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

Logo CETOXOL® LOZENGES

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

CETOXOL® LOZENGES

COMPOSITION:
Each Lozenge contains:
  Cetylpyridinium Chloride 0,866 mg
  Benzocaine 5,000 mg
  Benzyl Alcohol 0,004 mL
PHARMACOLOGICAL CLASSIFICATION:
A 16.4 Naso, bucco-pharyngeal antiseptics.

PHARMACOLOGICAL ACTION:
Cetylpyridinium Chloride is active against the organisms causing inflammation of the mouth and throat.

In addition Cetylpyridinium Chloride is effective, rapid in action and long acting.

Benzocaine relieves pain and irritation caused by infections.

Benzyl alcohol has antiseptic and local anaesthetic properties.

INDICATIONS:
Cetoxol is indicated for the symptomatic relief of sore, infected and irritated throats.

CONTRA-INDICATIONS:
Contra-indicated in patients being treated with sulphonamides and in patients with low plasma-cholinesterase concentrations or in those receiving anticholinesterases.

It should not be given to patients with myasthenia gravis or hypersensitivity to the ingredients.

DOSAGE AND DIRECTIONS FOR USE:
Adults:
  Suck one lozenge every 3 hours when necessary. Do not exceed eight lozenges in 24 hours.
Children under 12 years:
Half a lozenge every 3 hours. SIDE EFFECTS AND SPECIAL PRECAUTIONS:
When taken by mouth Cetylpyridinium Chloride may cause nausea and vomiting.

It has depolarising muscle relaxant properties and toxic symptoms include dyspnoea and cyanosis due to paralysis of the respiratory muscles, possibly leading to asphyxia.

Depression of the central nervous system (possibly preceded by excitement and convulsions), hypotension and coma may occur.

Allergic reactions to Benzocaine may occur. Vasovagal attacks may be associated with local anaesthesia. Excitation of the central nervous system may be manifested by yawning, restlessness, excitement, dizziness, tinnitus, nystagmus, blurred vision, nausea and vomiting, muscle twitching and tremors, and convulsions. Numbness of the tongue and perioral region is an early sign of systemic toxicity. Excitation may be transient and followed by depression with drowsiness, respiratory failure and coma. Myocardial depression and peripheral vasodilatation resulting in hypotension and bradycardia, arrhythmias and cardiac arrest may occur.

Methaemoglobinaemia may occur.

Cetoxol should be given cautiously to patients with epilepsy, impaired cardiac conduction or respiratory function, or with liver damage.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In the event of accidental overdosage, a physician should be called.
Treatment is supportive and symptomatic.

IDENTIFICATION:
Plain, yellow lozenges.

PRESENTATION:
16 Foil packed lozenges.

STORAGE INSTRUCTIONS:
Store below 25
°C.
KEEP OUT OF REACH OF CHILDREN.

REFERENCE NUMBER:
H.1392 (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 February 1990

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