Instructions for use Tsinatropil-Zdorovye capsules 400 mg/25 mg blister No. 60
Composition
active ingredients: 1 capsule contains piracetam 400 mg, cinnarizine 25 mg;
excipients: calcium hydrogen phosphate, colloidal anhydrous silicon dioxide, magnesium stearate; capsule shell contains titanium dioxide (E 171), gelatin.
Dosage form
The capsules are hard.
Main physical and chemical properties: hard gelatin capsules of white color. The contents of the capsule are a mixture of granules and powder of white or white with a yellowish tinge. The presence of agglomerates of powder particles is allowed. The enterprise trademark - ZT - is allowed to be applied to the capsule.
Pharmacotherapeutic group
Psychostimulants and nootropics. ATX code N06B X.
Pharmacological properties
Pharmacodynamics.
Cinatropil®-Health is a combination drug. The active components of the drug are piracetam, a cyclic derivative of γ-aminobutyric acid, and cinnarizine, a selective calcium channel antagonist.
Piracetam is a nootropic that acts on the brain, improving cognitive functions such as learning ability, memory, attention, and mental performance. There are probably several mechanisms of action of the drug on the central nervous system: changing the speed of propagation of excitation in the brain; enhancing metabolic processes in nerve cells; improving microcirculation by influencing the rheological characteristics of the blood, without causing a vasodilator effect. Improves connections between the cerebral hemispheres and synaptic conduction in neocortical structures. After prolonged use of the drug, patients with decreased brain function show improvement in cognitive functions and improved attention.
Cinnarizine inhibits the contraction of vascular smooth muscle cells by blocking calcium channels. In addition to direct calcium antagonism, cinnarizine reduces the contractile effect of vasoactive substances such as norepinephrine and serotonin by blocking the calcium channel receptors controlled by them. The blockade of calcium entry into cells depends on the type of tissue, resulting in antivasoconstrictor effects without affecting blood pressure and heart rate. Cinnarizine can further improve insufficient microcirculation by increasing the elasticity of the erythrocyte membrane and reducing blood viscosity. Cellular resistance to hypoxia increases. Cinnarizine inhibits stimulation of the vestibular system, which leads to the occurrence of nystagmus and other autonomic disorders. Cinnarizine prevents the occurrence of acute attacks of dizziness.
Pharmacokinetics.
The drug is rapidly and completely absorbed from the gastrointestinal tract. Cinnarizine reaches peak plasma concentrations 1 hour after oral administration. It is completely metabolized. It is 91% bound to blood proteins. 60% is excreted unchanged in the feces, the remaining amount is excreted in the urine as metabolites.
The maximum plasma concentration of piracetam is reached after 2-6 hours. Piracetam freely penetrates the blood-brain barrier and is excreted unchanged in the urine.
Indication
· Chronic and latent cerebral circulatory insufficiency in atherosclerosis and arterial hypertension; angiodystonic ischemic stroke and condition after a stroke.
· Post-traumatic cerebrasthenia.
· Encephalopathy of various origins.
· Psychoorganic syndrome with a predominance of memory impairment and other cognitive functions or disorders of the emotional-volitional sphere.
· Labyrinthopathy – dizziness, tinnitus, nausea, vomiting, nystagmus.
· Meniere's syndrome.
· Prevention of motion sickness.
Contraindication
Hypersensitivity to piracetam, cinnarizine or any auxiliary component of the drug; individual sensitivity to pyrrolidone derivatives.
Severe renal failure, acute cerebrovascular accident (hemorrhagic stroke), Huntington's chorea, parkinsonism, increased intraocular pressure, psychomotor agitation.
Pregnancy or breastfeeding.
Interaction with other medicinal products and other types of interactions
The simultaneous use of alcohol and drugs that depress the central nervous system (CNS), tricyclic antidepressants, may enhance their sedative effect.
The drug potentiates the effect of nootropic, antihypertensive and vasodilator drugs. Use together with vasodilator drugs enhances its effect, and the presence of cinnarizine reduces the activity of hypertensive drugs.
Cinatropil®-Health enhances the activity of thyroid hormones and may cause tremors and restlessness.
Diagnostic intervention: due to its antihistamine effect, cinnarizine, which is part of the drug, can mask positive reactions to skin reactivity factors during skin testing, therefore its use should be discontinued 4 days before it is performed.
Antiepileptic drugs: no interactions with carbamazepine, phenytoin, phenobarbital, sodium valproate have been noted (information is based on known data from the use of piracetam at a dose of 20 mg/day daily for 4 weeks).
May enhance the effects of oral anticoagulants.
In patients with severe recurrent thrombosis, the use of piracetam in high doses (9.6 g/day) did not affect the dosage of acenocoumarol to achieve a prothrombin time (INR) of 2.5-3.5, but with its simultaneous use, a significant decrease in the level of platelet aggregation, fibrinogen levels, von Willebrand factors (coagulation activity (VIII: C); ristocetin cofactor (VIII: vW: Rco) and plasma protein (VIII: vW: Ag)), blood viscosity and blood plasma was observed.
Pharmacokinetic interactions.
The likelihood of changes in the pharmacodynamics of piracetam under the influence of other drugs is low, since 90% of piracetam is excreted unchanged in the urine.
In vitro, piracetam does not inhibit cytochrome P450 isoforms CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 4A9/11 at concentrations of 142, 426, 1422 μg/ml.
At a concentration of 1422 μg/ml, a slight inhibition of CYP2A6 (21%) and 3A4/5 (11%) was observed. However, the Ki of these two CYP isomers is sufficient above 1422 μg/ml. Therefore, metabolic interactions with drugs metabolized by these enzymes are unlikely.
Application features
Kidney failure.
The drug should be administered with caution to patients with kidney disease. In cases of mild or moderate renal insufficiency, it is recommended to reduce the therapeutic dose or increase the interval between applications, especially if creatinine clearance is < 60 ml/min.
Liver failure.
The drug should be prescribed with caution to patients with liver disease. Patients with impaired liver function should monitor liver enzyme values.
Elderly patients.
During long-term therapy in elderly patients, regular monitoring of renal function is recommended; if necessary, the dose should be adjusted depending on the results of the creatinine clearance study.
Penetrates through the filter membranes of hemodialysis machines.
The use of the drug should be avoided in porphyria.
Impact on laboratory tests.
The drug may give a false-positive result during doping control in athletes, as well as when determining radioactive iodine, due to the presence of iodine-containing dyes in the capsule shell.
Effect on platelet aggregation.
Due to the fact that piracetam reduces platelet aggregation, it is necessary to prescribe the drug with caution to patients with impaired hemostasis, with conditions that may be accompanied by bleeding (gastrointestinal ulcer), during major surgical operations (including dental interventions), patients with symptoms of severe bleeding or patients with a history of hemorrhagic stroke; as well as to patients using anticoagulants, platelet antiaggregants, including low doses of acetylsalicylic acid.
Like other antihistamines, Cinatropil®-Health may cause irritation in the epigastric region; taking it after meals may reduce the symptoms of gastric irritation.
You should refrain from taking alcohol or antidepressants at the same time, as the drug may cause drowsiness, especially at the very beginning of treatment (see section "Interaction with other medicinal products and other types of interactions").
Use during pregnancy or breastfeeding
Do not use the drug during pregnancy or breastfeeding. If treatment with the drug is necessary, breastfeeding should be discontinued.
Ability to influence reaction speed when driving vehicles or other mechanisms
Caution should be exercised when driving or operating other machinery due to possible adverse reactions from the central nervous system.
Method of administration and doses
Tsinatropil®-Health capsules should be taken orally after meals, without chewing, with water.
Adults
1-2 capsules 3 times a day.
The course of treatment is 1-3 months, depending on the severity of the disease.
Do not use for longer than 3 months without a break! 2-3 courses per year are possible.
Children
Do not apply.
Overdose
Symptoms: increased manifestations of side effects of the drug. In isolated cases of acute overdose, dyspeptic phenomena (bloody diarrhea, abdominal pain), changes in consciousness from drowsiness to stupor and coma, vomiting, extrapyramidal symptoms, arterial hypotension were observed. In children, with overdose, excitation reactions predominate - insomnia, anxiety, euphoria, irritability, tremor, rarely - nightmares, hallucinations, convulsions.
Treatment: induce vomiting, perform gastric lavage (preferably within the first hour after ingestion), use activated charcoal. Conduct symptomatic therapy. Hemodialysis is possible.
Adverse reactions
Nervous system: hyperkinesia, ataxia, headache, insomnia, vestibular disorders, dizziness, increased frequency of epileptic seizures/possible risk of worsening of epilepsy, balance disorders, tremor, hypersomnia, lethargy, dyskinesia, parkinsonism, fatigue. Prolonged use in elderly patients may lead to the development of extrapyramidal phenomena.
On the part of the digestive tract: dry mouth, dyspepsia, abdominal pain, upper abdominal pain, stomach discomfort, diarrhea, cholestatic jaundice, increased salivation, nausea, vomiting.
Skin: angioedema, dermatitis, itching, rash, urticaria, photosensitivity, hyperhidrosis (increased sweating), actinic keratosis, lupus erythematosus and lichen planus.
Mental disorders: increased excitability, nervousness, confusion, drowsiness, depression, anxiety, hallucinations.
Musculoskeletal system: muscle rigidity.
Others: asthenia, sexual arousal, hemorrhagic disorders.
With a long course of treatment, in rare cases, weight gain may occur.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
Hard capsules No. 30 (10×3), No. 60 (10×6) in blisters in a box.
Vacation category
According to the recipe.
Producer
Limited Liability Company "Pharmaceutical Company "Zdorovya".
Location of the manufacturer and its business address
Ukraine, 61013, Kharkiv region, Kharkiv city, Shevchenko street, building 22.
