البلد: مالطا
اللغة: الإنجليزية
المصدر: Medicines Authority
MELDONIUM DIHYDRATE
Pharmexon Consulting s.r.o. Pitterova 2855/7, Zizkov, Prague, 130 00, Czech Republic
C01EB22
MELDONIUM DIHYDRATE 500 mg
HARD CAPSULE
MELDONIUM DIHYDRATE 500 mg
POM
CARDIAC THERAPY
Licence number in the source country: NOT APPLICAPABLE
Authorised
2021-08-16
Page 1 of 4 PACKAGE LEAFLET: INFORMATION FOR THE USER MELDOPHARM 500 MG HARD CAPSULES meldonium dihydrate 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 Meldopharm is and what it is used for 2. What you need to know before you use Meldopharm 3. How to use Meldopharm 4. Possible side effects 5. How to store Meldopharm 6. Contents of the pack and other information 1. WHAT MELDOPHARM IS AND WHAT IT IS USED FOR Meldopharm contains the active substance meldonium dihydrate (it will be referred to as meldonium throughout the leaflet). Meldonium is a structural analogue of gamma-butyrobetaine (GBB), substance that can be found in each cell of the body. Under the conditions of poor cardiac (heart) blood flow, Meldopharm widens the blood vessels, positively affects metabolism of the heart muscle and restores the balance between oxygen delivery and its consumption in the cells. In the case of heart failure, Meldopharm improves the ability of heart muscle to contract and increases the tolerance to physical overload. Meldopharm can be used as supplementary treatment for mild long-term heart failure. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE MELDOPHARM DO NOT USE MELDOPHARM - if you are allergic to meldonium dihydrate or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor before using Meldopharm: - if you have chronic kidney or liver diseases. CHILDREN Meldopharm is not to be used by children because it may not be safe or effective. OTHER MEDICINES A اقرأ الوثيقة كاملة
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Meldopharm 500 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 500 mg of meldonium dihydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. White hard gelatin capsules size 00. The content – white crystalline powder with faint odor. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adjuvant treatment of mild chronic cardiac insufficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ The usual daily dose is 500-1000 mg of meldonium. The daily dose may be divided into two single doses. The maximum daily dose is 1000 mg. The treatment course varies from 4 to 6 weeks. _Elderly _ No specific recommendation for the use in this age group. Elderly patients with hepatic and/or renal impairment may require lower doses (see section 4.4). _Patients with hepatic and/or renal disorders _ As the medicinal product is eliminated through the kidney, in patients with renal disorders, as well as those with liver diseases, doses should be reduced (see section 4.4). _Paediatric population _ Due to lack of data on the safety and efficacy, the medicinal product is not recommended for use in children. Method of administration For oral administration. It is advised to use meldonium in the morning because of the possible stimulating effect. In order to avoid gastrointestinal disturbances the medicinal product can be taken with food. 4.3 CONTRAINDICATIONS Page 2 of 6 Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients with chronic liver and renal diseases should use this medicinal product carefully because no studies were held to find out the effects on elevated risk patients. Paediatric population No clinical data are available on the meldonium safety to children, therefore it is not recommended for children. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS اقرأ الوثيقة كاملة