NEURODAR®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NEURODAR® (NEURODAR®)

Composition:

Active substance: citicoline sodium;

One coated tablet contains 500 mg of citicoline sodium calculated as citicoline;

Excipients: lactose monohydrate; microcrystalline cellulose; povidone; sodium croscarmellose; colloidal anhydrous silicon dioxide; magnesium stearate; coating Opadry 03F58750 white.

Medicinal form. Coated tablets.

Main physicochemical characteristics: smooth, capsule-shaped, white film-coated tablets.

Pharmacotherapeutic group. Psychostimulants, drugs used in attention deficit hyperactivity disorder (ADHD), and nootropic agents. ATC code N06BX06.

Pharmacological Properties

Pharmacodynamics.

Citicoline stimulates the biosynthesis of structural phospholipids in neuronal membranes, as confirmed by magnetic resonance spectroscopy data. Due to this mechanism of action, citicoline enhances the functioning of membrane mechanisms such as ion-exchange pumps and receptors, the modulation of which is necessary for normal nerve impulse conduction. Thanks to its stabilizing effect on neuronal membranes, citicoline exhibits anti-edematous properties that promote reabsorption of brain edema.

Experimental studies have shown that citicoline inhibits the activation of certain phospholipases (A1, A2, C, and D), reducing the formation of free radicals, preventing the destruction of membrane systems, and preserving antioxidant defense systems such as glutathione.

Citicoline preserves neuronal energy reserves, inhibits apoptosis, and stimulates acetylcholine synthesis.

Experimental evidence has demonstrated that citicoline also exerts a preventive neuroprotective effect in focal cerebral ischemia.

Clinical studies have shown that citicoline significantly improves functional recovery rates in patients with acute ischemic cerebrovascular events, which correlates with a slowing of ischemic brain lesion progression as observed in neuroimaging.

In patients with traumatic brain injury, citicoline accelerates recovery and reduces the duration and severity of post-traumatic syndrome.

Citicoline improves levels of attention and consciousness, as well as cognitive and neurological deficits associated with cerebral ischemia, and helps reduce symptoms of amnesia.

Pharmacokinetics.

Citicoline is well absorbed after oral administration. Following administration, a significant increase in plasma choline levels is observed. When administered orally, the drug is almost completely absorbed. Studies have shown that bioavailability after oral and intravenous administration is practically equivalent.

The drug is metabolized in the intestine and liver, forming choline and cytidine.

After administration, citicoline is widely distributed into brain structures, with rapid incorporation of the choline fraction into structural phospholipids and the cytidine fraction into cytidine nucleotides and nucleic acids. In the brain, citicoline integrates into cellular, cytoplasmic, and mitochondrial membranes, participating in the formation of phospholipid fractions.

Only a small amount of the dose is excreted in urine and feces (less than 3%). Approximately 12% of the dose is eliminated via exhaled CO₂. Elimination of the drug in urine occurs in two phases: the first phase—within 36 hours—during which the elimination rate decreases rapidly, and the second phase—during which the elimination rate decreases much more slowly. The same biphasic pattern is observed in elimination via the respiratory tract. The rate of CO₂ elimination decreases rapidly—over approximately 15 hours—and then declines much more slowly.

Clinical characteristics.

Indications.

• Stroke, acute phase of cerebral circulation disorders and their neurological consequences.
• Traumatic brain injury and its neurological consequences.
• Cognitive and behavioral disorders due to chronic cerebrovascular and degenerative cerebral disorders.

Contraindications.

• Hypersensitivity to citicoline or to other components of the drug.
• Increased parasympathetic nervous system tone.

Interaction with other medicinal products and other forms of interaction.

Citicoline enhances the effect of levodopa. It should not be administered concurrently with medicinal products containing meclofenoxate.

Special precautions for use.

The medicine contains lactose. If the patient has been diagnosed with intolerance to certain sugars, medical advice should be sought before taking this medicinal product.

This medicinal product contains no more than 26.806 mg of sodium per tablet. Caution is advised when administering to patients on a sodium-controlled diet.

Use during pregnancy or breastfeeding.

Adequate data on the use of citicoline in pregnant women are lacking. Citicoline should not be used during pregnancy except in cases of urgent medical need. The medicine should be prescribed during pregnancy only if the expected therapeutic benefit outweighs the potential risk. Data on the passage of citicoline into breast milk and its effects on the fetus are not available.

Ability to affect reaction speed when driving or operating machinery.

In individual cases, certain adverse reactions from the central nervous system (CNS) may impair the ability to drive or operate complex machinery.

Shelf life.

3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Packaging.

10 tablets per blister; 1 blister per cardboard package № 10; 3 or 10 packages per cardboard box № 30 (10×3) or № 100 (10×10).

Prescription status.

By prescription only.

Manufacturer.

Kusum Healthcare Pvt Ltd/

Kusum Healthcare Pvt Ltd.

Manufacturer's address and place of business.

SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India/SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India.

Plot No. M-3, Indore Special Economic Zone, Phase-II, Pithampur, Distt. Dhar, Madhya Pradesh, Pin 454774, India/Plot No. M-3, Indore Special Economic Zone, Phase-II, Pithampur, Distt. Dhar, Madhya Pradesh, Pin 454774, India.

Marketing Authorization Holder.

Amaxa LTD/

Amaxa LTD.

Address of the Marketing Authorization Holder.

31 John Islip Street, London SW1P 4FE, United Kingdom/

31 John Islip Street, London SW1P 4FE, United Kingdom.