Structoflex - Knee Osteoarthritis - Glucosamine 625mg - 60 capsules

1. NAME OF THE MEDICINE

STRUCTOFLEX 625 mg, capsule

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Glucosamine ................................................ ........................................... 625 mg In the form of hydrochloride of glucosamine ............................................ 750 mg For one capsule. For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Capsule. Opaque brown capsule.

4. CLINICAL DATA

4.1. Therapeutic indications Relief of symptoms associated with mild to moderate osteoarthritis of the knee. 4.2. Dosage and method of administration 2 capsules (1250 mg glucosamine) once daily for symptomatic relief. Glucosamine is not indicated for the treatment of acute pain symptoms. Relief of symptoms (particularly pain) may not appear until after several weeks of treatment, or even longer in some cases. If there is no relief after 2 or 3 months, further glucosamine treatment should be reconsidered. The capsules should be swallowed with sufficient water. The capsules can be taken with or without meals. Additional information on special populations: Children and adolescents STRUCTOFLEX should not be used in children and adolescents below 18 years of age due to a lack of data regarding safety and efficacy. Elderly No specific studies have been performed in the elderly, but based on clinical experience no dose adjustment is required when treating healthy elderly patients. Renal and/or hepatic impairment In patients with renal and/or hepatic impairment, no dose recommendation can be made as no studies have been performed in this patient population. 4.3. Contraindications Known hypersensitivity to glucosamine or to any of the excipients. STRUCTOFLEX should not be used in patients allergic to shellfish because the active substance is extracted from them.4.4. Special warnings and precautions for use A physician should be consulted to rule out joint damage for which alternative treatment should be considered In patients with impaired glucose tolerance, monitoring of glucose levels is recommended blood glucose and, if necessary, insulin requirements before the start of treatment and at regular intervals during treatment In patients with a known risk factor for cardiovascular disease, monitoring of blood lipids is recommended, as hypercholesterolaemia has been observed in some patients treated with glucosamine. Exacerbated asthma symptoms onset after initiation of glucosamine therapy have been reported (symptoms resolved after discontinuation of glucosamine therapy). Asthma patients starting treatment with glucosamine should therefore be aware of the risk of aggravation of symptoms. 4.5. Interactions with other medicinal products and other forms of interaction Data on possible drug interactions with glucosamine are limited, but cases of potentiation of the effect of coumarin-type anticoagulants (eg warfarin) in case of co-administration of glucosamine have been reported. Patients treated with coumarin anticoagulants should therefore be closely monitored when starting or ending glucosamine treatment. Concomitant intake of glucosamine may increase the absorption and serum concentration of tetracyclines, but the clinical significance of this interaction appears to be limited. Due to the lack of data on possible drug interactions with glucosamine, one should generally be vigilant for a disturbance of the response to the drugs taken concomitantly or for an abnormal concentration of these. 4.6. Pregnancy and lactation Pregnancy There are no adequate data from the use of glucosamine in pregnant women. Animal studies have not provided sufficient data. STRUCTOFLEX should therefore not be used during pregnancy. Breast-feeding No data are available on the excretion of glucosamine in human milk. The use of glucosamine during lactation is therefore not recommended due to the lack of data on the safety of the infant.4.7. Effects on ability to drive and use machines The effects on the ability to drive and use machines have not been studied. In case of dizziness or drowsiness, it is not recommended to drive a vehicle and use machines. 4.8. Adverse effects The most common adverse effects associated with glucosamine treatment are nausea, abdominal pain, digestive disorders, constipation and diarrhoea. Cases of headache, fatigue, rash, pruritus and flushing have been reported. Reported side effects are generally mild and transient. Nervous system disorders, Headache, Fatigue, Dizziness, Gastrointestinal disorders, Nausea, Abdominal pain, Indigestion, Diarrhoea, Constipation, Vomiting, Skin and subcutaneous tissue disorders, Rash, Pruritus, Flushing, angioedema , Urticaria, General disorders and administration site conditions, Edema, Edema peripheral, Hepatobiliary disorders, Increased liver enzymes and jaundice, Sporadic and spontaneous cases of hypercholesterolaemia have been reported, but none cause and effect relationship could not be established. Diabetic patients: Deterioration of glycemic control in diabetic patients, the frequency of which is not known. Reporting suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continuous monitoring of the benefit/risk ratio of the medicinal product. Health professionals report any suspected adverse effects via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.4.9. Overdose Signs and symptoms of accidental or intentional glucosamine overdose may include headache, dizziness, disorientation, arthralgia, nausea, vomiting, diarrhea or constipation. In the event of an overdose, glucosamine treatment should be discontinued and standard measures implemented as needed. A case of overdose was reported in a 12-year-old girl who had taken 28 g of glucosamine hydrochloride orally. She presented with arthralgia, vomiting and disorientation, from which she fully recovered.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties Pharmacotherapeutic group: OTHER ANTI-INFLAMMATORY AND ANTI-RHEUMATIC AGENTS, NON-STEROIDAL. ATC Code: M01AX05. Glucosamine is an endogenous substance, a normal constituent of the polysaccharide chains of the cartilage matrix and of the glycosaminoglycans of the synovial fluid. In vitro and in vivo studies have shown that glucosamine stimulates the synthesis of physiological proteoglycans and glycosaminoglycans by chondrocytes and of hyaluronic acid by synoviocytes. The mechanism of action of glucosamine in humans is not known. The response time cannot be estimated. 5.2. Pharmacokinetic properties Glucosamine is a relatively small molecule (molecular mass 179), which dissolves easily in water and is soluble in hydrophilic organic solvents. The information available on the pharmacokinetics of glucosamine is limited. Absolute bioavailability is not known. The volume of distribution is approximately 5 liters and the half-life after intravenous administration is approximately 2 hours. About 38% of an intravenous dose is excreted unchanged in the urine. 5.3. Preclinical safety data D-glucosamine has low acute toxicity. There are no data on repeated dose toxicity testing in animals, reprotoxicity, mutagenicity and carcinogenicity. Results from in vitro and in vivo studies in animals have shown that glucosamine reduces insulin secretion and induces insulin resistance, possibly via glucokinase inhibition in beta cells. The clinical relevance of this observation is unknown.

6. PHARMACEUTICAL DATA

6.1. List of excipients Magnesium stearate. Composition of the capsule shell: gelatin, iron oxide red (E172), titanium dioxide (E171), iron oxide black (E172). 6.2. Incompatibilities Not applicable. 6.3. Shelf life 3 years. 6.4. Special precautions for storage Do not store above 30°C. 6.5. Nature and contents of container 60 or 180 capsules in blister packs (PVC/PVDC/Aluminium). Not all presentations may be marketed. 6.6. Special precautions for disposal and other handling No special requirements.

7. MARKETING AUTHORIZATION HOLDER

PIERRE FABRE MEDICAMENT 45, PLACE ABEL GANCE 92100 BOULOGNE 8. MARKETING AUTHORIZATION NUMBER(S) 346 919-2 or 34009 346 919 2 8: 60 capsules in blister packs (PVC/PVDC/Aluminum). 576 690-7 or 34009 576 690 7 2: 180 capsules in blister packs (PVC/PVDC/Aluminum). 9. DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION [to be completed by the holder] 10. TEXT UPDATE DATE [to be completed by the holder] 11. DOSIMETRY Not applicable. 12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS Not applicable. CONDITIONS OF PRESCRIPTION AND DELIVERY Medicine not subject to medical prescription.