Meldopharm 500mg hard capsules

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

Δραστική ουσία:

MELDONIUM DIHYDRATE

Διαθέσιμο από:

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

Φαρμακολογική κατηγορία (ATC):

C01EB22

INN (Διεθνής Όνομα):

MELDONIUM DIHYDRATE 500 mg

Φαρμακοτεχνική μορφή:

HARD CAPSULE

Σύνθεση:

MELDONIUM DIHYDRATE 500 mg

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

CARDIAC THERAPY

Περίληψη προϊόντος:

Licence number in the source country: NOT APPLICAPABLE

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2021-08-16

Φύλλο οδηγιών χρήσης

Page
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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

Αρχείο Π.Χ.Π.

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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