PACKAGE LEAFLET: INFORMATION FOR THE USER Meldonium Olainfarm 250 mg Capsules Read all of this leaflet carefully before you start using this medicine because it contains important information for you. This medicine is available without prescription. However, you still need to use your medicine carefully to get the best results. -
Keep this leaflet. You may need to read it again.
Ask your doctor or pharmacist if you need more information or advice.
You must talk to a doctor if you do not feel better or if you feel worse.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet 1.
What Meldonium Olainfarm is and what it is used for
What you need to know before you use Meldonium Olainfarm
Contents of the pack and other information
What Meldonium Olainfarm is and what it is used for
Meldonium Olainfarm contains meldonium dehydrate (further in the text referred to as meldonium), which is a structural analogue of gamma-butyrobetaine, substance found in the body cells. Meldonium positively affects energetic metabolism of the organism and moderately activates the central nervous system. Under the conditions of ischemia (oxygen deficiency in tissues), Meldonium Olainfarm restores energetic balance between oxygen delivery and its consumption in cells, activating those metabolism processes that need less oxygen for energy creation. Meldonium dilates the blood vessels improving blood supply to the body tissues. Meldonium Olainfarm also exerts cardioprotective effect (heart protection) under the conditions of ischemia and oxygen deficiency. Meldonium decreases the frequency of angina pectoris attacks (chest pain) and increases physical activity In case of heart failure the medicine improves myocardial (the heart muscle) contractility and increases tolerance of the organism to physical overload. In cases of acute and chronic ischemic cerebrovascular disorders Meldonium Olainfarm optimizes cerebral blood flow redistribution in favour of ischemic areas. Meldonium Olainfarm possesses CNS (central nervous system) stimulant activity. As a result the medicine improves memory, ability to concentrate and movement coordination. Meldonium Olainfarm is a medicine used in -
complex therapy during recovery period after disorders of the cerebral circulation and head traumas;
decreased work capacity, physical and psycho emotional overload.
It is recommended for use in combination with other medicines. 2. What you need to know before you use Meldonium Olainfarm Do not take Meldonium Olainfarm
if you are allergic to meldonium or any of the other ingredients of this medicine (listed in section 6)
- if you have liver and/or kidney impairement (liver and/or kidney problems) -
Warnings and precautions Tell your doctor, if you have a history of liver and/or kidney problems. Your doctor may want to monitor your liver and/or kidney function during the therapy. Children and adolescents Meldonium Olainfarm is not for use in children and adolescents under 18 years of age due to the lack of data on safety and efficacy in this age group. Other medicines and Meldonium Olainfarm Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Do not use Meldonium Olainfarm simultaneously with other medicines containing meldonium (the risk of side effects development). Meldonium Olainfarm can be taken together with other antianginal medicines (used to treat angina), anticoagulants (blood thinners), antiplatelet (prevent the blood from clotting) and antiarrhythmic agents, cardiac glycosides, diuretics (remove excess fluid from the body) and medicines that improve microcirculation (blood circulation in small blood vessels). Meldonium Olainfarm may intensify the actions of glyceriltrinitrate, nifedipine, beta-adrenoblockers, other hypotensive agents and peripheral vasodilators. Meldonium Olainfarm with food Concomitant intake with food may slightly delay absorption of the medicine. Pregnancy and breast-feeding Ask your doctor for advice before taking any medicine. You should not take Meldonium Olainfarm while you are pregnant or breast-feeding. Driving and using machines No studies on the effects of Meldonium Olainfarm on the ability to drive and use machines have been performed. 3. How to use Meldonium Olainfarm
Swallow the capsule whole with a sufficient amount of water. Do not chew or crush the capsule. The recommended adult daily dose of 500 mg (2 capsules) is used once a day in the morning or it may be divided into two single doses. It is recommended to take the medicine in the first half of a day, as it can cause agitation (feeling restless). If you take more Meldonium Olainfarm than you should Overdose can cause low blood pressure manifested by headache, dizziness, quicker heartbeat. If you have taken more Meldonium Olainfarm than you should, contact a doctor. If you forget to take Meldonium Olainfarm If you forget to take a dose, take it as soon as you remember. However, the dose should not exceed the indicated daily dose. Do not take a double dose to make up for the forgotten dose. If you stop taking Meldonium Olainfarm If you have any further questions on the use of this product, ask your doctor. 4. Possible side effects
Like all medicines, Meldonium Olainfarm can cause side effects, although not everybody gets them. Usually Meldonium Olainfarm is well tolerated. Common (affects 1 to 10 users in 100): headache, allergic reactions (skin redness, skin rash, itching), dyspepsia (nausea, stomach heaviness). Rare (affects 1 to 10 users in 10,000): low blood presure. Very rare (affects less than 1 in 10,000 users): tachycardia (a quicker heartbeat).
Not known (cannot be estimated from the available data): eosinophilia (increase in certain white blood cells), agitation (feeling restless). In case of an allergy, discontinue Meldonium Olainfarm straight away and consult a doctor. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. 5. How to store Meldonium Olainfarm
Do not store above 25 °C. Protect from moisture. Keep out of the reach and sight of children! Do not use this medicine after the expiry date which is stated on the container. The expiry date refers to the last day of that month. 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 Meldonium Olainfarm contains The active substance is meldonium. Each capsule contains 250 mg of meldonium dihydrate. The other ingredients are potato starch, silica colloidal anhydrous, calcium stearate. Capsule shell: gelatine, titanium dioxide E171. What Meldonium Olainfarm looks like and contents of the pack White/white hard gelatin capsules, containing white or almost white powder. 10 capsules in blister. 2 blisters (20 capsules) and the package leaflet in a carton box. Marketing Authorisation Holder and Manufacturer
Company name: Joint-Stock Company “OLAINFARM” Address: 5 Rūpnīcu Street, Olaine, LV 2114 Country: Latvia Telephone: +371-67013701 Telefax: +371-67013777 E-mail: This leaflet was last revised in
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