Package leaflet: Information for the user

Mildronate 500 mg hard capsules
Meldonium dihydrate
Please read all of this leaflet carefully before you start taking this medicine, because it contains
important information for you.

Keep this leaflet as you may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Mildronate is and what it is used for
What you need to know before you take Mildronate
How to take Mildronate
Possible side effects
How to store Mildronate
Contents of the pack and other information

1. What Mildronate is and what it is used for

Mildronate contains the active substance meldonium dihydrate (referred to throughout this leaflet as
meldonium). Mildronate is a structural analogue of gamma-butyrobetaine (GBB), a substance naturally
present in every cell of the body.
Under conditions of impaired blood flow to the heart, Mildronate dilates blood vessels, favourably
influences myocardial metabolism, and restores the balance between oxygen supply and oxygen
consumption in cells. In heart failure, Mildronate improves the contractile capacity of the heart muscle
and increases tolerance to physical exertion.
Mildronate may be used as an adjunctive treatment in mild, chronic heart failure.

2. Important information before using Mildronate

When not to use Mildronate

if the patient is allergic to meldonium dihydrate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Mildronate, consult a doctor:

if the patient has chronic kidney or liver diseases.

Children
Mildronate must not be used in children, as it may not be safe or effective.
Mildronate and other medicines
Tell your doctor or pharmacist if the patient is taking, has recently taken, or might take any other medicines.
If advised by a doctor, Mildronate may be used in combination with the following medicines affecting the cardiovascular system:

antianginal drugs (used in the treatment of angina),
anticoagulants (blood-thinning medicines),
antiarrhythmics (used in the treatment of heart rhythm disorders),
cardiac glycosides (used in the treatment of heart failure),
diuretics (help reduce fluid volume in the body).

Mildronate may enhance the effect of several cardiac drugs, such as:

nitroglycerin,
nifedipine,
beta-blockers,
antihypertensive drugs,
peripheral vasodilators.
The doctor will take this into account when recommending treatment with Mildronate, as doses may need to be reduced.

Mildronate and food
Food slightly delays absorption of this medicine, but does not reduce its effect.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Mildronate must not be used during pregnancy.
Breastfeeding must not be performed during meldonium treatment.
Driving and operating machinery
Mildronate has no influence on the ability to drive or operate machinery.

3. How to use Mildronate

This medicine should always be used exactly as prescribed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.

Capsules should be taken orally.
Mildronate may be taken with food, preferably in the morning.

Adults
The recommended dose is 500–1000 mg of meldonium per day. The daily dose may be divided into
two single doses. The maximum daily dose is 1000 mg. The duration of treatment is 4 to 6 weeks.
Elderly patients
Elderly patients with impaired liver and/or kidney function may require lower doses (see "Warnings and precautions").
Patients with impaired liver and/or kidney function
Lower doses should be used in patients with impaired liver and/or kidney function (see "Warnings and precautions").
Talk to your doctor if the effect of Mildronate is too strong or too weak.
Use in children
This medicine should not be used in children.
Taking more Mildronate than recommended
This medicine is low in toxicity and does not cause severe adverse effects. If hypotension (low blood pressure) occurs,
symptoms such as headache, dizziness, increased heart rate, or weakness may appear.
If you take more Mildronate than recommended, contact your doctor immediately.
Missing a dose of Mildronate
If you forget to take Mildronate, take it as soon as possible. However, if it is almost time for the next dose,
skip the missed dose. Continue with your regular dosing schedule. Do not take a double dose to make up
for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Mildronate is generally well tolerated.
Common (may affect up to 1 in 10 people):

allergic reactions (flushing, rash, itching, swelling),
headache,
gastrointestinal discomfort (dyspepsia, nausea, vomiting, bitter taste in the mouth).

Very rare (may affect up to 1 in 10,000 people):

increased heart rate,
decreased blood pressure.

Unknown (frequency cannot be estimated from available data):

eosinophilia (increased number of white blood cells called eosinophils),
agitation,
fatigue.

Concomitant and underlying diseases may cause other possible adverse reactions, such as
proteinuria (presence of increased protein levels in urine), liver function disorders due to improper
diet, and mood changes. The relationship between these events and the use of meldonium is
unlikely.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your
doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of
Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical
Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Mildronate

Do not store above 25°C.
Keep in the original packaging to protect from moisture.
This medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister
after "EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the Package and Other Information

What Mildronate contains

The active substance is meldonium dihydrate. Each hard capsule contains 500 mg of meldonium dihydrate.
Other ingredients are: potato starch (dried), colloidal anhydrous silica, calcium stearate. Hard gelatin capsule shell: titanium dioxide (E171), gelatin.

What Mildronate looks like and contents of the pack
White hard gelatin capsules, size 00. The contents are white crystalline powder with a faint odour.
10 hard capsules in a PVC/PVDC/Aluminium blister.
2 or 6 blisters (20 or 60 hard capsules) in a cardboard box.

Marketing Authorisation Holder
AS GRINDEKS
Krustpils iela 53, Rīga, LV-1057, Latvia
Tel.: +371 67083205
Fax: +371 67083505
E-mail: [email protected]

Manufacturer
AS GRINDEKS
Krustpils iela 53, Rīga, LV-1057, Latvia
Tel.: +371 67083205
Fax: +371 67083505
E-mail: [email protected]

This medicinal product is authorised in the European Economic Area under the following names:
Malta Meldoxon 500 mg hard capsules
Croatia Myldrox 500 mg tvrde kapsule
Poland Mildronate
Slovenia Mildronate 500 mg trde kapsule