Movex® comfort

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MOVEK® COMFORT (MOVEX® COMFORT)

Composition:

Active substances: glucosamine sulfate, chondroitin sodium sulfate;

One tablet contains 500 mg of glucosamine sulfate and 400 mg of chondroitin sodium sulfate;

Excipients: microcrystalline cellulose, colloidal anhydrous silicon dioxide, talc, sodium croscarmellose, sodium starch glycolate (type A), hypromellose, polyethylene glycol 6000, titanium dioxide (E 171), tartrazine (E 102), ethylcellulose.

Pharmaceutical form. Coated tablets.

Main physico-chemical properties: yellow, oval-shaped, biconvex coated tablets with a score line on one side.

Pharmacotherapeutic group. Agents used in musculoskeletal disorders. Non-steroidal anti-inflammatory and antirheumatic agents.

ATC code M01AX.

Pharmacological properties.

Pharmacodynamics.

Glucosamine is a substrate for the formation of joint cartilage and stimulates regeneration of cartilage tissue. Glycosaminoglycans and proteoglycans are components of the complex matrix from which cartilage is composed.

Glucosamine is part of endogenous glycosaminoglycans of cartilage tissue, stimulates the production of proteoglycans, and enhances sulfate uptake by joint cartilage.

Thus, glucosamine replenishes endogenous glucosamine deficiency. It participates in the biosynthesis of proteoglycans and hyaluronic acid, thereby counteracting the progression of degenerative processes in joints, spine, and surrounding soft tissues; stimulates the formation of chondroitin sulfate, normalizes calcium deposition in bone tissue, and promotes restoration of joint functions and relief from pain syndrome.

Sodium chondroitin sulfate exerts a chondroprotective effect, stimulates regeneration of cartilage tissue, and exhibits anti-inflammatory and analgesic properties. Sodium chondroitin sulfate, which affects phosphorus-calcium metabolism in cartilage tissue, is a high-molecular-weight mucopolysaccharide (m.w. 20,000–30,000). The drug slows down bone resorption and reduces calcium loss, and retards degenerative processes in cartilage tissue. It prevents compression of connective tissue, provides lubrication of joint surfaces, and normalizes the production of synovial fluid.

Pharmacokinetics.

Glucosamine sulfate. Bioavailability of glucosamine after oral administration is 25–26%. After distribution in tissues, the highest concentrations are found in the liver, kidneys, and cartilage tissue. Approximately 90% of orally administered glucosamine, in the form of glucosamine salt, is absorbed from the small intestine and enters the liver via the portal circulation. A significant portion of absorbed glucosamine is metabolized in the liver and broken down into urea, water, and carbon dioxide. About 30% of the administered dose persists for a prolonged period in connective tissue. It is excreted mainly by the kidneys and, to a very minor extent, in feces.

Sodium chondroitin sulfate. After a single dose, maximum plasma concentration (Cmax) of chondroitin is reached within 3–4 hours, and in synovial fluid within 4–5 hours. Concentration in synovial fluid exceeds that in plasma. Bioavailability of sodium chondroitin sulfate is 13–15%. It is excreted by the kidneys within 24 hours.

Clinical characteristics.

Indications.

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

Contraindications.

Hypersensitivity to any component of the drug, hepatic or renal dysfunction in decompensation stage, tendency to bleeding. Do not use the drug in case of allergy to mollusks.

Interaction with other medicinal products and other types of interactions.

When used concomitantly, absorption and serum concentration of tetracyclines may increase, but the clinical significance of this interaction has not been established; absorption of penicillins and chloramphenicol may be reduced.

When the drug is used, the need for nonsteroidal anti-inflammatory agents decreases.

The drug may enhance the effect of anticoagulants (oral vitamin K antagonists, including warfarin), requiring monitoring of coagulation parameters during concomitant use. It may affect blood concentration of cyclosporine and warfarin.

Special precautions for use.

Do not exceed the recommended dose.

In patients with diabetes mellitus and those with impaired glucose tolerance, blood glucose levels should be monitored more frequently at the beginning and during treatment with the medicinal product.

Patients with known risk factors for cardiovascular diseases should be monitored for blood lipid levels, as cases of hypercholesterolemia have been reported during treatment with glucosamine.

The drug 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 condition.

The drug should be used under medical supervision in patients with thrombophlebitis.

Use with caution in patients with renal or hepatic impairment.

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.

The medicinal product contains 2.2 mmol of sodium per 1 tablet. Caution is advised when administering to patients on a sodium-controlled diet.

The colouring agent tartrazine (E 102) may cause allergic reactions.

Use during pregnancy or breastfeeding.

Due to the absence of clinical data on the efficacy and safety of the drug during pregnancy or breastfeeding, the drug should not be used during these periods.

Ability to influence reaction speed when driving or operating machinery.

Studies on the effect of the drug on reaction speed when driving or operating machinery have not been conducted. Caution should be exercised when driving or performing tasks requiring attention. If drowsiness, fatigue, dizziness, and/or visual disturbances occur during treatment, patients should refrain from driving or operating machinery.

Dosage and Administration.

Take tablets orally, swallowing with a small amount of liquid.

For the first 3 weeks, take 1 tablet three times a day; thereafter,
1−2 tablets twice daily for 3 months. Repeat the course 2−3 times per year.

Under a physician's prescription, treatment may be prolonged.

Children.

There is no experience with use in children; therefore, use is not recommended.

Overdose.

Overdose may enhance adverse effects. In case of overdose, symptomatic treatment is recommended.

Adverse reactions.

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

Skin and subcutaneous tissue disorders: dermatitis, alopecia.

Immune system disorders: allergic reactions, including skin rashes, urticaria, hyperemia, eczema, pruritus, angioneurotic edema.

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

Other: edema.

All adverse effects disappear after discontinuation of treatment.

Reporting suspected adverse reactions

Reporting of suspected adverse reactions after marketing authorization is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal 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 Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions.

Store out of reach of children in the original packaging at a temperature not exceeding 25 °C.

Packaging.

30, 60 or 120 tablets in a bottle, 1 bottle in a cardboard box;

2 bottles of 60 tablets each in a cardboard box.

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

Manufacturer.

MediTop Pharmaceuticals Ltd.

Manufacturer's address and location of its business operations.

Edő Endre u. 1., Pilisborosjenő, 2097, Hungary.

Marketing Authorization Holder: MOVI HEALTH LLC

Address of the Marketing Authorization Holder:

162 A Shevchenka Street, village Shevchenkove, Kyiv-Sviatoshyn district, Kyiv region, 08140, Ukraine

INSTRUCTION

for medical use of the medicinal product

MOVEX® COMFORT

(MOVEX® COMFORT)

Composition:

Active substances: glucosamine sulfate, chondroitin sulfate sodium;

One tablet contains: glucosamine sulfate 500 mg, chondroitin sulfate sodium 400 mg;

Excipients: microcrystalline cellulose, colloidal anhydrous silicon dioxide, talc, sodium croscarmellose, sodium starch glycolate (type A), hypromellose, polyethylene glycol 6000, titanium dioxide (E 171), tartrazine (E 102), ethylcellulose.

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: yellow, oval-shaped, biconvex film-coated tablets with a break line on one side.

Pharmacotherapeutic group. Agents used in the treatment of disorders of the musculoskeletal system. Non-steroidal anti-inflammatory and antirheumatic agents.

ATC code M01AX.

Pharmacological Properties.

Pharmacodynamics.

Glucosamine is a substrate for the formation of joint cartilage and stimulates regeneration of cartilaginous tissue. Glycosaminoglycans and proteoglycans are components of the complex matrix that constitutes cartilage.

Glucosamine is part of endogenous glycosaminoglycans in cartilage tissue, stimulates the production of proteoglycans, and enhances sulfate uptake by articular cartilage.

Thus, glucosamine replenishes endogenous glucosamine deficiency. It participates in the biosynthesis of proteoglycans and hyaluronic acid, thereby counteracting the progression of degenerative processes in joints, spine, and surrounding soft tissues; stimulates the formation of chondroitin sulfate, normalizes calcium deposition in bone tissue, and promotes restoration of joint functions and relief from pain syndrome.

Sodium chondroitin sulfate exerts a chondroprotective effect, stimulates regeneration of cartilage tissue, and exhibits anti-inflammatory and analgesic properties. Sodium chondroitin sulfate, which influences phosphorus-calcium metabolism in cartilage tissue, is a high-molecular-weight mucopolysaccharide (m.w. 20,000–30,000). The drug slows down bone resorption and reduces calcium loss, decelerates degenerative processes in cartilage tissue. It prevents compression of connective tissue, "lubricates" joint surfaces, and normalizes the production of synovial fluid.

Pharmacokinetics.

Glucosamine sulfate. Bioavailability of glucosamine after oral administration is 25–26%. After distribution in tissues, the highest concentrations are found in the liver, kidneys, and cartilage tissue. Approximately 90% of orally administered glucosamine, in the form of glucosamine salt, is absorbed from the small intestine and enters the liver via the portal circulation. A significant portion of absorbed glucosamine is metabolized in the liver, breaking down into urea, water, and carbon dioxide. About 30% of the administered dose persists in connective tissue for a prolonged period. It is primarily excreted by the kidneys and, to a very minor extent, in feces.

Sodium chondroitin sulfate. After a single dose, maximum plasma concentration (Cmax) of chondroitin is reached within 3–4 hours, and in synovial fluid – within 4–5 hours. Concentration in synovial fluid exceeds that in plasma. Bioavailability of sodium chondroitin sulfate is 13–15%. It is excreted by the kidneys within 24 hours.

Clinical characteristics.

Indications.

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

Contraindications.

Hypersensitivity to any component of the drug, hepatic or renal dysfunction in decompensation stage, tendency to bleeding. Do not use the drug in case of allergy to molluscs.

Interaction with other medicinal products and other types of interactions.

When used concomitantly, absorption and serum concentration of tetracyclines may increase, but the clinical significance of this interaction has not been established; absorption of penicillins and chloramphenicol may be reduced.

When using the drug, the need for nonsteroidal anti-inflammatory agents decreases.

The drug may enhance the effect of anticoagulants (oral vitamin K antagonists, including warfarin), requiring monitoring of coagulation parameters during concomitant use. May affect blood concentration of cyclosporine and warfarin.

Special precautions for use.

Do not exceed the recommended dose.

In patients with diabetes mellitus and those with impaired glucose tolerance, blood glucose levels should be monitored more frequently at the beginning and during treatment with the medicinal product.

In patients with known risk factors for cardiovascular diseases, monitoring of blood lipid levels is recommended, as cases of hypercholesterolemia have been reported during treatment with glucosamine.

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 condition.

Use under medical supervision in patients with thrombophlebitis.

Use with caution in patients with renal or hepatic impairment.

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.

The medicinal product contains 2.2 mmol of sodium per 1 tablet. Caution is advised when administering to patients on a sodium-controlled diet.

The colouring agent tartrazine (E 102) may cause allergic reactions.

Use during pregnancy or breastfeeding.

Due to the lack of clinical data on the efficacy and safety of using the medicinal product during pregnancy or breastfeeding, it should not be used during these periods.

Ability to influence reaction speed when driving or operating machinery.

Studies on the effect of the medicinal product on reaction speed when driving or operating machinery have not been conducted. Caution should be exercised when driving or performing tasks requiring attention. If somnolence, fatigue, dizziness, and/or visual disturbances occur during treatment, patients should refrain from driving or operating machinery.

Dosage and Administration.

Take tablets orally, swallowing with a small amount of liquid.

For the first 3 weeks, take 1 tablet 3 times a day; thereafter,
1−2 tablets 2 times a day for 3 months. Repeat the course 2−3 times per year.

Under a physician's supervision, treatment may be prolonged.

Children.

There is no experience with use in children; therefore, administration is not recommended.

Overdose.

May result in an intensification of adverse effects. In case of overdose, symptomatic treatment is recommended.

Adverse reactions.

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

Skin and subcutaneous tissue disorders: dermatitis, alopecia.

Immune system disorders: allergic reactions, including skin rash, urticaria, hyperemia, eczema, pruritus, angioedema.

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

Other: edema.

All adverse effects disappear after discontinuation of treatment.

Reporting of suspected adverse reactions

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 medicinal product. Healthcare professionals and patients or their legal representatives are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life: 3 years.

Storage conditions.

Store in the original packaging, out of reach of children, at a temperature not exceeding 25 °C.

Packaging.

30, 60 or 120 tablets in a bottle, 1 bottle in a cardboard box;

2 bottles of 60 tablets each in a cardboard box.

Supply category: Over-the-counter.

Manufacturer:

Sava Helskea Ltd.

Manufacturer's address and place of business:

GIDC Estate, 507-B-512, Vadhvan City - 363 035, Surendranagar, India.

Marketing Authorization Holder: MOVI HEALTH LLC

Address of the Marketing Authorization Holder:

162 A, Shevchenka Street, Shevchenkove, Kyiv-Sviatoshynskyi district, Kyiv region, 08140, Ukraine