Mildronate 500 mg hard capsules

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Saatavilla:

AS GRINDEKS Krustpils iela 53 Riga, LV-1057 , Latvia

ATC-koodi:

C01EB22

INN (Kansainvälinen yleisnimi):

MELDONIUM DIHYDRATE 500 mg

Lääkemuoto:

HARD CAPSULE

Koostumus:

MELDONIUM DIHYDRATE 500 mg

Prescription tyyppi:

POM

Terapeuttinen alue:

CARDIAC THERAPY

Tuoteyhteenveto:

Licence number in the source country: NOT APPLICAPABLE

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2020-01-09

Pakkausseloste

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PACKAGE LEAFLET: INFORMATION FOR THE USER
MILDRONATE 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 Mildronate
is and what it is used for
2.
What you need to know before you use Mildronate
3.
How to use Mildronate
4.
Possible side effects
5.
How to store Mildronate
6.
Contents of the pack and other information
1.
WHAT MILDRONATE IS AND WHAT IT IS USED FOR
Mildronate 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, Mildronate
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, Mildronate improves the
ability of heart muscle to contract and increases the tolerance to
physical overload.
Mildronate can be used as supplementary treatment for mild long-term
heart failure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MILDRONATE
DO NOT USE MILDRONATE
-
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 Mildronate:
-
if you have chronic kidney or liver diseases.
CHILDREN
Mildronate is not to be used by children because it may not be safe or
effective.
OTHER MEDICINES A

Valmisteyhteenveto

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7 SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Mildronate
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. 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.
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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.
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 OF
INTE