Somazina 100 mg/ml Oral Drops 30 ml

Somazina 100 mg/ml Oral Drops 30 ml

Composition:

Active Ingredient: Citicoline (as citicoline sodium 104.5 mg) — 100 mg per 1 ml of drops.
Excipients: Purified water and auxiliary liquid oral formulation components.

Product Description:

• Nootropic agent that serves as a precursor to key ultrastructural components of the cell membrane, primarily phospholipids.
• It possesses a broad spectrum of activity: it promotes the restoration of damaged cell membranes, inhibits the action of phospholipases, prevents the excessive formation of free radicals, and inhibits cell death by affecting apoptotic mechanisms. 
• In the acute phase of stroke, citicoline reduces the volume of damaged brain tissue and improves cholinergic transmission. 
• In traumatic brain injury, it reduces the duration of post-traumatic coma and the severity of neurological symptoms, while also shortening the recovery period. 
• In chronic cerebral hypoxia, citicoline is effective in treating cognitive disorders such as memory impairment, lack of initiative, and difficulties in performing daily activities and self-care. It increases attention and consciousness levels while reducing manifestations of amnesia.

Indications for Use:

• Acute period of ischemic stroke (as part of combination therapy).
• Recovery period of ischemic and hemorrhagic strokes.
• Traumatic brain injury: acute (as part of combination therapy) and recovery periods.
• Cognitive and behavioral disorders associated with degenerative and vascular diseases of the brain.

Method of Administration and Dosage:

• Oral administration (by mouth) as drops, with or without food.
• Cognitive disorders:
  Adults: 500–1000 mg per day for 3 months.
  Children: 500–750 mg per day for 3 months.
• Acute and subacute cerebrovascular disorders (when swallowing is preserved):
  Adults: 500–2000 mg per day for 6 weeks.
  Children: 500–750 mg per day for 6 weeks.

Contraindications:

Severe vagotonia (predominance of the parasympathetic nervous system tone).
Rare hereditary conditions associated with fructose intolerance.
Known hypersensitivity or allergy to citicoline or any inactive ingredients of the drug.

Precautions:

During treatment, patients should exercise caution when performing potentially hazardous activities requiring heightened attention and rapid psychomotor reactions (e.g., driving motor vehicles, operating machinery, or working as a dispatcher/operator).
The drug may stimulate the parasympathetic system and cause transient fluctuations in blood pressure.

Adverse Reactions / Side Effects:

• Allergic Reactions: Very rarely (<1/10,000) — skin rash, pruritus, urticaria, anaphylactic shock, angioedema.
• Central Nervous System: Very rarely (<1/10,000) — headache, dizziness, hallucinations, insomnia, agitation, tremor, numbness in paralyzed limbs.
• Cardiovascular System: Very rarely (<1/10,000) — feeling of heat, transient changes in blood pressure (hypotension or hypertension).
• Gastrointestinal System: Very rarely (<1/10,000) — nausea, vomiting, diarrhea, decreased appetite, transient changes in liver enzyme activity.
• Respiratory System: Very rarely (<1/10,000) — dyspnea / shortness of breath.

Pregnancy and Lactation:

Use during pregnancy and lactation is permissible only if the potential benefit to the mother outweighs the potential risk to the fetus or infant (adequate clinical data on the use of citicoline in pregnant women are lacking).
If treatment during lactation is necessary, breastfeeding should be discontinued.

Storage Conditions:

Store at room temperature in a dry place, protected from light.
Keep out of reach of children.

Packaging:

Cardboard box containing a 30 ml dark glass bottle with a calibrated dropper/pipette.