Instructions Structum hard capsules 500 mg blister No. 60
Composition
active ingredient: chondroitin sodium sulfate;
1 capsule contains chondroitin sodium sulfate 500 mg;
excipients (capsule contents): talc;
excipients (capsule shell): gelatin, indigotine (E 132), titanium dioxide (E 171).
Dosage form
The capsules are hard.
Main physicochemical properties: opaque blue capsule containing white or yellowish powder with agglomerates.
Pharmacotherapeutic group
Nonsteroidal anti-inflammatory and antirheumatic drugs.
ATX code M01A X25.
Pharmacological properties
Pharmacodynamics.
Chondroitin sulfate is an important component of bones and joint cartilage, which helps maintain the integrity of the cartilage matrix due to:
increasing the anabolic activity of chondrocytes (stimulation of proteoglycan synthesis);
inhibition of the adverse effects of interleukin-1β on the cartilage matrix;
preventing excessive degradation of the cartilage matrix (by inhibiting elastase in tissues, as well as by reducing the activity of metalloproteases such as stromelysin and collagenase, in parallel with increasing the activity of tissue metalloprotease inhibitor, which blocks these enzymes).
Chondroitin sulfate also improves homeostasis of the synovial environment of the joints by stimulating the synthesis of hyaluronic acid, thus contributing to the maintenance of proper viscosity of the synovial fluid. Due to its enzymatic and anti-free radical properties, chondroitin sulfate inhibits the development of inflammatory reactions.
Pharmacokinetics.
After oral administration, chondroitin sulfate is absorbed in the gastrointestinal tract, with peak plasma concentrations achieved after 4 hours.
The drug accumulates mainly in synovial fluid. It is excreted mainly with feces.
Indication
Adjunctive therapy for degenerative diseases of the joints and spine (osteoarthrosis, intervertebral osteochondrosis).
Contraindication
Hypersensitivity to the active substance or to any of the excipients of the medicinal product.
Interaction with other medicinal products and other types of interactions
Interaction studies have not been conducted.
Application features
The medicine contains a small amount of ethanol (alcohol), less than 100 mg/dose. The capsule of the medicine contains 7.5 mg of ethanol (alcohol), which corresponds to 1.9 μl of beer or 0.8 μl of wine. This amount of alcohol does not have any noticeable effect. (Ethanol appears from the production process of the active substance).
This medicinal product contains 45.7 mg sodium, equivalent to 2% of the maximum daily intake of 2 g sodium for adults. Caution should be exercised in patients on a controlled sodium diet.
Use during pregnancy or breastfeeding
There are no or limited data (less than 300 pregnant women) from the use of chondroitin sulfate in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
As a precautionary measure, it is best to avoid using Structum® during pregnancy.
It is not known whether chondroitin sulfate or its metabolites are excreted in human milk. A risk to the newborn/infants cannot be excluded. Therefore, Structum® should not be used during breast-feeding.
Animal studies have not shown any effect on fertility.
Ability to influence reaction speed when driving vehicles or other mechanisms
No relevant clinical studies have been conducted.
Method of administration and doses
The capsules should be swallowed whole with plenty of water (250 ml).
Adults and children over 15 years of age should take 1 capsule (500 mg) twice a day (total 1 g per day).
There is insufficient data on the use of chondroitin sulfate in patients aged 0 to 18 years. Therefore, the use of chondroitin sulfate in children is not recommended.
Children
The drug is contraindicated in children under 15 years of age.
Overdose
Treatment is symptomatic.
Adverse reactions
The following are data on adverse reactions observed in 7 clinical trials involving a total of 2244 patients, of whom 1154 were treated with this drug.
Adverse reactions are presented according to the MedDRA classification and are indicated by the following frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10000 to < 1/1000), very rare (< 1/10000), with an unknown frequency (available data do not allow to estimate the frequency of these reactions).
From the nervous system
Common: dizziness.
Gastrointestinal tract
Common: diarrhea, abdominal pain, nausea.
Rare: vomiting.
Skin and subcutaneous tissue disorders
Uncommon: urticaria, pruritus, rash.
Rare: angioedema, erythema.
General disorders
Uncommon: facial swelling.
Reporting suspected adverse drug reactions is important. This allows the benefit-risk balance of the medicine to be monitored. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
12 capsules in a blister. 5 blisters in a cardboard box.
or
20 capsules in a blister. 3 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Pierre Fabre Medicine Production.
Pierre Fabre Medicament Production.
Location of the manufacturer and address of its place of business
Progipharm production site, Rue du Lycee, 45500 Gien, France / site Progipharm, Rue du Lycee, 45500 Gien, France.
