Decongestant Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Decongestant Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient per tablet
Pseudoephedrine hydrochloride 60 mg
3 PHARMACEUTICAL FORM
Tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the relief of nasal and sinus congestion without causing drowsiness.
4.2 Posology and method of administration
Adults and children over 12 years: One tablet. The dose may be taken 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.
For oral administration.
4.3 Contraindications
Hypersensitivity to any of the ingredients. Avoid in patients with cardiovascular disease, severe renal impairment, diabetes mellitus, closed angle glaucoma, hyperthyroidism, prostatic enlargement and phaeochromocytoma.
4.4 Special warnings and 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.
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 digitised patients.
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 anxiety, restlessness, tremor, insomnia, tachycardia, cardiac arrhythmias, palpitations, hypertension, nausea, vomiting and headache and occasionally urinary retention and skin rashes. Hallucinations have been reported rarely, particularly in children.
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 absorbed from the gastrointestinal tract 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 Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Explotab Maize starch pdr Microcrystalline cellulose Pregelled maize starch Stearic acid.
6.2 Incompatibilities
None stated.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
None.
6.5 Nature and contents of container
A card carton containing a blister push-through pack consisting of a PVC/PVDC blister heat sealed to a hard temper aluminium foil.
Pack size: 12
6.6 Special precautions for disposal
None.
7 MARKETING AUTHORISATION HOLDER
ASPAR PHARMACEUTICALS LIMITED
29-30 CAPITOL WAY
COLINDALE
LONDON
NW9 OEQ
UNITED KINGDOM
8 MARKETING AUTHORISATION NUMBER(S)
PL 08977/0021
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
January 2007
10 DATE OF REVISION OF THE TEXT
18/06/2008