Chondra-sila®

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

Composition:

Active substances: 1 capsule contains: chondroitin sodium sulfate – 200 mg; glucosamine hydrochloride – 250 mg;

Excipients: magnesium stearate, lactose monohydrate;

gelatin capsule contains: gelatin, titanium dioxide (E 171), yellow FCF (E 110).

Pharmaceutical form. Capsules.

Main physicochemical properties: hard gelatin capsules size 0. Capsule body white in color, cap orange. Contents of the capsule – a mixture of crystalline and amorphous powders of whitish-yellow color.

Pharmacotherapeutic group.

Agents used in pathologies of the musculoskeletal system. Non-steroidal anti-inflammatory and anti-rheumatic agents.

ATC code M01AX.

Pharmacological properties.

Pharmacodynamics.

The pharmacological effect of the medicinal product Chondra-Sila® is due to the action of its components—chondroitin sulfate and glucosamine hydrochloride.

Chondroitin sulfate is a high-molecular-weight mucopolysaccharide involved in the formation of cartilage tissue. It reduces the activity of enzymes that destroy joint cartilage and stimulates regeneration of articular cartilage. Chondroitin sulfate reduces inflammatory activity at early stages and thus slows down degeneration of cartilage tissue. It helps reduce pain, improve joint function, and decrease the need for nonsteroidal anti-inflammatory drugs in patients with osteoarthritis of knee and hip joints.

Glucosamine hydrochloride has chondroprotective properties, reduces the deficiency of glycosaminoglycans in the body, and participates in the biosynthesis of proteoglycans and hyaluronic acid. Due to its tropism for cartilage tissue, glucosamine hydrochloride initiates the process of sulfur fixation during the synthesis of chondroitin sulfate. Glucosamine hydrochloride selectively acts on articular cartilage, serving as a specific substrate and stimulator of hyaluronic acid and proteoglycan synthesis. It inhibits the formation of superoxide radicals and enzymes responsible for cartilage tissue damage (collagenases and phospholipases), prevents the destructive effects of glucocorticoids on chondrocytes, and counteracts the disruption of glycosaminoglycan biosynthesis caused by nonsteroidal anti-inflammatory drugs.

Pharmacokinetics.

After single oral administration of the drug at the average therapeutic dose, maximum plasma concentration of chondroitin sulfate is reached within 3–4 hours and in synovial fluid within 4–5 hours. Bioavailability of chondroitin sulfate is 13%. Elimination occurs predominantly via the kidneys within 24 hours.

After oral administration, 90% of glucosamine is absorbed from the intestine, and over 25% passes from blood plasma into cartilage tissue and synovial membranes of joints. In the liver, part of the drug is metabolized into urea, carbon dioxide, and water.

Bioavailability of glucosamine is 25%, due to first-pass liver metabolism. The highest concentrations of glucosamine are found in the liver, kidneys, and articular cartilage. Approximately 30% of the administered dose persists for a prolonged period in bone and muscle tissues. Glucosamine is primarily excreted unchanged in urine and partially in feces. Elimination half-life is 68 hours.

Clinical characteristics.

Indications.

Degenerative-dystrophic joint and spinal disorders: osteoarthrosis, periarthritis of the shoulder and scapula, osteochondrosis, fractures (to accelerate formation of bone callus).

Contraindications.

Hypersensitivity to any component of the drug, predisposition to bleeding, thrombophlebitis, severe hepatic or renal dysfunction, diabetes mellitus, phenylketonuria. Do not use in patients with hypersensitivity (allergy) to seafood.

Interaction with other medicinal products and other forms of interaction.

No specific studies on drug interactions have been conducted; however, physico-chemical and pharmacokinetic properties of glucosamine and chondroitin suggest a low probability of interaction.

The medicinal product is compatible with nonsteroidal anti-inflammatory drugs and corticosteroids. When taking Хондра-Сили® (Chondra-Syly®), the need for nonsteroidal anti-inflammatory drugs decreases.

Chondroitin sulfate may enhance the effect of anticoagulants, requiring more frequent monitoring of blood coagulation parameters during concomitant use. Some sources indicate that concomitant use of glucosamine and warfarin may increase the international normalized ratio (INR) and lead to bleeding. Therefore, coagulation parameters should be monitored when used concomitantly.

In combined use, enhances gastrointestinal absorption of tetracyclines and reduces absorption of penicillins and chloramphenicol.

Treatment efficacy increases when the diet is enriched with vitamins A and C, and salts of manganese, magnesium, copper, zinc, and selenium.

Special precautions for use.

• The dose recommended by the physician should not be exceeded.
• Asthma exacerbations have been reported in patients with asthma following the initiation of glucosamine treatment; therefore, such patients should be aware of the potential worsening of symptoms.
• In rare cases, edema and/or fluid retention have been observed in patients with cardiac and/or renal insufficiency. This may be related to the osmotic effect of chondroitin sulfate.

1 capsule contains 0.045 g of lactose. Do not use in patients with rare hereditary diseases such as lactose intolerance, glucose/galactose malabsorption, or lactase deficiency.

This medicinal product contains, as an excipient, the colorant sunset yellow FCF (E 110), which may cause allergic reactions.

Use during pregnancy or breastfeeding.

Adequate and well-controlled studies on the safety and efficacy of the drug during pregnancy and breastfeeding have not been conducted; therefore, use of the drug during these periods is not recommended.

Ability to influence reaction speed when driving or operating machinery.

Unknown. No studies have been conducted on the effect of the medicinal product on the ability to drive or operate machinery. However, patients should monitor any changes in their reaction speed before driving or operating machinery.

Dosage and Administration.

Take the medicinal product orally, swallowing with a small amount of water.

For adults, the recommended dose is 2 capsules three times daily. The minimum duration of treatment is 2 months. The treatment course is usually repeated with a 3-month interval.

Children. There is no experience with the use of the drug in children; therefore, its use is not recommended.

Overdose.

Cases of overdose have not been reported. In the event of overdose, symptomatic treatment and gastric lavage are recommended.

Side effects.

The side effects described below were reported during the post-marketing use of the medicinal product. Since the information was provided voluntarily from a population of unknown size, it is not always possible to establish the frequency of these reactions.

Gastrointestinal disorders.

Epigastric pain, abdominal pain, dyspepsia, constipation, flatulence, diarrhea, nausea, and vomiting.

Immune system disorders.

Allergic reactions, including skin rashes, urticaria, pruritus, erythema, eczema, dermatitis, maculopapular rashes, swelling, angioneurotic edema. If allergic reactions occur, treatment should be discontinued and medical advice should be sought.

Nervous system disorders.

Dizziness, headache, drowsiness, insomnia, increased fatigue, general weakness.

Other adverse reactions reported in scientific publications.

There have been reports of extrasystoles, visual disturbances, and alopecia during administration of 1200 mg of chondroitin sulfate; however, these are very rare.

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.

Keep out of reach of children.

Packaging. 10 capsules in a blister. 6 blisters in a carton.

Supply category. Over-the-counter.

Manufacturer. JSC "Farmak".

Manufacturer's address and place of business.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.