(and dosage form):
Each 5 mL of suspension contains :
Terfenadine 30 mg
Benzyl alcohol 1,00% v/v
A 5.7.1 Antihistamines.
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.
Symptomatic relief of symptoms and signs associated with allergic skin conditions, allergic rhinoconjunctivitis, seasonal and perennial allergic rhinitis.
DO NOT TAKE CONCURRENTLY WITH KETOKONAZOLE OR ITRACONAZOLE. DO NOT 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:
SHAKE THE BOTTLE. DO NOT EXCEED THE RECOMMENDED DOSE.
Adults and children
12 years and older: Two medicine measures (10 mL) twice daily.
Children 6 - 12 years: One medicine measure (5 mL) twice daily.
Children 3 - 6 years: Half a medicine measure (2,5 mL) twice daily.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Triludan lacks 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 central nervous system depressants. Other reported side-effects include: mild gastrointestinal 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 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.
Homogenous white suspension with cherry odour and taste.
100 mL amber glass bottle.
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:
08786 - 10/94
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