Meldonium-LF capsules 250mg №10×4

Name:
Meldonium-LF capsules 250mg No. 10×4.
Description:
Appearance of the preparation MELDONIUM-LF and contents of the package White-colored hard gelatin capsules, cylindrical in shape with hemispherical ends (dosage 500 mg). Hard gelatin capsules of yellow color, cylindrical shape with hemispherical ends (dosage 250 mg). 10 capsules in a blister pack made of a film based on unplasticized polyvinyl chloride and aluminum foil. Two, three, four or six blister packs along with instructions for medical use in a cardboard pack. Release form Capsules, 250 mg and 500 mg Active ingredient Meldonium dihydrate. Composition Each capsule contains: active ingredient: meldonium dihydrate – 250 mg or 500 mg; excipients: anhydrous colloidal silicon dioxide, magnesium stearate, potato starch. Composition of a hard gelatin capsule for a dosage of 500 mg: titanium dioxide (E 171), gelatin. Composition of a hard gelatin capsule for a dosage of 250 mg: titanium dioxide (E 171), azorubine (E 122), Ponceau 4R (E 124), quinoline yellow (E 104), gelatin. What is the drug MELDONIUM-LF and what it is used forThe active substance of the drug MELDONIUM-LF 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, MELDONIUM-LF 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 load, exhaustion of forces quickly sets in in the body, but as a result of the use of MELDONIUM-LF, the body gets used to withstand the load, economically use oxygen and quickly restore energy reserves to prepare for new loads. Meldonium-LF, acting as gamma-butyrobetaine, can accelerate the transmission of a nerve impulse in the body, in connection with which all responses are accelerated, and the overall metabolism in the body improves. Therefore, when using the drug MELDONIUM-LF, a tonic effect is felt – memory improves, thinking accelerates, dexterity of movements increases, the body’s resistance to harmful conditions increases. The drug MELDONIUM-LF is used as part of combination therapy in the following cases: , chronic heart failure (NYHA I-III functional class), cardiomyopathy, functional disorders of the cardiovascular system; – acute and chronic ischemic disorders of cerebral circulation; – with physical and psycho-emotional overload, accompanied by a decrease in working capacity; – during the recovery period after suffering cerebrovascular diseases, traumatic brain injury and encephalitis (according to the doctor’s recommendations). Contraindications Do not take MELDONIUM-LF if: – you are allergic to meldonium or any of the other ingredients of this medicine listed in section 6 of the package insert; – you have increased intracranial pressure (in violation of the venous outflow, intracranial tumors); – you have severe hepatic and / or renal insufficiency (there is no sufficient data on the safety of use); – during pregnancy and lactation. The drug should not be used in children and adolescents under the age of 18 years (safety has not been verified). Special instructions and precautions Before using the drug MELDONIUM-LF, consult your doctor or pharmacist or nurse. The medicinal product MELDONIUM-LF 250 mg contains azo dyes (azorubine and Ponceau 4R), which can cause allergic reactions. Other drugs and MELDONIUM-LF Tell your doctor or pharmacist if you are taking, have recently taken or may start taking any other medicines. – Meldonium-LF can be used together with anti-angina drugs, cardiac glycosides and diuretic drugs (promote the formation and excretion of urine from the body). – Meldonium-LF 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). – Meldonium-LF 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 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. Pregnancy, breast-feeding and fertility Pregnancy If you are pregnant or breastfeeding, think you are pregnant or are planning to become pregnant, talk to your doctor or pharmacist before using this medicine. Animal studies are insufficient to assess the effect of the drug on pregnancy, embryo / fetus development, childbirth and postpartum development. The potential risk to humans is unknown, so the use of meldonium during pregnancy is contraindicated. Breast-feeding It is not known whether the drug is excreted in human breast milk. A risk to newborns/infants cannot be excluded, therefore the use of the drug during breastfeeding is contraindicated. Driving vehicles and working with mechanisms There are no data on the effect on the ability to drive vehicles and maintain mechanisms. Use Always take the drug in full accordance with the recommendations of your doctor. If in doubt, consult with your doctor. Your doctor will select the dose of the drug that is necessary for you. Adults are prescribed 0.5-1.0 g (2-4 capsules of 250 mg or 1-2 capsules of 500 mg) per day, using the entire dose at once or dividing it into 2 doses. The maximum daily dose is 1.0 g. The duration of treatment is 4-6 weeks. Treatment courses can be repeated 2-3 times a year. Reduced performance, physical and psycho-emotional overload and during the recovery period after suffering cerebrovascular diseases, traumatic brain injury and encephalitis For adults, the daily dose is 500 mg (1 capsule of 500 mg or 2 capsules of 250 mg). A single dose in the morning is recommended. The duration of the course of treatment is determined by the doctor. Patients with renal and hepatic insufficiency The dose of meldonium should be reduced. Elderly patients with insufficient activity of the liver and / or kidneys The dose of meldonium must be reduced. Children The drug is contraindicated for use in children under 18 years of age due to lack of sufficient data. Method of applicationFor oral administration. Due to the possible tonic effect, it is recommended to apply in the first half of the day. Use in children and adolescents There are no data on the safety and efficacy of the drug in children and adolescents (under 18 years of age), therefore this drug is not recommended for use in children and adolescents. If you have taken a larger dose of MELDONIUM-LF than prescribed There are no data on cases of drug overdose. 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 forget to take MELDONIUM-LF It is important to take the medicine regularly at the same time every day. If you forget to take a dose, take it as soon as you remember, unless it is time for your next dose. In this case, simply take the next dose of the drug. Do not take a double dose to make up for a missed dose. If you stop using the drug MELDONIUM-LF When using the drug, no adverse reactions are observed. If you have any questions about the use of the drug, ask your doctor or pharmacist or nurse. Side effects Like all medicines, MELDONIUM-LF can cause side effects, although not everyone gets them. The following are side effects observed in previous clinical studies (marked *), side effects reported in the period after registration of the drug. 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, urticaria; angioedema (difficulty breathing or swallowing, or swelling of the throat, face, hands and feet, lips and/or tongue); anaphylactic reaction (sudden general allergic reaction, the symptoms of which are 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 “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, a feeling of heat; 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, pain in the upper abdomen and migraine have also been reported. Reporting adverse reactions If you experience any adverse reactions, please consult your physician. This recommendation applies to any possible adverse reactions, including those not listed in the package insert. You can also report adverse reactions to the information database on adverse reactions (actions) to drugs, including reports of drug inefficiency detected in the state (UE “Center for Expertise and Testing in Health Care M3 RB”, http://www. .rceth.by). By reporting adverse reactions, you help to get more information about the safety of the drug. Storage conditions Store at a temperature not exceeding 25 ºС. Keep out of the reach of children. Do not use after the expiry date stated on the packaging. The expiry date is the last day of the month. Do not dispose of the drug down the drain. Ask your pharmacist how to get rid of leftover medication that you no longer need. These measures will help protect the environment. Conditions of releaseAccording to a doctor’s prescription. Buy Meldonium-LF capsules 250mg No. 10×4