Bengay^® (Cream) Instructions for Use

Marketing Authorization Holder

J&JTL, LLC (Russia)

Manufactured By

JNTL Consumer Health (France), S.A.S. (France)

Contact Information

JNTL LLC (Russia)

ATC Code

M02AC (Preparations with salicylic acid derivatives)

Active Substances

Methyl salicylate (Ph.Eur. European Pharmacopoeia)

Racementhol (Rec.INN WHO registered)

Dosage Form

Bengay®

Cream for external use 150 mg+100 mg/1 g: tube 50 g

Dosage Form, Packaging, and Composition

Cream for external use white in color, homogeneous, with a characteristic odor.

Excipients: stearic acid – 130 mg, glyceryl monostearate – 80 mg, anhydrous lanolin – 20 mg, sorbitan trioleate (polysorbate 85) – 20 mg, sorbitan tristearate (span 65) – 10 mg, trolamine (triethanolamine) – 10 mg, purified water – 480 mg.

50 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Topical anti-inflammatory drug

Pharmacotherapeutic Group

Preparations for external use for muscle and joint pain; preparations with salicylic acid derivatives

Pharmacological Action

It causes muscle relaxation, enhances blood flow, facilitates the removal of irritating metabolic products (primarily lactic acid), allows increasing the duration of physical exercises and improves their tolerance.

The irritating effect of racementhol contributes to a decrease in pain sensations. The local action is accompanied by vasodilation, causing a sensation of cooling, turning into a sensation of slight burning and tingling, followed by an analgesic effect.

Methyl salicylate is an anti-inflammatory analgesic. It non-selectively inhibits cyclooxygenase, reducing the synthesis of prostaglandins. It normalizes increased capillary permeability, improves microcirculation processes, reduces swelling and infiltration of inflamed tissues. It has only a local action.

Pharmacokinetics

With external use, the concentration of racementhol in the systemic circulation is insignificant.

Methyl salicylate, when applied externally, penetrates into tissues through intact skin, while an analgesic concentration in the systemic circulation is not achieved. Salicylates are excreted mainly by the kidneys; the excretion rate depends on the plasma concentration and urine pH.

Indications

• To reduce pain and stiffness in joints and muscles due to injuries, sprains, and inflammation;
• To reduce lower back pain;
• For myalgia (muscle pain) before and after sports activities.

ICD codes

Dosage Regimen

Apply the cream externally only.

Administer a thin layer of cream directly to the painful area.

Rub the cream gently into the skin until it is completely absorbed.

Repeat the application every few hours, as needed for pain relief.

Do not exceed 3 to 4 applications per day.

Limit the total duration of continuous use to 10 days.

Discontinue use and consult a physician if pain persists beyond 10 days.

Avoid contact with eyes, mucous membranes, and broken or irritated skin.

Do not apply with occlusive dressings or heating pads.

Wash hands thoroughly immediately after application.

Discontinue use if skin irritation or a rash occurs.

Adverse Reactions

The frequency of adverse effects is defined as follows: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/10,000).

Post-marketing data

Immune system disorders very rare – angioedema.

Respiratory system disorders very rare – dyspnea (due to hypersensitivity).

Injuries, poisonings and procedural complications very rare – burns at the application site.

General disorders and administration site conditions very rare – reactions at the application site (including blisters, burning, hyperemia, erythema, irritation, pain, paresthesia, urticaria, itching, and rash).

Contraindications

• Impaired skin integrity and inflammatory skin diseases at the application site;
• Children under 12 years of age;
• Pregnancy (III trimester);
• Hypersensitivity to any component of the drug.

With caution the drug should be prescribed in the I and II trimesters of pregnancy, during lactation (breastfeeding), with salicylate intolerance, Reye’s syndrome.

Use in Pregnancy and Lactation

If they enter the systemic circulation, salicylates cross the placental barrier and into the milk of nursing women and can adversely affect the fetus, especially in the III trimester of pregnancy (for example, cause premature closure of the arterial duct or prolonged labor). Although topical application of methyl salicylates is not expected to increase their plasma concentration to levels dangerous to the fetus, when deciding on the possibility of prescribing the drug during pregnancy and breastfeeding, the expected potential benefit of therapy with the drug for the mother and the potential risk to the fetus or child should be assessed.

Pediatric Use

Contraindicated in children under 12 years of age.

Special Precautions

The drug is for external use only.

Do not use with occlusive dressings, warming compresses.

If skin irritation occurs, discontinue use of the drug.

Avoid contact with eyes, mucous membranes, and areas of skin irritation.

The patient should be informed that if the pain persists for 10 days or more, and the cream does not provide relief, it is necessary to consult a doctor.

Cross-allergy to other salicylates is possible.

The patient should be informed that if the medicine is no longer usable or the expiration date has passed, it should not be disposed of in sewage or on the street. It is necessary to place the medicine in a bag and put it in a trash container. These measures will help protect the environment.

Use in pediatrics

Do not use in children under 12 years of age.

Effect on ability to drive vehicles and mechanisms

The drug does not affect the ability to drive a car and operate machinery.

Overdose

Overdose of racementhol and methyl salicylate has been observed in isolated cases, mainly in children, with accidental ingestion of drugs containing these substances.

Overdose with external use is rare and only with improper use of the drug (application to mucous membranes, to large areas of damaged or infected skin).

Symptoms of methyl salicylate overdose agitation, increased depth of breathing, hyperpyrexia.

Symptoms of racementhol overdose nausea, abdominal pain, vomiting and symptoms of CNS depression, such as dizziness, unsteady gait, facial flushing, drowsiness, respiratory depression, and coma.

Treatment symptomatic and supportive therapy; correction of electrolyte and water balance, administration of adsorbents and saline laxatives, forced diuresis, external body cooling; in severe cases – blood transfusion, hemodialysis.

Drug Interactions

The drug causes skin hyperemia and reflexively enhances blood circulation in the subcutaneous tissue, thus, concomitant use with other topical drugs may lead to increased absorption of them.

In patients sensitive to acetylsalicylic acid, skin allergic reactions, as well as angioedema, were noted with topical application of methyl salicylate.

When used concomitantly with acetylsalicylic acid, toxic effects of salicylates may be observed.

In patients taking anticoagulants, for example, warfarin, bleeding may occur since this drug contains salicylate.

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 – 2 years. Do not use after the expiration date printed on the packaging.

Dispensing Status

The drug is available without a prescription.

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.