Fezam® (Phezam®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substancePiracetam + CinnarizinePiracetam + Cinnarizine
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    • Dosage form: & nbspCapsules.
    Composition:

    1 capsule contains as active substances - piracetam 400 mg, cinnarizine 25 mg. Excipients - lactose monohydrate 55.0 mg, silicon colloidal dioxide 15.0 mg, magnesium stearate 5.0 mg. The capsule shell contains titanium dioxide 2%, gelatin 98%.

    Description:

    Solid, cylindrical gelatin capsules of white color, No. 0.

    The powder mixture, from white to almost white, allows the presence of conglomerates, which, when pressed with a glass rod, easily turn into powder.

    Pharmacotherapeutic group:Nootropic agent.
    ATX: & nbsp

    N.06.B.X   Other psychostimulants and nootropic drugs

    Pharmacodynamics:

    Combined drug with pronounced antihypoxic, nootropic and vasodilating effect. The components mutually potentiate the decrease in the resistance of the blood vessels of the brain and contribute to the increase in blood flow in them.

    Piracetam activates metabolic processes in the brain by enhancing energy and protein metabolism,accelerate the utilization of glucose by cells and increase their resistance to hypoxia; improves interneuronal transmission in the central nervous system (CNS), improves regional blood flow in the ischemic zone.

    Cinnarizine is a selective blocker of slow calcium, channels and an antagonist of histamine H1 receptors. It is found that it inhibits the entry of calcium ions into cells and reduces their content in the depot of the plasmolemma, lowers the tone of the smooth muscles of arterioles, reduces their reaction to biogenic vasoconstrictors (catecholamines, angiotensin and vasopressin). Has a vasodilating effect (especially with respect to cerebral vessels, enhancing the antihypoxic effect of piracetam), without having a significant effect on blood pressure. It shows moderate antihistamine activity, reduces the excitability of the vestibular apparatus, lowers the tone of the sympathetic nervous system. Increases the elasticity of erythrocyte membranes, their ability to deform, reduces the viscosity of the blood.

    Pharmacokinetics:

    The drug is quickly and completely absorbed in the gastrointestinal tract. The maximum concentration of pyracetam in the plasma is created in 2-6 hours.It freely penetrates through the blood-brain barrier, the maximum concentration in the cerebrospinal fluid after 2-8 hours. Bioavailability is 100%. Plasma does not bind to proteins. The apparent volume of distribution of pyracetam is about 0.6 l / kg. Penetrates into all organs and tissues, passes the placental barrier. Selectively accumulates in the cerebral cortex, mainly in the frontal, parietal and occipital lobes, the cerebellum and basal ganglia. It is not metabolized. The half-life (T1) of plasma is 4-5 hours, of cerebrospinal fluid - 8.5 hours. 80-100% of piracetam is excreted by the kidneys unchanged by renal filtration. The renal clearance of piracetam in healthy volunteers is 86 ml / min.

    T1 is prolonged with renal failure. The pharmacokinetics of pyracetam do not change in patients with hepatic insufficiency. It penetrates the hemodialysis apparatus through the filter membranes.

    After oral administration, the absorption of cinnarizine is slow. The maximum concentration of cinnarizine in plasma is created in 1-4 hours. With plasma proteins binds to 91%. It is actively and completely metabolized by the isoenzymes of the liver CYP2D6 by dealkylation. T1 is 4 hours. 1/3 of metabolites is excreted by the kidneys, 2/3 - through the intestine.

    Indications:

    • Insufficiency of cerebral circulation (atherosclerosis of cerebral vessels, recovery period of ischemic and hemorrhagic strokes, craniocerebral trauma, encephalopathy of various origins).
    • Intoxication.
    • Diseases of the central nervous system, accompanied by a decrease in intellectual-mnestic functions (memory, attention, mood).
    • Conditions after a traumatic brain injury.
    • Psycho-organic syndrome with predominance of asthenia and adynamia.
    • Asthenic syndrome of psychogenic genesis.
    • Labyrinthopathy - dizziness, noise in the ears, nausea, vomiting; nystagmus.
    • Meniere's syndrome.
    • Prevention of migraine and kinetosis.
    • In the complex therapy of low learning in children with psycho-organic syndrome.

    Contraindications:

    • Hypersensitivity to pyracetam, cinnarizine or to any of the excipients included in the formulation;
    • Severe renal (creatinine clearance <20 ml / min) and / or hepatic impairment;
    • Psychomotor agitation at the time of prescribing;
    • Horea Huntington;
    • Children under 5 years;
    • Pregnancy and lactation;
    • Hemorrhagic stroke;
    • Patients with rare hereditary diseases: galactose intolerance, lactase deficiency or glucose-galactose malabsorption (contains lactose monohydrate).

    Carefully:

    Parkinson's disease; conditions associated with increased intraocular pressure; impaired liver and / or kidney function, impaired hemostasis, severe bleeding.

    Pregnancy and lactation:

    Despite the lack of data on the presence of teratogenic effects of pyracetam and cinnarizine, the use of the drug in pregnancy is not recommended. The appointment of Fezam to pregnant women is only indicated if the intended benefit to the mother exceeds the potential risk to the fetus.

    Piracetam is excreted in breast milk, therefore it is recommended to stop breastfeeding while taking it.

    Dosing and Administration:

    Inside.

    Usual Adult Dose - 1-2 capsules three times a day for 1-3 months depending on the severity of the disease. The course of treatment -2-3 times a year.

    Children (over 5 years) - 1-2 capsules 1-2 times a day.

    The course of treatment is 1,5 - 3 months.

    Side effects:

    In very rare cases, hypersensitivity reactions are allergic reactions in the form of skin rash, dermatitis, itching, swelling, photosensitivity.

    From the gastrointestinal tract: in some cases, increased salivation, nausea, vomiting, diarrhea, abdominal pain.

    From the central and peripheral nervous system: hyperkinesia, nervousness, drowsiness, depression; in isolated cases - dizziness, headaches, ataxia, imbalance, insomnia, confusion, agitation, anxiety, hallucinations.

    Other: increased sexual activity. With prolonged therapy in elderly patients may appear tremor.

    Overdose:

    Fezam ® is very well tolerated by patients, in case of an overdose there are no serious side effects that require drug discontinuation.

    In case of an overdose, the symptoms of excitement predominate in children: insomnia, anxiety, euphoria, irritability, tremor and, in rare cases, nightmares, hallucinations and convulsions.

    Treatment is symptomatic, which may include hemodialysis. You should wash the stomach, induce vomiting. There is no specific antidote.

    Interaction:

    With the simultaneous administration of medications, oppressive central nervous system, tricyclic antidepressants and alcohol, sedative effects are enhanced.

    The drug potentiates the action of nootropic and antihypertensive agents.

    Vasodilators increase the effect of the drug.

    Improves tolerability of antipsychotic drugs and tricyclic antidepressants.

    It is possible to enhance the effect of oral anticoagulants.

    Special instructions:

    The drug should be administered with caution to persons with liver and / or kidney disease. In cases of mild to moderate renal insufficiency (especially if creatinine clearance less than 60 mL / min) should reduce or increase the therapeutic dose intervals between doses.

    In persons with impaired liver function, monitoring of liver enzymes is necessary.

    Avoid alcohol during treatment.

    The drug may cause a false positive response when controlling doping agents in athletes.

    The drug strengthens the activity of thyroid hormones and can cause tremors and anxiety.

    Effect on the ability to drive transp. cf. and fur:

    During treatment caution should be exercised when driving and operating machinery and equipment, since the beginning of treatment, cinnarizine can cause drowsiness.

    Form release / dosage:Capsules (400 mg + 25 mg).
    Packaging:

    10 capsules in a blister, 6 blisters with instructions for use in a cardboard box.

    Storage conditions:

    In a dry and dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children!

    Shelf life:

    3 years. Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N012828 / 01
    Date of registration:18.05.2009
    The owner of the registration certificate:Balkanfarma - Dupnitsa ADBalkanfarma - Dupnitsa AD Bulgaria
    Manufacturer: & nbsp
    Representation: & nbspAktavis, Open Company Aktavis, Open Company
    Information update date: & nbsp15.10.2015
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