Oil camphor (Solution) Instructions for Use

Marketing Authorization Holder

West, LLC (Russia)

Manufactured By

Samaramedprom, OJSC (Russia)

ATC Code

M02AX10 (Other drugs)

Active Substance

Camphor (Ph.Eur. European Pharmacopoeia)

Dosage Form

Oil camphor

Solution for external use, oily 10%: vial

Dosage Form, Packaging, and Composition

30 ml – dark glass bottles.
30 ml – polyethylene bottles.
50 ml – dark glass bottles.
50 ml – polyethylene bottles.

Clinical-Pharmacological Group

Drug with local irritant and analgesic action

Pharmacotherapeutic Group

Drugs for external use for muscle and joint pain; other drugs for external use for muscle and joint pain

Pharmacological Action

Camphor oil has antiseptic, locally irritant, analgesic, and anti-inflammatory effects.

By stimulating the sensitive nerve endings of the skin, it dilates blood vessels and improves the trophism of organs and tissues.

Indications

• Arthralgia;
• Myalgia;
• Sciatica;
• Radiculitis;
• Prevention of pressure sores.

ICD codes

Dosage Regimen

Apply the solution externally by rubbing it into the affected area two to three times daily.

The duration of treatment is determined by the physician based on the therapeutic response and the clinical picture.

Use only for external application; avoid contact with mucous membranes, eyes, and open wounds.

Adverse Reactions

Allergic skin reactions, including urticaria, rash, and pruritus, may occur at the application site.

Local skin irritation, such as erythema or a burning sensation, is possible, especially with prolonged use.

Discontinue use immediately and consult a physician if any adverse reactions manifest.

Contraindications

• Hypersensitivity to camphor or any excipients in the formulation.
• Application to damaged skin, including open wounds, abrasions, or severe inflammatory skin conditions.
• Patients with a history of epilepsy or a known predisposition to convulsive disorders.
• Diagnosed eczema, dermatitis, or other acute inflammatory skin diseases at the intended site of application.

Exercise caution during pregnancy, lactation, and in pediatric patients due to limited safety data.

Use in Pregnancy and Lactation

During pregnancy or breastfeeding, it is used taking into account the benefit/risk ratio for the woman/fetus (child), which is determined by the doctor.

Pediatric Use

Use with caution in children.

Special Precautions

The drug is prescribed for external use only.

Not used in children due to lack of clinical experience.

Effect on ability to drive vehicles and mechanisms

Studies on the effect of the drug on the speed of reaction when driving a vehicle or working with other mechanisms have not been conducted.

Overdose

No specific reports of overdose from external use are documented. Accidental ingestion is dangerous and requires immediate medical attention.

Symptoms of camphor poisoning may include nausea, vomiting, dizziness, agitation, confusion, tremors, and convulsions.

In case of accidental ingestion, do not induce vomiting and seek emergency medical care immediately.

Drug Interactions

No specific pharmacokinetic or pharmacodynamic drug interactions have been identified for topical application.

The potential for interaction with other topically applied medicinal products exists; avoid concurrent application to the same area without medical advice.

Inform your physician about all concomitant medications, including prescription, over-the-counter, and herbal products.

Storage Conditions

Store in a place protected from light. Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

Over-the-counter.

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.