SANGIVA

INSTRUCTIONS for medical use of the medicinal product SANGIVIT®

Composition:

Active substances: chlorobutanol hemihydrate, choline salicylate, hexetidine;

1 ml of solution contains: hexetidine 1.0 mg; choline salicylate 5.0 mg; chlorobutanol hemihydrate, calculated as chlorobutanol 2.5 mg;

Excipients: sodium saccharin, ethanol 96%, polysorbate 20, levomenthol, anise oil, lemon oil, lime oil, eucalyptus oil, methyl salicylate, citric acid monohydrate, purified water.

Pharmaceutical form. Oral solution.

Main physicochemical properties: clear, colorless or slightly yellowish liquid with a characteristic aromatic odor.

Pharmacotherapeutic group. Agents used in throat diseases. Antiseptics. ATC code R02A A20.

Pharmacological Properties.

Pharmacodynamics.

The action of the medicinal product is due to its three active components.

Antibacterial and antifungal activity. Hexetidine exerts antibacterial effects against both Gram-positive and Gram-negative microbial strains, as well as against both aerobic and anaerobic organisms.

Against aerobic strains, hexetidine generally produces a bacteriostatic effect, with weak bactericidal activity. Against anaerobic strains, hexetidine exerts a pronounced bactericidal effect. The mechanism of action involves competitive interaction with thiamine: the structure of hexetidine resembles that of thiamine, which is essential for microbial growth.

Anti-inflammatory activity. Choline salicylate provides analgesic, antipyretic, and anti-inflammatory effects. It is used for the treatment of diseases affecting the oral cavity.

Analgesic activity. Chlorobutanol exerts an analgesic effect. It can be used, in particular, in otorhinolaryngology (nasal drops, mouthwashes) and in dental practice (applications and irrigations). It can classically be used as a local anesthetic.

Pharmacokinetics.

The active substances bind to the oral mucosa, from which they are gradually released.

Clinical characteristics.

Indications.

Local treatment of oral infections. Postoperative care in dentistry.

Contraindications.

• Hypersensitivity to any component of the medicinal product.
• Atrophic pharyngitis.
• Bronchial asthma or any other respiratory tract diseases associated with existing airway hypersensitivity.

Interaction with other medicinal products and other forms of interaction.

Do not use together with medicinal products containing antiseptics.

Hexetidine may be inactivated by alkaline solutions.

Special precautions for use

Do not swallow when using. Avoid contact of the medicinal product with eyes, as it contains ethanol.

The medicinal product should be used with caution in patients with epilepsy. The medicinal product may lower the epileptic threshold and may cause seizures in children.

Use with caution in patients with a tendency to allergic reactions, including bronchial asthma, especially in patients allergic to acetylsalicylic acid. If signs of hypersensitivity to the medicinal product occur, its use should be discontinued immediately.

Since the medicinal product contains ethanol, it should be administered with caution to patients with liver diseases.

Prolonged use is not recommended, as it may alter the natural microbial balance of the oral cavity and pharynx, with a risk of bacterial and fungal overgrowth.

If general clinical signs of bacterial infection occur, systemic antibacterial therapy should be initiated.

If symptoms persist for more than 5 days and/or body temperature remains elevated, the treatment strategy should be reassessed.

If inflammation worsens, treatment with this medicinal product should be discontinued.

Use during pregnancy or breastfeeding

There are no human data available on the potential of hexetidine to cross the placenta or be excreted in breast milk. Therefore, the medicinal product should not be used during pregnancy and breastfeeding.

Ability to affect reaction speed when driving or operating machinery

The medicinal product contains ethanol. Drivers are advised not to operate a vehicle or machinery for at least 30 minutes after using the medicinal product.

Method of Administration and Dosage

Use as a topical agent for rinsing the oral cavity.

For one mouth rinse in adults and children aged 6 years and older: pour the medicinal agent into the measuring cup up to the 10 ml mark and dilute with warm water to the 50 ml mark, or dissolve 2 teaspoons of the medicinal agent in ¼ cup of warm water.

Perform 2 to 4 rinses per day.

Do not swallow.

Treatment duration — 5 days.

Children

Do not use in children under 6 years of age.

Overdose

No reports of overdose have been reported.

Alcohol intoxication due to the presence of ethanol may occur if a sufficient amount of the solution is absorbed through the oral mucosa.

The concentration of hexetidine in the medicinal product is not toxic when used as directed.

Acute alcohol intoxication is unlikely. However, if a child swallows a large dose of the medicinal product, alcohol intoxication may occur due to the presence of ethanol.

No cases of excessive use of hexetidine leading to hypersensitivity reactions have been reported.

Treatment of overdose is symptomatic and rarely required. In case a child swallows the contents of the bottle, seek immediate medical attention. Consider gastric lavage within 2 hours after ingestion and take measures to manage symptoms of alcohol intoxication.

Adverse Reactions.

Respiratory, thoracic and mediastinal disorders: cough, dyspnea.

Gastrointestinal disorders: dry mouth, dysphagia, salivary gland enlargement, pain on swallowing. Gastrointestinal disturbances, primarily nausea and vomiting, may occur if the medicinal product is accidentally swallowed.

Nervous system disorders: ageusia, dysgeusia, altered taste sensation for up to 48 hours (sweet taste may change to bitter).

Immune system disorders: hypersensitivity reactions, including urticaria, angioneurotic edema, laryngospasm, bronchospasm.

Skin and subcutaneous tissue disorders: allergic contact dermatitis, skin reactions (rash).

General disorders and administration site conditions: local reactions: reversible discoloration of teeth and tongue; mucosal sensitivity (burning, numbness); irritation (pain, sensation of warmth, itching) of the tongue and/or oral mucosa; decreased sensitivity; mucosal paraesthesia; inflammation; vesicles; development of mucosal ulcers; throat irritation; local swelling at site of contact; dryness of nasal/throat mucosa.

Reporting of suspected adverse reactions.

Reporting of suspected adverse reactions after authorization of the medicinal product is important. It allows ongoing monitoring of the benefit-risk balance of the product. Healthcare professionals and patients, as well as their legal representatives, are encouraged to report any suspected adverse reactions and/or lack of efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Do not freeze.

Keep out of reach and sight of children.

Packaging.

100 ml in a bottle; 1 bottle with a measuring cup in a carton.

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

Manufacturer. JSC "Pharmaceutical Company "Darnytsia".

Manufacturer's address and location of business activity.

13, Boryspilska Street, Kyiv, 02093, Ukraine.