Country: Malta
Language: English
Source: 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
2020-01-09
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE USER MELDONIUM PHARMEXON 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 Meldonium Pharmexon is and what it is used for 2. What you need to know before you use Meldonium Pharmexon 3. How to use Meldonium Pharmexon 4. Possible side effects 5. How to store Meldonium Pharmexon 6. Contents of the pack and other information 1. WHAT MELDONIUM PHARMEXON IS AND WHAT IT IS USED FOR Meldonium Pharmexon 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, Meldonium Pharmexon 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, Meldonium Pharmexon improves the ability of heart muscle to contract and increases the tolerance to physical overload. Meldonium Pharmexon can be used as supplementary treatment for mild long-term heart failure. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE MELDONIUM PHARMEXON DO NOT USE MELDONIUM PHARMEXON - 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 Meldonium Pharmexon: - if you have chronic kidney or liver Read the complete document
Summary PAR – Generics 1/10 _CMDh/305/2013 _ _March 2018, Rev.02 _ SUMMARY PUBLIC ASSESSMENT REPORT GENERICS MELDONIUM PHARMEXON 500MG HARD CAPSULES MELDONIUM DIHYDRATE MT/H/0388/001/DC Summary PAR – Generics 2/10 SUMMARY PUBLIC ASSESSMENT REPORT GENERICS General guidance: In principle information from the PL should be included and standard texts/sentences should be used where possible. Meldonium Pharmexon 500 mg hard capsules Meldonium dihydrate, hard capsules 500mg This is a summary of the public assessment report (PAR) for Meldonium Pharmexon. It explains how Meldonium Pharmexon was assessed and its authorisation recommended as well as its conditions of use. It is not intended to provide practical advice on how to use Meldonium Pharmexon. For practical information about using Meldonium Pharmexon, patients should read the package leaflet or contact their doctor or pharmacist. WHAT IS MELDONIUM PHARMEXON AND WHAT IS IT USED FOR? Meldonium Pharmexon is a ‘generic medicine’. This means that Meldonium Pharmexon is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Mildronate 500mg kietosios kapsulės. Meldonium Pharmexon is used in the treatment as supplementary treatment for mild long-term heart failure. _ _ HOW DOES MELDONIUM PHARMEXON WORK? 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, Meldonium Pharmexon 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, Meldonium Pharmexon improves the ability of heart muscle to contract and increases the tolerance to physical overload. HOW IS MELDONIUM PHARMEXON USED? The pharmaceutical form of Meldonium Pharmexon is hard capsules and the route of administration is oral administration. Meldonium Pharmexon can be taken with food, preferably in the morning. Adults The Read the complete document