Mildronate

Package Leaflet: Information for the User

Mildronate 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.

Contents of the pack

• 1. What Mildronate is and what it is used for
• 2. Before you take Mildronate
• 3. How to take 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 (referred to as meldonium in this leaflet). Mildronate is a structural analogue of gamma-butyrobetaine (GBB), a substance found in every cell of the body.
In conditions of poor blood flow to the heart, Mildronate dilates blood vessels, has a beneficial effect on the metabolism of the heart muscle, and restores the balance between oxygen supply and consumption in cells. In the case of heart failure, Mildronate improves the heart muscle's ability to contract and increases tolerance to physical overload.
Mildronate can be used as an adjunctive treatment for mild, long-term heart failure.

2. Before you take Mildronate

When not to take Mildronate

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

Warnings and precautions

Before taking Mildronate, consult your doctor:

• if you have chronic kidney or liver disease.

Children

Mildronate should not be taken by children, as it may not be safe or effective.

Mildronate with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If your doctor recommends, Mildronate can be taken in combination with the following medicines that affect the cardiovascular system:

• anti-anginal medicines (used to treat angina),
• anticoagulant medicines (blood thinners),
• anti-arrhythmic medicines (used to treat heart rhythm disorders),
• cardiac glycosides (used to treat heart failure),
• diuretic medicines (help reduce the amount of water in the body).

Mildronate may enhance the effect of certain cardiac medicines, such as:

• nitroglycerin,
• nifedipine,
• beta-adrenolytics,
• blood pressure-lowering medicines,
• peripheral vasodilators. Your doctor will take this into account when recommending Mildronate, as doses may need to be reduced.

Mildronate with food

Food slightly delays the absorption of this medicine but does not reduce its effect.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Mildronate should not be taken during pregnancy.
Do not breastfeed while taking meldonium.

Driving and using machines

Mildronate does not affect the ability to drive or use machines.

3. How to take Mildronate

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

• The capsules should be taken orally.
• Mildronate can be taken with food, preferably in the morning.

Adults
The recommended dose is 500-1000 mg of meldonium per day. The daily dose can be divided into two single doses. The maximum daily dose is 1000 mg. The duration of treatment is from 4 to 6 weeks.
Elderly patients
Patients with impaired liver and/or kidney function may require smaller doses (see "Warnings and precautions").
Patients with liver and/or kidney impairment
Smaller doses should be used in patients with liver and/or kidney impairment (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.

Overdose

This medicine is slightly toxic and does not cause severe side effects. If hypotension (low blood pressure) occurs, headache, dizziness, rapid heart rate, or weakness may occur.
If you take more Mildronate than you should, contact your doctor immediately.

Missed dose

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.
Continue to take your medicine as directed. Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 (flushing, rash, itching, swelling),
• headache,
• gastrointestinal disorders (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.

Not known(frequency cannot be estimated from the available data):

• eosinophilia (increased number of white blood cells called eosinophils),
• excitement,
• weakness.

Underlying diseases may cause other possible side effects, such as proteinuria (excess protein in the urine), liver function disorders caused by an improper diet, and mood changes. The connection between these effects and the use of meldonium is unlikely.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.
Side effects can be reported to the Department of Monitoring of Adverse Reactions to 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, you can help provide more information on the safety of this medicine.

5. How to store Mildronate

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

6. Contents of the pack and other information

What Mildronate contains

• The active substance is meldonium dihydrate. Each hard capsule contains 500 mg of meldonium dihydrate.
• The other ingredients are: potato starch (dried), colloidal silica anhydrous, calcium stearate. The 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 a white crystalline powder with a slight odor.
10 hard capsules in a PVC/PVDC/Aluminum blister.
2 or 6 blisters (20 or 60 hard capsules) in a cardboard box.

Marketing Authorization Holder

AS GRINDEKS.
Krustpils iela 53, Rīga, LV-1057, Latvia
Phone: + 371 67083205
Fax: +371 67083505
Email: grindeks@grindeks.lv

Manufacturer

AS GRINDEKS.
Krustpils iela 53, Rīga, LV-1057, Latvia
Phone: + 371 67083205
Fax: +371 67083505
Email: grindeks@grindeks.lv

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

Malta
Meldoxon 500 mg hard capsules
Croatia
Myldrox 500 mg hard capsules
Poland
Mildronate
Slovenia
Mildronate 500 mg hard capsules

Date of last revision of the leaflet 17.03.2023