Finalgon^® (Ointment, Cream) Instructions for Use

ATC Code

M02AX10 (Other drugs)

Active Substances

Nonivamide (Rec.INN registered by WHO)

Nicoboxil (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Drug with local irritant and analgesic action

Pharmacotherapeutic Group

Local irritant

Pharmacological Action

Nonivamide is a synthetic analogue of capsaicin and has analgesic properties, which are manifested as a result of the gradual penetration of the active substance into peripheral nociceptive C-fibers and A-delta nerve fibers with repeated application of the drug to the skin. Nonivamide has a vasodilating effect, which is accompanied by an intense, prolonged sensation of warmth, due to the stimulation of afferent nerve endings in the skin.

Nicoboxil is a derivative of nicotinic acid, which has vasodilating properties with the participation of prostaglandins I2 and E2. The hyperemic effect of nicoboxil (butoxyethyl ester of nicotinic acid) develops faster and has a greater intensity than the hyperemic effect of nonivamide.

Combined action

Nonivamide and Nicoboxil have complementary vasodilating properties, cause skin hyperemia, increase the rate of enzymatic reactions, and activate metabolism.

The appearance of hyperemia and an increase in skin temperature within a few minutes after application indicate the rapid penetration of the active components of the drug into the skin.

The effect of Finalgon^® is manifested locally, develops within a few minutes and reaches a maximum after 20-30 minutes.

The analgesic effect of the combination of 0.4% nonivamide and 2.5% nicoboxil was demonstrated in an efficacy study in patients with acute nonspecific low back pain. It was found that in patients using Finalgon^® (2 cm of ointment per application up to 3 times/day for 4 days), a clinically significant reduction in the intensity of low back pain was observed as early as 4 hours after the first application; on the last day of treatment, determined individually, a clinically significant reduction in pain was also observed. In a clinical study, it was found that pain reduction began after 1-2 hours.

Pharmacokinetics

Data on the pharmacokinetics of Finalgon^® are not available.

Indications

• Arthritis;
• Arthralgia and myalgia of rheumatic origin;
• Sports injuries, bruises and ligament damage;
• Myalgia caused by excessive physical exertion;
• Lumbago;
• Neuritis;
• Sciatica;
• Bursitis and tenosynovitis;
• Acute nonspecific low back pain;
• For preliminary “warming up” of muscles before physical exercises, sports competitions;
• As part of complex vasodilator therapy for peripheral circulatory disorders.

ICD codes

Dosage Regimen

Cream

Apply externally 2-3 times/day.

For preliminary warming of muscles before physical exercises, sports competitions, it is recommended to rub in approximately 30 minutes before they start.

Ointment

Treatment should be started by applying a small amount of the drug to a small area of skin to assess the individual reaction. The individual reaction to the drug can vary significantly: some people will only need to apply a small amount of the ointment to cause the necessary warming effect, while in others the warming effect is mild or may be absent.

Start using the drug with the lowest dose. To do this, using the supplied applicator, a column of the drug no larger than 0.5 cm is applied to an area of skin the size of a palm with light rubbing movements. To enhance the therapeutic effect, the area of skin on which the drug is applied can be covered with woolen cloth.

With repeated use, the reaction to the ointment may decrease, which requires an increase in the dose, which is selected individually. The maximum recommended dose of the drug is no more than 1 cm column of ointment per area the size of a palm (approximately 10×20 cm).

If necessary, the ointment is used 2-3 times/day.

For preliminary warming of muscles before physical exercises, sports competitions, it is recommended to rub in approximately 30 minutes before they start.

The patient should be warned that if the desired effect is not achieved within 10 days, they should consult a doctor.

After applying the drug to the skin, wash your hands thoroughly with soap.

Adverse Reactions

During clinical studies and long-term experience with the drug, the following side effects have been identified

From the immune system anaphylactic reactions, hypersensitivity.

From the nervous system paresthesia, burning sensation.

From the respiratory system cough, shortness of breath.

From the skin and subcutaneous tissues vesicles or pustules at the application site, erythema, local skin reaction (e.g., contact dermatitis), itching, rash, facial swelling, urticaria, sensation of heat at the application site.

Contraindications

• Children and adolescents under 18 years of age (due to insufficient data on efficacy and safety for this group of patients);
• Hypersensitivity to nicoboxil, nonivamide or excipients of the drug.

The drug should not be applied to sensitive skin, open wounds, inflamed areas of skin, areas of skin with increased permeability: neck, lower abdomen, inner side of the thighs.

Use in Pregnancy and Lactation

No special studies of Finalgon^® in pregnant and breastfeeding women have been conducted, therefore the drug should not be prescribed during pregnancy and lactation.

No studies on the effect of the drug on fertility have been conducted.

Pediatric Use

Contraindicated in children under 12 years of age

Special Precautions

The drug causes skin hyperemia, resulting in redness, sensation of warmth, itching and burning at the application site. These symptoms may be more pronounced when applying an excessive amount of the drug or in case of intensive rubbing on the skin surface. The use of excessive amounts of the drug or intensive rubbing on the skin surface can lead to the formation of vesicles or pustules at the site of ointment application.

After using Finalgon^®, hands should be washed immediately with soap.

Care must be taken to avoid accidental contact of the drug on other areas of the skin or contact of the drug on another person.

Avoid accidental contact of the drug on the face, eyes, nose or mouth. This can lead to temporary facial swelling, facial pain, conjunctival inflammation, eye hyperemia, burning in the eyes, visual impairment, oral discomfort and stomatitis.

Before or after applying the drug to the skin, you should not take a hot bath or shower.

Sweating or applying heat to the site of drug application can cause skin redness and an intense sensation of warmth even several hours after applying Finalgon^®.

The drug contains sorbic acid, which may cause local skin irritation (e.g., contact dermatitis).

Effect on ability to drive vehicles and mechanisms

No special clinical studies have been conducted on the effect of the drug on the ability to drive a car and operate machinery. However, caution should be exercised when driving and working with machinery while using the drug.

Overdose

Symptoms the effect of skin hyperemia and the severity of dose-dependent side effects may worsen after applying an excessive amount of Finalgon^® ointment. The use of excessive amounts of the drug can lead to the formation of vesicles or pustules at the site of ointment application.

Overdose of the drug can cause systemic reactions (redness of the upper body, increased body temperature, “hot flashes”, painful hyperemia, decreased blood pressure), because nicotinic acid esters have good transdermal absorption.

Treatment: if an excessive amount of the drug is used, the effect can be reduced by removing the ointment from the skin surface using vegetable oil or a fatty cosmetic cream, from the eye mucosa (in case of accidental contact) – using medical petroleum jelly. If necessary, symptomatic treatment should be carried out.

Drug Interactions

No drug interaction of Finalgon^® with other drugs used locally or systemically has been identified.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 4 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

RU/FIN-151007

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.