Meldonium Mildronate Capsules

What is medicine Mildronate and what is it used for?

 

The active substance in Mildronate is meldonium dihydrate (hereafter referred to as meldonium). Meldonium (Mildronate) is a structural analogue of gamma butyrobetaine, a substance found in every cell in the body. The action of this medicinal product is based on its positive effect on the body’s energy metabolism, as well as its mild activation of the central nervous system.

In ischaemic conditions (oxygen and nutrient deprivation, insufficient elimination of metabolic end products) Meldonium restores the balance of oxygen supply and consumption processes in cells, activates those metabolic processes that require less oxygen for energy production. The drug also dilates the blood vessels, thus improving the blood supply to the tissues.

Meldonium has a pronounced cardioprotective (heart-protective) action, which means that Mildronate protects the heart in ischaemic conditions. In heart failure, Mildronate capsules improves the contractility of the heart muscle, increases resistance to exercise; in angina pectoris (severe attacks of pain in the heart area), it increases exercise capacity and reduces the frequency of angina attacks.

In ischaemic cerebral circulatory disorders, Meldonium capsules improves blood circulation and blood supply to the ischaemic area of the brain.

Meldonium  also has a tonic effect on the central nervous system. They improve memory, concentration and motor coordination.

Mildronate Grindex is used as combination therapy in the following cases:

• cardiovascular diseases: stable exertional angina pectoris, chronic heart failure (NYHA functional class I-III), cardiomyopathy, functional cardiovascular disorders;
• acute and chronic ischaemic cerebrovascular disorders;
• reduced work capacity, physical and psycho-emotional overload;
• recovery from cerebrovascular disorders, head injuries and encephalitis.

How to take Meldonium Mildronate?

Always take this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or
pharmacist. For oral use. Capsules should be swallowed with water. The medicine can be taken before or after food.Due to the possible stimulant effect, it is recommended to take in the first half of the day.

Dosage of Meldonium Mildronate capsules

 

Adults
Cardiovascular diseases, cerebrovascular disorders
The dose is 500-1000 mg per day. The daily dose may be taken all at once or divided into two doses.The maximum daily dose is 1000 mg.
Decreased work capacity, physical overstrain and recovery period after cerebrovascular accident disorders, head injuries .
The dose is 500 mg daily. The daily dose can be taken all at once or divided into two doses.
The maximum daily dose is 500 mg. The duration of the treatment course is 4-6 weeks. The course of treatment can be repeated 2-3 times a year, in advance after consultation with a doctor.

Elderly patients
Elderly patients with hepatic and/or renal impairment may require reduction of the dose of Mildronate.
Patients with renal impairment.
Patients with mild to moderate renal impairment should take a lower dose of Mildronate
dose.
Patients with hepatic impairment
Patients with mild to moderate hepatic impairment should take a lower dose of Mildronate
dose

Use in children and adolescents.

There are no data on the safety and efficacy of Mildronate in children and adolescents (under 18 years of age).

If you have taken Mildronate more than prescribed.
There are no data on Mildronate overdose. The medicine is low-toxic and does not cause severe side effects.In case of low blood pressure, headache, dizziness, fast heartbeat are possible,general weakness. In case of overdose, see a doctor immediately.
If you forget to take your next dose of Mildronate on time, do so immediately. However, if you are about tothe next time you take the medicine, skip the missed dose and continue taking the medicine as directed, observingthe usual intervals between doses.Do not take a double dose to make up for a missed dose.
No adverse effects have been observed when stopping this medicine. If you have any questions about this medicinetaking this medicine, ask your doctor or pharmacist.

What you need to know before taking Meldonium Mildronate?

 

Do not take Mildronate in the following cases:

– if you are allergic to meldonium dihydrate or any of the other ingredients (listed in section 6) of this medicine;
– if you have severe hepatic and/or renal insufficiency (insufficient data on safety of use);
– during pregnancy and breastfeeding;
– children and adolescents under 18 years of age (safety of use has not been tested).

Warnings and precautions for use

Do not take this medicine together with other medicines containing meldonium, as this may increase the occurrence of side effects risk of side effects.
Children and adolescents
This medicine should not be used in children and adolescents under 18 years of age because there are no data on the effects of meldonium safety and efficacy in these age groups.

Mildronate with food
Diet slightly delays the absorption of this medicinal product.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you think you may be pregnant or are planning to
pregnancy, consult your doctor or pharmacist before taking this medicine.
Data on the use of meldonium during pregnancy are not available. Potential risks to humans are not known, therefore Mildronate should not be used during pregnancy (see Do not use Mildronate in these circumstances).
Available animal data show excretion of meldonium in milk. It is not known whether the drug is excreted in human breast milk. Risks to neonates/infants cannot be excluded, therefore during breastfeeding should not be used (see Do not use Mildronate in these circumstances).

Possible side effects of Mildronate

Like all medicines, this medicine may cause side effects, although not everyone gets them. Usually
Mildronate is well tolerated.The following are side effects that have been observed in previous clinical trials (marked*) and adverse reactions reported during the post-marketing period.

Common (may occur in less than 1 in 10 patients):
– Allergic reactions*;- headache*;- indigestion*.

Rare (may occur in less than 1 in 1000 patients):

– hypersensitivity, allergic dermatitis, urticaria, angioedema (difficulty breathing orswelling of the face, hands and feet, lips and/or tongue), anaphylactic reaction (sudden
general allergic reaction with symptoms such as itching, urticaria, oedema, difficulty breathing,wheezing, rapid heart rate, rapid fall in blood pressure, dizziness, unconsciousnessloss of consciousness, shock);- agitation, feelings of fear, intrusive thoughts, sleep disturbances;- feeling of “ants running”, tremor, decreased sensitivity, ringing in the ears, dizziness, pacing
disturbances, near unconsciousness or presyncope, loss of consciousness;- changes in heart rhythm, palpitations, rapid heart rate, atrial fibrillation,abnormal heart rhythm (arrhythmia), chest discomfort/chest pain;
– increase or decrease in blood pressure, hypertensive crisis (rapid arterialhypertensive hypertension), increased blood flow to tissues (hyperaemia), pallor;- sore throat, cough, difficulty breathing, temporary cessation of respiratory movements;- disturbed sense of taste (metallic taste in mouth), loss of appetite, retching, nausea,vomiting, gas, diarrhoea, abdominal pain;- rash, generalized/macular (circumscribed, without elevation)/papular (small, dense, with elevation)rash, itching;- back pain, muscle weakness, muscle spasms;- frequent urination;- general weakness, chills, weakness, oedema, facial oedema, leg oedema, hot flushes, cold flushesFeeling of heat, cold sweat;- abnormal electrocardiogram (ECG), increased heart rate; eosinophilia (specific
increase in the number of white blood cells)*.