Meldonium Pharmexon 500mg Hard Capsules

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Aktivna sestavina:

MELDONIUM DIHYDRATE

Dostopno od:

Pharmexon Consulting s.r.o. Pitterova 2855/7, Zizkov, Prague, 130 00, Czech Republic

Koda artikla:

C01EB22

INN (mednarodno ime):

MELDONIUM DIHYDRATE 500 mg

Farmacevtska oblika:

HARD CAPSULE

Sestava:

MELDONIUM DIHYDRATE 500 mg

Tip zastaranja:

POM

Terapevtsko območje:

CARDIAC THERAPY

Povzetek izdelek:

Licence number in the source country: NOT APPLICAPABLE

Status dovoljenje:

Authorised

Datum dovoljenje:

2020-01-09

Navodilo za uporabo

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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

Lastnosti izdelka

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