CELEBIS

Drug formulation:

active substance:

1 hard capsule contains: meldonium 250 mg;

adjuvants: potato starch, silicon dioxide, calcium stearate;

capsule (shell and cap): titanium dioxide (E 171), gelatin.

Dosage form.

Hard capsules.

Manufacturer name and location.

JSС «Grindeks».

Latvia, Riga, LV-1057, 53 Krustpils St.

Pharmacotherapeutic group.

Drugs stimulating metabolic processes. ATC Code С01Е В17.

Meldonium is a structural analog of γ-butyrobetaine, a substance contained in every cell of human body. In case of high stress or insufficient blood supply tissues accumulate toxic metabolic products – underoxidized activated forms of fatty acids capable of destroying the organism cells. Meldonium blocks activity of γ-butyrobetaine hydroxylase, hampers formation of toxic products and prevents their negative effect on cells membrane. Improves cellular resistance to high stress. Meldonium intensifies synthesis of γ-butyrobetaine which possesses anti-oxidant and vasorelaxant action, and the blood supply is restored first of all in areas where it was disturbed. Under the conditions of high stress and oxygen insufficiency (ischemia of any origin) Celebis® restores balance between oxygen supply and consumption by cells of heart and brain, activates alternative mechanisms of energy supply, improves metabolic processes, increases supply of nutrients and oxygen, restores energy balance at cellular level.

Celebis® improves contractive and pumping functions of myocardium, possesses cardioprotective effect, protects cardiac muscle from toxic action of adrenaline and alcohol, decreases myocardial infraction zone.

According to clinical studies data, inclusion of Celebis® into combined treatment of stable exertional stenocardia gives the possibility to decrease frequency and intensity of heart attacks, and to reduce nitrates intake. The drug possesses apparent antianginal and antiarrhythmic action, improves efficiency and effectiveness of cardiac performance, increases heart resistance to physical and psychoemotional stress, prevents further development and exacerbation of heart disease. In patients with chronic cardiac insufficiency Celebis ® increases tolerance to physical stress, improves quality of life and adaptive abilities of people suffering from cardiovascular diseases. At the same time the drug contributes to improvement of lipidic metabolism: decreases the level of total cholesterol, prevents development of atherosclerotic processes in coronary and peripheric vessels.

In case of signs of brain circulation impairment (periodic headache, memory and attention impairment, rapid fatigability) Celebis® demonstrates antihypoxic action and improves brain blood supply. The drug optimizes redistribution of the volume of cerebral blood flow for the benefit of those brain regions which suffer first from oxygen insufficiency, increases neurons resistance to hypoxia. Improves cerebral function, eliminates functional disturbances in somatic and vegetative nervous system activity, removes consequences and protects from stress, possesses apparent cerebroprotective effect. Contributes to fast elimination of consequences of alcohol toxic effect on nervous system (abstinence syndrome). In cases of disturbances of neurological character (after acute disturbances of cerebral blood flow, brain operations, head injuries, tick-borne encephalitis) accelerates restoration of physical and intellectual functions during recovery period.

Due to its combined action, Celebis® improves general tonus and adaptive abilities of organism, increases physical and intellectual performance, improves ability of organism to withstand stresses and rapidly restore its energy reserves.

Indications.

During the periods of high physical and psychoemotional overstress, in order to protect heart and improve its performance.

During the recovery period in order to rapidly eliminate consequences after cerebrovascular disturbances, head injuries and cerebral traumas in course of combined treatment.

Contraindications.

Hypersensitivity to meldonium or any other drug component, high intracranial pressure (in cases of venous drainage impairment, intracranial tumors), organic damages of central nervous system (CNS). Pregnancy and breast-feeding periods. Children’s age.

 

Peculiarities of application.

In case of concurrent chronic liver and kidney disease it is necessary to consult a doctor before application of the drug. Due to possible stimulating effect of Celebis® it is recommended to take it during the first half of the day.  

Application during pregnancy or breast-feeding periods. Clinical studies of safety and experience of drug application in women during pregnancy and breast-feeding periods are absent. In order to prevent possible negative effect on foetus the drug is not prescribed during pregnancy period. If mother requires treatment with the drug, breast-feeding shall be stopped.

Ability to affect the rate of reactions when driving or operating other mechanisms. Does not affect the rate of reactions when driving or operating other mechanisms.

Children. Experience of application in children under 18 is absent.

Method of application and dosage.

The drug is taken internally irrespective of meals once a day (in the morning) or divided into 2 doses during the first half of the day.

Daily dose for adults – 500 mg (2 capsules).

Maximum daily dose is 1000 mg (4 capsules).

Total period of treatment – 4-6 weeks.

If necessary, the course of treatment or prophylaxis may be repeated.

Overdosage.

Any information about cases of overdosage is absent. The drug is low-toxic and does not cause severe side effects. When taken in doses which are ten times larger than recommended, the change of blood pressure levels is possible. In case of overdosage it is required to turn to the doctor who will prescribe relevant treatment.

Side effects.

Cardiovascular system: rarely – tachycardia, arrhythmia, changes in blood pressure.

Blood formation system: eosinophilia.

Central nervous system: rarely – headache, dizziness, psychomotor disorders, paresthesia, tremor, excitement.

Gastrointestinal tract: rarely – diarrhoea, nausea, vomiting, abdominal pain, dyspeptic phenomena, metallic taste in mouth, dry mouth or hypersalivation.

Allergic reactions: rarely – redness and skin itching, urticaria, rash, angioneurotic oedema, very rarely – anaphylactic shock.

Breathing system: dyspnoea, dry cough.

Other: shiver, chest pain, weakness, hyperthermia, hyperhidrosis.

Interaction with other drugs and other types of interaction. 

Celebis® can be taken with other medicines.

The drug can be applied with nitrates of durable action and other antianginal drugs, cardiac glycosides, and diuretic agents. Also the drug can be taken in combination with anticoagulants, antiaggregants, antiarrhythmic drugs and other medicines improving microcirculation.

It should be mentioned that Celebis® can intensify action of drugs which contain nitroglycerin, nifedipine, beta-adrenoreceptor blocking agents, other antihypertensive drugs and peripheral vasodilators.

Celebis® hard capsules 250 mg should not be taken with drugs that contain meldonium, since this may increase the risk of side effects.

Effective period. 4 years.

Do not apply after the expiration date indicated on the packaging.

Storage conditions. Store in dry place under the temperature under 25° С. Store out of reach of children.

Packaging. 10 capsules in aluminium foil blister; 2 blisters in carton box.

Category of selling. Without prescription.