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

Logo MEDI-KEEL A THROAT LOZENGES
MEDI-KEEL A HONEY AND LEMON THROAT LOZENGES
MEDI-KEEL A BLACKCURRANT THROAT LOZENGES

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

MEDI-KEEL A THROAT LOZENGES
MEDI-KEEL A HONEY AND LEMON THROAT LOZENGES
MEDI-KEEL A BLACKCURRANT THROAT LOZENGES

COMPOSITION:
Each lozenge contains:
Cetylpyridinium chloride         1,5 mg
Benzocaine         12,0 mg

PHARMACOLOGICAL CLASSIFICATION:
A.16.3 Surface anaesthetics

PHARMACOLOGICAL ACTION:
Benzocaine is a mild local anaesthetic. Cetylpyridinium Chloride is quarternary pyridinium antiseptic compound. It has antibacterial and antifungal properties. Some gram-negative bacteria, especially Pseudomonas cepacia, are resistant.

INDICATIONS:
For the symptomatic relief of sore throat.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients.
Known sensitivity to benzocaine or cetylpyridinium chloride. Benzocaine is contra-indicated in patients with low plasma-cholinesterase concentrations or in those receiving anticholinesterases. Safety in pregnancy and lactation has not been established. Not recommended for children under 6 years of age.

DOSAGE AND DIRECTIONS FOR USE:
Dissolve one lozenge slowly in the mouth, every 2-3 hours as required.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Some patients may become hypersensitive after repeated use. Severe sore throat or sore throat accompanied by fever or headache or nausea and vomiting, or any sore throat persisting for more than 2 days, may be serious. In such cases, consult a physician.
Systemic adverse effects may occur with benzocaine, as a result of the absorption of large amounts through mucous membranes or damaged skin or from highly vascular areas. Excitation of the central nervous system may be manifested by yawning, restlessness, excitement, nervousness, dizziness, tinnitus, nystagmus, blurred vision, nausea and vomiting, muscle twitching, tremors and convulsions. Numbness of the tongue and peri-oral region is an early sign of systemic toxicity. 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 vasodilation resulting in hypotension and bradycardia, arrhythmias and cardiac arrest may occur.
Idiosyncratic reactions have been reported. Allergic reactions may occur. Benzocaine should be given with caution to patients with epilepsy, impaired cardiac conduction or respiratory function, or with liver damage; patients with myasthenia gravis are particularly susceptible to the effects of local anaesthetics.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage 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 with convulsions, hypotension and coma may occur.
Treatment is symptomatic and supportive

IDENTIFICATION:
Medi-Keel A throat lozenges: yellow, oval, translucent, biconvex lozenge with peppermint/ spearmint flavour.
Medi-Keel A Honey and Lemon throat lozenges: honey-yellow, oval, translucent, biconvex lozenge with lemon honey flavour.
Medi-Keel A Blackcurrant throat lozenges: maroon, oval, translucent, biconvex lozenge with blackcurrant flavour.

PRESENTATION:
Blister pack of 16 lozenges.

STORAGE INSTRUCTIONS:
Store in cool place (below 25°C) protected from moisture. Protect from light. Keep out of reach of children.

REFERENCE NUMBER:
Medi-Keel A Throat Lozenges: T/16.3/223
Medi-Keel A Honey and Lemon Throat Lozenges: 33/16.3/0496
Medi-Keel A Blackcurrant Throat Lozenges: 33/16.3/0495

NAME AND BUSINESS ADDRESS OF APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue, Bryanston Ext 77
Private Bag X69, Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
07/07/86

New addition to this site: April 2004
Source: Pharmaceutical Industry

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