Cholisal^® (Gel) Instructions for Use

Marketing Authorization Holder

Bausch Health, LLC (Russia)

Manufactured By

Pharmaceutical Works Jelfa, S.A. (Poland)

Contact Information

BAUSH HEALTH LLC (Russia)

ATC Code

A01AD11 (Other drugs)

Active Substances

Choline salicylate (Rec.INN registered by WHO)

Cetalkonium chloride (Rec.INN registered by WHO)

Dosage Form

Cholisal®

Dental gel 87 mg+0.1 mg/1 g: 10 g or 15 g tubes

Dosage Form, Packaging, and Composition

Dental gel in the form of a colorless, transparent, homogeneous mass with the odor of anise oil.

Excipients : Excipients : hydroxyethylcellulose, methylparaben, propylparaben, glycerol, star anise oil, ethanol 96%, water.

10 g – aluminum tubes (1) – cardboard boxes.
15 g – aluminum tubes (1) – cardboard boxes.

Clinical-Pharmacological Group

A drug with antimicrobial, anti-inflammatory, and analgesic action for topical use in dentistry

Pharmacotherapeutic Group

NSAID

Pharmacological Action

With topical application, Choline salicylate is rapidly absorbed by the oral mucosa, exerting a local analgesic, anti-inflammatory, and antipyretic effect.

It inhibits COX activity, the functions of macrophages and neutrophils, the production of interleukin-1, and suppresses the synthesis of prostaglandins.

It also has antimicrobial and antifungal action in both acidic and alkaline environments.

Cetylalkonium chloride is an antiseptic that acts on bacteria, fungi, and viruses.

The gel ethanol-containing adhesive base ensures rapid onset of effect and prolonged retention of the active substances on the mucous membrane.

The analgesic effect occurs within 2-3 minutes and lasts for 2-8 hours.

Pharmacokinetics

It is well absorbed when applied to mucous membranes.

Indications

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

• Stomatitis of various etiologies;
• Gingivitis;
• Periodontitis;
• Damage to the oral mucosa from wearing dentures;
• Injuries of the oral mucosa;
• Teething pain in children;
• Cheilitis;
• Candidiasis of the oral mucosa;
• Minor surgical interventions in the oral cavity;
• Lichen planus localized on the oral mucosa;
• Lesions of the oral mucosa in Stevens-Johnson syndrome (as part of combination therapy).

ICD codes

Dosage Regimen

Cholisal^® is applied topically 2-3 times/day before meals (for pain relief) or after meals and before bedtime.

A strip of gel 1 cm long for adults and 0.5 cm for children is squeezed onto a clean finger and rubbed into the affected area of the oral mucosa with light massaging movements.

For periodontal diseases, the gel should be placed into the gingival pockets or used as compresses, or gently rubbed into the gums 1-2 times/day.

Adverse Reactions

Local reactions transient burning sensation at the application site, which resolves on its own.

Other allergic reactions.

Contraindications

• Hypersensitivity to salicylates and other components of the drug.

Use with caution during pregnancy, breastfeeding, and in children under 1 year of age.

Use in Pregnancy and Lactation

Cholisal^® should be used with caution during pregnancy and breastfeeding.

Pediatric Use

Use with caution in children under 1 year of age.

Special Precautions

If the first signs of adverse reactions appear, the patient should immediately consult their doctor.

The drug should be used only topically.

Cholisal^® does not contain sugar.

Effect on ability to drive vehicles and operate machinery

The drug does not limit psychophysical activity, the ability to drive vehicles or operate moving machinery.

Overdose

No cases of overdose with Cholisal^® have been identified.

Drug Interactions

When using Cholisal^®, the effect of other concurrently used anti-inflammatory, antipyretic, and analgesic agents may be enhanced.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F); do not freeze.

Shelf Life

The shelf life is 3 years. Do not use after the expiration date printed on the packaging.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.