Combitropil capsules 400mg + 25mg, No. 30

• disorders of cerebral circulation (with atherosclerosis of the vessels of the brain, ischemic stroke, follow-up period after hemorrhagic stroke, after traumatic brain injury);

• encephalopathy of various origins;

• comatose and subcomatous states after intoxication and brain trauma;

• diseases of the central nervous system, accompanied by a decrease in intellectual and mnestic functions;

• labyrinthopathies of various origins (accompanied by dizziness, tinnitus, nystagmus, nausea and vomiting), Meniere's syndrome;

• depression;

• psychoorganic syndrome with a predominance of signs of asthenia and adynamia;

• asthenia of psychogenic origin;

• prevention of migraine and kinetosis;

• impaired memory, mental function and concentration;

• lag in intellectual development in children.

The drug should be taken orally.

Adults - 1-2 caps. 3 times / day for 1-3 months, depending on the severity of the disease.

Children from 5 years old - 1-2 caps. 1-2 times / day for 1-3 months.

Treatment courses are carried out 2-3 times a year.

In chronic renal failure (CC <60 ml / min), a dose reduction or an increase in the interval between doses of the drug is necessary.

Active ingredients: cinnarizine - 25 mg, piracetam - 400 mg.
Excipients: microcrystalline cellulose, lactose (milk sugar), magnesium stearate, talc.
The composition of the gelatinous capsule: titanium dioxide, methyl parahydroxybenzoate, propyl parahydroxybenzoate, acetic acid, gelatin.

• severe liver failure;

• severe renal failure;

• parkinsonism;

• pregnancy;

• lactation period;

• children under 5 years of age;

• hypersensitivity to the components of the drug.

The drug should be used with caution in Parkinson's disease, renal or hepatic failure.

Trade name Combitropil

INN or Generic Name : Piracetam + Cinnarizine

Dosage form : capsules

Composition per capsule :
Active ingredients: cinnarizine - 25 mg, piracetam - 400 mg.
Excipients: microcrystalline cellulose, lactose (milk sugar), magnesium stearate, talc.
The composition of the gelatinous capsule: titanium dioxide, methyl parahydroxybenzoate, propyl parahydroxybenzoate, acetic acid, gelatin.

Description : Capsules No. 0 white. The contents of the capsules are white or almost white powder.

Pharmacotherapeutic group : nootropic agent.

ATX code : [N06BX]

Pharmacological action
Combined drug with a pronounced antihypoxic, nootropic and vasodilating effect.
Both components mutually potentiate their own antihypoxic effect and have a vasodilating effect. The combination drug also significantly increases blood flow in the brain. The toxicity of the combination does not exceed the toxicity of the individual components of the drug.
Piracetam is a nootropic drug. It has a positive effect on the metabolic processes of the brain: it increases the concentration of ATP in the brain tissue, enhances the synthesis of RNA and phospholipids, stimulates glycolytic processes, and enhances the utilization of glucose.
Improves the integrative activity of the brain, promotes the consolidation of memory, facilitates the learning process.
Changes the rate of propagation of excitation in the brain, improves microcirculation, while not exerting a vasodilating effect, suppresses the aggregation of activated platelets. It has a protective effect in case of brain damage caused by hypoxia, intoxication, electroshock; enhances alpha and beta activity, reduces delta activity on the EEG, reduces the severity of vestibular nystagmus.
Improves interneuronal transmission and synaptic conduction in neocortical structures, increases mental performance, improves cerebral blood flow. The effect develops gradually.
Has practically no sedative and psychostimulating effects.
Cinnarizine is a selective blocker of slow calcium channels, reduces the intake of Ca2 + into cells and reduces its content in the plasmolemma depot, reduces the tone of smooth muscles of arterioles, reduces their response to biogenic vasoconstrictor substances (epinephrine, norepinephrine, dopamine, angiotensin, vasopressin, serotonin).
It has a vasodilating effect (especially in relation to cerebral vessels, enhancing the antihypoxic effect of piracetam), without significantly affecting blood pressure. Shows moderate antihistamine activity, reduces the excitability of the vestibular apparatus, lowers the tone of the sympathetic nervous system. In patients with impaired peripheral circulation, it improves the blood supply to organs and tissues (including the myocardium), enhances postischemic vasodilation. Increases the elasticity of erythrocyte membranes, their ability to deform, reduces blood viscosity.

Pharmacokinetics
The combined preparation is rapidly and completely absorbed in the gastrointestinal tract. The bioavailability of piracetam is 95%. The therapeutic effect appears after 1-6 hours. The maximum level of cinnarizine in plasma is noted after 1-4 hours, piracetam - after 2-6 hours. The metabolism of cinnarizine occurs completely in the liver (by dealkylation). 60% of cinnarizine is excreted unchanged in the feces, the rest in the urine in the form of metabolites in about 5 hours. The maximum level of cinnarizine after 1-4 hours is noted not only in the blood, but also in the liver, kidneys, heart, lungs, spleen and brain. Binds 91% to plasma proteins. Piracetam crosses the blood-brain barrier, accumulates in the brain tissue 1-4 hours after ingestion. It is excreted from the cerebrospinal fluid much more slowly than from other tissues.Practically not metabolized. The half-life is 4.5 hours (7.7 hours from the brain). It is excreted by the kidneys - 2/3 unchanged within 30 hours.

Indications

• disorders of cerebral circulation (with atherosclerosis of the vessels of the brain, ischemic stroke, follow-up period after hemorrhagic stroke, after traumatic brain injury);

• encephalopathy of various origins;

• comatose and subcomatous states after intoxication and brain trauma;

• diseases of the central nervous system, accompanied by a decrease in intellectual and mnestic functions;

• labyrinthopathies of various origins (accompanied by dizziness, tinnitus, nystagmus, nausea and vomiting), Meniere's syndrome;

• depression;

• psychoorganic syndrome with a predominance of signs of asthenia and adynamia;

• asthenia of psychogenic origin;

• prevention of migraine and kinetosis;

• impaired memory, mental function and concentration;

• lag in intellectual development in children.

Dosage regimen

The drug should be taken orally.

Adults - 1-2 caps. 3 times / day for 1-3 months, depending on the severity of the disease.

Children from 5 years old - 1-2 caps. 1-2 times / day for 1-3 months.

Treatment courses are carried out 2-3 times a year.

In chronic renal failure (CC <60 ml / min), a dose reduction or an increase in the interval between doses of the drug is necessary.

Side effect

From the nervous system: irritability, sleep disturbance, headache, tremors of the limbs.

From the digestive system: dyspepsia, epigastric pain, dry mouth.

Allergic reactions: skin rash.

Contraindications for use

• severe liver failure;

• severe renal failure;

• parkinsonism;

• pregnancy;

• lactation period;

• children under 5 years of age;

• hypersensitivity to the components of the drug.

The drug should be used with caution in Parkinson's disease, renal or hepatic failure.

Application during pregnancy and lactation

The use of the drug during pregnancy and during breastfeeding is contraindicated.

Application for violations of liver function

The use of the drug is contraindicated in severe hepatic insufficiency.

Application for impaired renal function

The use of the drug is contraindicated in severe renal failure.

Application in children

Contraindication: children's age (up to 5 years). Children over the age of 5 years, 1-2 caps. 1-2 times / day for 1-3 months.

special instructions

During the period of treatment, liver function should be monitored.

At the beginning of treatment, the patient should refrain from drinking alcohol.

Due to the content of cinnarizine, the drug can cause a positive reaction in athletes during a doping test.

The drug should be used with caution in case of increased intraocular pressure.

Influence on the ability to drive vehicles and use mechanisms

During the period of treatment, care must be taken when driving a car and engaging in activities that require increased concentration of attention and speed of psychomotor reactions.

Overdose

There is no data on drug overdose.

Drug interactions

CombitropilЃ enhances the effects of drugs that depress the central nervous system, ethanol, as well as nootropic and antihypertensive drugs.

Improves the tolerance of antipsychotic drugs (neuroleptics) and tricyclic antidepressants.

Vasodilating drugs enhance the effect of Combitropil.

Terms and conditions of storage

The drug should be stored out of the reach of children, in a dry, dark place at a temperature not exceeding 25 ? C.

Shelf life is 2 years.

Conditions of dispensing from pharmacies

The drug is available with a prescription.