Somaxon

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SOMAXON (SOMAXON)

Composition:

Active substance: citicoline;

One coated tablet contains sodium citicoline equivalent to 500 mg or 1000 mg of citicoline;

Excipients:

for the 500 mg tablet: corn starch, lactose monohydrate, povidone, crospovidone, sodium starch glycolate (type A), colloidal anhydrous silicon dioxide, magnesium stearate, microcrystalline cellulose;

for the 1000 mg tablet: corn starch, lactose monohydrate, povidone, crospovidone, sodium starch glycolate (type A), colloidal anhydrous silicon dioxide, magnesium stearate;

Tablet coating: hypromellose, titanium dioxide (E 171), propylene glycol, iron oxide red (E 172).

Pharmaceutical form. Coated tablets.

Main physicochemical properties: red coated tablet, with a dividing line on one side and smooth on the other side.

Pharmacotherapeutic group.

Psychostimulants, drugs used in attention deficit hyperactivity disorder (ADHD), and nootropic agents. ATC code N06B X06.

Pharmacological properties.

Pharmacodynamics.

Citicoline stimulates the biosynthesis of structural phospholipids in neuronal membranes, thereby promoting improved membrane function, including the activity of ion-exchange pumps and neurotransmitter receptors. Due to its membrane-stabilizing effect, citicoline possesses anti-edematous properties and reduces cerebral edema. Citicoline reduces the severity of symptoms associated with cerebral dysfunction following pathological conditions such as traumatic brain injury and acute cerebrovascular disorders. Citicoline decreases the degree of amnesia and improves the condition in cognitive, sensory, and motor disturbances. Citicoline ameliorates symptoms observed in cerebral hypoxia and ischemia, including memory impairment, emotional lability, and difficulties in performing daily activities and self-care.

Pharmacokinetics.

Since citicoline is a naturally occurring compound present in the body, classical pharmacokinetic studies are not feasible due to the difficulty in quantitatively distinguishing between exogenous and endogenous citicoline. Bioavailability studies have shown that oral and parenteral administration result in nearly equivalent bioavailability. In pharmacokinetic studies, citicoline was observed to be almost completely absorbed. Elimination is very slow, primarily via the respiratory tract and urine. After 5 days of administration, approximately 16% of the dose was recovered, indicating that the remainder of the dose was incorporated into metabolism.

Clinical characteristics.

Indications.

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

Contraindications.

Hypersensitivity to the components of the drug or to other substances related from a chemical point of view.

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 simultaneously with medicinal products containing meclofenamate.

Special precautions for use.

Somaxon contains lactose. Patients with such rare hereditary conditions as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.

Use during pregnancy or breastfeeding.

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

Ability to influence the speed of reactions 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.

Dosage and Administration.

The recommended dose is 500 to 2000 mg per day (1-4 tablets), depending on the severity of symptoms and the patient's condition.

For 500 mg dosage: 1 to 4 tablets per day.

For 1000 mg dosage: 1 to 2 tablets per day.

The dosage and duration of treatment depend on the severity of brain damage and are determined by the physician.

Elderly patients do not require dose adjustment.

Children.

Experience with the use of citicoline in children is limited; therefore, the medicinal product should be administered to children only when the expected benefit outweighs any potential risk.

Overdose.

Cases of overdose have not been reported.

Adverse reactions.

Adverse reactions occur very rarely (<1/10,000), including isolated cases.

Psychiatric disorders: hallucinations.

Nervous system disorders: severe headache, dizziness.

Cardiovascular disorders: arterial hypertension, arterial hypotension, tachycardia.

Respiratory system disorders: dyspnea.

Gastrointestinal disorders: nausea, vomiting, diarrhea.

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

General disorders: chills, swelling, increased body temperature, excessive sweating.

Shelf life.

2 years.

Storage conditions.

Store at a temperature not exceeding 25 °C in the original packaging and in a place inaccessible to children.

Packaging.

10 tablets in a blister pack, 3 blisters in a cardboard box.

Prescription status.

Prescription only.

Manufacturer.

Mepro Pharmaceuticals Private Limited.

Manufacturer's address and location of business activity.

Unit II, Q-Road, Phase IV, GIDC, Wadhwan, Surendranagar, Gujarat, 363 035, India.

Marketing Authorization Holder.

Mili Healthcare Limited.

Address of the Marketing Authorization Holder.

Fairfax House 15, Fulwood Place, London, WC1V 6AY, Great Britain.