Bile medicine conserved (Emulsion) Instructions for Use

Marketing Authorization Holder

Samson-Med LLC (Russia)

ATC Code

M02AX10 (Other drugs)

Active Substance

Bile (Grouping name)

Dosage Form

Bile medical conserved

Topical emulsion 900 ml/1.013 l: 100 ml or 250 ml jar or bottle

Dosage Form, Packaging, and Composition

Emulsion for topical use in the form of a liquid from yellow-brown to dark brown with a greenish tint or from light green to dark green with a brownish tint, with a characteristic odor; sediment may be present.

Excipients: ethyl alcohol 96% – 100 ml, furacilin solution in 70% alcohol – 10 ml, formalin – 1 ml, flavoring – 2 ml.

100 ml – glass bottles (1) – cardboard packs.
250 ml – glass bottles (1) – cardboard packs.
100 ml – polyethylene terephthalate bottles (1) – cardboard packs.
250 ml – polyethylene terephthalate bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Drug with local irritant action for external use

Pharmacotherapeutic Group

Drugs for external use for muscle and joint pain; other drugs for external use for muscle and joint pain

Pharmacological Action

It has a local irritant effect.

Indications

• Arthralgia;
• Post-traumatic myalgia (without violation of skin integrity).

ICD codes

Dosage Regimen

Apply topically as compresses. Soak a gauze pad with the emulsion and apply it to the affected area. Cover the gauze with waxed paper and secure with a bandage.

Keep the compress for 24 hours. If the gauze dries out, remoisten it with water at room temperature and re-secure it. Change the compress with a new gauze pad every 24 hours.

The typical treatment course is 6 to 10 days. Discontinue use and consult a doctor if no improvement is seen, symptoms worsen, or new symptoms appear.

Adverse Reactions

Possible adverse reactions include allergic reactions and skin irritation at the application site.

Skin irritation typically resolves quickly after discontinuation of the drug. If skin irritation occurs, subsequent use of compresses is permitted only after a 30-day interval.

Drug Interactions

Do not mix this emulsion with any other medicines or topical preparations. Concurrent use with other topical agents on the same area is not recommended due to the potential for unpredictable local skin reactions.

Contraindications

• Hypersensitivity to bile, furacilin, ethyl alcohol, formalin, flavoring, or any other component of the drug.
• Application to skin with impaired integrity, including open wounds, cuts, or abrasions.
• Presence of any skin diseases (e.g., dermatitis, eczema, psoriasis) at the sites of intended application.
• Use in children under 12 years of age.

Overdose

Overdose with topical use is unlikely. Symptoms of systemic overdose are not described.

Prolonged application or use on large body surface areas may increase the risk of local adverse reactions, such as severe skin irritation or burns, especially if an occlusive dressing like plastic film is used instead of waxed paper.

If signs of a severe local reaction (e.g., intense redness, blistering, pain) occur, discontinue use immediately and rinse the affected area with water. Seek medical attention if symptoms are severe or persistent.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is possible only if the intended benefit to the mother outweighs the potential risk to the fetus and child. It is necessary to consult a doctor.

Pediatric Use

Contraindicated for use in children under 12 years of age.

It should be used with caution in children over 12 years of age.

Special Precautions

Avoid getting this agent on open wounds, in the eyes, and on mucous membranes.

Only waxed paper should be used for compresses, because the use of polyethylene film promotes the occurrence of a “greenhouse effect”, which can lead to skin burns.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°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.