. Warning: Do not exceed the stated dose.
Interaction with other Medicinal Products and other Forms of Interaction Should not be given to patients being treated with monoamine oxidase inhibitors or within 14 days of stopping such treatment. May enhance the effects of anticholinergic drugs such as tricyclic antidepressants. May increase the possibility of arrhythmias in digitalised patients. May increase the vasoconstrictor effects of ergot alkaloids.
Pregnancy and Lactation The safety of decongestant tablets during pregnancy and lactation has not been established but in view of a possible association of foetal abnormalities with first trimester exposure to pseudoephedrine, the use of the product during pregnancy should be avoided. The amounts of pseudoephedrine secreted into breast milk are considered to be too small to be harmful.
Effects on Ability to Drive and Use Machines No adverse effects known.
Undesirable Effects Adverse effects may include dry mouth, anxiety, restlessness, tremor, insomnia, tachycardia, cardiac arrhythmias, palpitations, hypertension, nausea, vomiting, headache and occasionally urinary retention in males and skin rashes. Hallucinations have been reported rarely, particularly in children.
Overdose Symptoms of overdosage include irritability, restlessness, palpitations, hypertension, difficulty in micturition, nausea, vomiting, thirst and
convulsions. In severe overdosage gastric lavage and aspiration should be performed. Symptomatic and supportive measures should be undertaken, particularly with regard to cardiovascular and respiratory systems. Convulsions should be controlled with intravenous diazepam. Chlorpromazine may be used to control marked excitement and hallucinations. Severe hypertension may need to be treated with an alpha-adrenoreceptor blocking drug, such as phentolamine. A beta blocker may be required to control cardiac arrhythmias.
PHARMACOLOGICAL PROPERTIES Pharmacodynamic Properties Pseudoephedrine is a sympathomimetic agent with direct and indirect effects on adrenergic receptors. It has alpha and beta adrenergic activity and some stimulant effect on the central nervous system. The sympathomimetic effect of pseudoephedrine produces vasoconstriction which in turn relieves nasal congestion.
Pharmacokinetic Properties Pseudoephedrine is readily and completely absorbed from the gastrointestinal tract. It is resistant to metabolism by monoamine oxidase and is largely excreted in the urine unchanged. It has an elimination half-life of 5 to 8 hours but its urinary elimination and hence half-life is pH dependent. Pseudoephedrine is rapidly distributed throughout the body, its volume of distribution being 2 to 3L/KG bodyweight.
Pre-clinical Safety Data There are no preclinical data of relevance to the prescriber which are additional to that already included.
PHARMACEUTICAL PARTICULARS List of Excipients
Sodium Starch Glycolate Maize Starch prd Microcrystalline Cellulose Pregelled Maize Starch Purified Water Stearic Acid
Incompatibilities None are known.
Shelf-Life 36 months.
Special Precautions for Storage None.
Nature and contents of container Blister pack of white or clear 250 microns PVC coated with 40gsm PVdC and 20 micron aluminium foil.
Pack sizes: 6, 7, 10, 12 tablets. 6.6. Instructions for Use, Handling and Disposal None.
MARKETING AUTHORISATION HOLDER
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA
MARKETING AUTHORISATION NUMBER(S) PL 00014/0375
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION 28 January 1988 / 17 December 1997
DATE OF REVISION OF THE TEXT
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