Chondroitin®-fitofarm

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT HONDROITIN®-FITOPHARM (CHONDROITIN-PHYTOPHARM)

Composition:

Active substance: sodium chondroitin sulfate;

1 g of emulgel contains sodium chondroitin sulfate (calculated as 100% dry substance) 50 mg;

Excipients: imidourea, dimethyl sulfoxide, propylene glycol, polyethylene glycol (macrogol) cetylstearyl ether, coco-capric/caprylic esters, cetyl alcohol, hydroxypropyl starch phosphate, citric acid monohydrate, sodium citrate, dimethicone, purified water.

Pharmaceutical form. 5% emulgel for external use.

Main physicochemical properties: white emulgel with a slight specific odor. Should be homogeneous in appearance.

Pharmacotherapeutic group.

Medicinal products used in the treatment of musculoskeletal disorders. Chondroitin sulfate.

ATC code M01AX25.

Pharmacological properties.

Pharmacodynamics.

Chondroitin®-Fitofarm contains chondroitin sulfate, a naturally derived component obtained from cartilage tissue of bovine tracheae. Chondroitin sulfate is a high-molecular-weight mucopolysaccharide that inhibits degenerative processes in cartilage tissue. It suppresses enzymes promoting cartilage degradation, stimulates glycosaminoglycan synthesis, supports restoration of the joint capsule and articular cartilage surfaces, increases production of synovial fluid, stimulates synthetic processes in chondrocytes, thereby improving their structure, and promotes regeneration of the cartilage matrix.

Chondroitin®-Fitofarm reduces pain in affected joints, enhances joint mobility, and slows the progression of osteoarthritis and osteochondrosis.

Pharmacokinetics.

The drug is well absorbed through the skin surface. Maximum plasma concentration of chondroitin sulfate is reached within 3–4 hours after application. Bioavailability is 25%. The compound is primarily excreted via the kidneys within 24 hours.

Clinical characteristics.

Indications.

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

Contraindications.

Thrombophlebitis, individual hypersensitivity to the components of the medicinal product, tendency to bleeding, acute inflammatory processes in the area of application.

Interaction with other medicinal products and other types of interactions.

When applied topically, interactions of the drug with other medicinal products have not been established.

Special precautions for use.

The product should be applied only to intact areas of skin, avoiding contact with open wounds, eyes, and mucous membranes.

The medicinal product contains cetostearyl alcohol, which may cause local reactions (e.g. contact dermatitis). Propylene glycol may cause skin irritation.

Use during pregnancy or breastfeeding.
Safety and efficacy have not been established; therefore, the medicinal product is not recommended for use.

Effects on ability to drive and use machines.
No effect.

Method of Administration and Dosage

Apply the emulgel 2–3 times daily as a thin layer to the affected area of skin, gently rubbing in until completely absorbed. The duration of treatment is determined individually, depending on the efficacy and tolerability of the therapy, and is generally 2–3 weeks.

Children. Do not use in children.

Overdose.

Cases of overdose have not been reported. If the recommended application guidelines are followed, overdose is unlikely.

Side effects

The medicinal product is usually well tolerated; however, skin irritation and allergic reactions including itching, hyperemia, burning sensation, and skin rash may occur. If any adverse reactions occur, discontinue use of the medicinal product and consult a physician.

Reporting of adverse reactions following registration of the medicinal product is of great importance. It enables ongoing monitoring of the benefit-risk balance of the product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

25 g or 40 g of emulgel in a tube; 1 tube per carton.

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

Manufacturer.

JSC "FITOPHARM".

Manufacturer's address and place of business.

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

Marketing Authorization Holder. JSC "FITOPHARM".

Address of the Marketing Authorization Holder.

Ukraine, 02100, city of Kyiv, Boulevard of the Verkhovna Rada, building 7, floor 3, room 18.