Mundisal (Gel) Instructions for Use

Marketing Authorization Holder

Mundipharma, GmbH (Germany)

ATC Code

A01AD11 (Other drugs)

Active Substance

Choline salicylate (Rec.INN registered by WHO)

Dosage Form

Mundisal

Gel for topical application 8.7%: tube 8 g

Dosage Form, Packaging, and Composition

Gel for topical application 8.7% transparent, soft, with an anise odor.

Excipients: hypromellose – 23 mg, glycerol 85% – 50 mg, sodium cyclamate – 2 mg, anise oil – 1.426 mg, menthol – 0.576 mg, ethanol 96% – 382 mg, purified water – up to 1000 mg.

8 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

NSAID

Pharmacological Action

Choline salicylate is a derivative of salicylic acid.

When applied externally and topically, it exerts anti-inflammatory and analgesic effects.

It possesses antimicrobial and antifungal activity.

Indications

For topical application to the mucous membranes of the oral cavity as an analgesic and anti-inflammatory agent in the treatment of periodontal diseases, lesions of the mucous membrane, diseases occurring with an inflammatory reaction and pain; minor surgical interventions.

As part of complex therapy – multiform exudative erythema (including Stevens-Johnson syndrome).

For symptomatic relief of ear pain in acute otitis media, chronic otitis media, external otitis, myringitis.

Softening of hardened earwax prior to the procedure of its removal from the ear.

ICD codes

Dosage Regimen

Apply topically to the oral mucosa or externally to the ear canal.

For oral conditions (gingivitis, stomatitis, mucosal lesions): apply a 0.5-inch (1 cm) strip of gel to the affected area with a clean fingertip or cotton swab.

Gently massage the gel into the inflamed or painful site.

Use 3 to 4 times daily, preferably after meals and before bedtime.

Do not eat or drink for 30 minutes after application to ensure local effect.

For ear pain (otitis externa, otitis media, myringitis): instill 3 to 4 drops into the affected ear.

Gently massage the tragus of the ear to facilitate penetration.

Apply drops 3 to 4 times daily for analgesia.

For cerumenolysis (softening impacted earwax): instill 5 to 10 drops into the affected ear.

Allow drops to remain for at least 15-30 minutes prior to ear irrigation or wax removal.

Use for cerumen removal twice daily for 3 to 4 days.

Do not use in the ear if eardrum perforation is suspected or confirmed.

The maximum daily dose should not exceed the equivalent of one 8 g tube.

Treatment duration is typically 5 to 7 days; consult a physician if symptoms persist.

In children under 1 year, use only under direct medical supervision.

Adverse Reactions

Possible: allergic reactions.

In ear diseases use in patients with perforation of the eardrum may lead to hearing impairment.

Contraindications

Hypersensitivity to salicylates.

Depending on the used dosage form: complete or incomplete combination of bronchial asthma, recurrent nasal and sinus polyposis and intolerance to acetylsalicylic acid or other NSAIDs (including in history); impaired integrity of the eardrum; pregnancy, breastfeeding period; children under 1 year of age.

With caution

Depending on the dosage form: allergic (“hay”) rhinitis, polyps of the mucous membrane of the nasal passages; pregnancy, breastfeeding period; children under 1 year of age.

Use in Pregnancy and Lactation

Use with caution during pregnancy and breastfeeding as indicated, in recommended doses and dosage forms.

It is necessary to strictly follow the instructions in the prescribing information for choline salicylate preparations regarding contraindications for use during pregnancy and breastfeeding for specific dosage forms.

Pediatric Use

Use in children is possible as indicated, in age-appropriate recommended doses and dosage forms.

It is necessary to strictly follow the instructions in the prescribing information for choline salicylate preparations regarding contraindications for use in children of different ages for specific dosage forms of choline salicylate.

In children under 1 year of age, the use of this agent is possible only under medical supervision.

Special Precautions

Salicylic acid derivatives entering the middle ear through a damaged eardrum can cause hearing impairment or deafness.

In this regard, Choline salicylate should not be used without a prior examination by an otorhinolaryngologist and without a doctor’s prescription.

Drug Interactions

With simultaneous use, Choline salicylate enhances the effect of other anti-inflammatory and analgesic agents.

Storage Conditions

Store at 15°C (59°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.