International Name: Mildronate 250 mg #40 capsules

Indications for Use:

Meldonium is used as part of complex therapy in the following cases:

• Decreased work capacity, physical and psycho-emotional fatigue
  
  

• Recovery period after cerebrovascular disorders, head injuries, and encephalitis
  
  

Composition:

• Capsules: Each capsule contains 250 mg of meldonium dihydrate
  
  

Excipients:

• Dried potato starch, silicon dioxide, calcium stearate
  
  

• Capsule (body and cap): titanium dioxide (E 171), gelatin
  
  

Dosage and Administration:

• Route: Oral
  
  

• To minimize the risk of stimulating effects, it is recommended to take the medication in the first half of the day
  
  

• Adults: Daily dose is 500 mg (2 capsules)
  
  

• Can be taken in a single dose or divided into 2 doses
  
  

• Maximum daily dose: 500 mg
  
  

• Course duration: 4–6 weeks
  
  

• Course repetition: 2–3 times per year
  
  

Special Considerations:

• Elderly patients: Dose adjustment may be needed in case of liver and/or kidney impairment
  
  

• Renal impairment: Since the drug is excreted via the kidneys, patients with mild to moderate kidney impairment should take a reduced dose
  
  

• Hepatic impairment: Patients with mild to moderate liver impairment should take a reduced dose
  
  

Pediatric Population:

• Safety and efficacy in children and adolescents under 18 years have not been established; therefore, use is contraindicated
  
  

Contraindications:

• Hypersensitivity to meldonium or any other component of the medication
  
  

• Severe liver and/or kidney failure (insufficient data on safety)
  
  

Pregnancy and Lactation:

• Safety during pregnancy and lactation has not been established
  
  

Storage Conditions:

• Store at temperatures up to 25°C
  
  

• Keep in original packaging to protect from moisture
  
  

• Keep out of reach of children