Package leaflet: information for the user. MILDRONĀTS 0.5 g/5 ml solution for injection. Meldonium dihydricum

Transcription

1 Package leaflet: information for the user MILDRONĀTS 0.5 g/5 ml solution for injection Meldonium dihydricum Read all of this leaflet carefully before you start using this medicine because it contains important information for you. - Keep this leaflet! You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What medicine Mildronāts is and what it is used for 2. What you need to know before you use medicine Mildronāts 3. How to use medicine Mildronāts 4. Possible side effects 5. How to store medicine Mildronāts 6. Contents of the pack and other information 1. What medicine Mildronāts is and what it is used for The active substance of medicine Mildronāts is meldonium dihydrate (further in the text meldonium). Meldonium (Mildronāts) is a structural analogue of gamma-butyrobetaine a substance that can be found in each cell of the body. This medicine works by affecting positively the body's energy metabolism, as well as have a mild central nervous system activating effect. Under conditions of ischemia (oxygen and nutrient deficiency, insufficient elimination of metabolic end products), Mildronāts restores the balance between oxygen delivery and consumption in the cells, activates the metabolic processes which require less oxygen consumption to produce energy. The medicine dilates also blood vessels, thus improving the blood supply to the tissue. Medicine Mildronāts has pronounced cardioprotective (heart protective) effect, which means that the medicine protects the heart under oxygen deficiency and ischemic conditions. In the case of heart failure Mildronāts improves the ability of heart muscle to contract, increases the tolerance to physical load; in patients with angina pectoris (severe pain attacks in the area of heart) the medicine enhances physical performance and reduces the frequency of angina attacks. In ischemic cerebrovascular disorders Mildronāts improves blood circulation and blood supply to the area of brain affected by ischemia. Medicine Mildronāts is also characterized by a tonic effect on the central nervous system, therefore it improves memory, the ability to concentration and coordination of movements. Medicine Mildronāts is used in combination therapy in the following cases: cardiovascular diseases stable effort angina pectoris, chronic heart failure (NYHA functional class I-III), cardiomyopathy, functional cardiovascular disorders;

2 acute and chronic ischaemic (connected to restriction of blood supply) cerebrovascular disorders; decreased performance, physical and psychoemotional overload; during recovery period after cerebrovascular disorders, head trauma and encephalitis. 2. What you need to know before you use medicine Mildronāts Do not use medicine Mildronāts in the following cases: - if you are allergic to meldonium dihydrate or any of the other ingredients of this medicine (listed in section 6); - if you have severe liver and/or kidney failure (there are no sufficient data on safety); - during pregnancy and breast-feeding period; - in children and adolescents under 18 years of age (the safety has not been established). Warnings and precautions Talk to your doctor or pharmacist before using medicine Mildronāts. Tell your doctor if you have ever had liver or kidney diseases; it may be necessary to carry out the liver and/or kidney pointer control. Children and adolescents This medicine should not be used in children and adolescents up to 18 years of age due to lack of data on meldonium safety and efficacy in these age groups. Other medicines and Mildronāts Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. - Medicine Mildronāts may be used in combination with long-acting nitrates and other antianginal agents for the treatment of stable angina, cardiac glycosides and diuretics (increase urine production and excretion from the body) to treat heart failure. Medicine Mildronāts may be combined with anticoagulants (reducing blood clotting), antiplatelet agents (preventing blood clots in the blood vessels), medicines to prevent heart rhythm disorders and other medicines that improve the microcirculation (blood circulation in tiny blood vessels). - Medicine Mildronāts may intensify the action of glyceryl trinitrate, nifedipine, beta adrenoblockers, other blood pressure lowering agents and medicines that dilate blood vessels. In patients with chronic heart failure combined administration of lisinopril may be prescribed. Additional effects observed using meldonium in combination with orotic acid prevention of ischemia/blood flow restoration caused damage. - Concomitant use of Sorbifer and meldonium in patients with iron deficiency anemia improves fatty acid composition in red blood cells. - Meldonium may be prescribed to patients with acquired immunodeficiency syndrome (AIDS) in addition to azidotimidine or other medicines, as the combined use of these medicines has a positive effect on the treatment of AIDS. - Meldonium overdose may aggravate cyclophosphamide induced toxic effects on the heart.

3 - Carnitine deficiency resulting from the use of D-carnitine (carnitine inactive isomer)-meldonium may increase ifosfamide induced toxic effects on the heart. - Meldonium shows a protective effect of indinavir induced toxic effects on the heart and in the case of the efavirenz-induced neurotoxicity. Do not use this medicine in combination with other meldonium containing medicines as it can increase risk of side effects. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Animal studies are insufficient with respect to Mildronāts effects on pregnancy, embryonal/foetal development, parturition or postnatal development. The potential risk for humans is unknown. Therefore, medicine Mildronāts should not be used during pregnancy (see Do not use medicine Mildronāts in the following cases). Available data in animals have shown meldonium excretion in breast milk. It is not known whether the medicine is excreted into human breast milk. The risk to the newborns/infants cannot be excluded, therefore this medicine should not be used during breast-feeding period (see Do not use medicine Mildronāts in the following cases). Driving and using machines There are no data on the effects on the ability to drive and use machines. 3. How to use medicine Mildronāts Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Medicine Mildronāts is given to you by injection into your vein. The use of the medicine does not provide special preparation prior to administration. It is advised to take the medicine in the first half of the day because of possible stimulating effect. Posology Adults Cardiovascular diseases and cerebrovascular disorders The daily dose is mg (5-10 ml) given into your vein. The daily dose may be used as a single dose or divided into two single doses. The duration of treatment is usually days, thereafter continuing treatment with oral dosage forms. The duration of treatment course is 4-6 weeks. The course of treatment can be repeated 2-3 times a year. Older people Elderly patients with liver and/or kidney disorders may require lower doses of medicine Mildronāts.

4 Patients with kidney and/or liver disorders In patients with mild to moderate liver and/or kidney disorders reduced doses of Mildronāts should be used. Use in children and adolescents There are no data on Mildronāts safety and efficacy in children and adolescents (under 18 years of age), therefore this medicine in children and adolescents should not be used (see Do not use medicine Mildronāts in the following cases). If you use more medicine Mildronāts than you should There are no data of Mildronāts overdose. The medicine is of low toxicity and causes no severe side effects. In case of decreased blood pressure, headache, dizziness, increased heart rate (tachycardia), general weakness may occur. In case of overdose, contact your doctor immediately. If you forget to use medicine Mildronāts If you forget to use your Mildronāts dose on time, use it immediately. However, if it is nearly time for the next dose, skip the missed dose and continue to use the medicine as prescribed, observing the usual intervals between usage times. Do not use a double dose to make up for a forgotten dose. If you stop using medicine Mildronāts Stopping the use of this medicine, undesirable effects have not been observed. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Usually Mildronāts is well tolerated. The following side effects were seen in previously conducted clinical trials (marked with *), and the side effects that have been reported in post-marketing period. Common (may affect more than 1 in 10 patients): - allergic reactions*; - headache*; - indigestion*. Rare (may affect less than 1 in patients): - hypersensitivity, allergic dermatitis, hives, angioedema (difficulty breathing or swallowing, or swelling of the face, hands and feet, lips and/or tongue), anaphylactic reaction (sudden generalized allergic reaction with symptoms such as itching, hives, swelling, difficulty breathing, wheezing, increased heart rate, drop in blood pressure, dizziness, loss of consciousness, shock); - agitation, anxiety, obsessive thoughts, sleep disorders; - "ants crawling" sensation, tremor, hypoaesthesia, ringing in the ears, dizziness, abnormal gait, condition close to unconsciousness or presincope, loss of consciousness; - changes in heart rate, palpitations, increased heart rate, atrial fibrillation, heart rhythm disturbances (arrhythmias), chest discomfort/pain in the chest;

5 - increases or decreases in blood pressure, hypertensive crisis (rapid arterial blood pressure), increased blood flow to the tissues (hyperemia), paleness; - inflammation of the throat, cough, difficulty breathing, momentary stops of breathing movement; - dysgeusia (metallic taste in the mouth), loss of appetite, retching, nausea, vomiting, flatulence, diarrhoea, abdominal pain; - rash, general/macular (ring-fenced, with no elevation)/papular (small, dense, with elevation), rash, pruritus; - back pain, muscle weakness, muscle spasms; - frequent urination; - general weakness, chills, malaise, oedema, facial oedema, leg oedema, feeling hot, feeling cold, cold sweat; - changes in electrocardiogram (ECG), increase in heart rate; eosinophilia (specific white blood cell count increased)*. Pain in the upper abdomen and migraine are reported in connection with the use of medicine Mildronāts. Reporting of side effects If you get any side effects, talk with your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via State Agency of Medicines, Jersikas Street 15, Riga, LV-1003 Tel.: ; Fax: Website: By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store medicine Mildronāts Do not store above 25 C. Do not freeze. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date refers to the last day of that month. Do not take this medicine if you notice particles in the solution or change in solution color, as well as in case if the ampoule is broken. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Mildronate contains - The active substance is meldonium dihydrate (Meldonium dihydricum). 1 ml of solution contains 100 mg meldonium dihydrate. One ampoule (5 ml) conatins 500 mg meldonium dehydrate.

6 - The other ingredient is water for injections What Mildronate looks like and contents of the pack A clear, colourless liquid. 5 ml of solution in clear glass ampoule. 5 ampoules in a PVC liner. 2 liners (10 ampoules) in a cardboard box. Marketing Authorisation Holder and Manufacturer AS GRINDEKS. Krustpils iela 53, Rīga, LV-1057, Latvia Tel.: Fax: grindeks@grindeks.lv For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: This leaflet was last revised in 12/2015