KALGARON STRAWBERY

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Compra

Foglio illustrativo Foglio illustrativo (PIL)
11-07-2021
Scheda tecnica Scheda tecnica (SPC)
03-05-2021

Principio attivo:

CETYLPYRIDINIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE ( AS MONOHYDRATE)

Commercializzato da:

RAFA LABORATORIES LTD

Codice ATC:

R02AD02

Forma farmaceutica:

LOZENGES

Composizione:

CETYLPYRIDINIUM CHLORIDE 1.25 MG; LIDOCAINE HYDROCHLORIDE ( AS MONOHYDRATE) 1 MG

Via di somministrazione:

PER OS

Tipo di ricetta:

Not required

Prodotto da:

RAFA LABORATORIES LTD, JERUSALEM

Area terapeutica:

LIDOCAINE

Indicazioni terapeutiche:

For the relief of severe sore throat. Relief of mouth and throat infections.

Data dell'autorizzazione:

2020-02-03

Foglio illustrativo

                                1
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
This medicine is sold without a doctor's prescription
KALGARON MINT
KALGARON STRAWBERRY
KALGARON ORANGE
LOZENGES
ACTIVE INGREDIENTS:
Each lozenge contains:
Cetylpyridinium chloride (CPC) 1.25 mg and Lidocaine hydrochloride 1
mg.
For a list of the other ingredients, see section 6. See also
'Important information about some
of the medicine's ingredients in section 2.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have any further
questions, please refer to your doctor or pharmacist.
Use this medicine according to the instructions in the dosage section
in this leaflet. Consult
your pharmacist if you require additional information.
Refer to your doctor if the symptoms do not improve within 5 days, if
they get worse or if you
experience new symptoms.
This medicine is not intended for children under 6 years of age.
1. WHAT IS THE MEDICINE INTENDED FOR?
This medicine is intended for the relief of severe sore throat and for
relief of mouth and throat
infections.
THERAPEUTIC GROUP:
Cetylpyridinium chloride - quaternary ammonium antiseptic.
Lidocaine - local anesthetic.
2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE:
•
If you are sensitive (allergic) to the active ingredients, to other
anesthetics substances, to
quaternary ammonium antiseptics, or to any of the other ingredients
the medicine contains
(for a list of the other ingredients, see section 6).
•
In children aged under 6.
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:
•
The anesthetic action of the medicine may interfere with swallowing
and may cause
inhalation of food (aspiration) during the meal (may be expressed as
coughing), or
cause you to bite your tongue. Therefore caution should be taken when
using it.
Likewise, do not use the medicine before eating or drinking. See also
'Use of the
medicine and food' section.
•
Do not use for more then 5 consecutive days, since this may 
                                
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Scheda tecnica

                                1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
KALGARON MINT
KALGARON ORANGE
KALGARON STRAWBERRY
LOZENGES
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
The tablet contains cetylpyridinium chloride (CPC) 1.25 mg and
lidocaine hydrochloride 1 mg.
For the complete list of the excipients, see section 6.1.
3. PHARMACEUTICAL FORM:
Lozenges
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
For the relief of severe sore throat. Relief of mouth and throat
infections.
4.2. DOSAGE AND METHOD OF ADMINISTRATION
Oral.
For adults and children over the age of 6 years.
DOSAGE
One tablet to be sucked every 3 to 4 hours:
•
Adults: do not take more than 6 tablets a day.
•
Children from 6 to 15 years of age: do not take more than 4 tablets a
day.
METHOD OF ADMINISTRATION
Suck the tablet slowly. Do not crunch or swallow it. Wait at least 2
hours between tablets.
Do not take the tablet near to meal times.
4.3. CONTRAINDICATIONS
Children under the age of 6 years.
Kalgaron is contraindicated in case of known hypersensitivity to
antiseptics in the quaternary ammonium
class, local anesthetics or one of the excipients indicated in section
6.1.
4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE
2
WARNINGS
Possibility of swallowing the wrong way on account of anesthetizing of
the junction between the digestive
tract and the respiratory system:
•
Use this medicine carefully in children under the age of 12 years.
•
Do not use this medicine before meals or before drinking.
The indication is for a treatment lasting no more than 5 days since it
might expose to an imbalance of the
normal microbial flora of the mouth cavity with risk of bacterial or
fungal dissemination.
Repeated or prolonged treatment on the mucous membrane may expose to
the risk of toxic systemic
effects of contact anesthetics (impairing of the central nervous
system with convulsions, depression of the
cardiovascular system).
•
Kalgaron Mint contains about 12 mg of lactose. Patients with rare
hereditary problems of galactose
intolerance, total lactase 
                                
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