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

Logo PRODOL (SOLUTION)

SCHEDULING STATUS:
Schedule 1.

PROPRIETARY NAME
(and dosage form):

PRODOL (SOLUTION)

COMPOSITION:
Each 1 mL contains:

Benzocaine 10 mg
Cetylpyridinium chloride 1 mg
Ethanol 15% v/v

PHARMACOLOGICAL CLASSIFICATION:
a.4 Local Anaesthetic.

PHARMACOLOGICAL ACTION:
Prodol has local anaesthetic, fungicidal and bactericidal properties.

INDICATIONS:
Alleviation of pain and discomfort caused by minor irritation from sore gums, cold sores, fever blisters and denture irritation.

CONTRA-INDICATIONS:
Sensitivity to any of the ingredients or related substances. This preparation should not be used by people with high temperature or serious sore throat, unless prescribed by a doctor. It should not be used by infants younger than six (6) months. Benzocaine is contraindicated in patients receiving anticholinesterases or those with low plasma-cholinesterase.

DOSAGE AND DIRECTIONS FOR USE:
Children and adults: Apply the solution to the affected area with a clean finger or a piece of cottonwool every 3 –4 hours. Minimum quantities must be applied. Do not exceed a maximum of five drops per application. Do not use for longer than seven days.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Local anaesthetics may provoke types I and IV hypersensitivity reactions. Allergic reactions may occur as a result of repeated handling or topical use. Adverse effects may include excitation of the Central Nervous System, 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. There may be simultaneous effects on the cardiovascular system with myocardial depression and peripheral vasodilation resulting in hypotension and bradycardia; arrhythmia and cardiac arrest may occur.
Methaemoglobinaemia has been reported following the topical application of benzocaine in usual and toxic concentrations. Infants younger than 3 months appear to be susceptible to induced methaemoglobinaemia probably due to their limited enzyme capacity.
Benzocaine should be given with caution to patients with epilepsy, impaired cardiac conduction, shock, or liver damage; patients with myasthenia gravis are particularly susceptible to the effects of local anaesthetics. Benzocaine may antagonize the action of sulphonamides. Topical solutions of quatemary ammonium antiseptics such as cetylpyridium chloride do not generally cause irritation, but some patients may become hypersensitive after repeated applications.
Patients suffering from traumatic mucosa and sepsis should use the preparation with care. If pain, redness, rash, irritation and swelling persists, or if infection occurs, discontinue use and consult a doctor or dentist.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Excessive ingestion of the solution may result in nausea and vomiting. Benzocaine has low systemic toxicity. Should syndromes of cyanosis appear, discontinue treatment immediately and consult your doctor. Treatment is symptomatic and supportive.

IDENTIFICATION:
A clear off-white transparent viscous liquid, slightly sweet and odourless.

PRESENTATION:
20 mL round amber glass bottles available.

STORAGE INSTRUCTIONS:
Store at room temperature, below 25°C. Protect from light. KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
Z/4/111.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
TECHNIKON LABORATORIES (PTY) LTD
1073 Anvil Road, Robertville, Florida. Tel: (011) 674-1091

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
12 March 1996

New addition to this site: February 2007
Source: Pharmaceutical Industry

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