Mildronate caps 250mg blister pack №10×4

Name:
Mildronate.
Description:
The active substance of Mildronate® is meldonium 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 oxygen delivery and consumption in cells, activates 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, in connection with which 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. The main active ingredient is Meldonium Release form Hard gelatin capsules of white color. 10 capsules in a blister of PVC film with polyvinylidene chloride coating and aluminum foil. 2 blisters along with instructions for medical use in a cardboard pack. Dosage 250 mg Indications for use The drug Mildronate® is used as part of 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). Dosage and administration Always use the drug in full accordance with the recommendations of your doctor or pharmacist. If in doubt, ask your doctor or pharmacist for advice. Due to the possible stimulating effect, it is desirable to apply in the morning. Recommended dose Adults The daily dose for adults is 500 mg (2 capsules). The entire dose can be taken in the morning at one time, or divided into 2 doses (1 capsule each). The duration of the course of therapy is determined by the doctor. Special groups of patients Elderly patients For elderly patients with impaired liver and / or kidney function, a reduction in the dose of Mildronate® is possible. Patients with impaired renal function Since the drug is excreted from the body through the kidneys, patients with mild to moderate renal impairment should use a lower dose of meldonium. Patients with hepatic impairment Patients with mild to moderate hepatic impairment should use a lower dose of meldonium. Use in children and adolescents There are no data on the safety and efficacy of Mildronate® in children and adolescents (under 18 years of age), therefore this drug should not be used in children and adolescents (see Do Not Use This Drug). If you have used the drug Mildronate® more than you should There are no data on cases of overdose of the drug Mildronate®. The drug has low toxicity and does not cause severe side effects. In case of low blood pressure, headaches, dizziness, accelerated heart activity (tachycardia), general weakness are possible. In case of overdose, contact your doctor immediately. If you forgot to use the drug Mildronate® If you forgot to take the next dose of the drug Mildronate® on time, do it immediately. However, if the next dose of the drug is approaching, skip the forgotten dose and continue to use the drug as recommended, observing the usual intervals between doses of the drug. Do not use a double dose to replace a forgotten dose. If you stop using the drug Mildronate® When you stop using this drug, no adverse reactions are observed. If you have any questions about the use of the drug, ask your doctor or pharmacist. Use during pregnancy and lactation If you are pregnant or breastfeeding, think you are pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Animal studies are insufficient to assess the effect of Mildronate® on pregnancy, embryo/fetal development, childbirth and postpartum development. The potential risk to humans is unknown, therefore Mildronate® should not be used during pregnancy (see Do Not Use This Drug). It is not known whether the drug is excreted in human breast milk. A risk to newborns/infants cannot be excluded, so this drug should not be used while breastfeeding (see Do Not Use This Drug). Precautions: Talk to your doctor or pharmacist before using Mildronate®. Tell your doctor if you have had liver and / or kidney failure, as it may be necessary to monitor the indicators of liver and / or kidney activity. Children and adolescents This drug should not be used in children and adolescents under 18 years of age, as there are no data on the safety and efficacy of meldonium in these age groups. There is no data on the effect on the ability to drive vehicles and maintain mechanisms. Interactions with other drugs Tell your doctor or pharmacist if you are taking, have recently taken or may start taking any other medicines. – Mildronate® can be used together with anti-angina drugs, cardiac glycosides and diuretic drugs (promote the formation and excretion of urine from the body). – Mildronate® can be combined with anticoagulants (delay blood clotting), antiplatelet agents (prevent the formation of blood clots in blood vessels), drugs that eliminate heart rhythm disturbances and other drugs that improve microcirculation (blood circulation in small blood vessels). – Mildronate® can enhance the effect of drugs containing glyceryl trinitrate, nifedipine, beta-blockers, other drugs that lower blood pressure and dilate blood vessels. – With the simultaneous use of meldonium with lisinopril, a positive effect of combination therapy is observed. – An additional effect is observed when using meldonium in combination with orotic acid to eliminate damage caused by ischemia/resumption of blood flow. – As a result of the simultaneous use of Sorbifer and meldonium in patients with anemia caused by iron deficiency, the composition of fatty acids in red blood cells improves. – For patients with acquired immunodeficiency syndrome (AIDS), in addition to azidothymidine or other drugs for its treatment, the doctor may prescribe meldonium, since the combined use of these drugs has a positive effect on the treatment of AIDS. – An overdose of meldonium can increase the toxic effect of cyclophosphamide on the heart. – Carnitine deficiency resulting from the use of D-carnitine (an inactive isomer of carnitine)-meldonium may increase the toxic effect of ifosfamide on the heart. – Meldonium shows a protective effect against the toxic effects of indinavir on the heart and in case of neurotoxicity caused by efavirenz. Do not use this medicine together with other medicines containing meldonium as the risk of side effects may be increased. Contraindications – if you are allergic to meldonium dihydrate or any other components of the drug; – with an increase in intracranial pressure (in violation of venous outflow, intracranial tumors); – if you have severe hepatic and / or renal insufficiency (there is no sufficient data on the safety of use); – during pregnancy and lactation; – children and adolescents under the age of 18 (safety not tested). Composition – active substance – meldonium dihydrate. One capsule contains 250 mg of meldonium dihydrate, excipients: dried potato starch, hydrated silicon dioxide (Siloid 244 FP), calcium stearate. Capsule (body and cap): titanium dioxide (E 171), gelatin. Side effects Like all medicines, Mildronate® can cause side effects, although not everybody gets them. If you experience any adverse reactions, talk to your doctor or pharmacist. This recommendation applies to any possible adverse reactions, including those not listed in the instructions. The following are adverse reactions observed in previous clinical studies (marked with *), adverse reactions reported in the post-registration period. Common (may affect up to 1 in 10 people): allergic reactions*; headache*; * indigestion. Rare (may affect up to 1 in 1,000 people): hypersensitivity, allergic dermatitis, hives, angioedema (difficulty breathing or swallowing, or swelling of the throat, face, hands and feet, lips and/or tongue), anaphylactic reaction ( a sudden general allergic reaction, the symptoms of which are itching, hives, swelling, shortness of breath, shortness of breath, rapid heartbeat, rapid drop in blood pressure, dizziness, loss of consciousness, shock); agitation, fear, obsessive thoughts, sleep disturbances; feeling of “running goosebumps”, trembling, decreased sensitivity, tinnitus, dizziness, gait disturbances, fainting, loss of consciousness; heart rhythm changes, palpitations, atrial fibrillation, chest discomfort/chest pain; increase / decrease in blood pressure, hypertensive crisis (rapid increase in blood pressure), increased blood flow to the tissues (hyperemia), pallor; inflammation in the throat, cough, shortness of breath, short-term cessation of breathing; taste disturbances (metallic taste in the mouth), loss of appetite, gagging, nausea, vomiting, gas accumulation, diarrhea, abdominal pain; general / macular (limited, without elevation) / papular (small, dense with elevation) rashes, itching; back pain, muscle weakness, muscle spasms; frequent urination; general weakness, chills, weakness, swelling, swelling of the face, swelling of the legs, feeling hot, feeling cold, cold sweat; changes in the electrocardiogram (ECG), acceleration of the heart, eosinophilia (an increase in the number of specific white blood cells) *. In connection with the use of the drug Mildronate®, pain in the upper abdomen and migraine have also been reported. Reporting Adverse Reactions It is important to report suspected reactions after registration of a medicinal product in order to ensure continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are encouraged to report any suspected adverse drug reactions through the national adverse reaction reporting systems of the member states of the Eurasian Economic Union. In the Republic of Belarus, it is recommended to report adverse reactions to the information database on adverse reactions (actions) to drugs, including reports of drug failure (UE Center for Expertise and Testing in Healthcare of the Ministry of Health of the Republic of Belarus, site rceth.by). Storage conditionsStore at a temperature not exceeding 25 °C. Store in original packaging to protect from moisture. Keep out of the reach of children. Do not use the drug after the expiration date indicated on the package after “Best before”. The expiry date is the last day of the month. Do not dispose of drugs down the drain. Ask your pharmacist how to dispose of drugs you no longer need. These measures will help protect the environment. Buy Mildronate caps 250mg in a blister pack No. 10×4