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

Logo AURONE® FORTE EAR DROPS

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

AURONE® FORTE EAR DROPS

COMPOSITION:
Each 15 mL contains:
  Phenazone 750,00 mg
  Benzocaine 150,00 mg
  Chlorbutol 150,00 mg
  Glycerol to 15 mL
PHARMACOLOGICAL CLASSIFICATION:
A 16.2 Aural preparations, ear drops.

PHARMACOLOGICAL ACTION:
Aurone® Forte Ear Drops combines the antibacterial and antifungal properties of Chlorbutol with the local anaesthetic properties of Phenazone and Benzocaine.

INDICATIONS:
For the treatment of acute otitis media, simple catarrhal otitis, furunculosis and other inflammatory conditions and infections of the ear.

CONTRA-INDICATIONS:
Sensitivity to any of the ingredients. The administration of Phenazone is contra-indicated where there is a family history of porphyria.

WARNING:
Should not be used in conditions with ear discharge or perforated tympanic membrane.
KEEP OUT OF REACH OF CHILDREN.

DOSAGE AND DIRECTIONS FOR USE:
5-10 drops, warmed to body temperature, to be instilled into the ear every two hours and the ear lightly plugged with cotton wool.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Phenazone may give rise to skin eruptions in susceptible individuals.

Benzocaine may cause methaemoglobinaemia.

Allergic reactions may appear.

The application of local anaesthetics to the skin for prolonged periods or to extensive areas should be avoided.

Local anaesthetics should be given cautiously to patients with epilepsy, impaired cardiac conduction, shock, myasthenia gravis or with liver damage.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Acute poisoning with Chlorbutol may produce central nervous system depression with weakness, loss of consciousness, and depressed respiration. The systemic toxicity of local anaesthetics mainly involves the central nervous system and the cardiovascular system. Excitation of the CNS may be manifested by restlessness, excitement, nervousness, dizziness, tinnitus, blurred vision, nausea and vomiting, muscle twitching and tremors, and convulsions. Numbness of the tongue and perioral region may appear as an early sign of systemic toxicity. Excitation may be transient and followed by depression with drowsiness, respiratory failure, and coma. Effects on the cardiovascular system may be myocardial depression and peripheral vasodilation resulting in hypotension and bradycardia, arrhythmias and cardiac arrest. Treatment is symptomatic and supportive.

IDENTIFICATION:
Thick, colourless liquid.

PRESENTATION:
15 mL Dropper bottle.

STORAGE INSTRUCTIONS:
Store below 25
°C.
Keep container tightly closed.
KEEP OUT OF REACH OF CHILDREN.

APPLICATION NUMBER:
H.1390 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF APPLICANT:
S.A.D. SELF MEDICATION [PTY] LIMITED
Co. Reg. No. 92/04769/07
Robbie de Lange Road, Wilsonia, EAST LONDON, 5201
P O Box 422, EAST LONDON, 5200

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
21 January 1975

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