Cidokan^® (Capsules) Instructions for Use

Marketing Authorization Holder

Aliym, JSC (Russia)

ATC Code

N06BX (Other psychostimulants and nootropic drugs)

Active Substances

Piracetam (Rec.INN registered by WHO)

Cinnarizine (Rec.INN registered by WHO)

Dosage Form

Cidokan®

Capsules 400 mg+25 mg: 10, 20, 30, 40, 50, 60, 70, 80 or 90 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 0, with a white body and cap; the capsule contents are a mixture of powder and granules, white or almost white in color.

Excipients: lactose monohydrate, colloidal silicon dioxide (aerosil), magnesium stearate.

Composition of the hard gelatin capsules (body and cap): titanium dioxide, gelatin.

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
10 pcs. – blister packs (7) – cardboard packs.
10 pcs. – blister packs (8) – cardboard packs.
10 pcs. – blister packs (9) – 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 decreases its content in the plasmalemma depot, reduces the tone of arteriole smooth muscles, and diminishes their response to biogenic vasoconstrictive substances (epinephrine, norepinephrine, dopamine, angiotensin, vasopressin, serotonin). It has a vasodilating effect (especially concerning the vessels of the brain, enhancing the antihypoxic action 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 blood-brain barrier. 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 isoenzyme CYP2D6.

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 via renal filtration. The renal clearance of piracetam in healthy volunteers is 86 ml/min. T_1/2 of cinnarizine is 4 hours. One-third of the metabolites are excreted in the urine, and two-thirds 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 apparatus.

Indications

Cerebrovascular 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 motion sickness.

ICD codes

Dosage Regimen

Administer the capsules orally with water, with or after food.

For adults, the standard therapeutic dosage is 1 to 2 capsules, taken three times daily.

The maximum daily dose for adults is 6 capsules (equivalent to 2400 mg piracetam and 150 mg cinnarizine).

For children over 5 years of age, the dosage is 1 to 2 capsules, taken one to two times daily.

For migraine prophylaxis, use a lower dosage of 1 capsule twice daily.

For the prevention of motion sickness, take 1 capsule 30 minutes before travel.

Adjust the dosage based on the patient’s tolerance and therapeutic response.

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

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

The duration of treatment is determined by the treating physician based on the underlying condition; courses typically last from several weeks to several months.

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 lactation (breastfeeding).

Use in Hepatic Impairment

The drug is contraindicated for use in impaired liver function.

Use in Renal Impairment

The drug is contraindicated for use in impaired renal function.

Pediatric Use

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

Special Precautions

Prescribe with caution to 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 drug doses should be increased.

In patients with impaired liver function, it is necessary to monitor the levels 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.

Effect on the ability to drive vehicles and operate machinery.

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

Drug Interactions

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

Improves tolerance to 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.