Name:
] Mildronate caps 250mg in blister pack #10×2 [
Description:
] Hard gelatin capsules, size #1, white; the contents of the capsules – white crystalline powder with a slight odor; the powder is hygroscopic. [Main active ingredient] Meldonium. Meldonium is a structural analogue of the precursor of carnitine – gamma-butyrobetaine (GBB), a substance that is found in every cell of the human body. [Form of release] Capsules. [Dosage] 250mg in a blister pack No. 10×2. [Producer] AO Grindeks, Latvia. [Special instructions] For patients with a history of impaired liver and kidney function, caution should be exercised when using the drug (monitoring of liver and kidney function) The ability to influence the reaction rate when driving vehicles or working with other mechanisms. Studies have not been conducted to assess the impact on the ability to drive transport and maintain mechanisms. [Pharmacological action] Metabolic agent. Mildronate® 250 mg increases the body’s resistance to stress and the ability to quickly restore energy reserves. It has a tonic effect. Under conditions of increased load, Mildronate® 250 mg optimizes intracellular energy processes, restores balance between the delivery and need of cells for oxygen, eliminates the accumulation of toxic metabolic products in cells, protecting them from damage. Mildronate® 250 mg increases the body’s resistance to physical and mental stress. Mildronate® 250 has a tonic effect and the ability to quickly restore energy reserves in case of overload. Mildronate® 250 has a stimulating effect on the central nervous system (CNS) – increasing motor activity and physical endurance. [Pharmacodynamics] The active substance of the drug Mildronate is medonium dihydrate (meldonium). Meldonium is a structural analogue of a substance found in every cell of the body – gamma butyrobetaine. The basis of the action of this drug is a positive effect on the energy metabolism of the body, as well as a slight activation of the central nervous system. During exercise, Mildronate restores the balance between the delivery and consumption of oxygen in cells, activating metabolic processes in them, which require less oxygen consumption for energy production. Usually, under conditions of increased stress, exhaustion of forces quickly sets in in the body, but as a result of the use of Mildronate, the body gets used to withstand the load, economically use oxygen and quickly restore energy reserves to prepare for new loads. Mildronate, acting as gamma butyrobetaine, can accelerate the transmission of nerve impulses in the body, and therefore, all responses are accelerated, and the overall metabolism in the body improves. Therefore, when using the drug Mildronate, a tonic effect is felt – memory improves, thinking accelerates, dexterity of movements increases, and the body’s resistance to harmful conditions increases. [Pharmacokinetics] After a single oral administration of meldonium in doses of 25, 50, 100, 200, 400, 800 or 1500 mg, the maximum plasma concentration (Cmax) and the area under the time-concentration curve (AUC) increase in proportion to the applied dose. The time to reach maximum plasma concentration (tmax) is 1-2 hours. With repeated doses, steady-state plasma concentration is reached within 72-96 hours after the first dose. Accumulation of meldonium in blood plasma is possible. Food slows down the absorption of meldonium without changing Cmax and AUC. [Indications for use] In complex therapy in the following cases: – with physical and psycho-emotional overload, accompanied by a decrease in performance; – during the recovery period after suffering cerebrovascular diseases, traumatic brain injury and encephalitis (according to the doctor’s recommendations). [Method of application and dose] Apply inside. The daily dose for adults is 500 mg (2 capsules). The entire dose is used in the morning in one dose or divided into 2 doses (1 capsule each). Due to the possible stimulating effect, the drug is recommended to be taken in the morning. The duration of the course of therapy is determined by the doctor. [Use during pregnancy and lactation] Animal studies are insufficient to assess the effect of meldonium on pregnancy, embryo/fetal development, childbirth and postpartum development. The potential risk to humans is unknown, so do not use during pregnancy. Available animal data indicate excretion of meldonium into maternal milk. It is not known if the drug is excreted in human breast milk. A risk to newborns/infants cannot be excluded, therefore this medicine should not be used during lactation. [Precautions] The drug should be used with caution in diseases of the liver and / or kidneys. Contraindicated for use in children and adolescents under 18 years of age (efficacy and safety not established). [Interaction with other drugs] Mildronate® enhances the effect of coronary dilating agents, some antihypertensive drugs, cardiac glycosides. Mildronate® can be combined with prolonged forms of nitrates, other antianginal drugs, anticoagulants and antiplatelet agents, antiarrhythmics, diuretics and bronchodilators. In view of the possible development of tachycardia and arterial hypotension, caution should be exercised when combined with nitroglycerin (for sublingual use) and antihypertensive agents (especially alpha-blockers and short-acting forms of nifedipine). Simultaneous use of the drug together with other meldonium preparations is not allowed, since the risk of adverse reactions may increase. [Contraindications] Hypersensitivity to meldonium or any other component of the drug. Increased intracranial pressure (in violation of venous outflow, intracranial tumors). Hepatic and renal insufficiency (there are no sufficient data on the safety of use). During pregnancy and breastfeeding. Children under 18 years of age (safety of use has not been verified. [Composition] 1 capsule contains: active ingredient – meldonium dihydrate 250 mg; excipients – dried potato starch, silicon dioxide, calcium stearate; capsule (body and cap) – titanium dioxide ( E 171), gelatin. [Overdose] No cases of overdose have been reported. The drug is of low toxicity and does not cause severe adverse reactions. Symptoms: in case of low blood pressure, headache, dizziness, tachycardia, general weakness. Treatment: symptomatic. In case of severe overdose it is necessary to monitor the functions of the liver and kidneys.With a significant decrease in blood pressure, drugs to regulate pressure should be used.[Side effect]The drug is usually well tolerated.However, in sensitive patients, as well as in cases of exceeding the dose, side effects are possible.Side effects are presented according to the systemic MedDRA organ classes using the Med classification DRA by frequency of manifestation: often (≥1/100 to <1/10), rare (≥1/10,000 to <1/1000). On the part of the immune system Often: allergic reactions. Rarely: hypersensitivity, allergic dermatitis, urticaria, angioedema, anaphylactic reaction. On the part of the psyche Rarely: agitation, fear, obsessive thoughts, sleep disturbances. From the side of the nervous system Often: headaches. Rare: paresthesia, tremor, hypoesthesia, tinnitus, vertigo, dizziness, gait disturbances, presyncope, loss of consciousness. From the side of the heart Rarely: arrhythmia, palpitations, tachycardia / sinus tachycardia, atrial fibrillation, chest discomfort / chest pain. On the part of the vessels Rarely: increase / decrease in blood pressure, hypertensive crisis, hyperemia, pallor of the skin. On the part of the respiratory system, chest and mediastinum Rarely: inflammation in the throat, cough, dyspnea, apnea. From the gastrointestinal tract Often: dyspepsia. Rare: dysgeusia (metallic taste in the mouth), loss of appetite, gagging, nausea, vomiting, gas accumulation, diarrhea, abdominal pain. On the part of the skin and subcutaneous tissues Rarely: rashes, general / macular / papular rashes, itching. From the musculoskeletal and related systems Rarely: back pain, muscle weakness, muscle spasms. From the side of the kidneys and urinary system Rarely: pollakiuria. General disorders and reactions at the injection site Rarely: general weakness, trembling, asthenia, edema, swelling of the face, swelling of the legs, sensation of heat, sensation of cold, cold sweat. If any of the side effects listed in the instructions get worse, or if you notice any other side effects not listed in the instructions, tell your doctor. [Shelf life] Shelf life is 4 years. Do not use after the expiry date stated on the packaging. [Storage conditions] The drug should be stored out of the reach of children, in a dry place at a temperature not exceeding 25°C. [Terms of dispensing from pharmacies] Without a prescription. [Packaging] 10 capsules in a blister made of PVC-coated PVC film and aluminum foil. 2 or 4 blisters along with instructions for medical use in a pack of cardboard. Buy Mildronate capsules 250 mg No. 10x2 Price for Mildronate capsules 250 mg No. 10x2
INN | Meldonium |
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The code | 69 245 |
Barcode | 4 750 232 002 100 |
Active substance | Meldonium |
Manufacturer | Grindeks JSC, Latvia |
Importer | IOOO "Interfarmaks", Republic of Belarus, 223028, Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Zvezdnaya, 19A-5, pom. 5-2 |
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