Decongestant Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Decongestant Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Pseudoephedrine hydrochloride 60mg/tablet
3. PHARMACEUTICAL FORM
Tablets
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
For the relief of nasal and sinus congestion without causing drowsiness. For oral administration.
4.2. 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.
4.3 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.
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.
4.5. 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.
4.6. 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.
4.7. Effects on Ability to Drive and Use Machines
No adverse effects known.
4.8 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.
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.
4.9. 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.
5. PHARMACOLOGICAL PROPERTIES
5.1. 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.
5.2. 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.
5.3. Pre-clinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that
already included.
6. PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Sodium Starch Glycolate Maize Starch prd Microcrystalline Cellulose Pregelled Maize Starch Purified Water Stearic Acid
6.2. Incompatibilities
None are known.
6.3. Shelf-Life
36 months.
6.4. Special Precautions for Storage
None.
6 PHARMACEUTICAL PARTICULARS
6.5 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.
None.
7. MARKETING AUTHORISATION HOLDER
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA
8. MARKETING AUTHORISATION NUMBER(S)
PL 00014/0375
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
28 January 1988 / 17 December 1997
10 DATE OF REVISION OF THE TEXT
1st April 2015