INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo FENDIN 60 TABLETS
FENDIN 120 TABLETS

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

FENDIN 60 TABLETS
FENDIN 120 TABLETS

COMPOSITION:
Each FENDIN 60 tablet contains:
Terfenadine USP 60 mg
Cetylpyridinium chloride 2,5% m/m

Each FENDIN 120 tablet contains: Terfenadine USP 120 mg
Cetylpyridinium chloride 2,5% m/m

PHARMACOLOGICAL CLASSIFICATION:
A 5.7.1 Anti-histaminics

PHARMACOLOGICAL ACTION:
Terfenadine is a H1-receptor antagonist.
Terfenadine is well-absorbed after oral administration and is metabolised by the hepatic cytochrome P-450 system and has active metabolites. It's elimination half-life is about 20,3 hours. In children terfenadine has been found to have shorter elimination half-life values.
Histamine skin wheal studies have shown that terfenadine in single and repeated doses of 60 mg has an anti-histaminic effect beginning at 1 - 2 hours, reaching its maximum at 3 - 4 hours, and lasting in excess of 12 hours.
Sixty percent of the dose is eliminated in the faeces. Approximately 40% of the total dose is excreted renally.

INDICATIONS:
FENDIN is indicated for the relief of symptoms associated with seasonal allergic rhinitis such as sneezing, rhinorrhea, pruritis and lacrimation.
It is also indicated for the relief of symptoms of histamine related skin disorders (urticaria) such as erythema, pruritus, oedema and whealing.
Clinical studies conducted to date have not demonstrated the effectiveness of terfenadine in the common cold.

CONTRA-INDICATIONS:
Concomitant administration of terfenadine with ketoconazole or itraconazole is contra-indicated.
Terfenadine is also contra-indicated in patients with disease states or other concomitant medications known to impair its metabolism, including significant hepatic dysfunction, and concurrent use of clarithromycin, erythromycin and troleandomycin. QT prolongation has been demonstrated in some patients taking terfenadine in these settings, and rare cases of serious cardiovascular events, including death, cardiac arrest, and torsades de pointes, have been reported in these patient populations. It is contra-indicated in significant liver impairment, in pre-existing prolongation of the QT interval or in electrolyte imbalance.
FENDIN is contra-indicated in patients with a known hypersensitivity to terfenadine or any of its ingredients.
Pregnancy and lactation.
Patients with porphyria.

DOSAGE AND DIRECTIONS FOR USE:
Do not exceed the recommended dosage.
The recommended dosage of FENDIN 60 tablets in adults is 60 mg (1 tablet of 60 mg) twice daily.
The recommended dosage of FENDIN 120 tablets in adults is 120 mg (1 tablet of 120 mg) once daily.
Children: This product is not suitable for use in children below the age of 12 years.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Terfenadine 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: Increase in appetite, mild gastro-intestinal disturbances, reduced saliva, dry tongue, lips and throat, visual disturbances, sweating, restlessness, headache, fatigue, weakness, nervousness, dizziness and cough. Hypersensitivity reactions and ventricular arrhythmias.
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 or to an electrolyte imbalance or both. Discontinue if syncope occurs.

Interactions:
Ketoconazole and Itraconazole.
Concurrent use with ketoconazole or itraconazole may increase plasma levels of terfenadine, because of inhibition of the P-450 metabolic pathways by these antifungals, increased plasma levels of terfenadine may result in cardiotoxic effects (prolongation of the QT interval, torsades de pointes, and other ventricular arrhythmias).
Due to the chemical similarity of fluconazole, metronidazole, and miconazole to ketoconazole, caution is also recommended with concurrent use of these other imidazole antifungals and terfenadine.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Signs and symptoms of overdosage may be absent or mild but adverse cardiac events including cardiac arrest, ventricular arrhythmias including torsades de pointes and QT prolongation have been reported at overdoses of 360 mg and QTc prolongations of up to 30% have been observed at a dose of 300 mg b.i.d. Seizures and syncope have also been reported.
In overdose cases, where ventricular arrhythmias are associated with significant QTc prolongation, treatment with antiarrhythmics known to prolong QTc intervals is not recommended.
Therefore, in cases of overdosage, cardiac monitoring for at least 24 hours is recommended and for as long as QTc is prolonged, along with standard measures to remove any unabsorbed medicine. Limited experience with the use of hemoperfusion or haemodialysis was not successful in completely removing the acid metabolite of terfenadine from the blood.
Haemodialysis does not effectively remove the major metabolite from the blood.
Treatment of the signs and symptoms of overdosage should be symptomatic and supportive after the acute stage.

IDENTIFICATION:
FENDIN 60: White to off-white, flat round uncoated tablets having bevelled edges embossed with "T" surrounded by two circles on one side and "60" on the other side.
FENDIN 120: White to off-white, flat round uncoated tablets having bevelled edges embossed with "T" surrounded by two circles on one side and "120" on the other side with a scoreline.

PRESENTATION:
FENDIN 60 Tablets: Carton containing 6 x 10 tablets in blister strips.
  Carton containing 10 x 10 tablets in blister strips.
FENDIN 120 Tablets: Carton containing 3 x 10 tablets in blister strips.
  Carton containing 10 x 10 tablets in blister strips.

STORAGE INSTRUCTIONS:
Store below 25°C, protected from moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
FENDIN 60: 30/5.7.1/0195
FENDIN 120: 30/5.7.1/0336

NAME AND BUSINESS ADDRESS OF APPLICANT:
RANBAXY (SA) (PTY) LTD.
Lincoln House
Epsom Downs Office Park
13 Sloane Street
Epsom Downs
Bryanston

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
FENDIN 60: 21.06.96
FENDIN 120: 14 November 1996

PLTF017

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