Fescetam (Capsules) Instructions for Use

Marketing Authorization Holder

Adipharm, EAD (Bulgaria)

ATC Code

N06BX (Other psychostimulants and nootropic drugs)

Active Substances

Piracetam (Rec.INN registered by WHO)

Cinnarizine (Rec.INN registered by WHO)

Dosage Form

Fescetam

Capsules 400 mg+25 mg: 40, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, cylindrical, size No. 0, white in color (white/white); the capsule contents are a powdery mixture from white to almost white, the presence of conglomerates is allowed, which turn into powder when pressed with a glass rod.

Excipients: Starlac (lactose monohydrate – 85%, corn starch – 15%) – 43 mg, colloidal anhydrous silicon dioxide – 3 mg, magnesium stearate – 5 mg; capsule shell – gelatin, titanium dioxide (E171), capsule cap – gelatin, titanium dioxide (E171).

10 pcs. – blisters (4) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.
15 pcs. – blisters (4) – cardboard packs.
15 pcs. – blisters (6) – cardboard packs.

Clinical-Pharmacological Group

A drug that improves cerebral circulation and metabolism

Pharmacotherapeutic Group

Nootropic agent

Pharmacological Action

A combined medicinal product with a pronounced antihypoxic, nootropic and vasodilating effect.

Piracetam activates metabolic processes in the brain by enhancing energy and protein metabolism, accelerating glucose utilization by cells and increasing their resistance to hypoxia; improves interneural transmission in the CNS, improves regional blood flow in the ischemic zone.

Cinnarizine is a selective blocker of slow calcium channels, reduces the entry of Ca²⁺ into cells and reduces its content in the plasmalemma depot, reduces the tone of arteriole smooth muscles, and reduces their response to biogenic vasoconstrictor substances (epinephrine, norepinephrine, dopamine, angiotensin, vasopressin, serotonin). It has a vasodilating effect (especially concerning the vessels of the brain, enhancing the antihypoxic effect of piracetam), without significantly affecting blood pressure. It exhibits moderate antihistamine activity, reduces the excitability of the vestibular apparatus, and lowers the tone of the sympathetic nervous system. It increases the elasticity of erythrocyte membranes, their ability to deform, and reduces blood viscosity.

Pharmacokinetics

After oral administration, the drug is completely absorbed from the gastrointestinal tract. C_max of piracetam in plasma is achieved in 2-6 hours. The bioavailability of piracetam is 100%. The absorption of cinnarizine is slow. C_max of cinnarizine in plasma is reached in 1-4 hours. Piracetam does not bind to plasma proteins. The apparent V_d is about 0.6 l/kg. Piracetam freely penetrates the BBB. C_max of piracetam in the cerebrospinal fluid is reached in 2-8 hours. It penetrates into all organs and tissues, and crosses the placental barrier. It selectively accumulates in the cerebral cortex, mainly in the frontal, parietal and occipital lobes, cerebellum and basal ganglia. The binding of cinnarizine to plasma proteins is 91%. Piracetam is not metabolized. Cinnarizine is actively and completely metabolized in the liver by dealkylation involving the CYP2D6 isoenzyme.

T_1/2 of piracetam from blood plasma is 4-5 hours, from 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. T_1/2 of cinnarizine is 4 hours. 1/3 of metabolites are excreted in the urine, 2/3 – in the feces.

T_1/2 of piracetam is prolonged in renal failure. The pharmacokinetics of piracetam do not change in patients with hepatic insufficiency. It penetrates through the filtering membranes of hemodialysis machines.

Indications

Cerebral circulation disorders (ischemic stroke, recovery period after hemorrhagic stroke); encephalopathy in portal hypertension; comatose and subcomatose states after intoxications and brain injuries; diseases of the central nervous system accompanied by a decrease in intellectual and mnestic functions; depression; psycho-organic syndrome with a predominance of signs of asthenia and adynamia; asthenia of psychogenic origin; labyrinthopathies; Ménière’s syndrome; intellectual developmental delay in children; prevention of migraine and kinetoses.

ICD codes

Dosage Regimen

Administer orally.

For adults, take 1-2 capsulesthree times daily.

For children over 5 years of age, take 1-2 capsulesonce or twice daily.

Adjust the dosing frequency based on the clinical indication and patient tolerance.

For migraine prophylaxis and motion sickness, use the lower end of the dosage range.

In patients with mild to moderate renal impairment (creatinine clearance less than 60 ml/min), reduce the dose or increase the interval between administrations.

The drug is contraindicated in severe renal impairment and severe hepatic impairment.

Do not use in children under 5 years of age.

Take the capsules with water, with or without food.

The total daily dose and duration of therapy are determined by the physician based on the patient’s condition and treatment response.

Adverse Reactions

From the nervous system: hyperkinesia, nervousness, drowsiness, depression; in isolated cases – dizziness, headache, ataxia, imbalance, insomnia, confusion, agitation, anxiety, hallucinations.

Allergic reactions very rarely – skin rash, dermatitis, itching, swelling, photosensitivity.

From the digestive system in some cases – increased salivation, nausea, vomiting, diarrhea, abdominal pain.

Other increased sexual activity.

Contraindications

Hypersensitivity; severe hepatic and/or renal failure; parkinsonism; pregnancy; lactation period; children’s age (under 5 years).

With caution

In Parkinson’s disease, impaired liver and/or kidney function, hemostasis disorders, severe bleeding.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and during lactation (breastfeeding).

Use in Hepatic Impairment

The drug is contraindicated for use in case of impaired liver function

Use in Renal Impairment

The drug is contraindicated for use in case of impaired kidney function

Pediatric Use

Contraindication — children’s age (under 5 years).

Special Precautions

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

In mild to moderate renal failure (creatinine clearance less than 60 ml/min), the therapeutic dose should be reduced or the interval between doses of the drug should be increased.

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

Patients should avoid alcohol consumption while taking this combination.

The drug enhances the activity of thyroid hormones and may cause tremor and anxiety.

Influence on the ability to drive vehicles and operate machinery.

During administration, patients should exercise caution when driving vehicles and working with machinery and equipment, since at the beginning of treatment Cinnarizine may cause drowsiness.

Drug Interactions

Enhances the effects of nootropic, hypotensive drugs, agents that depress the central nervous system (including ethanol).

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

Vasodilating drugs enhance the action.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.