Capsicam^® (Ointment) Instructions for Use

Marketing Authorization Holder

Grindeks, JSC (Latvia)

Manufactured By

Tallinn Pharmaceutical Plant, JSC (Estonia)

Or

Grindeks, JSC (Latvia)

Contact Information

GRINDEKS JSC (Latvia)

ATC Code

M02AX10 (Other drugs)

Dosage Form

Capsicam®

Ointment for external use: tubes 15 g, 30 g, or 50 g

Dosage Form, Packaging, and Composition

Ointment for external use is white or white with a slightly yellowish tint, with a specific smell of camphor and turpentine.

Excipients: emulsifying cetylstearyl alcohol (type A) – 97 mg, sodium cetylstearyl sulfate – 38 mg, polysorbate 80 – 20 mg, bronopol – 1 mg, purified water – up to 1 g.

30 g – aluminum tubes (1) – cardboard boxes.
50 g – aluminum tubes (1) – cardboard boxes.

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

A combined drug for external use. It is an analgesic and warming ointment containing substances that have a vasodilating and irritating effect on sensitive nerve endings, thereby exerting a local irritant and analgesic effect, and causing hyperemia.

Local skin irritation causes a change in blood supply and a selective reduction in the trophism of internal organs innervated by the same segments of the spinal cord. Additional irritation in the corresponding segment of the spinal cord causes additional activation of the antinociceptive system, which prevents the conduction of pain impulses to the cerebral cortex and improves pain tolerance.

Skin temperature increases by 1-2°C (28.4°F) within 2-3 hours. The analgesic effect occurs after 30-40 minutes and lasts up to 3-6 hours. With repeated use, the ointment retains its effect for 10-14 days.

Pharmacokinetics

The ointment is quickly absorbed into nearby tissues. Absorption into the systemic circulation is insignificant.

Indications

• Muscle pain;
• Joint pain;
• As a warming ointment for athletes.

ICD codes

Dosage Regimen

For external use only.

For muscle and joint pain – apply 1-3 g of ointment to the area of the painful area using the applicator and rub lightly into the skin 2-3 times/day.

When used as a warming agent for athletes, apply a small amount of ointment (approximately 2-3 g) to the massage area using the applicator and rub in with massaging movements until the skin is slightly reddened. After training, the ointment should be washed off the skin with cool water.

The duration of the treatment course depends on the nature and severity of the disease, but the drug should not be used for more than 10 days without consulting a doctor.

If the patient forgot to apply the drug, the ointment should be applied as soon as possible and continued to be used as usual. Do not apply a double dose if the previous application time was missed.

If the effect of the drug is too strong or too weak, the patient should consult a doctor or pharmacist.

Adverse Reactions

Allergic reactions such as itching, swelling, or urticaria are possible. If such reactions develop, the patient should stop using the ointment and consult a doctor. Symptoms disappear 8-12 hours after stopping the use of the ointment.

Contraindications

• Hypersensitivity to the components of the drug;
• Ulcers and skin diseases;
• Pregnancy;
• Breastfeeding period;
• Childhood.

Use in Pregnancy and Lactation

The drug is contraindicated for use during pregnancy and lactation due to the lack of safety data for the ointment in this category of patients.

Pediatric Use

The drug is contraindicated in childhood.

Special Precautions

Avoid getting the ointment on open wounds and mucous membranes. To avoid side effects, it is recommended to first apply a small amount of ointment to the skin to determine sensitivity to the drug.

After each procedure, wash your hands with cool water and soap.

Effect on the ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles and work with technical devices.

Overdose

Symptoms: if too much ointment is applied to the skin, skin redness, mild transient itching, or a burning sensation may occur.

Treatment: in case of accidental ingestion of the ointment, a doctor should be consulted. The drug packaging should be taken to the doctor.

Drug Interactions

No drug interactions of Capsicam^® have been noted.

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.

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.