Kamident-zdorovya

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT KAMIDENT-ZDOROVYE (CAMIDENT-ZDOROVYE)

Composition:

Active substances:

1 g of gel contains lidocaine hydrochloride 20 mg, chamomile flower tincture (1:8.5) (extractant – ethanol 70%) 200 mg, thymol 1 mg;

Excipients: methylparaben (E 218), carbomer, sodium saccharin, tromethamine, cinnamon oil, purified water.

Pharmaceutical form. Oral gel.

Main physicochemical properties: gel of homogeneous consistency, ranging in color from greenish-yellow to yellow-brown, with a characteristic odor.

Pharmacotherapeutic group. Agents for use in dentistry. ATC code A01A D11.

Pharmacological properties.

Pharmacodynamics. The combination of active substances of the medicinal product has analgesic, anti-inflammatory, and antibacterial properties. Lidocaine is a potent local anesthetic of the amide type, and its mechanism of action is based on stabilization of cell membranes through blockade of sodium channels. Compared to procaine, lidocaine is more effective and safer, and may also possess antibacterial properties.

Chamomile flower tincture exerts anti-inflammatory, antiseptic, and wound-healing effects.

Chamomile flower tincture contains a complex mixture of structurally diverse anti-inflammatory and antibacterial substances that enhance the overall therapeutic effect. Sesquiterpenes, which constitute over 50% of the active components of chamomile, are therapeutically the most important. The anti-inflammatory effect of chamomile is primarily due to chamazulene and (-)-alpha-bisabolol, which also possess antibacterial and antifungal properties.

Thymol is a phenol derivative with antimicrobial and clearly expressed antifungal properties. It has broad antiseptic activity and, unlike phenol, a significantly lower level of toxicity. In addition, thymol exhibits antiviral properties.

Clinical characteristics.

Indications. Treatment of mild forms of infectious lesions of the gums and oral mucosa, including herpes labialis with blister formation, gingivitis, and aphthous erythema.

Symptomatic treatment of irritation, hypersensitivity, and/or mucosal discomfort caused by dental prostheses.

Prevention of pain and discomfort associated with teething. Reduction of irritation and discomfort caused by orthodontic procedures.

Contraindications. Renal and hepatic insufficiency, arterial hypertension, cardiac insufficiency grade II–III. Hypersensitivity to any component of the drug, to other amide-type local anesthetics, or to other members of the Compositae family. Mucosal injury of the oral cavity.

Interaction with other medicinal products and other forms of interaction. Not established.

If simultaneous use of any other medicinal products is required, medical advice should be sought.

Special precautions for use.

Avoid contact with eyes or open wounds. Hands should be thoroughly washed after applying the gel. The medicinal product may cause numbness of the tongue; therefore, food and drinks should be consumed with caution after application of the gel.

Prolonged use in high doses should be carried out under medical supervision. High doses should not be used for longer than the specified period without consulting a physician.

Prolonged and frequent use of the product may lead to systemic allergic adverse reactions, disturbances of the central nervous system and cardiovascular system.

If severe redness or swelling of the gums occurs, or if serious accompanying symptoms develop, consult a physician.

The presence of methylparaben (E 218) in the formulation may cause allergic reactions (possibly delayed).

Use during pregnancy or breastfeeding. Safety during pregnancy or breastfeeding has not been established. Therefore, the product should not be used during these periods.

Ability to affect reaction speed when driving or operating machinery. Unknown.

Method of administration and dosage.

Apply a 0.5 cm strip of gel to the painful or inflamed area 3 times daily, with gentle massage.

Use in children from 3 months of age. Apply the medication no more than 3 times daily. For topical use, apply to the oral mucosa.

Duration of treatment – until symptoms resolve.

Children. The medication may be used in children from 3 months of age for teething pain associated with eruption of primary teeth.

Overdose. Cases of overdose have not been reported.

Side effects.

Sometimes after application of the gel, itching, hyperemia, mild burning, irritation, allergic reactions including contact allergic reactions, skin rashes, and angioneurotic edema may occur.

If any adverse reactions occur, discontinue use of the product and consult a physician immediately.

Shelf life. 2 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 10 g or 20 g in a tube in a carton.

Availability. Over-the-counter (without prescription).

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROV'YA".

Manufacturer's address.

Ukraine, 61013, Kharkiv region, city of Kharkiv, Shevchenka Street, building 22.