Active substanceRisedronic acidRisedronic acid Similar drugsTo uncover Rizarteva pills inwards TEVA, LLC Russia Risendros® pills inwards Zentiva c.s. Czech Republic Dosage form: & nbspFilm coated tablets Composition:Each tablet contains:Active substance: risedronate sodium 35 mg.Excipients:Kernel: microcrystalline cellulose - 230.5 mg, crospovidone - 8.0 mg, magnesium stearate - 1.5 mg.Film Sheath: hypromellose 2910/5 - 5.57 mg, talc - 2.388 mg, macrogol 6000 - 0.82 mg, titanium dioxide 1.1 mg, iron oxide red (E 172) 0.02 mg, iron oxide yellow oxide E 172). -0.102 mg Description:Two-convex round tablets of orange color, covered with a film membrane. Pharmacotherapeutic group:Bone resorption inhibitor-bisphosphonate ATX: & nbspM.05.B.A BisphosphonatesM.05.B.A.07 Risedronic acid Pharmacodynamics:Means for the treatment of osteoporosis, belongs to the group of bisphosphonates, regulates phosphorus-calcium metabolism, reduces bone resorption, stimulates osteogenesis.Inhibitor of bone resorption. Risedronic acid binds to hydroxyapatite at the cellular level and suppresses the function of osteoclasts, reduces bone resorption. The time to reach the maximum therapeutic effect is 3-6 months, the duration of the therapeutic action is 12 months. Pharmacokinetics:Absorption of the drug after ingestion is relatively fast, and is approximately 1 hour. The average bioavailability of the drug is 0.63%, it decreases with food intake. The connection with plasma proteins is 24%. The volume of distribution is 6.3 l / kg. There is no evidence to confirm the systemic metabolism of risedronic acid. Approximately half of the absorbed dose is excreted by the kidneys within 24 hours. The average renal clearance is 105 ml / min and the average total clearance is 122 ml / min. Kidney clearance is independent of the concentration of the drug, there is a linear relationship between renal clearance and creatinine clearance.Unabsorbed risedronic acid is excreted through the intestine in an unmodified form. Indications:- Treatment of established postmenopausal osteoporosis.- Treatment of osteoporosis in men with a high risk of fractures. Contraindications:- Hypersensitivity to the components of the drug;- Hypocalcemia;- Severe renal impairment (creatinine clearance less than 30 ml / min);- Pregnancy and the period of breastfeeding (lactation);- Children under 18 years. Carefully:- with erosive and ulcerative lesions of the mucous membrane of the gastrointestinal tract (including in the anamnesis),in patients with a history of esophageal dysfunction (such as stricture or achalasia);- if it is impossible to stay in an upright position for at least 30 minutes after taking the pill. Pregnancy and lactation:There is insufficient data on the use of risedronate sodium in pregnant women. Tests on animals showed the presence of reproductive toxicity. The potential risk to humans is unknown. Animal tests indicate that a small amount of risedronate sodium penetrates into breast milk. Risedronate sodium should not be used during pregnancy and during breastfeeding. Dosing and Administration:The recommended adult dose is 35 mg once a week. The tablet should be taken on the same day of the week. The absorption of risedron acid depends on the intake of food, so to ensure adequate absorption, patients should take RYZENDROS® at least 30 minutes before the first meal, another medicine or drink (other than water). Patients need to be explained that if they missed the dose, it is necessary to take the drug on the day they remembered it.Then the patient should return to taking one pill once a week on the day of the usual appointment. Do not take two tablets on the same day. The tablet should be taken whole and not chewed, it is better to stand, and wash down with plain water (> 120 ml). After taking the pillpatients should not lie down for 30 minutes. During treatment, compliance withadequate diet with sufficient calcium and vitamin D. If necessary, additional prescription of calcium and vitamin D. The optimal duration of osteoporosis treatment with bisphosphonates has not been established. The need for continuation of therapy should be periodically re-evaluated based on the assessment of the benefits and risks of using RIZENDROS® individually for each patient, especially after 5 years or more of use. Elderly patients Correction of the dose of RIZENDROS® in patients is not required, as the parameters of bioavailability, distribution and elimination of the drug in elderly patients (over 60 years) do not differ significantly from those in young patients. Similar indicators were registered in very elderly people - at the age of 75 years and older. Patients with renal insufficiency In patients with mild and moderate renal failure (creatinine clearance more than 30 ml / min), dose adjustment and dosage regimen of RIZENDROS® are not required. The use of the drug is contraindicated in patients with severe renal dysfunction (creatinine clearance less than 30 ml / min).ChildrenThe use of the drug RIZENDROS® is contraindicated at the age of 18 years due to insufficient data on its effectiveness and safety. Side effects:Most of the adverse effects observed in clinical trials were mild to moderate, and, as a rule, did not require discontinuation of therapy.Undesirable phenomena are listed below with a conditional division into the following groups: very frequent (>10 %); frequent (>1% and <10%); infrequent (>0.1% and <1%); rare (>0.01% and <0.1%); very rare (<0.01%).From the digestive system:Frequent: constipation, indigestion, nausea, abdominal pain, diarrhea. Infrequent: gastritis, esophagitis, dysphagia, duodenitis, ulcer of the esophagus. Rare: glossitis, stricture of the esophagus.From the nervous system:Frequent: headache.Rare: dizziness, asthenia, increased fatigue.From the musculoskeletal system:Frequent: musculoskeletal pain.Rare: cramps calf muscles.Very rarely: osteonecrosis of the jaw (after extraction of the tooth or inflammation of the oral cavity).From the sense organs:Infrequent: iritis (sclera hyperemia, pain in the eyes).Rare: amblyopia, blurred vision, dry mucous membranes of the eyes, ringing in the ears.Other: infections (including urinary tract), increased blood pressure.Unknown: the frequency can not be set based on the available data:- hair loss;- Allergic reactions: angioedema, hives;- Skin disorders: leukocytoclastic vasculitis, Stevens-Johnson syndrome and toxic epidermal necrolysis;anaphylactic reaction;- Serious hepatic impairment (in most reported cases, patients also received other drugs that could cause hepatic impairment);- a slight decrease in serum calcium and phosphate concentrations. Overdose:Symptoms (potentially): hypocalcemia.Treatment: reception of milk, the appointment of antacids containing magnesium, calcium or aluminum.With a significant overdose to remove the unabsorbed drug, it is recommended to wash the stomach. Interaction:Medicines containing polyvalent cations, such as calcium, magnesium, iron and aluminum, can reduce the absorption of the drug.There are no clinically relevant interactions with nonsteroidal anti-inflammatory drugs (including acetylsalicylic acid), H2-histamine receptor blockers, proton pump inhibitors, antacid drugs, slow calcium channel blockers, beta-blockers, thiazide diuretics, glucocorticosteroids, anticoagulants, anticonvulsant drugs , cardiac glycosides.Compatible with hormone replacement drugs. Special instructions:Before starting therapy with the drug, it is necessary to correct hypocalcemia, as well as other pathologies that affect bone and mineral metabolism (for example, parathyroid dysfunction, vitamin D deficiency). If there is insufficient intake of calcium and vitamin D with food, their additional reception is necessary.The efficacy of bisphosphonates in the treatment of postmenopausal osteoporosis has been demonstrated in patients with low bone mineral density and / or previous fractures. Elderly age or the presence of clinical risk factors for fractures in themselves are not sufficient criteria for starting osteoporosis treatment with bisphosphonates.Data on the effectiveness of bisphosphonates, including risedronate, in elderly women (> 80 years) are limited. The use of bisphosphonates is associated with the occurrence of esophagitis, gastritis, ulcers of the esophagus and gastroduodenal ulcers. Thus, the preparation RIZENDROS® should be used with caution:- Patients who have a history of abnormal esophagus, slowing esophageal transit or emptying (eg, stricture or achalasia of the esophagus).- Patients who can not remain in an upright position for at least 30 minutes after taking the pill.- If the drug is prescribed to patients with active or recent diseases of the esophagus or upper gastrointestinal tract (including the established diagnosis of Barrett's esophagus).Physicians prescribing the drug should instruct patients to strictly follow the dosage instructions for RIZENDROS® and be wary of any signs or symptoms on the part of the esophagus. Patients should be instructed about the need to seek medical help in a timely manner if they develop symptoms of esophageal irritation, such as dysphagia, swallowing pain, chest pain, or heartburn that has first appeared / worsened.Cases of osteonecrosis of the jaw after extraction of the tooth and / or local infection (including osteomyelitis) in cancer patients have been reported. Before the start of treatment with bisphosphonates in patients with concomitant risk factors (for example, oncological disease, chemotherapy, radiation therapy, corticosteroids, poor oral hygiene), a dental examination with appropriate therapeutic dentistry should be performed. During treatment, these patients should avoid invasive dental interventions whenever possible. Food, drinks (other than plain water), and medications containing polyvalent cations (such as calcium,magnesium, iron and aluminum) interfere with the absorption of bisphosphonates, and they should not be taken concomitantly with the preparation RIZENDROS®. Against the background of bisphosphonate therapy, atypical subatmospheric and diaphyseal fractures of the femur were reported mainly in patients receiving long-term treatment for osteoporosis. These fractures occur after minimal injury or without it. Discontinuation of bisphosphonate therapy in patients suspected of having an atypical hip fracture should be considered during a patient's examination based on an individual assessment of the benefit-risk ratio.During treatment with bisphosphonates, the patient should be advised to report any pain in the area of the thigh, hip, or groin. Each patient with a presence in the clinical picture of such symptoms should be examined for atypical fracture of the hip. Effect on the ability to drive transp. cf. and fur:The adverse effect of the drug RIZENDROS® on the ability to drive vehicles and engage in activities that require concentration and speed of psychomotor reactions were not reported.But since the drug in rare cases can cause dizziness, asthenia and increased fatigue, care should be taken when driving vehicles and working with mechanisms. Form release / dosage:Film coated tablets 35 mg. Packaging:For 2 or 4 tablets in a blister of OPA / A1 / PVC / A1. 1 blister (2 tablets each), 1, 2 or 3 blisters (4 tablets each) in a cardboard box together with instructions for use. Storage conditions:Does not require special storage conditions.Keep out of the reach of children. Shelf life:2 years.Do not use after the expiration date. Terms of leave from pharmacies:On prescription Registration number:LSR-009819/09 Date of registration:03.12.2009 The owner of the registration certificate:Zentiva c.s.Zentiva c.s. Czech Republic Manufacturer: & nbspSaneka Pharmaceuticals as. The Slovak Republic Representation: & nbspZENTIVA PHARMA, LLCZENTIVA PHARMA, LLC Information update date: & nbsp18.09.2015 Illustrated instructions × Illustrated instructions Instructions