Somazina®

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

Composition:

Active substance: citicoline (as sodium salt);

1 ml of solution contains 100 mg of citicoline in the form of the sodium salt;

Excipients: sorbitol (E 420), glycerol, methylparaben (E 218), propylparaben (E 216), sodium citrate, sodium saccharin, strawberry flavor 1487-S, potassium sorbate, citric acid (adjusted to pH 6), purified water.

Pharmaceutical form. Oral solution.

Main physicochemical properties: clear, colorless to slightly yellowish solution.

Pharmacotherapeutic group.

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

ATC code N06B X06.

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 regulation of which is essential for normal nerve impulse conduction. Due to its stabilizing effect on neuronal membranes, 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 breakdown of membrane systems, and preserving antioxidant defense systems such as glutathione.

Citicoline preserves neuronal energy reserves and inhibits apoptosis, thereby improving 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 increases functional recovery rates in patients with acute cerebrovascular disorders, which correlates with a slowed progression of ischemic brain lesions 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, helps reduce symptoms of amnesia, and alleviates cognitive and other neurological disorders associated with cerebral ischemia.

Pharmacokinetics.

Citicoline is well absorbed after oral, intramuscular, and intravenous administration. Plasma choline levels increase significantly following administration by these routes. Absorption after oral administration 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 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 excreted as exhaled CO₂. Urinary excretion of the drug occurs in two phases: the first phase lasts approximately 36 hours, during which the excretion rate rapidly decreases, and the 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 excretion rapidly decreases after approximately 15 hours, then declines much more slowly thereafter.

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 disturbances due to chronic cerebrovascular and degenerative cerebral disorders.

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

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

Special precautions for use

Patients with hereditary fructose intolerance should not take Somazin®, oral solution, as the product contains sorbitol. Methylparaben (E 218) and propylparaben (E 216) contained in the product may cause allergic reactions (usually of delayed type).

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

Use during pregnancy or breastfeeding. There are insufficient data on the use of Somazin® 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 product should be administered only if the expected benefit to the woman outweighs the potential risk to the fetus.

Ability to affect reaction speed while 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.

Dosage and Administration

Administer orally. The recommended dose for adults is from 500 mg (5 ml) to 2000 mg (20 ml) per day, divided into 2–3 doses. May be taken regardless of food intake.

The medication, previously mixed with a small amount of water, should be taken using a dosing syringe. The dosing syringe must be rinsed with water after each use.

The recommended dose of the medication in sachets is 1–2 sachets (10–20 ml) per day, depending on the severity of the disease. The medication may be taken directly from the sachet or mixed with a small amount of water.

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

Elderly patients do not require dose adjustment.

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

Overdose. Cases of overdose have not been reported.

Adverse Reactions.

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

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

Cardiovascular system: arterial hypertension, arterial hypotension, tachycardia.

Respiratory system: dyspnea.

Gastrointestinal system: nausea, vomiting, diarrhea.

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

General reactions: chills.

Shelf life. 3 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 30 °C.

Do not freeze or refrigerate. Slight opalescence may occur during storage, which disappears when the product is kept at room temperature (≈20 °C).

Keep out of reach of children.

Incompatibilities. Not established.

Packaging. 30 ml of the preparation in a vial; 1 vial and a dosing syringe in a cardboard box.

10 ml in a sachet; 6 or 10 sachets in a cardboard box.

Prescription category. Prescription only.

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

Manufacturer's address and place of business.

Registered office:
Gran Vía Carlos III, 94, 08028 Barcelona, Spain.

Place of manufacture:
c/Joan Busqueta, 1-9, 08173 Sant Cugat del Vallès (Barcelona), Spain.