Stomaflor^® (Ointment) Instructions for Use

Marketing Authorization Holder

Avan, LLC (Russia)

Manufactured By

Partner, JSC (Russia)

ATC Code

A01AD (Other drugs for the treatment of oral diseases)

Active Substances

Bifidobacterium bifidum (Group Group name)

Hippophaes oleum (Group Group name)

Lactobacillus plantarum (Group Group name)

Dosage Form

Stomaflor®

Ointment for topical use 5 million CFU+ 5 million CFU+ 60 mg/1 g: tube 10 g

Dosage Form, Packaging, and Composition

Ointment for topical use light brown or orange in color, homogeneous, with a faint odor of sea buckthorn oil.

* adsorbed on colloidal silicon dioxide.

Excipients: sunflower oil – 0.036-0.044 g, polysorbate 80 – 0.0027-0.0033 g, low molecular weight polyvinylpyrrolidone – 0.086-0.1 g, colloidal silicon dioxide – 0.00054-0.00066 g, petrolatum – 0.65-0.79 g, paraffin P2 – 0.072-0.088 g, sucrose – 0.002-0.0025 g, gelatin – 0.00027-0.00033 g.

10 g – aluminum tubes (1) – cardboard cartons.

Clinical-Pharmacological Group

Drug used for periodontal diseases and gingivitis

Pharmacotherapeutic Group

MIBP-eubiotic

Pharmacological Action

A combined agent, the action of which is determined by the properties of its constituent components. It has reparative and anti-inflammatory effects, restoring the normal microflora of the oral cavity.

The active components included in the product have a complementary action. Bifidobacteria (B. bifidum) and lactobacilli (L. plantarum) suppress the growth of pathogenic and opportunistic bacteria (staphylococci, streptococci, Proteus, Klebsiella, etc.), accelerate the normalization of the quantitative and qualitative composition of the microflora, activate the repair of the mucous membrane, and enhance the anti-inflammatory effect of sea buckthorn oil.

Sea buckthorn oil is a source of carotene (provitamin A), tocopherols (vitamin E), and other lipophilic substances, reduces the intensity of free radical processes and protects cellular and subcellular membranes from damage, and stimulates reparative processes in case of damage to the mucous membrane.

Indications

Gingivitis and periodontal diseases: acute and chronic gingivitis; chronic periodontitis, including chronic generalized periodontitis.

ICD codes

Dosage Regimen

Apply the ointment topically to the oral mucosa.

Use a clean finger or a cotton swab to place a small amount of ointment, approximately 0.5-1 cm strip, directly onto the affected gingival or periodontal areas.

Administer the ointment two to three times daily, following oral hygiene procedures such as brushing teeth.

After application, refrain from eating or drinking for at least 30-60 minutes to maximize local contact time.

The standard treatment course is 10 to 14 days. The duration can be extended up to 21 days based on clinical response and physician recommendation.

For chronic conditions, repeat courses of therapy may be necessary, with intervals determined by a healthcare professional.

Do not use concurrently with antibacterial mouth rinses containing chlorhexidine or similar agents immediately before or after application, as this may reduce the viability of the probiotic components.

If using systemic antibiotics, maintain a minimum interval of 3-4 hours between taking the antibiotic and applying the ointment.

Discontinue use and consult a physician if signs of a local allergic reaction occur.

Adverse Reactions

Possible local allergic reactions.

Contraindications

Allergic reactions to sea buckthorn oil.

Use in Pregnancy and Lactation

There are no data on the use of the product during pregnancy and breastfeeding.

Special Precautions

It is not recommended to use oral forms simultaneously with antibiotics, or to dissolve the preparation in hot water (above 40°C) and store it in dissolved form.

The use of suppositories can be combined with the simultaneous administration of antibacterial, antiviral, and immunostimulating drugs.

Drug Interactions

When taking antibiotics concomitantly, it is recommended to observe a 3-4 hour interval between their intake.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°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.