Dentinox-gel n

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DENTINOX-GEL N (DENTINOX-GEL N)

Composition:

Active ingredients:
1 g of gel contains:

• Chamomile tincture (Tinctura Matricariae) (1:5) (extraction solvent – 70% ethanol) – 150 mg,
• Lidocaine hydrochloride – 3.4 mg,
• Polidocanol 600 (Macrogol lauryl ether) – 3.2 mg;

Excipients:
propylene glycol, xylitol, sorbitol solution 70% (E 420), sodium edetate, carbomer (974P), sodium hydroxide, polysorbate 20, sodium saccharin, purified water.

Pharmaceutical form.
Gingival gel.

Main physicochemical properties:
yellow-colored gel with a characteristic odor.

Pharmacotherapeutic group.
Agents used in dentistry.

ATC code: A01AD11.

Pharmacological properties.

Pharmacodynamics.

The use of the herbal anti-inflammatory component, chamomile tincture, and local anesthetics, lidocaine and polidocanol 600 (macrogol lauryl ether), in a low specifically selected dose for children helps prevent pain associated with teething.

Chamomile tincture: herbal anti-inflammatory component.

Lidocaine hydrochloride: local anesthetic and analgesic component in an effective yet safe dose (0.34%).

Polidocanol 600 (macrogol lauryl ether): local anesthetic and analgesic component that adheres well to the oral mucosa and provides prolonged therapeutic effect.

The medicinal product does not cause dental caries.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

For relief during teething (irritation of gums, inflammation, and pain).

Contraindications.

Hypersensitivity to chamomile or other members of the Compositae (Asteraceae) family, lidocaine or related local anesthetics (amide-type), or hypersensitivity to any of the excipients.

Mucosal lesions of the oral cavity.

Due to the presence of sorbitol, the product should not be used in patients with hereditary fructose intolerance.

Special precautions.

Avoid contact with eyes. Do not exceed the recommended dosage without consulting a physician. Avoid applying the medicinal product on open wounds. Hands should be thoroughly washed after application of the gel. The product may cause numbness of the tongue; therefore, food and drinks should be taken cautiously after application of the gel.

If severe redness or swelling of the gums or serious adverse reactions occur, consult a physician.

Interaction with other medicinal products and other forms of interaction.

Not known. If concomitant use with any other medicinal products is required, consult a physician.

Special precautions for use.

Propylene glycol

Dentinox-Gel N contains propylene glycol. When applied locally in the oral cavity, the medicinal product may cause irritation of the mucous membranes of the gums.

Use during pregnancy or breastfeeding

The product is intended for use in children only. There are no studies on the use of the product during pregnancy or breastfeeding.

Ability to influence reaction speed when driving or operating machinery

The product is intended for use in children only. The effect on psychomotor reactions has not been studied.

Method of Administration and Dosage

At the first signs of tooth eruption, apply a pea-sized drop of gel onto the gums at the site of tooth eruption using a finger or a cotton swab, and gently rub in. Apply 2–3 times daily, especially after eating and before bedtime.

Dentinox-Gel N is used during the eruption of primary (deciduous) teeth, as well as during the eruption of permanent teeth.

Children.

The product is intended for use in children only.

Overdose.

No cases of overdose have been observed when following the recommended dosage. No cases of intoxication have been reported.

Side effects.

Temporary mild burning, irritation, redness. Allergic reactions are possible, including contact allergic reactions, skin rashes, itching, angioneurotic edema. If any adverse reactions occur, discontinue use of the drug and consult a physician immediately.