Meldonium 500 mg hard capsules

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Meldonium dihydrate

Prieinama:

AS Grindeks

ATC kodas:

C01EB22

INN (Tarptautinis Pavadinimas):

Meldonium dihydrate

Vaisto forma:

Capsule, hard

Gydymo sritis:

meldonium

Autorizacija statusas:

Not marketed

Leidimo data:

2023-10-13

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE
PATIENT
MELDONIUM 500 MG HARD CAPSULES
meldonium dihydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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
is and what it is used for
2.
What you need to know before you take Meldonium
3.
How to take Meldonium
4.
Possible side effects
5.
How to store Meldonium
6.
Contents of the pack and other information
1.
WHAT MELDONIUM IS AND WHAT IT IS USED FOR
Meldonium 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
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
improves the ability of heart muscle to
contract and increases the tolerance to physical overload.
Meldonium can be used as supplementary treatment for mild long-term
heart failure in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MELDONIUM
DO NOT TAKE MELDONIUM
-
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 taking Meldonium:
-
if you have chronic kidney or liver diseases.
Anti-doping warning
Athletes must be aware that this medicinal product may cause a
positive reaction to “anti-do

Prekės savybės

Health Products Regulatory Authority
15 December 2023
CRN00DZGW
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Meldonium 500 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 500 mg of meldonium dihydrate (equivalent
to 401.14 mg of meldonium).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule.
Hard capsule (23.3 mm in length), with a white body and cap.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adjuvant treatment of mild chronic cardiac insufficiency in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The usual daily dose is 500‑1000 mg (1 - 2 capsules) of meldonium
dihydrate. The daily dose of 1000 mg 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. The capsules should be swallowed whole with
water.
It is advised to take 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
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.
Health Products Regulatory Authority
15 Decembe