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Ripronat (Meldonium) 250 mg (40 capsules)




The instruction for medical use of RIPRONAT medicine the Trade name Ripronat Mezhdunarodnoye the unlicensed name Meldonium Dosage Form of the Capsule of 250 mg Structure 1 capsule contains active agent – meldonium of 250 mg excipients: starch corn modified (StarCap 1500), silicon dioxide colloidal / Aerosil 200, calcium stearate structure of a cover: titan dioxide (E171), gland (III) oxide yellow (E172), gelatin. The description Solid brilliant gelatin capsules No. 1 with the body and a lid of cream color. Capsule contents – powder of white or almost white color. Pharmacotherapeutic group Other cardiotonic drugs. Meldonium. The ATX C01EB22 code the Pharmacological Pharmacokinetics Later properties of intake drug is quickly soaked up from zheludochno – an intestinal path, the bioavailability is it about 78%. The maximum concentration in blood plasma is reached in 1 – 2 hour after reception. Elimination half-life makes 3 – 6 hours. It is metabolized in an organism with formation of two main metabolites which are removed by kidneys. Elimination half-life makes 3-6 hours. A pharmacodynamics Ripronat – a structural analog of a γ-butyrobetaine, the predecessor of a carnitine. As a result of decrease in concentration of a carnitine the γ-butyrobetaine having vazodilatiruyushchy properties is strongly synthesized. In case of intense ischemic injury of a myocardium the use of drug slows down formation of a necrotic zone, shortens the rehabilitation period, improves blood circulation in the ischemia center, promotes redistribution of blood in favor of the ischemic site. In heart failure Ripronat increases contractility of a myocardium, increases tolerance to physical activity, reduces the frequency of attacks of stenocardia. In the conditions of increased load drug restores balance between delivery and the need of cells for oxygen, eliminates accumulation of toxic products of exchange in cells, protecting them from damage. As a result of use the organism gains ability to maintain loading and to quickly restore power reserves. Ripronat has tonic effect. Drug is capable to eliminate functional disturbances somatic and the autonomic nervous system at patients with an alcoholism in the period of abstinency. Indications – coronary heart disease (stenocardia, a myocardial infarction), chronic heart failure and a dishormonal cardiomyopathy (as a part of complex therapy) – acute and chronic disorders of cerebral circulation (brain strokes and cerebrovascular insufficiency) (as a part of complex therapy). The route of administration and doses Apply inside. The capsule is swallowed, washing down with water. Medicine can be applied to or after a meal. Due to the possible stimulating effect medicine is recommended to apply in the first half of day. Adult Diseases of heart and vascular system, disturbance of cerebral circulation the Dose makes 500–1000 mg a day. A daily dose it is possible to apply all at once or to divide into two single doses. The maximum daily dose makes 1000 mg. The lowered working capacity, an overstrain and the period of recovery the Dose is 500 mg a day. The maximum daily dose makes 500 mg. Duration of a course of treatment is 4-6 weeks. It is possible to repeat a course of treatment 2-3 times a year. Elderly patients Elderly patients with disturbances of activity of a liver and/or kidneys need to reduce meldonium dose. Patients with disturbances of activity of kidneys As medicine is removed from an organism through kidneys, patients with disturbances of activity of kidneys from easy to moderate severity should apply a smaller dose of meldonium. Patients with disturbances of activity of a liver the Patients with disturbances of activity of a liver from easy to moderate severity should apply a smaller dose of meldonium. Side effects Often – allergic reactions – headaches – dyspepsia Seldom – hypersensitivity, allergic dermatitis, rashes (the general / makuleznye / papular), an itching, urticaria, a Quincke’s disease, anaphylactic reaction – excitement, sensation of fear, the notions of compulsion, a sleep disorder – paresthesia, a hypesthesia, sonitus, vertigo, dizziness, disturbance of gait, a preunconscious state, a loss of consciousness – change of a heart rhythm, heartbeat, tachycardia / sinus tachycardia, fibrillation of auricles, arrhythmia, sensation of discomfort in a breast/stethalgia – fluctuations of arterial blood pressure, hypertensive crisis, hyperaemia, pallor of integuments – inflammation in a throat, cough, dispnoe, an apnoea – a dysgeusia (metal taste in a mouth), loss of appetite, emetic desires, nausea, vomiting, accumulation of gases, diarrhea, an abdominal pain, – dorsodynias, muscle weakness, muscular spasms – a pollakiuria – the general weakness, a shiver, an asthenia, hypostasis, a face edema, hypostasis of legs, feeling of heat, cryesthesia, cold sweat – deviations in the electrocardiogram (ECG), acceleration of cardiac performance, the Contraindication eosinophilia – hypersensitivity to active agent or to kakomulibo to drug excipient – increase in intracranial pressure (at disturbance of venous outflow, intracranial tumors) – a heavy liver and/or renal failure in view of lack of sufficient data on safety of use – pregnancy and the period of a lactation – children’s and teenage age up to 18 years, in view of lack of data on clinical use of drug during this period. Medicinal interactions are Strengthened by action of koronarodilatiruyushchy means, some hypotensive drugs, cardiac glycosides. It is possible to combine with anti-anginal means, anticoagulants, antiagregant, antiarrhytmic means, diuretics, bronchial spasmolytics. Meldonium can strengthen effect of the drugs containing glitseriltrinitrat, nifedipine, beta blockers, other antihypertensives and peripheral vazodilatator. At the patients with chronic heart failure accepting at the same time for reduction of symptoms meldonium and lisinopril the positive action of combination therapy (vazodilatation of the main arteries, improvement of peripheric circulation and quality of life, reduction of a mental and physical stress) is revealed. At use of meldonium in a combination with orotovy acid for elimination of the damages caused by ischemia/reperfusion the additional pharmacological action was observed. As a result of simultaneous use of Sorbifer and meldonium for patients with the anemia caused by deficiency of iron the composition of fatty acids in red blood cells improved. Meldonium helps to eliminate the pathological changes of heart caused by azidothymidine (AZT) and indirectly influences the reactions of an oxidizing stress caused AZT leading to dysfunction of mitochondrions. Use of meldonium in a combination with AZT or other drugs for treatment of acquired immunodeficiency syndrome (AIDS) positively influences therapy of AIDS. In the test of the loss of an attitudinal reflex caused by ethanol, meldonium reduced dream duration. During the spasms caused by pentylenetetrazole the significant anticonvulsant effect of meldonium is established. In turn, at use before therapy meldonium α2-адреноблокатора yohimbine in a dose of 2 mg/kg and inhibitor of the N-(G) nitrogen oxide synthase (NOS) – nitro – L – arginine in a dose of 10 mg/kg, completely blocks anticonvulsant effect of meldonium. The overdose of meldonium can increase the cardiotoxicity caused by cyclophosphamide. The deficit of a carnitine which is formed at use of a D-carnitine (pharmacological inactive isomer) – meldonium, can increase the cardiotoxicity caused ifosfamidy. Meldonium has protective action in case of the cardiotoxicity caused indinaviry and the neurotoxicity caused efavirenzy. In view of possible development of moderate tachycardia and arterial hypotension, it is necessary to be careful at a combination with the medicines having the same effect including with other drugs containing meldonium. Special instructions Patients at prolonged use of drug should be careful with chronic diseases of a liver and/or kidneys (it is necessary to carry out control of functions of a liver and/or kidneys). Meldonium is not drug of the first row at a sharp coronary syndrome. The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Should be careful when driving or potentially dangerous mechanisms. Overdose Symptoms: sharp changes of arterial blood pressure, mainly towards hypotension are possible. Treatment – symptomatic and drug withdrawal. A form of release and packing On 10 capsules in blister strip packaging from a film of polyvinylchloride and aluminum foil. On 4 or 6 planimetric packs together with the instruction for medical use in the state and Russian languages place in a pack from cardboard. To Store storage conditions at a temperature not above 25 °C in the dry place. To store out of children’s reach! 3 years not to apply a period of storage after an expiration date. Prescription status According to the prescription the Owner of a trademark and the certificate of registration is the ROTAFARM company, Great Britain, Producer “Romfarm Company of S.R. L.”, Otopen, Eroilor St. 1A, Romania (“Rompharm Company S.R.L.”, Otopeni, Eroilor Street 1A, Romania) the Owner of the registration certificate is the ROTAFARM company, Great Britain the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of TROKA-S Pharm LLP, RK, Almaty, Suyunbaya 222 Ave. of B Ph. / fax: 8 (7272) 529090 The address of the organization responsible for post-registration observation of safety of medicine of TROKA-S PHARMA LLP acting through Toleuisheva Sandugash, Almaty, Suyunbaya Avenue 222-b Cellular ph. +7 701 786 33 98, (24-hour access). e-mail:
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