Artejja® emulgel

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ARTEJDA® EMULGEL (ARTEDJA EMULGEL)

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) cetostearyl ether, caprylic/capric triglyceride, cetostearyl alcohol, hydroxypropyl starch phosphate, citric acid monohydrate, sodium citrate, dimethicone, purified water.

Pharmaceutical form. 5% emulgel for external use.

Main physico-chemical properties: white emulgel with a weak specific odor. It should be homogeneous in appearance.

Pharmacotherapeutic group.

Drugs affecting the musculoskeletal system. Chondroitin sulfate.

ATC code M01AX25.

Pharmacological properties.

Pharmacodynamics.

"Artedzha® emulgel" contains a natural component chondroitin sulfate, which is obtained from cartilage tissue of cattle trachea. Chondroitin sulfate is a high-molecular-weight mucopolysaccharide that inhibits degenerative processes in cartilage tissue. It suppresses enzymes promoting cartilage degradation, stimulates glycosaminoglycan synthesis, promotes restoration of joint capsule and articular cartilage surfaces, increases production of intra-articular fluid, stimulates synthetic processes in chondrocytes improving their structure, and facilitates recovery of cartilage matrix.

"Artedzha® emulgel" reduces pain in affected joints and improves their mobility, as well as slows 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%. It is mainly excreted via 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 medicinal product. Thrombophlebitis, 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 reactions. Dimethyl sulfoxide may irritate the skin.

Use during pregnancy or breastfeeding.

Safety and efficacy have not been established; therefore, the product should be used only if, in the opinion of the physician, the benefit outweighs the potential risk.

Ability to affect reaction speed when driving or operating machinery. No effect.

Dosage and Administration.

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 therapy, and usually lasts 2–3 weeks. If necessary, the course may be repeated.

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 drug is usually well tolerated; however, skin irritation and allergic reactions including itching, hyperemia, burning sensation, skin rash may occur, which require discontinuation of the drug. In case of any adverse reactions, administration of the medicinal product should be stopped and medical advice should be sought.

Shelf life. 2 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

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

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

Manufacturer.

PJSC «FITOFARM».

Manufacturer's address and location of its business activity.

17 Chumatska Street, Boryspil, Kyiv region, 08303, Ukraine.

Marketing Authorization Holder.

Delta Medical Promotions AG.

Address of the Marketing Authorization Holder.

Oetenbachgasse 26, Zurich CH-8001, Switzerland.