INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CAMPHOR OIL

Composition:

Active substance: racemic camphor;

1 ml of solution contains 0.1 g of racemic camphor;

Excipient: sunflower oil.

Pharmaceutical form. 10% oily solution for topical use.

Main physicochemical properties: clear yellow oily liquid with the odor of camphor.

Pharmacotherapeutic group.

Agents used locally for joint and muscle pain.

ATC code M02AX10.

Pharmacological properties.

Pharmacodynamics.

Camphor oil exerts antimicrobial, anti-inflammatory, counterirritant, analgesic, and antipruritic effects when applied topically. These properties are due to the presence in the camphor molecule of a functionally active oxygen group with high oxidative potential, which disrupts microbial cell membranes and destroys numerous active compounds causing inflammation, pain, and irritation of skin sensory receptors.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications. Indicated for use in rheumatism, arthritis, arthralgia, myositis, neuralgia, sciatica, and skin pruritus.

Contraindications. Bronchial asthma, skin injuries due to burns, impaired skin integrity, pyogenic skin infections. Hypersensitivity to the components of the medicinal product.

Special precautions. For external use only. Avoid contact of the preparation with eyes, mucous membranes, and open wounds. Do not rub into nostrils. In isolated cases, allergic reactions may occur. If such reactions appear, discontinue use of the product and wash off any residue from the application sites with warm water and soap.

Interaction with other medicinal products and other types of interactions. Interactions are currently unknown.

Special precautions for use.

Camphor oil is a traditional herbal medicinal product for use according to indications supported by long-standing use.

The user should consult a physician if symptoms persist during use of the medicinal product or if adverse reactions occur that are not listed in the instructions for medical use.

Use during pregnancy or breastfeeding. Use should be based on the benefit-risk ratio for the woman and risk for the fetus (child), as determined by a physician.

Ability to influence reaction speed when driving or operating machinery. Not studied.

Method of administration and dosage.

Apply camphor oil externally to adults, either alone or in combination with methyl salicylate, turpentine, and other medicinal agents for topical use. Apply externally for rubbing and compresses in the indicated pathological conditions. The method of application, number of applications, and duration of each application depend on the nature of the disease, its severity, and the characteristics of concomitant therapy.

Children. Do not use in children due to lack of clinical experience.

Overdose.

Possible intensification of adverse reactions, sensation of strong warmth and burning.

In case of accidental ingestion, abdominal pain, nausea, vomiting, diarrhea, symptoms of central nervous system depression, dizziness, ataxia, seizures, flushing, drowsiness, and respiratory difficulty may occur.

Adverse reactions.

Skin-related: allergic reactions, including skin rashes, urticaria, itching, skin irritation, redness, dermatitis, including contact dermatitis.

Nervous system-related: seizures.

Respiratory system-related: bronchospasm.

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 ml in bottles.

Availability category. Over-the-counter.

Manufacturer. JSC "FITOFARM".

Manufacturer's address and location of business activity.

2 Sybirtseva Street, Bakhmut, Donetsk region, Ukraine, 84500.

Marketing Authorization Holder. JSC "FITOFARM".

Address of the Marketing Authorization Holder.

12 Almatinska Street, Kyiv, Ukraine, 02092.