EASY GEL

Israel - English - Ministry of Health

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Active ingredient:
BENZYDAMINE HYDROCHLORIDE 5 %
Available from:
TEVA PHARMACEUTICAL INDUST.LTD
ATC code:
M01AX07
Pharmaceutical form:
GEL
Administration route:
DERMAL
Manufactured by:
TEVA PHARMACEUTICAL INDUSTRIES LTD
Therapeutic group:
BENZYDAMINE
Therapeutic indications:
Local acute inflammatory disorders.
Authorization number:
040552582200
Authorization date:
2009-04-01

Documents in other languages

Patient Information leaflet Patient Information leaflet - Hebrew

15-01-2021

" עעבקנהזןולעטמרופ " רשואוקדבנונכותותואירבהדרשמי ." רשואמןולע : לירפא 2009

“This leaflet format has been determined bytheMinistryof Health and the content thereof has

been checked and approved.”Date of approval: April 2009.

EASY GEL

GEL

Composition

Active Ingredient

Benzydamine hydrochloride 5%

Others Ingredients

Isopropyl alcohol, glycerin, hydroxyethyl cellulose, lavender perfume, purified water.

Mechanism of Action

Benzydamine hydrochloride is a topical analgesic and anti-inflammatory agent.

Easy Gel is well absorbed through the skin and provides an anti-inflammatoryand

anesthetic action.

Indications

Treatment of local, acute inflammatory disorders accompanied bypain,swelling,

redness, and heat limited to the affected area, e.g. muscles and joints.

Contraindications

Hypersensitivity to the product.

Warnings

Use in Pregnancy and Lactation

Safety of use in pregnancy and lactation has not been established.

Adverse Reactions

Photosensitivity reactions have been reported, aswellaslocalskinreactions

varying from erythema to papular eruption. The skin returnedtonormalupon

discontinuation of treatment.

Precautions

For external use only.

To avoid possible irritation, Easy Gelshould be kept away from eyes andmucosal

surfaces.

Avoid use on open wounds.

Long-term treatment with topical products may lead to sensitization phenomena.In

this case, treatment should be discontinued and appropriate therapy should be taken.

When this medication is applied on large areas for prolongedperiodsoftime,

systemic absorption might take place. In such acase,adversereactions,typicalto

those occurring after oral administration of drugsbelongingtothisgroup,might

appear. These include: nausea, gastrointestinal disturbances, and pruritus.

Directions for Use

Applyenoughgelto the painful area and massage gently 3 times daily. In cases of

severe pain, the treatment may be repeated up to 6 times daily.

It is recommended that treatment be limited to not more than 10 days.

Accidental Ingestion

In case of accidental ingestion the patient should contact a physician.

Pharmaceutical Precautions

Avoid extremes of temperature. Store in a cool, dry place.

Registration Number

040 55 25822 00.

Manufacturer

Teva Pharmaceutical Industries

P.O.Box 3190, Petah Tikva 49131

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