MENOLIDIN

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MENOLIDYN

Composition:

Active substances: levomenthol, lidocaine hydrochloride monohydrate, benzocaine;

1 g of gel contains: levomenthol — 25 mg; lidocaine hydrochloride monohydrate (calculated as anhydrous substance) — 10 mg; benzocaine — 10 mg;

Excipients: propylene glycol, carbomer, ethanol (96%), sodium hydroxide solution 18%, purified water.

**Pharmaceutical form.** Gel.

Main physicochemical properties: opaque, homogeneous gel with a characteristic menthol odor. A slight yellowish tint may be present.

Pharmacotherapeutic group. Products used locally for joint and muscular pain. ATC code M02AX.

Pharmacological Properties

Pharmacodynamics

Menolidin is a combination drug whose properties are determined by the action of its active components. In particular, due to the selective action of levomenthol on cold receptors, the gel induces a sensation of cold, while its irritant effect may be accompanied by slight anesthesia. Reflexively, levomenthol alters vascular tone, affecting both superficial and deeper blood vessels. Lidocaine hydrochloride exhibits sufficiently pronounced anesthetic activity. It does not alter vascular tone. Benzocaine produces surface anesthesia. The combination of these components in a single preparation ensures the ability to induce reversible impairment of excitability and conduction in nerve receptors and pathways upon direct contact, to exert an irritant and counterirritant effect, and to suppress nerve fiber membrane excitation, reduce the amplitude of the action potential, raise the depolarization threshold of the nerve fiber membrane, slow the rate of rise of the action potential, and reduce the degree of excitation in nerve elements.

Pharmacokinetics

No proprietary pharmacokinetic studies have been conducted. It is known that the active components do not enter the systemic circulation when the drug is applied to intact skin.

Clinical Characteristics

Indications

Neuralgias, myalgias, arthralgias.

Contraindications

Hypersensitivity to any component of the medicinal product. Hypersensitivity to lidocaine or other local anesthetics of the amide type (e.g., bupivacaine, etidocaine, mepivacaine, prilocaine). Hypersensitivity to benzocaine or other local anesthetics of the ester type (e.g., procaine, tetracaine). Children under 12 years of age.

Interaction with other medicinal products and other forms of interaction

Interaction studies have not been conducted.

Benzocaine contained in the medicinal product may reduce the antibacterial effect of sulfonamide drugs.

The drug does not enter systemic circulation when applied to intact skin; however, patients receiving Class I antiarrhythmic agents (e.g., tocainide, mexiletine) or other local anesthetics should use Menolidin with caution, due to the risk of cumulative systemic effects from lidocaine (particularly effects on the nervous and cardiovascular systems), as well as a possible enhancement of local analgesic action. The risk of cumulative systemic effects may increase with use of the drug at higher doses or when applied to large skin areas or damaged skin.

Monoamine oxidase inhibitors (MAOIs) enhance the local analgesic effect of lidocaine.

When using any other medicinal products concurrently, inform your physician.

Special precautions for use

Do not apply to skin showing signs of allergic reaction, to facial skin, or to damaged skin.

The medicinal product contains propylene glycol, which may cause skin irritation.

Use during pregnancy or breastfeeding

There is no experience with the use of the drug during pregnancy or breastfeeding. Before using Menolidin during pregnancy or breastfeeding, consult a physician for careful evaluation of the benefit-risk ratio.

Ability to affect reaction speed when driving or operating machinery

Has no effect.

Method of Administration and Dosage

For external use only. Apply a thin layer of gel to painful or affected areas of the skin and gently rub in. The frequency of application is 2–3 times daily.

The duration of treatment depends on the form and course of the disease, as well as on concomitant therapy. The maximum daily dose is 9 g.

Children

Do not use in children under 12 years of age (see section "Contraindications").

Overdose

With prolonged use, possible symptoms include dizziness, general weakness, decreased arterial pressure, and allergic reactions.

If such symptoms occur, discontinue the drug, wash off any residue from the skin surface with water, and consult a physician. Treatment is symptomatic.

Side effects

Possible allergic reactions (including hyperemia, skin irritation, itching, rash, swelling, urticaria), contact dermatitis.

In very rare cases, topical application of medicinal products containing lidocaine or benzocaine may cause severe allergic reactions, including anaphylactic shock (see section "Contraindications").

If you experience any allergic reactions, you must immediately consult a doctor. These adverse reactions require immediate discontinuation of the medicinal product and constitute contraindications to its further use.

Reporting suspected adverse reactions

Reporting adverse reactions following marketing authorization of the medicinal product is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and pharmacists, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life: 2 years.

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

Keep out of reach of children.

Packaging: 30 g or 40 g in a tube, 1 tube per cardboard box.

Availability category: Over-the-counter (without prescription).

Manufacturer: JSC "Lubnipharm".

Manufacturer's address and location of business activity: 16, Barvinkova St., Lubny, Poltava region, 37500, Ukraine.