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.
36 months.
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.
None are known.
Sodium Starch Glycolate
Maize Starch prd
Microcrystalline Cellulose
Pregelled Maize Starch
Purified Water
Stearic Acid
Tablets
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.
Skin and subcutaneous tissue disorders:
Frequency unknown: Severe skin reactions, including acute generalized exanthematous pustulosis (AGEP).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
There are no preclinical data of relevance to the prescriber which are additional to that already included.
For the relief of nasal and sinus congestion without causing drowsiness.
For oral administration.
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.
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.
The Boots Company PLC
1 Thane Road West
Nottingham
NG2 3AA
None.
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.
PL 00014/0375
|
Active ingredient | |
|
Pseudoephedrine hydrochloride | 60mg/tablet |
Severe Skin reactions
Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) may occur with pseudoephedrine-containing products. This acute pustular eruption may occur within the first 2 days of treatment, with fever, and numerous, small, mostly non-follicular pustules arising on a widespread oedematous erythema and mainly localized on the skin folds, trunk, and upper extremities. Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema, or many small pustules are observed, administration of Decongestant Tablets should be discontinued and appropriate measures taken if needed.
If symptoms are not controlled by Boots Decongestant Tablets, medical advice should be sought.
Keep all medicines out of the reach of children.
Warning: Do not exceed the stated dose.
No adverse effects known.
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.
None.
28 January 1988 / 17 December 1997 / 17 December 2002
