TINSET® - tablets; TINSET®

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

TINSET® - tablets
TINSET® - drops

SCHEDULING STATUS:
Schedule 2

PROPRIETARY NAME
(and dosage form):

TINSET^® - tablets
TINSET^® - drops

COMPOSITION:
Each tablet contains 30 mg oxatomide which is a diphenyl methylpiperazine derivative of a substituted benzimidazole, chemically known as
1–((3–4–(diphenylmethyl)–1–piperazinyl propyl))–1,3–di hydro–2H–benzimidazol–2–one.
Each mL of the drops (25 drops per mL) contains 26 mg oxatomide monohydrate equivalent to 25 mg oxatomide.

Preservatives:	Methylparaben 0,18% m/v.
	Propylparaben 0,02% m/v.

PHARMACOLOGICAL CLASSIFICATION:
A 5.7.1 Antihistaminics.

PHARMACOLOGICAL ACTION:
TINSET is an oral antihistamine with a two-fold effect as shown in in-vitro and in certain animal models:

a.	It stabilizes mast cells by inhibiting histamine release during certain experimental reactions in animal models.
b.	It exerts antihistamine effects thus preventing the effects of histamine released as a result of allergen-antibody interactions.

INDICATIONS:
TINSET is indicated in the symptomatic treatment of allergic rhinitis and chronic urticaria.
TINSET relieves the classical nasal and ocular symptoms associated with hay-fever.
In cases of chronic urticaria TINSET reduces the severity of the erythema, and pruritis.

CONTRA-INDICATIONS:
TINSET is contra-indicated in patients with known intolerance to the substance.
The safety of TINSET in pregnant or lactating women has not been established. TINSET should not be administered to pregnant or lactating women.

WARNING:
This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressant agents. Patients should be warned against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration may lead to accidents.
In infants and children, TINSET may act as a cerebral stimulant and symptoms of overdosage may include convulsions and hyperpyrexia.

DOSAGE AND DIRECTIONS FOR USE:

ADULTS:	30 mg (1 tablet) morning and evening.
CHILDREN:	1 mg/kg body mass twice daily.
	(1 drop = 1 mg).

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Sedation, varying from slight drowsiness to deep sleep and including inability to concentrate, lassitude, dizziness, hypotension, muscular weakness, and inco-ordination. Other side-effects include gastro-intestinal disturbances such as nausea, vomiting, diarrhoea or constipation, and epigastric pain. TINSET may produce headache, blurred vision, tinnitus, elation or depression, irritability, nightmares, anorexia, difficulty in micturition, dryness of the mouth, tightness of the chest and tingling, heaviness and weakness of the hands.
Dyskinetic neurological reactions have been observed.
Administration of TINSET may cause allergy.
Local application of antihistamines carries a risk of skin sensitization with eczematous eruptions, but dermatological reactions may also result from oral administration. Blood disorders, including agranulocytosis and haemolytic anaemia have been reported.
Patients are warned that TINSET may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers. Since TINSET has anticholinergic properties, it should be used with care in conditions liable to be exacerbated or otherwise adversely affected by atropine, such as glaucoma and prostatic hypertrophy. The side-effect of anticholinergic drugs such as atropine and tricyclic antidepressants may be enhanced by the concomitant administration of TINSET. TINSET may mask warning symptoms of damage caused by ototoxic drugs such as the amino-glycoside antibiotics. TINSET may affect the metabolism of drugs in the liver.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Somnolence or less commonly, excitability, are the symptoms of over-dosage. There is no specific treatment and overdosage should be managed along general symptomatic and supportive lines.

CONDITIONS OF REGISTRATION:
None.

IDENTIFICATION:

Tablet:	White, circular, biconvex tablets, 9 mm in diameter, inscribed " ^OX" above 30 on one side and "JANSSEN" on the other side.
Drops:	Sweet, white liquid.

PRESENTATION:

Tablets:	Cartons containing three blister packs, each containing 10 tablets.
Drops:	Amber glass bottles containing 30 mL of the drops, supplied with a graduated dropper.

STORAGE INSTRUCTIONS:
Tablets and Drops: Store below 25°C.
Protect from light.
Keep out of reach of children.

REGISTRATION (OR REFERENCE NUMBER):

Tablet:	Q/5.7.1/35.
Drops:	Q/5.7.1/36

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
JANSSEN
PHARMACEUTICA
Janssen Pharmaceutica (Pty) Ltd. (Reg. No. 80/11122/07)
15th Road, Halfway House, 1685.
© JANSSEN PHARMACEUTICA (Pty) Ltd.

DATE OF PUBLICATION:

22 November, 1983.

® Trademark
Highland Print

Code No.: 021799
88B0288