NooKam (Capsules) Instructions for Use

Marketing Authorization Holder

Camellia SPC, LLC (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

NooKam

Capsules 400 mg+25 mg: 60 pcs.

Dosage Form, Packaging, and Composition

Capsules size No. 0, with a white body and a blue cap; the capsule contents are a powder from white to white with a creamy tint.

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

Capsule composition: pharmaceutical gelatin, glycerol, propylparahydroxybenzoate (nipasol), methylparahydroxybenzoate (nipagin), sodium lauryl sulfate, purified water, brilliant blue dye.

10 pcs. – blister packs (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 interneuronal 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 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. The C_max of piracetam in plasma is reached in 2-6 hours. The bioavailability of piracetam is 100%. The absorption of cinnarizine is slow. The 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. The 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.

The 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. The T_1/2 of cinnarizine is 4 hours. 1/3 of metabolites are excreted in the urine, 2/3 – in the feces.

The 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; psychoorganic 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 with water. Swallow capsules whole; do not chew or crush.

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

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

Adjust the total daily dose and frequency based on individual tolerance and therapeutic response.

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

For prevention of motion sickness (kinetosis), take the first dose 30-60 minutes before the anticipated travel.

The maximum daily dose should not exceed 9 capsules for adults.

The treatment duration is determined by the treating physician; long-term therapy may be required for chronic conditions.

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 hepatic or renal failure and in children under 5 years of age.

If a dose is missed, take it as soon as remembered unless it is almost time for the next dose. Do not double the dose to make up for a forgotten one.

Adverse Reactions

From the nervous system: hyperkinesis, 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 kidney 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 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 mechanisms.

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 30°C (86°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.