Mildronate

Package Leaflet: Information for the Patient

Mildronate, 500 mg/5 mL, Solution for Injection

Meldonium Dihydrate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Mildronate and what is it used for
• 2. Important information before using 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 is Mildronate and what is it used for

Mildronate is a structural analogue of the carnitine precursor gamma-butyrobetaine (GBB), a substance that is found in every cell of the body.
In conditions of poor blood flow to the heart, Mildronate dilates blood vessels, activates anaerobic glycolysis, and stimulates the production and transport of ATP, restoring the balance between oxygen supply and consumption, thus protecting the cell. Mildronate has cardioprotective properties. In the case of chronic congestive heart failure, Mildronate improves the ability of the heart muscle to contract, increases tolerance to physical exertion, and helps to quickly prepare for new physical exertions. Due to these properties, Mildronate is used in the treatment of cardiovascular diseases.
Mildronate may be used as an adjunctive treatment in mild, long-term heart failure.
If there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before using Mildronate

When not to use Mildronate

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

If any of the above applies to the patient, they should inform their doctor or nurse before using the medicine.

Warnings and precautions

Before starting to use Mildronate, the patient should discuss it with their doctor or nurse:

• if the patient has chronic kidney or liver disease.

If the patient is unsure whether any of the above applies to them, they should consult their doctor before being given Mildronate.

Children and adolescents

The safety and efficacy of Mildronate in children have not been established.

Mildronate and other medicines

The patient should tell their doctor or nurse about all the medicines they are taking or have recently taken, as well as any medicines they plan to take.
If the doctor advises, Mildronate may be used in combination with the following medicines that affect the cardiovascular system: anti-anginal medicines, blood thinners (anticoagulants and antiplatelet agents), medicines used to treat heart rhythm disorders (anti-arrhythmics), cardiac glycosides, medicines that increase urine production and excretion (diuretics), etc. Mildronate may enhance the effect of some cardiac medicines, such as nitroglycerin, nifedipine, beta-adrenolytics, blood pressure-lowering medicines, and vasodilators. The doctor will take this into account when recommending Mildronate, as the doses may need to be reduced.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or nurse before using this medicine.
There are no available clinical data on the safety of using this medicine during pregnancy. To avoid possible adverse effects on the mother and fetus, the use of Mildronate is not recommended during pregnancy. It is not known whether the active substance passes into human milk. If the mother needs to be treated with this medicine, she should stop breastfeeding.

Driving and using machines

No adverse effects of Mildronate on the ability to drive and use machines have been observed.

3. How to use Mildronate

Mildronate is administered by a doctor or nurse via intravenous injection. The doctor will decide what dose is suitable for the patient and how and when the injection will be given. If there are any doubts, the patient should consult their doctor or nurse. It is recommended to use Mildronate in the morning due to its possible stimulating effect.
Adults
The usual daily dose is 500-1000 mg (5-10 mL) intravenously. The daily dose may be divided into two single doses. The maximum daily dose is 1000 mg. The duration of treatment is from 10 to 14 days, after which the treatment is continued with the oral form of the medicine. The duration of treatment is from 4 to 6 weeks. The treatment can be repeated 2 to 3 times a year.
Elderly patients
There are no special recommendations for this age group. Elderly patients with liver or kidney function disorders may require smaller doses (see "Warnings and precautions").
Patients with liver or kidney function disorders
Since the medicine is excreted by the kidneys, patients with kidney function disorders, as well as those with liver diseases, may require smaller doses (see "Warnings and precautions").

Use in children and adolescents

Due to the lack of data on safety and efficacy, the use of this medicine is not recommended in children.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Overdose of Mildronate

There are no data on overdose in humans. This medicine is low in toxicity and does not cause severe side effects. If a larger dose of Mildronate than recommended is used, the patient should immediately contact their doctor.

Missed dose of Mildronate

If the patient thinks they have missed a dose of Mildronate, they should contact their doctor or nurse.

Stopping the use of Mildronate

If the patient has any further doubts about the use of this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Mildronate can cause side effects, although not everybody gets them.
Mildronate is usually well tolerated.
Common(may affect up to 1 in 10 people):

• allergic reactions (redness, rash, itching, swelling),
• headache,
• discomfort in the stomach,
• 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 the available data):

• eosinophilia (increased number of white blood cells called eosinophils),
• excitement,
• general weakness. Underlying and concomitant diseases may cause other possible side effects, such as proteinuria (presence of increased amounts of protein in the urine, liver function disorders caused by improper diet, and mood changes). The connection between these effects and the use of Mildronate is unlikely. The frequency is unknown.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Mildronate

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions. Do not freeze.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Mildronate contains

• The active substance is meldonium dihydrate. 1 mL of the solution for injection contains 100 mg of meldonium dihydrate. 1 ampoule (5 mL) contains 500 mg of meldonium dihydrate.
• The other ingredient is water for injections.

What Mildronate looks like and contents of the pack

A clear, colorless liquid, practically free from visible particles.
Ampoules made of colorless borosilicate glass type I of hydrolytic resistance class with a protective ring or a single-point cut are packed in 5 pieces in PVC foil blisters. The blisters are packed in a cardboard box in 2 (10 ampoules) or 4 (20 ampoules) pieces.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

AS GRINDEKS
Krustpils iela 53,
Rīga, LV-1057,
Latvia
phone: + 371 67083205
email: [email protected]

This medicine is authorized in the Member States of the European Economic Area under the following names:

Croatia
Myldrox 500 mg/5 ml solution for injection
Malta
Meldoxon 500 mg/5 ml solution for injection
Poland
Mildronate
Slovenia
Mildronate 500 mg/5 ml solution for injection

Date of last revision of the leaflet: