Flut asthesin®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FLUTEASTHESIN® (FLUTEASTHESIN®)

Composition:

Active substance: benzocaine;

1 suppository contains 206 mg of benzocaine;

Excipients: cocoa butter, corn starch, methylparahydroxybenzoate (E 218), propylparahydroxybenzoate (E 216).

Pharmaceutical form. Suppositories.

Main physicochemical properties: suppositories from almost white to light yellow in color, torpedo-shaped.

Pharmacotherapeutic group.

Agents for the treatment of hemorrhoids and anal fissures for topical use. Local anesthetics. Benzocaine. ATC code C05AD03.

Pharmacological Properties.

Pharmacodynamics.

Benzocaine reversibly stabilizes the neuronal membrane, thereby reducing its permeability to sodium ions. This suppresses neuronal membrane depolarization and consequently blocks the generation and conduction of nerve impulses. Thus, benzocaine exerts a pronounced local anesthetic effect.

Pharmacokinetics.

The medicinal product is intended for rectal administration. Benzocaine, contained in the suppositories, is excreted in mucus or in very small amounts by the kidneys.

Clinical characteristics.

Indications.

External and internal hemorrhoids, fissures, erosion and microtraumas in the anal area, perianal pruritus with pronounced pain syndrome. As an anesthetic after proctological surgical procedures.

Contraindications.

Hypersensitivity to any component of the drug or to other amide-type local anesthetics, thromboembolic disease, granulocytopenia.

Interaction with other medicinal products and other forms of interaction.

The use of the drug is not recommended during concomitant regular administration of monoamine oxidase inhibitors (MAOIs), antidepressants, and antihypertensive agents without strict medical indications and physician supervision, due to the theoretical possibility of reduced MAOI efficacy or enhanced antihypertensive effects resulting from interaction with benzocaine, particularly in cases of significant overdose or prolonged use beyond recommended doses and duration.

Special precautions for use.

In case of profuse bloody discharge from the anus or presence of disease symptoms, or if the condition worsens during 7 days of treatment, additional consultation with a proctologist is necessary.

A physician should be consulted before starting use of this medicinal product in the following cases: pronounced arterial hypertension, severe cardiac arrhythmia, clinically evident thyrotoxicosis, or urinary retention.

The smallest necessary amount of the medicinal product should be used. There have been reports that administration of drugs containing benzocaine may cause methemoglobinemia. Symptoms such as cyanosis of the skin, lips, and nail beds, headache, dizziness, dyspnea (difficulty breathing), weakness, and tachycardia, which may occur during treatment, could indicate potentially life-threatening methemoglobinemia requiring immediate medical intervention (see section "Overdose").

Unless otherwise directed by a physician, the recommended daily dose should not be exceeded in order to minimize the risk of systemic adverse reactions.

In case of rectal bleeding, prompt medical consultation is required.

The medicinal product contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).

Use during pregnancy or breastfeeding.

During pregnancy, the drug should be used only if absolutely necessary, after careful evaluation by a physician of the benefit-risk ratio for the mother versus the fetus or child.

During breastfeeding, a decision should be made whether to discontinue breastfeeding or to discontinue use of the medicinal product, taking into account the importance of the drug for the mother.

Ability to affect reaction speed when driving or operating machinery.

Unknown.

Method of Administration and Dosage

The medicinal product should be administered rectally after hygiene procedures. Insert 1 suppository in the morning, after each bowel movement, and before bedtime. The daily dose should not exceed 4 suppositories per day. The usual duration of treatment is 7 days. If necessary, treatment may be extended up to 3 weeks or longer (after consultation with a physician). Regular use of the suppositories ensures a sustained therapeutic effect and relieves hemorrhoid symptoms.

Children

The medicinal product should be prescribed by a physician to children under 12 years of age only when absolutely necessary.

Overdose

Symptoms of overdose may be related to the pharmacological effects of benzocaine. Systemic absorption in overdose may manifest as drowsiness, anxiety, cardiac arrhythmias, excitation, and in severe cases, seizures, coma, decreased respiratory rate, or respiratory failure. There have been reports that drugs containing benzocaine may cause methemoglobinemia (see section "Special Warnings and Precautions for Use"). Symptoms such as cyanosis of the skin, lips, and nail beds, headache, dizziness, dyspnea (difficulty breathing), weakness, and tachycardia observed during treatment may indicate potentially life-threatening methemoglobinemia requiring immediate medical intervention.

Emergency treatment for overdose and development of methemoglobinemia consists of intravenous administration of methylene blue. Management of other overdose symptoms includes discontinuation of the drug and symptomatic therapy.

Adverse Reactions

Blood and lymphatic system disorders: Methemoglobinemia (skin, lips, and nail beds cyanosis, headache, dizziness, dyspnea, weakness, tachycardia).

General disorders and administration site conditions: Allergic reactions including hyperemia, skin rashes, itching; changes at the site of administration (irritation, swelling, pain).

Skin and subcutaneous tissue disorders: Allergic dermatitis, contact dermatitis.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions after registration of the medicinal product is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life.

2 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

6 suppositories in a strip. 2 strips in a cardboard box.

Availability category.

Over-the-counter (without prescription).

Manufacturer.

Kusum HealthCare Pvt Ltd /
Kusum Healthcare Pvt Ltd.

Manufacturer's address and location of business activity.

SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India /
SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India.