Chondroitin® complex

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT HONDROITIN® COMPLEX (CHONDROITIN COMPLEX)

Composition:

Active substances: glucosamine hydrochloride, sodium chondroitin sulfate;

1 capsule contains glucosamine hydrochloride equivalent to 100% substance 500 mg, sodium chondroitin sulfate equivalent to 100% substance 400 mg;

Excipients: sodium croscarmellose, magnesium stearate.

Pharmaceutical form. Capsules.

Main physicochemical properties: hard gelatin capsules with a colorless transparent body and a colorless transparent cap.

The contents of the capsules — white powder with a yellowish tint.

Pharmacotherapeutic group.

Medicinal products used in the treatment of diseases of the musculoskeletal system.

Other medicinal products used in the treatment of diseases of the musculoskeletal system.

ATC code M09AX.

Pharmacological Properties.

Pharmacodynamics.

CHONDROITIN® COMPLEX is a combined medicinal product for stimulation of cartilage tissue regeneration. The effect of the medicinal product is due to its constituent components.

Chondroitin sodium sulfate is a high-molecular-weight mucopolysaccharide involved in the structure of cartilage tissue. It reduces the activity of enzymes that destroy joint cartilage and stimulates its regeneration. In the early stages of inflammation, chondroitin sodium sulfate reduces inflammatory activity and thus slows down degeneration of cartilage tissue. It helps reduce pain syndrome, improves joint function, and decreases 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 glycosamines in the body, and participates in the biosynthesis of proteoglycans and hyaluronic acid. Due to its affinity 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 for the synthesis of hyaluronic acid and proteoglycans. It inhibits the formation of superoxide radicals and enzymes that cause cartilage tissue damage (collagenases and phospholipases), prevents the destructive effect of glucocorticoids on chondrocytes, and prevents impairment of glycosaminoglycan biosynthesis induced by nonsteroidal anti-inflammatory drugs.

Pharmacokinetics.

Absorption: after a single oral dose at the average therapeutic level, the maximum plasma concentration of chondroitin sodium sulfate is reached within 3–4 hours and in synovial fluid within 4–5 hours. The bioavailability of the drug is 13%. Elimination occurs mainly via the kidneys within 24 hours. 90% of administered glucosamine is absorbed in the intestine. Over 25% of the administered dose reaches cartilage tissue and joint synovial membranes from blood plasma. In the liver, 70% of the drug is metabolized to urea, carbon dioxide, and water.

Clinical characteristics.

Indications.

Degenerative-dystrophic diseases of joints and spine: primary and secondary osteoarthritis, periarthritis of the shoulder-blade, spinal osteochondrosis, fractures (to accelerate formation of bone callus).

Contraindications.

Hypersensitivity to any component of the medicinal product, thrombophlebitis, diabetes mellitus, severe renal/hepatic impairment, phenylketonuria, predisposition to bleeding, gastric or intestinal ulcer. Do not use in patients with hypersensitivity (allergy) to seafood.

Special precautions.

Do not exceed the recommended dose. At the beginning of treatment, monitoring of blood glucose levels is advisable in patients with diabetes mellitus.

Use with caution in patients with mild to moderate renal or hepatic insufficiency. Rarely, edema and/or fluid retention have been observed.

The medicinal product should be used with caution in patients with asthma, as such patients may be more susceptible to allergic reactions to glucosamine, potentially exacerbating symptoms of their disease.

Interaction with other medicinal products and other forms of interaction.

When used concomitantly, the medicinal product CHONDROITIN® COMPLEX enhances gastrointestinal absorption of tetracyclines and reduces that of semi-synthetic penicillins and chloramphenicol (levomycetin). CHONDROITIN® COMPLEX may be used in combination with nonsteroidal anti-inflammatory drugs and glucocorticoids. During treatment, the need for nonsteroidal anti-inflammatory drugs, glucocorticoids, and analgesics may decrease.

An enhanced effect of coumarin anticoagulants has been observed. Therefore, monitoring of coagulation parameters is advisable in patients.

Concomitant use of glucosamine and warfarin may potentiate the effect of the latter and lead to bleeding. Hence, coagulation parameters must be monitored during concomitant use.

Glucosamine may affect blood concentration of cyclosporine.

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

Special precautions for use.

This medicinal product contains sodium compounds. Caution should be exercised when administering to patients on a controlled sodium diet.

Use during pregnancy or breastfeeding.

The medicinal product is contraindicated during pregnancy. Breastfeeding must be discontinued during treatment with this medicinal product.

Ability to affect reaction speed when driving or operating machinery.

If dizziness, somnolence, fatigue, or visual disturbances occur during treatment with this medicinal product, patients should refrain from driving or operating machinery.

Dosage and Administration

HONDROITIN® COMPLEX is administered orally to adults, 1 capsule 3 times daily for the first 3 weeks; thereafter, 1 capsule twice daily for the following 2–3 months. The treatment course is usually repeated every 3 months.

Children

The medicinal product is not intended for use in children.

Overdose

Cases of overdose have not been reported. Overdose may lead to an intensification of adverse effects. In case of overdose, symptomatic treatment is recommended. If recommended doses are exceeded, standard supportive measures should be applied and medical advice should be sought.

Adverse reactions.

Gastrointestinal disorders: dyspepsia, epigastric pain, nausea, vomiting, flatulence, diarrhea, constipation.

Nervous system and sensory organ disorders: dizziness, general weakness, somnolence, headache, insomnia, increased fatigue, visual disturbances.

Immune system disorders: allergic reactions, including hyperemia and skin rashes, pruritus, urticaria, erythema, dermatitis, maculopapular eruptions, eczema, swelling, angioneurotic edema.

Skin and subcutaneous tissue disorders: hair loss.

Other adverse reactions: very rare extrasystoles.

If any adverse reactions occur, discontinue use of the medicinal product and consult a physician.

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

Shelf life.

2 years.

Storage conditions.

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

Keep out of reach and sight of children.

Packaging.

30 or 60 capsules in a container, 1 container per carton; or 6 capsules per blister, 5 or 10 blisters per carton.

Availability category.

Over-the-counter.

Manufacturer. JSC "FITOFARM".

Manufacturer's address and place of business.

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

Marketing Authorization Holder. JSC "FITOFARM".

Address of the Marketing Authorization Holder.

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

Date of last review.

INSTRUCTION

for medical use of the medicinal product

CHONDROITIN® COMPLEX

(CHONDROITIN COMPLEX)

Composition:

Active substances: glucosamine hydrochloride, chondroitin sodium sulfate;

1 capsule contains glucosamine hydrochloride equivalent to 100% substance 500 mg, chondroitin sodium sulfate equivalent to 100% substance 400 mg;

Excipients: sodium croscarmellose, magnesium stearate.

Pharmaceutical form. Capsules.

Main physicochemical characteristics: hard gelatin capsules with a colorless transparent body and a colorless transparent cap.

The capsule contents — white powder with a yellowish tint.

Pharmacotherapeutic group.

Medicinal products used in the treatment of diseases of the musculoskeletal system.

Other medicinal products used in the treatment of diseases of the musculoskeletal system.

ATC code M09AX.

Pharmacological properties.

Pharmacodynamics.

CHONDROITIN® COMPLEX is a combined medicinal product for stimulation of cartilage tissue restoration. The action of the medicinal product is due to its constituent components.

Chondroitin sodium sulfate is a high-molecular-weight mucopolysaccharide involved in the formation of cartilage tissue. It reduces the activity of enzymes that destroy articular cartilage and stimulates its regeneration. In early stages of inflammatory process, chondroitin sodium sulfate reduces its activity and thus slows down degeneration of cartilage tissue. It contributes to reduction of pain syndrome, improvement of joint function, and reduction of the need for nonsteroidal anti-inflammatory drugs in patients with osteoarthritis of knee and hip joints.

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

Pharmacokinetics.

Absorption: after single oral administration of the drug at the average therapeutic dose, maximum plasma concentration of chondroitin sodium sulfate is reached within 3–4 hours and in synovial fluid — within 4–5 hours. The bioavailability of the drug is 13%. Elimination occurs mainly via the kidneys within 24 hours. 90% of administered glucosamine is absorbed in the intestine. More than 25% of the administered dose reaches cartilage tissue and joint synovial membranes from blood plasma. In the liver, 70% of the drug is metabolized to urea, carbon dioxide, and water.

Clinical characteristics.

Indications.

Degenerative-dystrophic diseases of joints and spine: primary and secondary osteoarthritis, periarthritis of the shoulder, spinal osteochondrosis, fractures (to accelerate formation of bone callus).

Contraindications.

Hypersensitivity to any component of the drug, thrombophlebitis, diabetes mellitus, severe renal/hepatic impairment, phenylketonuria, tendency to bleeding, gastric or intestinal ulcer. Do not use in patients with hypersensitivity (allergy) to seafood.

Special precautions.

Do not exceed the recommended dose. At the beginning of treatment, it is advisable to monitor blood glucose levels in diabetic patients.

Use with caution in patients with mild to moderate renal or hepatic insufficiency. Rarely, edema and/or fluid retention have been observed.

Patients with asthma should use the product cautiously, as such patients may be more susceptible to allergic reactions to glucosamine, potentially exacerbating symptoms of their disease.

Interaction with other medicinal products and other forms of interactions.

When used concomitantly, the medicinal product CHONDROITIN® COMPLEX enhances gastrointestinal absorption of tetracyclines and reduces that of semi-synthetic penicillins and chloramphenicol. CHONDROITIN® COMPLEX can be used together with nonsteroidal anti-inflammatory drugs and glucocorticoids. During treatment, the need for nonsteroidal anti-inflammatory drugs, glucocorticoids, and analgesics may decrease.

An enhanced effect of coumarin anticoagulants has been observed. Therefore, monitoring of coagulation parameters is advisable in patients receiving these drugs.

Concomitant use of glucosamine and warfarin may enhance the effect of the latter and lead to bleeding. Therefore, coagulation parameters should be monitored when used concomitantly.

Glucosamine may affect blood concentration of cyclosporine.

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

Special precautions for use.

This medicinal product contains sodium compounds. Caution should be exercised when administering to patients who are on a controlled sodium intake diet.

Use during pregnancy or breastfeeding.

The medicinal product is contraindicated during pregnancy. Breastfeeding must be discontinued during treatment with this medicinal product.

Ability to influence reaction speed while driving or operating machinery.

If dizziness, somnolence, fatigue, or visual disturbances occur during treatment with this medicinal product, patients should refrain from driving or operating machinery.

Dosage and Administration.

HONDROITIN® COMPLEX is administered orally to adults, 1 capsule 3 times a day for the first 3 weeks; thereafter, 1 capsule twice a day for the following 2–3 months. The treatment course is usually repeated every 3 months.

Children.

The medicinal product is not intended for use in children.

Overdose.

Cases of overdose have not been reported. Overdose may lead to an increase in adverse effects. In case of overdose, symptomatic treatment is recommended. If recommended doses are exceeded, standard supportive measures should be applied and a physician should be consulted.

Side effects.

Gastrointestinal disorders: dyspepsia, epigastric pain, nausea, vomiting, flatulence, diarrhea, constipation.

Nervous system and sensory organ disorders: dizziness, general weakness, somnolence, headache, insomnia, increased fatigue, visual disturbances.

Immune system disorders: allergic reactions, including hyperemia and skin rashes, pruritus, urticaria, erythema, dermatitis, maculopapular eruptions, eczema, swelling, angioneurotic edema.

Skin and subcutaneous tissue disorders: hair loss.

Other side effects: very rare extrasystoles.

If any adverse reactions occur, discontinue use of the medicinal product and consult a physician.

Reporting of adverse reactions after registration of the medicinal product is highly important. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy through the Automated Information System for Pharmacovigilance at: https://aisf.dec.gov.ua.

Shelf life.

2 years.

Storage conditions.

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

Keep out of reach and sight of children.

Packaging.

30 or 60 capsules in a container, 1 container per carton; or 6 capsules per blister,
5 or 10 blisters per carton.

Availability.

Over-the-counter.

Manufacturer: JSC "FITOFARM".

(responsible for batch release, excluding batch control/testing).

Manufacturer's address.

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

Marketing Authorization Holder: JSC "FITOFARM".

Address of the Marketing Authorization Holder.

7, Verkhovnoї Rady Avenue, building 7, floor 3, room 18, Kyiv, Ukraine, 02100.