Meldokar

Patient Information Leaflet

Meldokar, 500 mg, hard capsules
Meldonium dihydricum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Meldokar is and what it is used for
2. Important information before taking Meldokar
3. How to take Meldokar
4. Possible side effects
5. How to store Meldokar
6. Contents of the pack and other information

1. What Meldokar is and what it is used for

Meldokar contains the active substance meldonium dihydrate (hereinafter referred to as meldonium). Meldonium is a compound similar to gamma-butyrobetaine – a natural substance present in every cell of the body. The drug supports energy production in cells and stimulates the central nervous system.

Meldokar supports the body in ischemic conditions, i.e., when cells receive insufficient oxygen and nutrients and are unable to effectively eliminate metabolic waste products. The drug helps restore the balance between oxygen supply and oxygen consumption in cells. Additionally, it activates metabolic processes that require less oxygen for energy production. Under the influence of the drug, blood vessels dilate, improving tissue perfusion.

Meldokar has cardioprotective properties, meaning it protects the heart, especially under conditions of oxygen deficiency or ischemia. In heart failure, the drug improves the myocardium's contractile capacity and increases its resistance to physical exertion. In patients with angina pectoris (severe chest pain), it enhances physical performance and reduces the frequency of angina attacks.

In cerebral ischemia (impaired cerebral blood circulation), the drug improves blood flow and increases perfusion of brain areas affected by ischemia.

Meldokar also affects the central nervous system, improving memory, concentration, and motor coordination.

Meldokar is used as an adjunctive (supportive) therapy in the treatment of:

• Heart and circulatory system disorders: stable (exertional) angina pectoris, chronic heart failure (stage I–III according to the NYHA scale);
• Chronic ischemic disturbances of cerebral blood circulation;
• Reduced physical performance and physical overexertion;
• The convalescence period following previous cerebral circulation disorders or head injuries.

2. Important information before taking Meldokar

When not to take Meldokar

• if the patient is allergic to meldonium or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe liver or kidney failure (insufficient safety data available);
• during pregnancy or breastfeeding;
• in children and adolescents under 18 years of age (safety of use has not been established).

Warnings and precautions
Before starting treatment with Meldokar, discuss this with your doctor or pharmacist:

• if the patient has a history of liver or (and) kidney disease, monitoring of their function may be necessary.

Treatment with Meldokar may lead to positive results in anti-doping tests.
Children and adolescents
This medicine should not be used in children and adolescents under 18 years of age, as there is no data on the safety and efficacy of meldonium in this age group.
Meldokar and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not take Meldokar together with:

• Other medicines containing meldonium (the active substance in Meldokar), as this may increase the risk of adverse effects.

Exercise caution when using Meldokar concomitantly with:

• Glyceryl trinitrate, nifedipine, beta-blockers, and other antihypertensive drugs and vasodilators, as Meldokar may enhance the effect of these medicines, leading to a decrease in blood pressure.
• Lisinopril – in patients with chronic heart failure, the doctor may recommend concomitant use of Meldokar and lisinopril to alleviate disease symptoms.
• Cyclophosphamide (a chemotherapeutic agent) – overdose of Meldokar during concomitant use with cyclophosphamide may increase its toxic effects on the heart.
• Ifosfamide (a chemotherapeutic agent) – in patients with carnitine deficiency, use of Meldokar may increase the risk of heart damage.

If prescribed by a doctor, Meldokar may be used together with the following medicines:

• Long-acting nitrates and other antianginal drugs (used in the treatment of angina pectoris).
• Cardiac glycosides (used in the treatment of heart failure) and diuretics (promoting urine production and excretion, used in heart failure treatment).
• Anticoagulants (reducing blood coagulability).
• Antiplatelet drugs (preventing blood clot formation in blood vessels).
• Antiarrhythmics (used in the treatment of cardiac arrhythmias).
• Drugs improving microcirculation (enhancing blood flow in small blood vessels).
• Iron sulfate – in patients with iron-deficiency anemia, concomitant use with Meldokar may positively affect red blood cell composition.
• Indinavir and efavirenz (drugs used in the treatment of AIDS) – Meldokar may reduce their harmful effects on the heart and nervous system.
• Orotic acid (vitamin B) – its combination with Meldokar may provide additional benefits in treating tissue damage caused by ischemia and reperfusion (restoration of blood flow to tissues after a period of ischemia).

Meldokar with food and drink
Food slightly delays absorption of the medicine, but does not reduce its effect (see section 3: "How to take Meldokar").
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.
Do not use Meldokar during pregnancy due to lack of safety data.
Do not breastfeed while taking this medicine, as it is unknown whether it passes into breast milk.
Driving and operating machinery
There is no data available on the effect of the medicine on the ability to drive or operate machinery.
If symptoms affecting concentration occur (e.g. dizziness), caution should be exercised.

3. How to take Meldokar

This medicine should always be taken as directed by a doctor or pharmacist. In case of
doubt, consult your doctor or pharmacist.
The capsules should be swallowed whole with water.
The medicine can be taken before or after meals.
Due to possible stimulating effects, it is recommended to take the medicine during the first half of the day.

Recommended dose
Adults
Cardiovascular diseases, cerebrovascular disorders
The recommended dose is 500 mg (1 hard capsule) to 1000 mg (2 hard capsules) per day.
The daily dose may be taken once or divided into two doses.
The maximum daily dose is 1000 mg.

Reduced performance, physical fatigue, and convalescence period after cerebrovascular disorders,
head injuries
The dose is 500 mg (1 hard capsule) per day.
The maximum daily dose is 500 mg.
The duration of treatment is 4 to 6 weeks. Treatment may be repeated 2–3 times per year.

Elderly patients (over 65 years of age)
In elderly patients with impaired liver and/or kidney function, the doctor may recommend
reducing the dose of Meldokar.

Patients with impaired kidney function
In patients with mild or moderate kidney impairment, the doctor may recommend
reducing the dose of Meldokar.

Patients with impaired liver function
In patients with mild or moderate liver impairment, the doctor may recommend
reducing the dose of Meldokar.

Use in children and adolescents
This medicine should not be used in children and adolescents under 18 years of age (see section 2: "Children and adolescents").

Taking more Meldokar than recommended
There is no data available on overdose with Meldokar.
In patients with low blood pressure, headache, dizziness, rapid heartbeat, and general weakness may occur.
If you take more medicine than recommended, contact your doctor immediately. The doctor will, if necessary, recommend appropriate symptomatic treatment.

Missed dose of Meldokar
If you miss a dose, take it as soon as possible. If you remember on the same day, you may take the missed dose and continue treatment as recommended. Do not take a double dose to make up for a missed dose.

Stopping Meldokar
No adverse effects related to discontinuation of this medicine have been observed.

If you have any further doubts about using 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.
Meldokar is generally well tolerated. The adverse reactions listed below were reported
in clinical trials (marked with *) and adverse reactions reported after marketing authorization.
You must immediately stop taking this medicine and contact your doctor or go to
the nearest hospital emergency department if any of the following occur:

• anaphylactic reaction (sudden, severe allergic reaction with symptoms such as itching, urticaria, swelling, breathing difficulties, wheezing, rapid heartbeat, sudden drop in blood pressure, dizziness, loss of consciousness, shock) – frequency: rare;
• angioedema (may cause difficulty breathing or swallowing, as well as swelling of the face, hands and feet, lips and/or tongue) – frequency: rare.

Common (may occur in less than 1 in 10 people):

• allergic reactions*;
• headache*;
• dyspepsia* (stomach discomfort, nausea, vomiting).

Rare (may occur in less than 1 in 1,000 people):

• hypersensitivity, allergic dermatitis, urticaria;
• restlessness, feeling of fear, obsessive thoughts, sleep disturbances;
• tingling sensation, tremor, sensory disturbances, tinnitus, dizziness, gait disturbances, pre-syncope, loss of consciousness;
• cardiac disorders (palpitations, increased heart rate, atrial fibrillation and other arrhythmias detected on ECG), chest discomfort or pain;
• increased or decreased blood pressure, hypertensive crisis (sudden rise in arterial blood pressure), increased blood flow to tissues (hyperaemia), pallor;
• pharyngitis, cough, breathing difficulties, transient apnea;
• taste disturbances (metallic taste in mouth), loss of appetite, choking, nausea, vomiting, bloating, diarrhea, abdominal pain;
• various types of rash: generalized, macular (flat, localized skin lesions), papular (small, dense, raised skin lesions), pruritus;
• back pain, muscle weakness, muscle cramps;
• frequent urination;
• general malaise, chills, feeling unwell, swelling, facial swelling, leg swelling, feeling hot or cold, cold sweats;
• eosinophilia (increased number of white blood cells called eosinophils)*.

During treatment with Meldokar, upper abdominal pain and migraine have also been reported.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions
at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 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 provide more information on the safety of this medicine.

5. How to store Meldokar

Store below 25°C. Keep in the original packaging to protect from moisture.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. 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 packaging and other information

What Meldokar contains

• The active substance is meldonium. Each hard capsule contains 500 mg of meldonium dihydrate.
• Other ingredients are:

contents of the capsule: potato starch, colloidal anhydrous silica, calcium stearate;
capsule composition: titanium dioxide (E171), gelatin.

What Meldokar looks like and contents of the pack
Meldokar is a white hard gelatin capsule containing a white or almost white powder.
The medicine is packed in aluminium/PVC/PCTFE/PVC blisters in a cardboard box.
Pack sizes: 10, 20, 30 or 60 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel. + 48 42 22-53-100

Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów