Sinarta

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SİNARTA® (SINARTA)

Composition:

Active substance: glucosamine sulfate;

1 sachet contains sodium salt of glucosamine sulfate, calculated as 100% substance – 1.884 g, calculated as glucosamine sulfate – 1.5 g;

Excipients: aspartame (E 951), sorbitol (E 420), anhydrous citric acid, polyethylene glycol (macrogol) 4000.

Pharmaceutical form. Oral powder for solution.

Main physicochemical properties: at the time of release: odorless crystalline powder, white or almost white; during the shelf life: odorless crystalline powder, white or almost white. The presence of light brown specks or lumps is permissible.

Pharmacotherapeutic group. Other non-steroidal anti-inflammatory and antirheumatic agents. ATC code M01AX05.

Pharmacological properties.

Pharmacodynamics.

The active ingredient is a salt of the aminomonosaccharide glucosamine sulfate, which is naturally present in the human body and is used together with sulfates for the biosynthesis of hyaluronic acid in synovial fluid and glycosaminoglycans of the ground substance of joint cartilage.

The mechanism of action of glucosamine sulfate involves stimulation of glycosaminoglycan synthesis and, consequently, of joint proteoglycans. In addition, glucosamine exhibits anti-inflammatory properties and slows down the degradation processes of joint cartilage, primarily due to its metabolic activities and ability to inhibit the activity of interleukin-1 (IL-1), thus contributing both to symptomatic relief in osteoarthritis and to the delay of structural joint damage, as evidenced by long-term clinical studies.

The efficacy of glucosamine sulfate in osteoarthritis becomes apparent within 2–3 weeks after the start of treatment.

Results from clinical studies of daily continuous treatment over 3 years indicate a progressive increase in efficacy with regard to both symptoms and slowing of structural joint damage, as confirmed by radiographic findings.

Glucosamine sulfate has demonstrated good tolerability. No significant effects of glucosamine sulfate on the cardiovascular, respiratory, autonomic, or central nervous system (CNS) have been observed.

Pharmacokinetics.

90% of the dose of glucosamine sulfate is rapidly and completely absorbed from the gastrointestinal tract, passes through biological barriers, and penetrates into tissues, primarily into joint cartilage tissue. Bioavailability is 26%. Elimination half-life is 68 hours.

Clinical characteristics.

Indications.

For relief of symptoms in mild to moderate knee osteoarthritis.

Contraindications.

Hypersensitivity to glucosamine or to any of the excipients; hepatic or renal dysfunction in the decompensation stage, predisposition to bleeding. The medicinal product Sinaрta® must not be administered to patients with allergy to shellfish, since the active substance is derived from shellfish.

Interaction with other medicinal products and other forms of interaction.

Data on possible interactions between medicinal products and glucosamine are limited. However, an increase in INR (international normalized ratio) has been observed during concomitant use of vitamin K antagonists. Therefore, patients receiving oral vitamin K antagonists should be closely monitored when starting or discontinuing glucosamine therapy. Concomitant administration of glucosamine may enhance the absorption and, consequently, the serum concentration of tetracyclines. However, the clinical significance of this interaction is likely to be limited.

Due to the limited data available on possible interactions with glucosamine, particular attention should be paid to any altered response related to changes in serum concentrations of concomitantly administered medicinal products.

Special precautions for use.

Prior to using the medication, consult a physician to rule out the presence of joint diseases for which alternative treatment methods are indicated.

Patients with impaired glucose tolerance should use glucosamine with caution. Patients with diabetes mellitus are advised to closely monitor their blood glucose levels and, if necessary, determine insulin requirements both before starting and periodically during treatment.

Patients with known risk factors for cardiovascular diseases should undergo monitoring of blood lipid levels, as hypercholesterolemia has been observed in several cases among patients receiving glucosamine.

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

The oral powder contains aspartame, a phenylalanine derivative, which may be hazardous for patients with phenylketonuria.

One sachet contains 6.6 mmol (151 mg) of sodium per dose. Caution is advised when administering to patients on a sodium-restricted diet.

The oral powder contains sorbitol. If a patient has a diagnosed intolerance to certain sugars, medical advice should be sought before taking this medicinal product.

Use under medical supervision in patients with impaired liver or kidney function, as well as in patients with thrombophlebitis.

Use in children and adolescents. Glucosamine should not be administered to children and adolescents (under 18 years of age), as the safety and efficacy of the medication in this patient group have not been established.

Use in elderly patients. No specific clinical studies have been conducted in elderly patients; however, based on clinical experience, dosage adjustment is not considered necessary for this patient group.

Use in patients with renal and/or hepatic impairment. Dosage recommendations cannot be provided for patients with impaired renal and/or hepatic function, as no studies have been conducted in these populations.

Use during pregnancy or breastfeeding.

There are no data available on the use of this medication during pregnancy or breastfeeding; therefore, the medication should not be used in these patient groups.

Ability to influence reaction speed when driving or operating machinery.

Studies on the effect of the medication on the ability to drive or operate machinery have not been conducted. Caution is advised when driving vehicles or performing tasks requiring attention. If drowsiness, fatigue, dizziness, or visual disturbances occur, driving and operating machinery are contraindicated.

Method of Administration and Dosage

For oral use.

Adult and elderly patients: Dissolve the contents of 1 sachet, equivalent to 1500 mg of glucosamine sulfate, in a glass of water and take once daily, preferably during a meal.

Glucosamine is not intended for the treatment of acute pain symptoms. Symptomatic relief (particularly pain relief) may occur only after several weeks of treatment, and in some cases, even longer.

If no symptomatic improvement is observed after 2–3 months of treatment, the treatment should be re-evaluated.

Children.

Do not use in children and adolescents (under 18 years of age), as the safety and efficacy of the drug have not been established in these patient populations.

Overdose.

Cases of overdose have not been reported. Considering studies on acute and chronic toxicity in animals, toxic symptoms are unlikely even with doses 200 times higher than the therapeutic dose. However, in the event of overdose, adverse reactions may be intensified; therefore, symptomatic treatment aimed at restoring fluid and electrolyte balance should be administered.

Adverse reactions.

The most commonly reported adverse reactions associated with the use of glucosamine are nausea, abdominal pain, dyspepsia, flatulence, constipation, diarrhea, headache, fatigue, and somnolence. These adverse reactions are generally transient and mild in severity.

Criteria for assessing the frequency of adverse drug reactions:

Immune system side effects: frequency unknown – allergic reactions (hypersensitivity);

Central and peripheral nervous system side effects: common – headache, drowsiness; frequency unknown – dizziness;

Eye disorders: frequency unknown – visual disturbances;

Vascular system side effects: uncommon – erythema (reddening);

Respiratory, thoracic and mediastinal side effects: frequency unknown – asthma, exacerbation of asthma;

Gastrointestinal side effects: common – abdominal pain, flatulence, dyspepsia, diarrhea, constipation, nausea; frequency unknown – vomiting;

Hepatobiliary side effects: frequency unknown – jaundice;

Skin and subcutaneous tissue side effects: uncommon – exanthema, pruritus, erythema, rash; frequency unknown – angioneurotic edema, urticaria;

General disorders: common – fatigue; frequency unknown – swelling, peripheral edema;

Investigations: frequency unknown – increased liver enzyme levels.

Frequency unknown – in patients with diabetes mellitus, a negative effect on blood glucose monitoring may occur.

There have been reports of isolated spontaneous cases of hypercholesterolemia; however, a causal relationship has not been established.

Shelf life. 3 years.

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

Storage conditions.

Store at a temperature not exceeding 25°C. Keep out of reach of children.

Packaging. 3.95 g per sachet. 10 or 30 sachets per carton.

Prescription category. Prescription only.

Manufacturer: JSC "Farmak".

Manufacturer's name and address of the place of business.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.