Camphor oil (Solution) Instructions for Use

Marketing Authorization Holder

Tver Pharmaceutical Factory, PJSC (Russia)

ATC Code

M02AX10 (Other drugs)

Active Substance

Camphor (Ph.Eur. European Pharmacopoeia)

Dosage Form

Camphor oil

Oil solution for external use 10%: fl. 30 ml, 50 ml, or 100 ml

Dosage Form, Packaging, and Composition

Oil solution for external use in the form of a transparent oily liquid of yellow color with a camphor odor.

Excipients: sunflower oil – up to 100 ml.

30 ml – orange glass bottles (1) – cardboard packs.
50 ml – orange glass bottles (1) – cardboard packs.
100 ml – orange glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Analgesic and local anesthetic agent for external use

Pharmacotherapeutic Group

Local irritant of natural origin

Pharmacological Action

A preparation for external use. It has antiseptic, local irritant, local 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.

Pharmacokinetics

When applied to the skin surface, it is partially absorbed and undergoes oxidation.

The oxidation products bind with glucuronic acid and are excreted by the kidneys.

A portion of the camphor is excreted unchanged through the respiratory tract and with bile.

Indications

• Arthralgia;
• Myalgia;
• Sciatica;
• Myositis;
• Radiculitis;
• Prevention of pressure sore development.

ICD codes

Dosage Regimen

Apply the preparation externally only.

Apply a small amount to the skin in the area of pain.

Rub it in with light movements until fully absorbed.

Repeat this procedure 2-3 times per day.

The standard treatment duration is 7-10 days.

Do not exceed the recommended frequency or duration of application.

For prevention of pressure sores, treat the at-risk skin areas 2-3 times per day.

Avoid application to broken skin, mucous membranes, or near the eyes.

Discontinue use and consult a physician if severe skin irritation or allergic reactions occur.

Adverse Reactions

Possible allergic skin reactions (urticaria), skin irritation, headache, dizziness.

Contraindications

• Hypersensitivity to the components of this preparation;
• Predisposition to convulsive reactions;
• Impaired integrity of the skin;
• Inflammatory skin diseases at the site of intended application (including dermatitis, eczema);
• Pregnancy;
• Breastfeeding period;
• Children and adolescents under 18 years of age.

Use in Pregnancy and Lactation

Use is contraindicated during pregnancy and breastfeeding.

Pediatric Use

The drug is contraindicated for use in children and adolescents under 18 years of age.

Geriatric Use

The drug is contraindicated for use in elderly patients.

Special Precautions

Avoid getting the preparation on open wounds, in the eyes, and on mucous membranes.

In case of overdose, agitation, tachycardia, and convulsions are observed. Symptomatic therapy is performed.

Effect on the ability to drive vehicles and machinery

During the treatment period, caution should be exercised when engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions (including driving vehicles, working with moving machinery).

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

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.