Somazina®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SOMAZINA® (SOMAZINA®)

Composition:

Active substance: citicoline (as sodium salt);

One tablet contains citicoline in the form of sodium salt 500 mg;

Excipients: talc, magnesium stearate, colloidal anhydrous silicon dioxide, sodium croscarmellose, hydrogenated castor oil, microcrystalline cellulose;

Coating: talc, magnesium stearate, titanium dioxide (E 171), polyethylene glycol 6000, methacrylate copolymer (type A).

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: white, elongated film-coated tablets with "C500" embossed.

Pharmacotherapeutic group. Agents acting on the nervous system. Psychoanaleptics. Psychostimulants, drugs used in attention deficit hyperactivity disorder (ADHD) and nootropic agents. Other psychostimulant and nootropic agents. Citicoline.

ATC code N06BX06.

Pharmacological Properties

Pharmacodynamics

Citicoline stimulates the biosynthesis of structural phospholipids in neuronal membranes, as confirmed by magnetic resonance spectroscopy data. Citicoline improves the function of membrane mechanisms such as ion pumps and receptors, the proper regulation of which is essential for normal nerve impulse conduction. Due to its membrane-stabilizing effect, citicoline exhibits anti-edematous properties that promote reabsorption of brain edema.

Clinical 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 and inhibits apoptosis, thereby enhancing cholinergic transmission.

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 cerebrovascular disorders, 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 and helps reduce symptoms of amnesia, cognitive deficits, and other neurological disorders associated with cerebral ischemia.

Pharmacokinetics

Citicoline is well absorbed following oral, intramuscular, and intravenous administration. Plasma choline levels increase significantly after administration by these routes. Oral absorption is nearly complete, and bioavailability is practically equivalent to that achieved with intravenous administration.

Depending on the route of administration, the drug is metabolized in the intestine and liver into 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. Upon reaching the brain, citicoline is incorporated into cellular, cytoplasmic, and mitochondrial membranes, participating in the formation of phospholipid fractions.

Only a small amount of the administered dose is excreted in urine and feces (less than 3%). Approximately 12% of the dose is excreted as exhaled CO₂. Renal elimination of the drug occurs in two phases: the first phase lasts approximately 36 hours, during which the excretion rate rapidly decreases, followed by a second phase in which the excretion rate declines much more slowly. A similar biphasic pattern is observed in CO₂ excretion: the rate of exhaled CO₂ elimination rapidly decreases within approximately 15 hours, after which it declines much more gradually.

Clinical characteristics.

Indications.

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

Contraindications. Hypersensitivity to any component of the drug. Increased tone of the parasympathetic nervous system.

Interaction with other medicinal products and other types of interactions. The drug should not be used simultaneously with preparations containing meclofenoxate. Enhances the effect of levodopa.

Special precautions for use.

This medicinal product contains 4.5 mmol (103.23 mg)/dose of sodium. Caution should be exercised when administering the drug to patients who are on a controlled sodium diet.

Use during pregnancy or breastfeeding. There are insufficient data on the use of Somazina® in pregnant women. Data on the excretion of citicoline in breast milk and its effects on the fetus are lacking. Therefore, during pregnancy or breastfeeding, the drug should be prescribed only when the expected benefit to the woman outweighs the potential risk to the fetus.

Ability to affect reaction speed when driving or operating machinery. In individual cases, certain adverse reactions from the central nervous system may affect the ability to drive or operate complex machinery.

Method of administration and dosage.

The recommended dose for adults is 500 to 2000 mg per day (1–4 tablets).

Dosage and duration of treatment depend on the severity of brain damage and are determined by a physician.

Elderly patients do not require dose adjustment.

Children. Experience with the use of the drug in children is limited.

Overdose. Cases of overdose have not been reported.

Side effects.

Very rare (<1/10,000) (including patient reports).

Central and peripheral nervous system disorders: severe headache, vertigo, hallucinations.

Cardiovascular disorders: arterial hypertension, arterial hypotension, tachycardia.

Respiratory system disorders: dyspnea.

Gastrointestinal disorders: nausea, vomiting, diarrhea.

Immune system disorders: allergic reactions, including: rash, hyperemia, exanthema, urticaria, purpura, pruritus, angioedema, anaphylactic shock.

General disorders: chills.

Shelf life. 3 years.

Storage conditions. Store out of reach of children at a temperature not exceeding 30 °C.

Packaging. 5 tablets in a blister. 2 or 4 blisters in a cardboard box.

Prescription category. Prescription only.

Manufacturer. Ferrer Internacional, S.A., Spain.

Manufacturer's address and place of business.

Registered office:

Gran Via Carlos III, 94, 08028 Barcelona (Spain)

Manufacturing site:

s/Joan Busqueta, 1-9, 08173, Sant Cugat del Vallès (Barcelona), Spain