Kamilidin (Gel) Instructions for Use

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

ATC Code

A01AD11 (Other drugs)

Active Substances

Lidocaine (Rec.INN registered by WHO)

Matricaria flowers (DAB German Pharmacopoeia)

Dosage Form

Kamilidin

Gel for topical application: 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190 or 200 g tubes

Dosage Form, Packaging, and Composition

Gel for topical application is homogeneous, yellow-brown in color with a characteristic odor.

Excipients : benzalkonium chloride 50% solution – 2 mg, Cinnamomum camphora oil – 1 mg, sodium saccharin – 1 mg, carbomer – 15 mg, trometamol – 28.1 mg, anhydrous formic acid 98% – 0.4 mg, ethanol 96% (ethyl alcohol) – 8.2 mg, purified water – 739.2 mg.

10 g, 15 g, 20 g, 25 g, 30 g, 35 g, 40 g, 45 g, 50 g, 55 g, 60 g, 65 g, 70 g, 75 g, 80 g, 85 g, 90 g, 95 g, 100 g, 110 g, 120 g, 130 g, 140 g, 150 g, 160 g, 170 g, 180 g, 190 g or 200 g – aluminum tubes (1) – cardboard packs.
10 g, 15 g, 20 g, 25 g, 30 g, 35 g, 40 g, 50 g, 60 g, 70 g, 80 g or 100 g – tubes made of combined material (1) – cardboard packs.

Clinical-Pharmacological Group

Topical antiseptic for use in dentistry

Pharmacotherapeutic Group

Drugs used in dentistry; other drugs for the local treatment of oral diseases

Pharmacological Action

Combined drug for topical application. Chamomile flower extract has anti-inflammatory, antiseptic, and regenerative properties. Lidocaine has a local anesthetic effect, which contributes to a rapid and prolonged reduction of pain during inflammation and damage to the oral mucosa and gums.

Indications

Pain syndrome during inflammation of the oral mucosa and lips: with stomatitis; with cheilitis and actinic cheilitis of the lips; with gingivitis (inflammation of the gums); with irritation of the oral mucosa from wearing dentures and braces; during the eruption of wisdom teeth; during dental procedures, after orthopedic operations in maxillofacial surgery.

ICD codes

Dosage Regimen

Apply the gel topically within the oral cavity.

Administer a pea-sized amount (approximately 0.5-1 cm strip) directly onto a clean finger or a cotton swab.

Gently apply to the affected areas of the oral mucosa, gums, or lips, ensuring complete coverage of the painful or inflamed site.

Use the gel three times daily or as directed by a dentist or physician.

Apply preferably after meals and before bedtime to prolong contact with the mucosa.

Do not eat or drink for at least 30 minutes after application to allow the drug to adhere properly.

The typical treatment duration is 5 to 7 days for acute conditions like stomatitis or gingivitis.

For teething pain or irritation from dental appliances, use as needed for symptom relief.

Do not exceed the recommended frequency or duration of use without medical supervision.

If symptoms persist after one week of use, discontinue the gel and consult a healthcare professional.

Avoid contact with eyes; if contact occurs, rinse immediately with copious amounts of water.

Adverse Reactions

Possible allergic reactions.

Contraindications

Pregnancy; lactation period (breastfeeding), children under 12 years of age; hypersensitivity to the active substances.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation (breastfeeding).

Pediatric Use

Contraindication: children under 12 years of age.

Special Precautions

If signs of allergy appear, discontinue use and consult a doctor.

Drug Interactions

Cases of interaction or incompatibility with other drugs have not been described.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°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.