Active substanceRisedronic acidRisedronic acid Similar drugsTo uncover Rizarteva pills inwards TEVA, LLC Russia Risendros® pills inwards Zentiva c.s. Czech Republic Dosage form: & nbspTablets, film-coated Composition:In 1 tablet, contains: active substance risedronate sodium monohydrate 37.07 mg (in terms of risedronate sodium 35.00 mg); Excipients: lactose monohydrate 139,90 mg, corn starch 35,00 mg, corn starch pregelatinized starch 36,50 mg, silicon dioxide colloid 2,50 mg, sodium stearyl fumarate 0.70 mg, magnesium stearate 0.40 mg; sheath Opaprai 16V23345 orange (hypromellose 3aP (E464) 1.49375 mg, hypromellose 5cP (E464) 1.49375 mg, titanium dioxide (E171) 1.40950 mg, macrogol-400 0.40 million mg, iron dye oxide yellow (E172) 0 , 11900 mg, polysorbate-80 (E433) 0.05000 mg, lacquer aluminum based on the dye sunset yellow sunset (E 110) 0.03350 mg, ferric oxide red oxide (E172) 0.00050 mg). Description:Round, biconvex tablets, covered with a film shell of orange color, with engraving "R35" on one side. On the cross-section - the core is white or almost white. Pharmacotherapeutic group:bone resorption inhibitor - bisphosphonate. ATX: & nbspM.05.B.A BisphosphonatesM.05.B.A.07 Risedronic acid Pharmacodynamics:Inhibitor of bone resorption. Risedronic acid binds to hydroxyapatite at the cellular level and suppresses the resorption of bone tissue caused by osteoclasts,while the activity of osteoblasts and the mineralization of bone tissue persist. The increase in the mass of bone tissue and the biomechanical strength of bones is dose-dependent. The maximum effect in men is reached within 3 months and persists for 24 months.In postmenopausal women, the content of biochemical markers of bone resorption decreases within 1 month, the maximum effect is achieved within 3-6 months. Pharmacokinetics:After oral administration, the maximum concentration is reached within 1 hour. Absorption does not depend on the dose taken. Bioavailability is 0.63%, does not depend on sex, and decreases with food intake, any liquid (except water), and other medications. The use of risedronic acid 30 minutes before breakfast or 2 hours after lunch reduces absorption by 55%, and application for 1 hour before breakfast - by 30% compared to taking on an empty stomach (no food or liquid intake for 10 hours before meals or through 4 hours after a meal). The equilibrium concentration of risedronic acid is reached within 57 days.The volume of distribution is 6.3 l / kg. Connection with blood plasma proteins - 24%. In bone tissue, 60% of the dose is accumulated. Risedronic acid is not metabolized in the body, it is excreted unchanged.On average, 50% of the absorbed risedronic acid is excreted by the kidneys within 24 hours, 85% of the administered intravenous (IV) dose is excreted by the kidneys within 28 days. The renal clearance is 105 ml / min and does not depend on the concentration of risedron acid, but there is a linear relationship between renal clearance of risedron acid and creatinine clearance (CC). The total clearance is 122 ml / min. The half-life period is three-phase, in the initial phase - 1.5 h, in the final phase - 480 h. Indications:- Treatment of osteoporosis in postmenopause, reduction of the risk of vertebral fracture, fracture of the neck of the femur;- Treatment of osteoporosis in men with a high risk of bone fractures. Contraindications:Hypersensitivity to risedronic acid and other components of the drug; conditions that lead to a slowing of food movement along the esophagus (including stricture or achalasia of the esophagus); the patient's inability to stand or sit for at least 30 minutes; hypocalcemia; renal failure of severe degree (KK) less than 30 ml / min; age under 18 years (effectiveness and safety not established); period of pregnancy and breastfeeding; hereditary lactose intolerance,deficiency of lactase or glucose-galactose malabsorption. Carefully:Diseases of the gastrointestinal tract (GIT) in the phase of exacerbation, including dysphagia, esophagitis, gastritis, duodenitis, peptic ulcer of the stomach and duodenum; hypoparathyroidism, hypovitaminosis D, malabsorption of calcium, renal failure (QC more than 30 ml / min). Dosing and Administration:Dosing and Administration Inside, 30 minutes before breakfast or 2 hours after eating, other medicines or beverages (except drinking water), squeezed water in a volume of at least 120 ml.After taking the pill should be in a vertical position for 30 minutes.The recommended dose is 35 mg once a week. If you skip the next dose, you should take it on the same day as the pass of the drug is detected. The next dose should be taken in the usual way. Take two tablets in one day.In elderly patients correction of the dose is not required. With mild and moderate renal failure (QC more than 30 ml / min) correction of the dose is not required. In severe renal failure (CC less than 30 ml / min) use of the drug is contraindicated. Side effects:The incidence of side effects is classified according to the recommendations of the World Health Organization: very often - not less than 10%; often - not less than 1%, but less than 10%; infrequently - not less than 0,1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely - less than 0.01%. 'From the side of the nervous system: often - headache, dizziness, asthenia, depression insomnia. On the part of the organs of vision: infrequently, iritis, uveitis. From the digestive tract: often - constipation, indigestion, nausea, vomiting, abdominal pain, diarrhea; infrequently, gastritis, esophagitis, dysphagia, duodenitis, ulcer of the esophagus; rarely - glossitis, stricture of the esophagus.From the side of the musculoskeletal system and connective tissue: often - pain in the bones, arthralgia, myalgia; frequency unknown - osteonecrosis of the jaw. Laboratory indicators: rarely - increased activity of "liver" transaminases; frequency is unknown - transient increase in calcium and phosphorus in the blood plasma.From the skin: frequency unknown - alopecia.Allergic reactions: frequency unknown - hives, angioedema, polymorphic exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).Other: frequency unknown - infection (including urinary tract), increased blood pressure. Overdose:Symptoms: hypocalcemia.Treatment: reception of milk, antacids containing aluminum, iv administration of calcium preparations, symptomatic therapy. Interaction:The simultaneous use of risedronic acid and polyvalent cations (calcium, magnesium, aluminum, iron salts) reduces the absorption of risedron acid.There are no clinically significant interactions with non-steroidal anti-inflammatory drugs, including acetylsalicylic acid, H2-histamine receptors, blockers, proton pump inhibitors, antacid agents, blockers of "slow" calcium channels, beta adrenoblockers, thiazide diuretics, glucocorticosteroids (GCS), anticoagulants, anticonvulsants, cardiac glycosides.Risedronic acid is compatible with estrogen. Special instructions:The effectiveness of bisphosphonates (BF) in the treatment of osteoporosis in postmenopausal women has been proved only in patients with low bone mineral density (BMD) (in the proximal femur or lumbar regionthe spinal column of the BMD is 2.5 or more standard deviations from the peak bone mass (the T-test is equal to or less than -2.5)) and / or fractures in the anamnesis.The patient's elderly age or the presence of risk factors for fracture in the patient are not sufficient grounds for using BF in osteoporosis.The effectiveness of treatment of osteoporosis of BF (including risedronic acid) in reducing the risk of fractures in elderly women (over 80 years) is less than in women of younger age, which may be explained by an increase in the significance of other age factors affecting the development of fractures (except osteoporosis).To monitor the effectiveness of treatment is recommended to determine the activity of alkaline phosphatase in blood plasma.During treatment, it is recommended that an adequate diet with sufficient calcium and vitamin D. is recommended. If necessary, supplementation with calcium and vitamin D is recommended. During treatment, a slight asymptomatic decrease in the calcium and phosphorus levels in the blood plasma is possible. Do not use food, beverages and medicines containing calcium, magnesium, aluminum, iron at the same time as the drug.The interval between taking BF and other medications should be at least 1h. In connection with the existing risk of irritation of the mucosa of the upper GI, as well as worsening of the underlying disease, it is advisable to be careful when using the drug in patients with gastrointestinal diseases in the acute phase, including dysphagia, esophagitis, gastritis, duodenitis, gastric ulcer and duodenum, and recently transferred (within the previous year), gastrointestinal disorders (gastric ulcer and duodenal ulcer, active bleeding from the gastrointestinal tract, surgical Barge stvo in the upper gastrointestinal tract).Special attention should be paid to any signs of the occurrence of adverse reactions in the esophagus. The patient should be informed of the need to stop taking the drug and contact a doctor when developing dysphagia, pain when swallowing, chest pain, or the appearance or intensification of heartburn.Hypocalcemia should be eliminated before starting treatment with risedronic acid. Hypovitaminosis D and hypoparathyroidism should be treated simultaneously with the onset of treatment with risedronic acid. There are reports of cases of osteonecrosis of the jaw, usually associated with tooth extraction and / or local infection (including osteomyelitis), in patients with oncological diseases receiving treatment regimens including BF (primarily for IV). Many of these patients also received chemotherapy and GCS. There are also reports of osteonecrosis of the jaw in patients with osteoporosis who take BF for oral administration. Before applying BF to patients with concomitant risk factors (for example, cancer, chemotherapy, radiation therapy, GCS therapy, insufficient oral hygiene), it is necessary to undergo dental examination with appropriate preventive dental treatment. Patients in the treatment of BF should, whenever possible, avoid invasive dental procedures. In patients with osteonecrosis of the jaw receiving BF, dental surgical procedures can lead to deterioration. If it is necessary to perform surgical interventions, it should be taken into account that there is no data on the possibility of reducing the risk of developing an osteonecrosis of the jaw after abolition of the BF.The recommendations of the attending physician for the use of BF should be based on an individual assessment of the benefit / risk ratio for each patient.The drug Rizarteva contains in its composition lactose. It is not recommended for patients with hereditary lactose intolerance, lactase deficiency or glucose-galactose malabsorption. The composition of the drug Rizarteva includes an auxiliary substance lacquer aluminum based on the dye sunset yellow (E110), which can cause allergic reactions. Effect on the ability to drive transp. cf. and fur:Does not affect the ability to drive a car and other mechanisms associated with an increased risk of injury. Form release / dosage:Tablets, film-coated, 35 mg. Packaging:4 tablets in a blister of PVC / PVDC / Al. foil. 1 or 3 blisters with instructionsfor use in a pack of cardboard. Storage conditions:Store at a temperature not exceeding 25 ° C.Keep out of the reach of children. Shelf life:3 years.Do not use after expiry date. Terms of leave from pharmacies:On prescription Registration number:LP-001568 Date of registration:06.03.2012 The owner of the registration certificate:TEVA, LLC TEVA, LLC Russia Manufacturer: & nbspTEVA Pharmaceutical Works Private, Ltd. Co. Hungary Representation: & nbspTeva Teva Israel Information update date: & nbsp17.09.2015 Illustrated instructions × Illustrated instructions Instructions