(and dosage form):
Each tablet contains:
Terfenadine 60 mg
Terfenadine is a selective histamine H1-receptor antagonist. Antihistamine effects begin at 1-2 hours, reach their maximum at 3-4 hours and lasts in excess of 12 hours
Terfenadine is well absorbed from the gastrointestinal tract. Plasma levels of the acid metabolite, but no parent compound, were detectable within 30 minutes, peaked at about 3 hours and disappeared with a terminal elimination half-life of about 17 hours.
Terfenadine is extensively bound to serum protein. Elimination studies showed that faecal excretion accounted for 60% of the dose while 40% of the dose was eliminated via the urine.
Relief of symptoms of acute pollinosis (seasonal rhinitis, hay fever, rhinoconjunctivitis) and perennial allergic rhinitis such as sneezing, rhinorrhea, pruritis and lacrimation.
Triludan is indicated for the relief of symptoms of histamine-mediated skin disorders (urticaria) such as erythemia, pruritis, oedema and whealing.
DO NOT TAKE CONCURRENTLY WITH KETOCONAZOLE OR ITRACONAZOLE. DO NO TAKE CONCURRENTLY WITH ERYTHROMYCIN OR OTHER MACROLIDE ANTIBIOTICS.
Safety in pregnancy has not been established. Triludan should not be taken during pregnancy or by lactating women. Known hypersensitivity to terfenadine.
Terfenadine undergoes extensive metabolism and as such is contra-indicated in patients with impaired hepatic function or those receiving treatment with potent inhibitors of hepatic oxidation.
DOSAGE AND DIRECTIONS FOR USE:
DO NOT EXCEED THE RECOMMENDED DOSE.
Adults and children 12 years and older: One tablet twice daily.
Children 6 - 12 years: Half of a tablet twice daily.
Children 3 - 6 years: Refer to Triludan Suspension package insert for correct dose.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Triludan lacks significant sedative effects. Patients should, however, be warned that a small number of individuals may experience sedation. It is, therefore, advisable to determine individual response before driving or performing complicated tasks. This effect may be compounded by the simultaneous intake of alcohol or other central nervous system depressants. Other reported side-effects include: mild gastro-intestinal disturbances; visual disturbances; sweating; restlessness; headache; fatigue; weakness; nervousness; dizziness and cough. Hypersensitivity reactions.
Precautions: Caution is required when treating patients with conditions leading to QT prolongation as reports of QT prolongation and/or ventricular tachycardia have been recorded. The events may be related to altered metabolism of terfenadine, to electrolyte imbalance or both. Discontinue use if syncope occurs.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Arrhythmias including ventricular tachycardia or fibrillation or torsade de pointes have been reported at single doses of 360 mg and have occurred up to 15 hours after the dose. Cardiac monitoring for at least 24 hours is recommended. Gastric lavage and symptomatic management are advised. Haemodialysis does not effectively remove the major metabolite from the blood.
White tablet with the letter "M" embossed within two concentric circles on one side, the other side scored.
Blister packages of 60 tablets.
Store below 25°C. Keep out of the reach of children.
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
The Premier Pharmaceutical Company Limited
Epsom Downs Office Park
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
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