ANESTEZOL®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Anestezol® (AnAesthesolum®)

Composition:

Active substances: benzocaine, bismuth subgallate, zinc oxide, menthol;

1 suppository contains benzocaine (0.1 g) 100 mg, bismuth subgallate (0.04 g) 40 mg, zinc oxide (0.02 g) 20 mg, menthol (0.004 g) 4 mg;

Excipients: polyethylene glycol 1500, polyethylene glycol 400.

Pharmaceutical form. Suppositories.

Main physicochemical properties: yellowish-green, bullet-shaped suppositories.

Pharmacotherapeutic group. Agents for the treatment of hemorrhoids and anal fissures for local use. Local anesthetics. ATC code C05AD.

Pharmacological properties.

Pharmacodynamics.

Anestezol*®* is a combination medicinal product whose therapeutic effect is determined by the pharmacological properties of its active ingredients. Anestezol*®* exerts local anesthetic, anti-inflammatory, and astringent actions.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Symptomatic treatment of hemorrhoids and anal fissures.

Contraindications.

Hypersensitivity to the components of the drug. Hypersensitivity to other amide-type local anesthetics.

Interaction with other medicinal products and other forms of interaction.

Not studied.

Special precautions.

During prolonged use of the drug, monitoring of blood parameters is necessary.

Use during pregnancy or breastfeeding.

The drug may be prescribed by a physician to women during pregnancy or breastfeeding, taking into account the risk/benefit ratio.

Ability to affect reaction rate when driving vehicles or operating machinery.

While being treated with this drug, it is recommended to avoid driving vehicles or performing tasks that require heightened attention and precise coordination.

Method of Administration and Dosage.

Before using the suppository, it is necessary to:

• tear off one suppository in the primary packaging along the perforation line of the blister pack;
• then pull the edges of the film in opposite directions to tear it apart and remove the suppository from the primary packaging.

The drug is administered rectally. The recommended dose is 1 suppository 1–2 times daily, after an enema or spontaneous bowel movement.

The duration of treatment is determined by the physician, taking into account the course and severity of the disease, as well as the therapeutic effect achieved.

Children. There are no data regarding the use of the drug in children.

Overdose.

Overdose is unlikely when the drug is used at therapeutic doses. Possible intensification of adverse reactions. Treatment is symptomatic.

Side effects.

Allergic reactions, skin rashes, and itching may occasionally occur. The drug may have a laxative effect and cause burning in the anal area. With prolonged use, blood-related reactions (methemoglobinemia) may develop.

Shelf life.

3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

5 suppositories per blister, 1 or 2 blisters per carton.

Availability.

Over-the-counter (without prescription).

Manufacturer.

Private Joint-Stock Company "Lekhim-Kharkiv".

Manufacturer's location and address of business activity.

36 Severina Pototskogo Street, Kharkiv, Kharkiv Region, Ukraine, 61115.