Atrican 250 (Capsules) Instructions for Use

Marketing Authorization Holder

Laboratoire Innotech International (France)

Manufactured By

Innothera Chouzy (France)

ATC Code

P01AX08 (Tenonitrozole)

Active Substance

Tenonitrozole (Rec.INN registered by WHO)

Dosage Form

Atrican 250

Enteric-coated capsules 250 mg: 8 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated capsules soft, from yellow to yellow-brown, oval; the capsule contents are an oily homogeneous mass of gray-brown color, with a faint characteristic odor.

Excipients: peanut oil – 194 mg, hydrogenated soybean oil – 6 mg, soy lecithin – 5 mg.

Capsule shell composition: gelatin – 134 mg, sorbitol and sorbitans solution – 66 mg, titanium dioxide (E171) – 1.5 mg, yellow iron oxide dye (E172) – 1 mg, glycerol – 3.5 mg, hypromellose phthalate – 30 mg, dibutyl phthalate – 5.2 mg.

8 pcs. – blisters (1) – cardboard packs.

Clinical-Pharmacological Group

Antiprotozoal drug used for trichomoniasis

Pharmacotherapeutic Group

Antiprotozoal agent

Pharmacological Action

Antitrichomonal agent. Tenonitrozole is active against Trichomonas vaginalis. It has a trichomonacidal effect. Also active against Candida albicans.

Pharmacokinetics

Well absorbed from the gastrointestinal tract. Slowly excreted.

Indications

Trichomoniasis of the genitourinary system (in women and men).

ICD codes

Dosage Regimen

Administer orally. Take one 250 mg capsule twice daily. Ingest capsules with meals to improve tolerability.

Maintain a consistent dosing schedule. The total duration of treatment is four consecutive days.

Ensure simultaneous treatment of the sexual partner to prevent reinfection. Abstain from sexual intercourse for the entire treatment course.

Swallow capsules whole. Do not crush or chew the enteric-coated capsules.

Strictly avoid consumption of alcohol and ethanol-containing medications during therapy and for several days after completion.

Complete the full prescribed course, even if symptoms improve. Do not exceed the recommended dosage or duration.

If a dose is missed, take it as soon as remembered. If it is nearly time for the next dose, skip the missed dose. Do not double the dose to catch up.

Discontinue use and consult a physician immediately if signs of hypersensitivity, such as skin rash or urticaria, appear.

Adverse Reactions

From the digestive system: nausea, epigastric discomfort, loss of appetite.

Allergic reactions: urticaria, skin rashes, itching.

Contraindications

Hypersensitivity to tenonitrozole; acute and chronic hepatic failure; childhood.

Use in Pregnancy and Lactation

During pregnancy, it can be used if indicated in cases where the intended benefit to the mother outweighs the potential risk to the fetus. If it is necessary to use during lactation, the issue of discontinuing breastfeeding should be decided.

Use in Hepatic Impairment

Contraindicated in acute and chronic hepatic failure.

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Special Precautions

Simultaneous treatment of the sexual partner is necessary. During the course of treatment for trichomoniasis, sexual intercourse should be avoided.

During treatment with tenonitrozole, wearing contact lenses is not recommended.

Yellow discoloration of the sclera and urine is possible.

If several courses of tenonitrozole therapy have been conducted, then upon completion of treatment, monitoring of the peripheral blood picture is recommended.

During treatment, consumption of alcohol and medicines containing ethanol should be avoided.

Tenonitrozole is not recommended for simultaneous use with disulfiram.

Drug Interactions

Incompatible with medicines containing ethanol.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.