BETADINE GARGLE

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

POVIDONE-IODINE

Available from:

RAFA LABORATORIES LTD

ATC code:

R02AA15

Pharmaceutical form:

CONCENTRATED SOLUTION

Composition:

POVIDONE-IODINE 7.5 %

Administration route:

MOUTHWASH, , , , , GARGLE, ,

Prescription type:

Not required

Manufactured by:

MUNDIPHARMA GMBH, GERMANY

Therapeutic area:

POVIDONE-IODINE

Therapeutic indications:

For the treatment of infectious/inflammatory diseases of oropharyngeal mucosa and gingiva caused by fungi, viruses and bacteria (oral thrush, aphthae, superinfected and herpetic ulcers, gingivitis, stomatitis, pharyngitis, supportive treatment of tonsillitis) ;treatment oral or pharyngeal injuries ; antiseptic treatment of the oral mucosa (e.g. prior to surgery), in particular in immunocompromised patients with a risk of endocarditis (prevention of bacteremia) ;prevention of radiation-induced mucositis in patients undergoing radiotherapy or radiochemotherapy.

Authorization date:

2018-03-08

Patient Information leaflet

1
The format of this leaflet was determined by the Ministry of Health
and its content was checked and
approved in March 2018
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is sold with a doctor's prescription only
BETADINE
® GARGLE
CONCENTRATED SOLUTION
GARGLE AND MOUTHWASH
ACTIVE INGREDIENT:
7.5% Povidone Iodine (equivalent to 0.75% available iodine).
For a list of the other ingredients, please see section 6.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE.
This leaflet contains concise information about the medicine. If you
have any further
questions, refer to your doctor or pharmacist.
This medicine was prescribed for your treatment, do not pass it on to
others. It may harm
them, even if it seems to you that their medical condition is similar
to yours.
1. WHAT IS THE MEDICINE INTENDED FOR?
This medicine is intended for infections in the mouth and throat:

For the treatment of infections/inflammations in the mouth, throat and
gums, caused
by fungi, bacteria or viruses.

For the treatment of mouth and throat injuries.

For disinfection of the oral cavity before surgeries.

Prevention of radiotherapy-induced mouth inflammations and ulcers.
THERAPEUTIC GROUP:
Antiseptics
2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF:

Do not use if you are sensitive (allergic) to the active ingredient,
to iodine, or to any of the
other ingredients this medicine contains (for a list of the other
ingredients, please see
section 6).

Do not use if you suffer from overactive thyroid gland
(hyperthyroidism) or other thyroid
disorders.

Do not use if you suffer from dermatitis herpetiformis (Duhring
disease), which is an
autoimmune disease with blisters.

Do not use before and after treatment with radioactive iodine (until
conclusion of the
treatment).
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:

Inform your attending doctor if you suffer from latent thyroid gland
diseases
(especially in elderly patients) particularly with prolong

Summary of Product characteristics

Betadine Gargle -DL-March 2018-01
THE FORMAT OF THIS LEAFLET WAS DETERMINED BY THE MINISTRY OF HEALTH
AND ITS CONTENT
WAS CHECKED AND APPROVED BY IT IN MARCH 2018
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Betadine Gargle
Concentrated Solution
Gargle and Mouthwash
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Betadine Gargle contains 7.5% povidone-iodine (0.75% available
iodine).
For the a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Concentrated Solution
Gargle and Mouthwash
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS

For the treatment of infectious-inflammatory diseases of the mucous
membranes
in the mouth, throat and the gingiva caused by fungi, viruses and
bacteria (e. g.
thrush, aphthae, superinfected and herpetic ulcers, gingivitis,
stomatitis,
pharyngitis, supporting treatment in the case of tonsillitis).

For the treatment of injuries in the mouth and throat region.

For antiseptic treatment of the oral mucous membrane (e. g. prior to
surgery),
especially in patients with immunodeficiency and patients at risk for
endocarditis
(prevention of bacteremia).

Prevention of radiation-induced mucositis in patients undergoing
radiotherapy or
radio-chemotherapy.
Betadine Gargle may be used in adults, infants, toddlers, children and
adolescents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Betadine Gargle is used undiluted or diluted with lukewarm water. The
screw cap
may be used for dosing. The screw cap has a volume of 5 ml.
DOSAGE:
FOR INFECTIOUS INFLAMMATORY DISEASES AND INJURIES IN THE MOUTH AND
THROAT
REGION
A dilution of 1:8 to 1:16 (approx. 2-4 caps in 125 ml water) is
recommended. Rinse
mouth and/or gargle for at least 30 seconds every 1-4 hours until the
disease
subsides.
ANTISEPSIS PRIOR TO SURGERY
Apply Betadine Gargle undiluted to the area of the planned surgery for
at least 30
seconds.
PREVENTION OF RADIATION-INDUCED MUCOSITIS
A dilution of 1:8 (approx. 4 caps in 125 ml water) is recommended. The
treatment
should be repeated several times dai