Fescetam capsules 400mg + 25mg, No. 60

- Insufficiency of cerebral circulation (atherosclerosis of cerebral vessels, the recovery period of ischemic and hemorrhagic strokes after traumatic brain injury, encephalopathy of various origins);

- psychoorganic syndrome with a predominance of symptoms of asthenia and adynamia;

- asthenic syndrome;

- labyrinthopathy (dizziness tinnitus nystagmus nausea vomiting);

- Meniere's syndrome;

- prevention of kinetosis.

Inside, regardless of the time of the meal.

Adults: the average daily dose is 1-2 capsules 3 times / day for 1-3 months, depending on the severity of the disease.

Children over 5 years old: the average daily dose is 1-2 capsules 1-2 times / day (no more than 3 months).

Patients with renal insufficiency of mild and moderate severity (CC less than 60 ml / min) should reduce the therapeutic dose or increase the interval between doses of the drug.

Each capsule contains:

active substances: piracetam 400 mg and cinnarizine 25 mg;

excipients: starlak (lactose monohydrate 85%, corn starch 15%) 43 mg, anhydrous colloidal silicon dioxide 3 mg, magnesium stearate 5 mg, capsule body - gelatin, titanium dioxide, capsule cap - gelatin, titanium dioxide (E171).

- Hypersensitivity to the components of the drug;

- intolerance to galactose lactase deficiency and glucose-galactose malabsorption;

- severe liver failure (more than 9 points on the Child-Pugh scale);

- severe renal dysfunction (creatinine clearance (CC) less than 20 ml / min);

- psychomotor agitation at the time of prescribing the drug;

- Huntington's chorea;

- hemorrhagic stroke;

- pregnancy;

- the period of breastfeeding;

- children under 5 years of age.

Carefully:

With increased intraocular pressure and with Parkinson's disease, arterial hypertension, renal failure (CC more than 20 ml / min), liver failure (less than 9 points on the Child-Pugh scale), hemostasis disorder, severe bleeding.

Trade name of the drug

Fescetam

International non-proprietary name

Piracetam + Cinnarizine

Dosage form

capsules

Composition

Each capsule contains:

active substances: piracetam 400 mg and cinnarizine 25 mg;

excipients: starlak (lactose monohydrate 85%, corn starch 15%) 43 mg, anhydrous colloidal silicon dioxide 3 mg, magnesium stearate 5 mg, capsule body - gelatin, titanium dioxide, capsule cap - gelatin, titanium dioxide (E171).

Description

Hard, cylindrical gelatin capsules, size # 0, white (white / white).

Contents of capsules: powder mixture from white to almost white, conglomerates are allowed, which, when pressed with a glass rod, turn into powder.

Pharmacotherapeutic group

Nootropic remedy

ATX code

N06BX

Pharmacodynamics:

Fescetam is a combined drug with a pronounced antihypoxic nootropic and vasodilating effect. The active components mutually potentiate a decrease in the resistance of the cerebral vessels and contribute to an increase in blood flow in them.

Piracetam is a nootropic drug. It activates metabolic processes in the brain by enhancing energy and protein metabolism, accelerating the utilization of glucose by cells and increasing their resistance to hypoxia. Improves interneuronal transmission in the central nervous system (CNS) and regional blood flow in the ischemic zone.

Cinnarizine is a selective blocker of 'slow' calcium channels. It was found that it inhibits the entry of calcium ions into cells and reduces their content in the plasmolemma depot. Reduces the tone of smooth muscles of arterioles reduces their reactions to biogenic vasoconstrictor substances (epinephrine norepinephrine dopamine angiotensin vasopressin). It has a vasodilating effect (especially in relation to cerebral vessels, enhancing the antihypoxic effect of piracetam) without significantly affecting blood pressure (BP). 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 blood viscosity.

Pharmacokinetics:

Suction

After oral administration, piracetam and cinnarizine are rapidly and almost completely absorbed from the gastrointestinal tract (GIT).

Cmax (maximum plasma concentration) of piracetam in blood plasma is created in 2-6 hours. The bioavailability of piracetam is 100%.

The absorption of cinnarizine is slow. Cmax of cinnarizine in blood plasma is achieved after 1-4 hours. The bioavailability of cinnarizine increases in an acidic environment.

Distribution

Piracetam does not bind to blood plasma proteins. The apparent Vd (volume of distribution) is about 06 l / kg. Piracetam freely penetrates the blood-brain barrier and placental barrier into all organs and tissues, as well as through the filtering membranes used in hemodialysis. Cmax of piracetam in the cerebrospinal fluid is achieved after 2-8 hours. Selectively accumulates in the cerebral cortex, mainly in the frontal parietal and occipital lobes of the cerebellum and basal ganglia.

The connection of cinnarizine with blood plasma proteins is 9%. After 1-4 hours after ingestion, the heart of the lungs, the spleen and the brain is found in the liver, kidneys.

Metabolism

Piracetam is practically not metabolized.

Cinnarizine is actively and completely metabolized in the liver by dealkylation with the participation of the CYP2D6 isoenzyme. The metabolic process begins 30 minutes after ingestion.

Withdrawal

T1 / 2 (half-life) of piracetam from blood plasma is 4-5 hours from cerebrospinal fluid - 85 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 / 2 of cinnarizine - 4 hours 1/3 of metabolites is excreted by the kidneys 2/3 - through the intestines.

Pharmacokinetics in special clinical situations

T1 / 2 of piracetam is lengthened in renal failure. The pharmacokinetics of piracetam does not change in patients with hepatic impairment.

Indications:

- Insufficiency of cerebral circulation (atherosclerosis of cerebral vessels, the recovery period of ischemic and hemorrhagic strokes after traumatic brain injury, encephalopathy of various origins);

- psychoorganic syndrome with a predominance of symptoms of asthenia and adynamia;

- asthenic syndrome;

- labyrinthopathy (dizziness tinnitus nystagmus nausea vomiting);

- Meniere's syndrome;

- prevention of kinetosis.

Contraindications:

- Hypersensitivity to the components of the drug;

- intolerance to galactose lactase deficiency and glucose-galactose malabsorption;

- severe liver failure (more than 9 points on the Child-Pugh scale);

- severe renal dysfunction (creatinine clearance (CC) less than 20 ml / min);

- psychomotor agitation at the time of prescribing the drug;

- Huntington's chorea;

- hemorrhagic stroke;

- pregnancy;

- the period of breastfeeding;

- children under 5 years of age.

Carefully:

With increased intraocular pressure and with Parkinson's disease, arterial hypertension, renal failure (CC more than 20 ml / min), liver failure (less than 9 points on the Child-Pugh scale), hemostasis disorder, severe bleeding.

Pregnancy and lactation:

Fescetam is contraindicated for use during pregnancy and during breastfeeding.

There have been no adequate and well-controlled studies on the safety of piracetam during pregnancy. Application is possible only in cases where the intended benefit to the mother outweighs the possible risk to the fetus. Piracetam passes into breast milk. In experimental studies, there was no negative effect of piracetam on the fetus.

During pregnancy and during breastfeeding, the use of cinnarizine is possible only in exceptional cases when the expected benefit to the mother significantly outweighs the potential risk to the fetus or infant.

Method of administration and dosage:

Inside, regardless of the time of the meal.

Adults: the average daily dose is 1-2 capsules 3 times / day for 1-3 months, depending on the severity of the disease.

Children over 5 years old: the average daily dose is 1-2 capsules 1-2 times / day (no more than 3 months).

Patients with renal insufficiency of mild and moderate severity (CC less than 60 ml / min) should reduce the therapeutic dose or increase the interval between doses of the drug.

Side effects:

Side effects by frequency of occurrence are distributed as follows: very often (? 10%) often (? 1% and <10%) infrequently (? 01% and <1%) rarely (? 001% and <01%) very rarely including individual messages (<001%).

From the digestive system: rarely - increased salivation nausea vomiting diarrhea abdominal pain.

From the side of the central nervous system and psyche: hyperkinesia, nervousness, increased sexual activity, sleepiness, depression; in some cases - dizziness headaches ataxia imbalance insomnia confusion agitation anxiety hallucinations

Allergic reactions: very rarely - skin rash, dermatitis, itching, edema, photosensitivity.

With prolonged therapy in elderly patients, tremor may occur.

Overdose:

Overdose information is limited.

Symptoms : in case of overdose, there are no serious side effects requiring discontinuation of treatment. In case of an overdose, gastrointestinal disturbances may occur.

In children, the phenomena of excitability predominate: insomnia, anxiety, irritability, euphoria, tremors and, in rare cases, nightmares, hallucinations.

Treatment: induce vomiting to perform gastric lavage. Treatment is symptomatic. The use of hemodialysis is possible. There is no specific antidote.

Interaction:

With simultaneous use with the drug Fescetam, it is possible to enhance the sedative effect of tricyclic antidepressants and ethanol that inhibit the activity of the central nervous system.

Fescetam potentiates the action of nootropic and antihypertensive drugs.

With simultaneous use of vasodilators enhance the effect of the drug.

Fescetam improves tolerance to antipsychotic drugs and tricyclic antidepressants.

Possible enhancement of the action of oral anticoagulants.

Special instructions:

Use with caution in patients with liver and / or kidney disease.

With renal failure of mild and moderate severity (CC less than 60 ml / min), the therapeutic dose should be reduced or the interval between doses should be increased.

In patients with impaired liver function, it is necessary to monitor the activity of 'liver' enzymes.

You should avoid drinking alcohol while taking Fescetam.

This drug should not be taken in patients with galactose intolerance, lactase deficiency and glucose-galactose malabsorption syndrome.

Impact on the ability to drive vehicles. Wed and fur .:

During the period of treatment, it is necessary to refrain from potentially dangerous activities requiring increased attention and high speed of psychomotor reactions.

Release form / dosage:

Capsules 400 mg + 25 mg.

Packaging:

10 or 15 capsules in a blister made of PBX / Al.

6 or 4 blisters with instructions for medical use in a cardboard box.

Storage conditions:

At a temperature not higher than 25 ? C.

Keep out of the reach of children.

Shelf life:

3 years

Do not use after the expiration date indicated on the package.

Vacation conditions

On prescription

Manufacturer

Adipharm EAD, 130 Simeonovsko shose Blvd., Sofia 1700, Bulgaria, Bulgaria

Marketing Authorization Holder / Organization Receiving Consumer Claims:

Adipharm EAD