MEDI-KEEL® A THROAT LOZENGES MEDI-KEEL® A HONEY AN

SCHEDULING STATUS: S1
PROPRIETARY NAME: MEDI-KEEL ® A THROAT LOZENGES
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MEDI-KEEL ® A HONEY AND LEMON THROAT LOZENGES
MEDI-KEEL ® A BLACKCURRANT THROAT LOZENGES
(AND DOSAGE FORM) (LOZENGE)
COMPOSITION :
Each lozenge contains:
Benzocaine 12,0 mg
Cetylpyridinium chloride
Contains sugar:
1,5 mg
Sucrose 2,32 g
Liquid glucose 1,54 g
Tartrazine free
PHARMACOLOGICAL CLASSIFICATION:
A 16.3 Surface anaesthetics
PHARMACOLOGICAL ACTION:
Benzocaine is a mild local anaesthetic.
Cetylpyridinium chloride is a quaternary 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.
CONTRAINDICATIONS:
Hypersensitivity to any of the ingredients.
Known sensitivity to benzocaine or cetylpyridinium chloride.
Benzocaine is contraindicated 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 to 3 hours as required.
SIDE EFFECTS AND SPECIAL PRECAUTIONS :
Benzocaine :
Some patients may become hypersensitive after repeated use.
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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 CNS 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 perioral 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.
Benzocaine is metabolised to paraaminobenzoic acid and can antagonise the action of
sulphonamides.
Benzocaine may impair swallowing and increase the risk of aspiration.
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:

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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 light and moisture.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBERS:
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 HOLDER OF THE CERTIFICATE OF REGISTRATION:
Adcock Ingram Limited
3011 William Nicol Drive
Bryanston
Private Bag X69, Bryanston, 2021
www.adcock.co.za
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
07July 1986

SKEDULERINGSTATUS: S1
EIENDOMSNAAM: MEDI-KEEL® A THROAT LOZENGES
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(EN DOSEERVORM)
MEDI-KEEL® A HONEY AND LEMON THROAT LOZENGES
MEDI-KEEL® A BLACKCURRANT THROAT LOZENGES
(SUIGTABLET)
SAMESTELLING:
Elke suigtablet bevat:
Bensokaïen 12,0 mg
Setielpiridiniumchloried
Bevat suiker:
1,5 mg
Sukrose 2,32 g
Vloeibare glukose 1,54 g
Tartrasienvry
FARMAKOLOGIESE KLASSIFIKASIE:
A 6.3 Oppervlakverdowingsmiddels
FARMAKOLOGIESE WERKING:
Bensokaïen is ‘n ligte plaaslike verdowingsmiddel. Setielpiridiniumchloried is ‘n kwaternêre
piridinium antiseptiese verbinding. Dit het antibakteriese en antifunguseienskappe. Sommige
Gram-negatiewe bakterieë, veral Pseudomonas cepacia, is weerstandbiedend.
INDIKASIES:
Vir die simptomatiese verligting van seerkeel.
KONTRA-INDIKASIES:
Hipersensitiwiteit vir enige van die bestanddele.
Bekende sensitiwiteit word teenaangedui vir bensokaïen of setielpiridiniumchloried.
Bensokaïen is teenaangedui by pasiënte met lae plasmacholinesterase-konsentrasies of by
diegene wat anticholinesterases ontvang. Veiligheid tydens swangerskap en laktasie is nog nie
vasgestel nie. Word nie aanbeveel vir kinders onder die ouderdom van 6 jaar nie.

DOSIS EN GEBRUIKSAANWYSINGS:
Los een suigtablet stadig elke 2 tot 3 uur soos nodig in die mond op.
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NEWE-EFFEKTE EN SPESIALE VOORSORGMAATREËLS:
Bensokaïen:
Sommige pasiënte kan moontlik na herhaalde dosisse hipersensitief word. Erge seerkeel of ‘n
seerkeel wat gepaard gaan met koors of hoofpyn of naarheid en braking, of enige seerkeel wat
vir langer as twee dae duur, mag ernstig wees. In sulke gevalle raadpleeg ‘n geneesheer.
Sistemiese nadelige uitwerkings kan by bensokaïen voorkom vanweë die absorbering van groot
hoeveelhede deur die slymvliese of beskadigde vel of uit vaatryke dele. Prikkeling van die
sentrale senustelsel kan vasgestel word wanneer die pasiënt tekens toon van aanhoudende
gaap, rusteloosheid en opgewonde lyk, senuweeagtigheid, duiseligheid, tinnitus, nystagmus,
dowwe visie, naarheid en braking, spiertrekkings, bewerasie en stuiptrekkings. As die tong en
die area om die mond gevoelloos begin word, is dit ‘n vroeë teken van sistemiese toksisiteit. Die
prikkeling kan van verbygaande aard wees en gevolg word deur depressie en lomerigheid,
asemhalingsversaking en koma.
Daar kan ‘n gelyktydige uitwerking op die hartvaatstelsel plaasvind, gepaard met miokardiese
depressie en perifere vaatverwyding wat hipotensie en bradikardie, aritmie en hartstilstand tot
gevolg kan hê.
Idiosinkratiese reaksies is al aangemeld. Allergiese reaksies kan voorkom. Bensokaïen moet
met omsigtigheid toegedien word aan pasiënte met epilepsie, belemmerde hart- of
asemhalingsfunksie of met lewerskade; pasiënte met myasthenia gravis is veral gevoelig vir die
uitwerking van plaaslike anestetika.
Bensokaïen word na paraäminobensoësuur gemetaboliseer wat die werking van sulfoonamiede
kan antagoniseer.
Bensokaïen kan die slukaksie verswak en kan daardeur die risiko van aspirasie verhoog.
BEKENDE SIMPTOME VAN OORDOSERING EN BESONDERHEDE VIR DIE BEHANDELING
DAARVAN:
‘n Oordosis kan naarheid en braking veroorsaak. Dit het depolariserende
spierverslappingseienskappe en die toksiese simptome sluit in dispnee en sianose vanweë ‘n
verlamming van die asemhalingspiere wat moontlik tot asfiksie aanleiding kan gee. Depressie
van die sentrale senuweestelsel met stuiptrekkings, hipotensie en koma mag voorkom.
Behandeling is simptomaties en ondersteunend.

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IDENTIFIKASIE:
MEDI-KEEL A THROAT LOZENGES: Geel, ovaal, deurskynende, bikonvekse suigtablet met ‘n
peperment /groenmentgeur.
MEDI-KEEL A HONEY AND LEMON THROAT LOZENGES: Heuning-geel, ovaal,
deurskynende, bikonvekse suigtablet met ‘n suurlemoen/heuninggeur.
MEDI-KEEL A BLACKCURRANT THROAT LOZENGES: Bruinrooi, ovaal, deurskynende,
bikonvekse suigtablet met ‘n swartbessiegeur.
AANBIEDING:
Stolppakkie met 16 suigtablette.
BERGINGSAANWYSINGS:
Bêre op ‘n koel plek (benede 25 ºC). Beskerm teen lig en vog.
HOU BUITE BEREIK VAN KINDERS.
REGISTRASIENOMMERS:
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
NAAM EN BESIGHEIDSADRES VAN DIE HOUER VAN DIE REGISTRASIE-
SERTIFIKAAT:
Adcock Ingram Limited
William Nicolrylaan 3011
Bryanston
Privaatsak X69, Bryanston, 2021
www.adcock.co.za
DATUM VAN PUBLIKASIE VAN HIERDIE VOUBILJET:
7 Julie 1986

16 Anaesthetic Lozenges
Specific relief for a sore throat:
• Anaesthetic
• Antibacterial
• Antifungal
LABEL DRAFT / ETIKETKONSEP
S1
MEDI-KEEL ® A THROAT LOZENGES
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MEDI-KEEL ® A HONEY AND LEMON THROAT LOZENGES
MEDI-KEEL ® A BLACKCURRANT THROAT LOZENGES
Each lozenge contains:
Benzocaine 12,0 mg
Cetylpiridinium chloride 1,5 mg
Contains sugar:
Sucrose 2,32 g
Liquid glucose 1,54 g
Tartrazine free
Dosage and directions for use:
Dissolve one lozenge slowly in the mouth.
Use every two hours as needed. If sore throat
does
not show improvement after 48 hours, consult
your doctor.
Storage:
Store in a cool place below 25 ºC, protected
from sunlight and moisture.
KEEP OUT OF REACH OF CHILDREN.
Batch No.:
Registration No:
Expiry date:
16 Verdowende Suigtablette
Vir die spesifiek verligting van seerkeel:
• Verdowend
• Antibakteries
• Swamwerend
Elke suigtablet bevat:
Bensokaïen 12,0 mg
Setielpiridiniumchloried 1,5 mg
Bevat suiker:
Sukrose 2,32 g
Vloeibare glukose 1,54 g
Tartrasienvry
Dosis en gebruiksaanwysings:
Laat een suigtablet stadig in die mond oplos.
Gebruik elke twee uur soos nodig. Indien seer
keel nie verbeter binne 48 uur, raadpleeg u dokter.
Bergingsaanwysings:
Bêre in ‘n koel plek benede 25 ºC, beskerm
teen lig en vog.
HOU BUITE BEREIK VAN KINDERS.
Lotnommer:
Registrasienr:
Vervaldatum:
Adcock Ingram Limited
www.adcock.co.za