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AURALYT® (EAR DROPS)

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

AURALYT^® (EAR DROPS)

COMPOSITION:
Each 1 mL contains:

	Glycerin dehydrated to make	1,0 mL
	Antipyrine	54,0 mg
	Benzocaine	14,0 mg

PRESERVATIVE:

Oxyquinoline sulphate

0,0376% m/v

PHARMACOLOGICAL CLASSIFICATION:
A.16.2 Aural preparations, ear drops.

PHARMACOLOGICAL ACTION:
AURALYT® has analgesic (pain-relieving) local anaesthetic and hygroscopic properties.

INDICATIONS:
AURALYT® is indicated for the relief of pain and reduction of inflammation in the congestive and serious stages of otitis media (middle ear infection), also for relief of discomfort in acute
stages of "swimmers ear". It is especially useful for children and in facilitating the removal of excessive impacted cerumen (ear wax). AURALYT® is also indicated as adjuvant therapy when other medicines such as antibiotics or sulphonamides are administered systemically for ear infection.

CONTRA-INDICATIONS:
Known hypersensitivity (allergy) to any of the ingredients or para-aminobenzoic acid and its derivatives or hydroxybenzoate preservatives. AURALYT® should not be used in conditions with ear discharge or perforated tympanic membrane (pierced eardrum).

WARNINGS:
Do not use if solution is brown or contains a precipitate. Discard this medicine six months after opening bottle. Discontinue promptly if sensitization (allergic reaction) or irritation occurs.

DOSAGE AND DIRECTIONS FOR USE:
Otitis media (middle ear infection):
Instil AURALYT® permitting the solution to run along the wall of the canal, until it is filled. Avoid touching the ear with the dropper. Then moisten a cotton pledget with AURALYT® and insert into meatus. Repeat every one to two hours until pain and congestion are relieved.

Removal of cerumen (ear wax): Instil AURALYT® three times daily for two days to help detach ear wax from wall of canal. Irrigate with warm water.

NOTE: Do not rinse dropper.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Benzocaine can cause a hypersensitivity reaction consisting of rash, urticaria and oedema. Individuals frequently exposed to ester-type local anaesthetics can develop contact dermatitis characterized by erythema and pruritus which may progress to vesiculation and oozing.

Absorption of antipyrine and benzocaine in the plasma may cause chills, nausea, vomiting, tinnitus and agranulocytosis. Such reactions are unlikely following application of AURALYT® to the external ear canal. The safety of AURALYT® for use during pregnancy and lactation has not been established. Use only if the expected benefits substantially outweigh the potential risk to the foetus, according to the judgement of the doctor.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
If AURALYT® is accidentally ingested the following symptoms may occur:

Glycerin:	Headache, thirst, nausea (queasiness) hyperglycemia, cardiac arrhythmias, and hyperosmolar non-ketotic coma.
Benzocaine:	Methaemoglobinaemia (modification of the normal blood pigments), restlessness, excitement, nervousness, dizziness, tinnitus (ringing in the ears), blurred vision, nausea and vomiting, muscle twisting and tremor and convulsions (seizures). Numbness of the tongue and perioral region may appear as an early sign of systemic intoxication. Excitation may be transient, and followed by depression with drowsiness, respiratory failure and coma. There may be simultaneous effects on the cardiovascular system with myocardial depression and peripheral vasodilatation resulting in hypotension and bradycardia, arrhythmias and cardiac arrest may occur.
Antipyrine:	Skin eruptions, nausea, drowsiness, convulsions and coma may occur. Treatment is supportive and symptomatic.

IDENTIFICATION:
Colourless to light amber, clear, viscous solution.

PRESENTATION:
White plastic dropper bottles of 15 mL or 30 mL capacity with a low density polyethylene dome screw cap.

STORAGE INSTRUCTION:
Store in a cool place below 25 °C, protected from light. Keep tightly closed.
KEEP OUT OF REACH OF CHILDREN.

REFERENCE NUMBER:
H.1480 (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

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
January 1991

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