Chondroflex

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT CHONDROFLEX

Composition:

Active ingredient: chondroitin sulfate;

1 g of ointment contains chondroitin sulfate 50 mg;

Excipients: dimethyl sulfoxide, lanolin, white soft paraffin, purified water.

Pharmaceutical form. Ointment.

Main physicochemical properties: ointment of light yellow color with a specific odor.

The ointment should be homogeneous in appearance.

Pharmacotherapeutic group.

Non-steroidal anti-inflammatory and antirheumatic agents. Chondroitin sulfate.

ATC code M01AX25.

Pharmacological properties.

Pharmacodynamics.

The active ingredient of the combination drug is chondroitin sulfate. This substance affects phosphorus-calcium metabolism in cartilage tissue, slows down resorption of bone tissue, inhibits the process of cartilage degeneration, prevents densification of connective tissue, and acts as a lubricant for joint surfaces. It normalizes production of synovial fluid, improves joint mobility, and participates in the regeneration of the ground substance of bone and cartilage tissue. When applied topically, the drug slows progression of osteoarthritis, reduces inflammation and pain in affected joints.

Pharmacokinetics.

Chondroitin sulfate is a high-molecular-weight mucopolysaccharide with a molecular weight of 20,000–30,000. Maximum plasma concentration is reached within 3–4 hours after administration, and in synovial fluid – within 4–5 hours. Bioavailability is 13%. It is mainly excreted by the kidneys within 24 hours.

Clinical characteristics.

Indications.

Degenerative-dystrophic joint and spinal disorders (mainly localized forms): osteoarthritis, osteochondrosis.

Contraindications.

Thrombophlebitis, tendency to bleeding, acute inflammatory processes in the area of application. Individual hypersensitivity to components of the medicinal product. Pregnancy. Lactation period. Childhood.

Interaction with other medicinal products and other types of interactions.

When applied topically, interaction of the drug with other medicinal products has not been established.

Special precautions for use

The product should not be applied to affected areas of the skin; contact with open wounds, eyes, and mucous membranes must be avoided.

The medicinal product contains dimethyl sulfoxide, which may cause skin irritation.

The product contains lanolin, which may cause local skin reactions (e.g. contact dermatitis).

Use during pregnancy or breastfeeding

The product is contraindicated during pregnancy or breastfeeding.

Effect on the ability to drive or operate machinery

No effect.

Method of Administration and Dosage.

The product is intended for external use. Apply the ointment in a thin layer over the affected area and gently rub in for 2–3 minutes until completely absorbed by the skin. Repeat application 2–3 times daily. The duration of treatment is determined individually, depending on the efficacy and tolerability of therapy, and usually lasts 2–3 weeks.

Recommended doses and treatment duration should not be exceeded.

Children.

The product should not be used in children due to insufficient clinical experience.

Overdose.

Cases of overdose are unlikely. If symptoms of skin irritation occur at the site of ointment application, treatment should be discontinued.

Side effects.

Hypersensitivity reactions, including itching, burning, rash, hyperemia.

Shelf life.

3 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25°C. Do not freeze.

Keep out of reach of children.

Packaging.

30 g per tube in a carton.

Supply category.

Over-the-counter.

Manufacturer/Applicant.

LLC "Ternopharm".

Location of manufacturer and its business address / location of applicant.

46010, 4 Fabrychna St., Ternopil, Ukraine.

Tel./fax: (0352) 521-444, www.ternopharm.com.ua