Chemical formula: C₆H₁₄N₂O₂ Molecular mass: 146.19 g/mol
Animal studies are insufficient with respect to meldonium effects on pregnancy, embryonal/foetal development, parturition and postnatal development. The potential risk for humans is unknown, therefore this medicine should not be used during pregnancy.
The available data in animals have shown that meldonium is excreted into breast milk. It is not known whether the medicine is excreted into human milk. The risk for newborns/infants cannot be excluded, therefore this medicine should not be used during breast-feeding period.
No data on the effects on the ability to drive and use machines.
The table below presents adverse reactions that have occurred in previous uncontrolled clinical trials and post-marketing period.
Adverse reactions are presented according to the MedDRA system organ classes and frequency convention: common (≥1/100 to <1/10), rare (≥1/10000 to <1/1000).
Adverse reactions reported in clinical trials and post-marketing period:
| Immune system disorders | |
| Common | Allergic reactions* |
| Rare | Hypersensitivity, allergic dermatitis, urticaria, angioedema, anaphylactic reaction |
| Psychiatric disorders | |
| Rare | Agitation, fear, obsessive thoughts, sleep disorders |
| Nervous system disorders | |
| Common | Headache* |
| Rare | “Ants crawling” sensation, tremor, hypoaesthesia, tinnitus, vertigo, dizziness, gait disturbances, presyncope, loss of consciousness |
| Cardiac disorders | |
| Rare | Heart rhythm changes, palpitations, tachycardia/sinus tachycardia, atrial fibrillation, arrhythmia, chest discomfort/chest pain |
| Vascular disorders | |
| Rare | Blood pressure increased/decreased, hypertensive crisis, hyperaemia, pallor |
| Respiratory, thoracic and mediastinal disorders | |
| Rare | Throat irritation, cough, dyspnoea, apnoea |
| Gastrointestinal disorders | |
| Common | Dyspepsia* |
| Rare | Dysgeusia (taste metallic), appetite loss, retching, nausea, vomiting, flatulence, diarrhoea, abdominal pain |
| Skin and subcutaneous tissue disorders | |
| Rare | Rash, macular/papular/generalized rash, pruritus |
| Musculoskeletal and connective tissue disorders | |
| Rare | Back pain, muscle weakness, muscle spasms |
| Renal and urinary disorders | |
| Rare | Pollakiuria |
| General disorders and administration site conditions | |
| Rare | General weakness, chills, asthenia, oedema, face oedema, oedema of legs, feeling hot, feeling cold, cold sweat |
| Investigations | |
| Rare | Abnormal electrocardiogram (ECG), heart rate increased, eosinophilia* |
* Adverse reactions reported during previous uncontrolled clinical trials.
In connection with meldonium use upper abdominal pain and migraine have been reported.
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