Universal reference book for medicines
Product name: HOLISAL ® (CHOLISAL)

Active substance: cetalkonium chloride, choline salicylate

Type: The drug with antimicrobial, anti-inflammatory and analgesic action for topical application in dentistry

Manufacturer: PHARMACEUTICAL WORKS JELFA (Poland)
Composition, form of production and packaging
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Gel dental in the form of a colorless, transparent, homogeneous mass with the smell of anise oil.
1 g

choline salicylate 87.1 mg

cetalkonium chloride 100 μg

Excipients: Hyethellosis - 20 mg, methylparahydroxybenzoate - 1.5 mg, propyl parahydroxybenzoate - 0.8 mg, glycerol - 50 mg, anise of ordinary seeds oil - 1.61 mg, ethanol 96% - 390 mg, water up to 1000 mg.

10 g - aluminum tubes (1) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

Combination drug for topical application in dentistry with antimicrobial, anti-inflammatory and analgesic action.

When topical application of choline, salicylate is rapidly absorbed by the oral mucosa, providing a local anesthetic, anti-inflammatory and antipyretic effect.
It inhibits the activity of COX, the function of macrophages and neutrophils, the production of interleukin-1 and inhibits the synthesis of prostaglandins. It also has antimicrobial and antifungal activity in acidic and alkaline environments.
Cetalkonium chloride - antiseptic, acts on bacteria, fungi and viruses.

Gel ethanol-containing adhesive base provides rapid development of the effect and permanently retains active substances on the mucous membrane.

Analgesic effect occurs in 2-3 minutes, while its duration is 2-8 hours.

PHARMACOKINETICS

When applied to mucous membranes, it is well absorbed.

INDICATIONS

For topical application on the oral mucosa as an analgesic and anti-inflammatory agent in the treatment of periodontal diseases, mucosal damage, diseases occurring with inflammatory reaction and pain:

- stomatitis of different etiology;

- gingivitis;

- periodontitis;

- damage to the oral mucosa while wearing dentures;

- trauma of the oral mucosa;

- pain with teething in children;

- cheilitis;

Candidiasis of the oral mucosa;

- small operative interventions in the oral cavity;

- red flat lichen if localized on the mucosa of the oral cavity;

- damage to the oral mucosa in the syndrome of Stevens-Johnson (as part of complex therapy).

DOSING MODE

Kholisal ® is applied topically 2-3 times / day before meals (for analgesia) or after meals and before bedtime.
A strip of gel 1 cm long for adults and 0.5 cm forchildren is squeezed out onto a clean finger and rubbed with light massaging movements into the affected area of ​​the oral mucosa.
With periodontal disease, the gel should be placed in the gingival pockets or applied as compresses, or gently rubbed into the gums 1-2 times / day.

SIDE EFFECT

Local reactions: a brief burning sensation at the site of the drug, which passes by itself.

Other: allergic reactions.

CONTRAINDICATIONS

- Hypersensitivity to salicylates and other components of the drug.

Caution should be used during pregnancy, during breastfeeding and in children under the age of 1 year.

PREGNANCY AND LACTATION

Caulisal ® should be used with caution in pregnancy and during breastfeeding.

APPLICATION FOR CHILDREN

Caution should be used in children younger than 1 year.

SPECIAL INSTRUCTIONS

When the first signs of side effects appear, the patient should immediately consult a doctor.

The drug should be used only for topical application.

The drug does not contain sugar.

Impact on the ability to drive vehicles and manage mechanisms

The drug does not limit psychophysical activity, ability to drive vehicles and service moving mechanisms.

OVERDOSE

Cases of overdose have not been identified.

DRUG INTERACTION

When applying Holysala in doses that are significantly higher than recommended, it is possible to increase the effect of other simultaneously used anti-inflammatory, antipyretic and analgesic agents.

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of the reach of children at a temperature of no higher than 25 ° C;
Do not freeze. Shelf life - 3 years.
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