Chondra-sila®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT HONDRA-SYLA® (HONDRA-SYLA)

Composition:

Active ingredient: chondroitin sulfate;

1 g of the ointment contains sodium chondroitin sulfate equivalent to 50 mg of the substance (100%);

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

Pharmaceutical form. Ointment.

Main physicochemical characteristics: pale yellow ointment with a weak specific odor.

Pharmacotherapeutic group.

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

ATC code M01AX25.

Pharmacological properties.

Pharmacodynamics.

The active ingredient of the drug is chondroitin sulfate, isolated from cartilage tissue of cattle tracheae. This substance exerts chondroprotective, chondrostimulating, regenerative, anti-inflammatory, and analgesic effects. Chondroitin sulfate improves phosphorus-calcium metabolism in cartilage tissue, slows down bone resorption, inhibits degenerative processes in cartilage tissue, and acts as a sort of joint surface lubricant. It normalizes the production of synovial fluid, improves joint mobility, participates in the regeneration of the ground substance of bone and cartilage tissue, and protects cartilage from damage. When applied topically, the drug slows the progression of osteoarthritis and reduces inflammation and pain in affected joints. Dimethyl sulfoxide, included in the formulation, enhances the penetration of chondroitin sulfate into deeper tissue layers.

Pharmacokinetics.

The drug is well absorbed through the skin surface. Maximum plasma concentration of chondroitin sulfate is reached within 3–4 hours after application, while in synovial fluid it is achieved within 4–5 hours. Bioavailability ranges from 20% to 40%. The drug is mainly excreted via the kidneys within 24 hours.

Clinical characteristics.

Indications.

Degenerative-dystrophic diseases of joints and spine (mainly localized forms): osteoarthritis, osteochondrosis.

Contraindications.

Individual hypersensitivity to components of the drug. Thrombophlebitis, tendency to bleeding, acute inflammatory processes in the area of application.

Interaction with other medicinal products and other types of interactions.

With topical application, interaction of the drug with other medicinal products has not been established.

Special precautions for use.

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

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

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

Use during pregnancy or breastfeeding.

Safety and efficacy have not been established; therefore, the medicinal product should not be used during pregnancy or breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

No influence.

Method of Administration and Dosage.

Apply externally. Apply the ointment in a thin layer to the affected area of skin 2–3 times daily, gently rubbing until completely absorbed.

The duration of treatment is determined individually, depending on the efficacy and tolerability of therapy, and usually lasts 2–3 weeks. If necessary, the course may be repeated.

Children.

The drug should not be used for the treatment of children.

Overdose.

Cases of overdose are unlikely. Possible cases of hypersensitivity may occur, requiring discontinuation of the drug and administration of symptomatic therapy.

Side effects.

Allergic reactions are possible, including itching, hyperemia, burning sensation, skin swelling, and skin rash.

If any adverse effects occur, discontinue use of the product, wash off any residue from the skin, and consult a doctor.

Shelf life. 3 years.

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

Storage conditions.

Store in a light-protected place at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

30 g in a tube. 1 tube in a carton.

Availability. Over-the-counter.

Manufacturer.

JSC "Farmak".

Manufacturer's address.

74 Kyrylivska Street, Kyiv, 04080, Ukraine.