Revision Year: 2015 Publisher: AS GRINDEKS, Krustpils iela 53, Rīga, LV-1057, Latvia Tel.: +371 67083205 Fax: +371 67083505 E-mail: grindeks@grindeks.lv
In patients with a history of hepatic and/or renal disorders, this medicine should be used with caution (regular monitoring of liver and/or kidney functions should be performed).
Meldonium may be used concurrently with long-acting nitrates and other antianginal agents to treat stable effort angina pectoris, with cardiac glycosides and diuretics to treat heart failure.
Meldonium may be combined with anticoagulants, antiaggregants, antiarrhythmic agents and other microcirculation improving medicines.
Meldonium may intensify the action of glyceryl trinitrate containing medicines, nifedipine, beta adrenoblockers, other hypotensive agents and peripheral vasodilators.
There is evidence of positive effect (main artery vasodilatation, improvement of life quality and peripheral circulation, physical and mental stress reduction) of combined administration of lisinopril and meldonium in patients with chronic cardiac insufficiency symptoms.
The combination of orotic acid and meldonium possesses additive pharmacological effects on recovery from ischemia/reperfusion injury.
Concomitant use of Sorbifer and meldonium in patients with iron deficiency anemia improves fatty acid composition of red blood cells.
Meldonium helps to prevent azidothymidine (AZT) induced cardiopathologic changes and indirectly acts on AZT caused oxidative stress reactions leading to mitochondrial dysfunction. Meldonium combined use with AZT or other medicines for acquired immune deficiency syndrome (AIDS) treatment, positive impact AIDS therapy.
Meldonium inhibited the sleeping time in ethanol induced loss of righting reflex test. In a pentylenetetrazole induced seizure test, significant anticonvulsant activity of meldonium was observed. However, the anticonvulsant activity of meldonium was completely blocked after pre-treatment with 2 mg/kg α2 adrenergic receptor antagonist yohimbine and 10 mg/kg nitric oxide synthase (NOS) inhibitor N-(G)-nitro-L-arginine.
Overdose of meldonium may aggravate cyclophosphamide induced cardiotoxicity.
Carnitine deficiency resulting from the use of D-carnitine (pharmacologically inactive isomer)-meldonium increases ifosfamide-induced cardiotoxicity.
Meldonium shows a protective effect in the case of indinavir-induced cardiotoxicity and efavirenz-induced neurotoxicity.
It is not recommended to use with other meldonium containing medicines because of increased risk of adverse effects.
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 (see section 4.3).
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 (see section 4.3).
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.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via State Agency of Medicines, Jersikas Street 15, Riga, LV-1003 Tel. +371 67078400; Fax +371 67078428. Website: www.zva.gov.lv.
In absence of compatibility studies, this medicine must not be mixed with other medicines.
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