Camphor oil

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT CAMPHOR OIL (OLEUM CAMPHORATUM)

Composition:

Active substance: racemic camphor;

1 ml of the preparation contains 0.1 g of racemic camphor;

Excipient: sunflower oil.

Pharmaceutical form. Oil for external use.

Main physicochemical properties.

Clear yellow liquid with the odor of camphor.

Pharmacotherapeutic group.

Agents used locally against joint and muscle pain.

ATC code M02AX10.

Pharmacological Properties.

Pharmacodynamics.

Camphor oil, when applied topically, exerts antimicrobial, anti-inflammatory, counterirritant, analgesic effects and relieves skin itching.

These properties are due to the presence in the camphor molecule of a functionally active oxygen molecule, which has a high oxidative potential, disrupts microbial cell membranes, destroys many active compounds causing inflammation, pain, and irritation of skin sensory receptors.

Pharmacokinetics. Pharmacokinetics has not been determined.

Clinical characteristics.

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

Contraindications.

Hypersensitivity to the components of the drug. Bronchial asthma, skin injuries due to burns, impaired skin integrity, and skin infections.

Safety precautions.

For external use only. Avoid contact with eyes, mucous membranes, and open wounds. Do not rub into nostrils. In isolated cases, allergic reactions may occur. If such reactions occur, discontinue use of the drug 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.

Usage peculiarities.

Use during pregnancy or breastfeeding.

Use according to the benefit-risk ratio for the woman and risk for the fetus (child), as determined by the physician.

Ability to affect reaction rate when driving vehicles or operating other machinery.

Not studied.

Method of Administration and Dosage.

Camphor oil is applied externally to adults, either alone or in combination with methyl salicylate, turpentine, and other locally acting medicinal agents. It is used externally for rubbing and compresses in the indicated pathological conditions. The method of application, number of applications, and duration of each application are determined by the nature of the disease, its severity, and the characteristics of concomitant therapy.

Children. Not to be used in children due to lack of clinical experience.

Overdose.

Excessive manifestations of adverse reactions may occur, including sensations of intense warmth and burning.

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

Side effects.

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

Nervous system: seizures.

Respiratory system: 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.

25 ml, 30 ml, 40 ml, 50 ml, or 100 ml in glass bottles stoppered with plugs and caps or dropper plugs and caps, in a carton or without a carton; 25 ml, 30 ml, 40 ml, or 50 ml in polymer bottles stoppered with dropper plugs and caps, in a carton or without a carton; 30 ml, 40 ml, 50 ml, or 100 ml in polymer bottles closed with caps, in a carton or without a carton.

Supply category. Over-the-counter (without prescription).

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's location and address of business activity.

69063, Ukraine, Zaporizhzhia, Akademika Amosova St., 75.

Marketing Authorization Holder. JSC Pharmaceutical Factory "Viola".

Address of the Marketing Authorization Holder.

69063, Ukraine, Zaporizhzhia, Akademika Amosova St., 75.