CITICO 100mg/ml oral sol 30ml
CTCo®
100 mg/ml oral solution 30 ml
citicoline/ citicoline
Prescription drug
Indications
The active substance in this medicine is citicoline, which:
- stimulates the synthesis of phospholipids, which make up the nerve cell membrane;
- improves cell membrane function;
- favors the reduction of cerebral edema;
- stores the energy reserve of the nerve cell;
- reduces apoptosis (programmed cell death);
- stimulates the synthesis of acetylcholine, which facilitates the transmission of impulses between nerve cells.
CTC is used to treat:
- acute stroke and the neurological consequences associated with it;
- brain injury and the neurological consequences associated with it;
- thinking, memory and behavioral disorders in brain diseases of vascular or degenerative origin.
Active ingredients
1 ml of oral solution contains 100 mg of citicoline, as citicoline sodium.
Dosage and method of administration
The recommended daily dose for adults is 500 – 2000 mg (5 ml – 20 ml) depending on the severity of the clinical manifestations.
The long-term use of the medicinal product is favored by its low toxicity and low incidence of adverse drug reactions.
Children and adolescents
Citicoline should not be used in children and adolescents unless specifically prescribed by a doctor. There is insufficient data on the use of citicoline in children, therefore it should only be used if the expected benefit outweighs any possible risk.
Elderly patients
The usual therapeutic dose is recommended; no dose adjustment is necessary in the absence of significant renal or hepatic disease.
Pregnancy
There are no data available on the potential effects of citicoline in pregnant women, therefore its safety in this group is considered to be uncertain. The medicinal product should only be used in cases where the potential benefits to the mother outweigh the risks to the foetus and newborn.
The solution is dosed using the supplied syringe as follows:
1. The dosing syringe is immersed with the plunger pressed to the bottom.
2. Withdraw the prescribed dose by pushing the plunger back up so that the liquid in the syringe corresponds exactly to the prescribed amount.
3. The medicinal product is taken alone or dissolved in half a glass of water (approximately 120ml)
The dosing syringe should be washed with water after each administration.
The medicinal product is intended for oral administration.
Read the leaflet before use!
Marketing Authorisation Holder:
DANSON-BG LTD, BULGARIA
1. name of the medicinal product
Citico 100 mg/ml oral solution
CiTiCo 100 mg/ml oral solution
2. Qualitative and Quantitative Composition
1 ml of solution contains 100 mg of citicoline as citicoline sodium.
Excipients with known effect:
Sorbitol - 200.00 mg/ml;
Glycerol - 50.00 mg/ml;
Methyl parahydroxybenzoate - 1.45 mg/ml;
Propyl parahydroxybenzoate - 0.25 mg/ml.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral solution.
Clear, colorless solution with a strawberry odor.
4. CLINICAL DATA
4.1. Therapeutic indications
· Treatment of acute stroke and its associated neurological consequences;
· Treatment of brain injury and its associated neurological consequences;
· Treatment of cognitive and behavioral disorders due to chronic vascular and degenerative brain diseases.
4.2. Dosage and method of administration
Dosage
Adults
The recommended daily dose is 500 – 2000 mg (5 ml – 20 ml).
The amount of the administered daily dose should be adjusted to the severity of the clinical symptoms, the anamnestic data and the patient's condition.
The long-term use of the medicinal product is favored by its low toxicity and low incidence of adverse drug reactions.
Old age
The usual therapeutic dose is recommended; no dose adjustment is necessary in the absence of significant renal or hepatic disease.
Pediatric population
There is insufficient data available on the use of citicoline in children, therefore the medicinal product can only be administered in cases where the benefit outweighs the possible risk of administration.
Method of administration
The medicinal product is intended for oral administration.
For a description of the instructions for use, see section 6.6.
4.3. Contraindications
Hypersensitivity to citicoline or to any of the excipients listed in section 6.1;
· Hypertonicity of the parasympathetic division of the ANS.
4.4. Special warnings and precautions for use
This medicinal product contains as excipients:
· Sorbitol, liquid (crystallizing) - the additive effect of concomitantly administered products containing sorbitol (or fructose), as well as the dietary intake of sorbitol (or fructose), should be taken into account.
The sorbitol content of oral medicinal products may affect the bioavailability of other oral medicinal products administered concomitantly.
· Glycerol – may cause headaches, stomach upset, and diarrhea.
· Methyl parahydroxybenzoate - may cause allergic reactions (possibly delayed).
· Propyl parahydroxybenzoate - may cause allergic reactions (possibly delayed).
4.5. Interaction with other medicinal products and other forms of interaction
Citicoline enhances the effects of L-Dopa-containing products.
It should not be administered concomitantly with medicinal products containing meclofenoxate.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no data available on the potential effects of citicoline in pregnant women, therefore its safety in this group is considered to be uncertain. The medicinal product should only be used in cases where the potential benefits to the mother outweigh the risks to the foetus and newborn (see section 5.3).
Breastfeeding
It is not known whether citicoline is excreted in breast milk, therefore the medicinal product should only be administered in cases where the potential benefits to the mother outweigh the risks to the newborn and infant.
Fertility
There are no data on the effects of citicoline on fertility.
4.7. Effects on ability to drive and use machines
Citicoline does not affect the ability to drive or use machines.
4.8. Adverse drug reactions
The frequency of adverse reactions presented below is classified according to the MedDRA convention:
Very common (≥ 1/10), Common (≥ 1/100 to ≤ 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), Not known (cannot be estimated from the available data).
System Organ Class/Frequency
Adverse reactions
Mental disorders
Very rare
Hallucinations
Nervous system disorders
Very rare
Headache, dizziness
Vascular disorders
Very rare
Increased blood pressure, decreased blood pressure
Respiratory, thoracic and mediastinal disorders
Very rare
Shortness of breath
Gastrointestinal disorders
Very rare
Nausea, vomiting, diarrhea
Skin and subcutaneous tissue disorders
Very common
Redness, itching, rash
General disorders and administration site conditions
Very rare
Tremor, swelling
Reporting suspected adverse reactions
Reporting of suspected adverse reactions after authorisation of a medicinal product is important. This allows for continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:
Executive Agency for Medicines
8 Damyan Gruev Street
1303 Sofia
tel.: +35928903417
website: www.bda.bg
4.9. Overdose
Symptoms
There is no evidence of overdose with the product. Citicoline is characterized by very low toxicity, therefore, even if therapeutic doses are significantly exceeded, intoxication is not expected.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: Other psychostimulants and nootropics.
ATC code: N06BX06
Mechanism of action
It stimulates the biosynthesis of structural phospholipids in the neuronal membrane, thereby improving its functional state, as well as that of the ion exchange pumps and receptors located in it, the modulation of which is necessary for the effective and correct transmission of neuronal impulses.
Citicoline copies the activation of phospholipids A1, A2, C and D, reducing the formation of free radicals and the destruction of membrane systems, protecting antioxidant defense systems.
Pharmacodynamic effects
Citicoline favors the reabsorption of cerebral edema thanks to its stabilizing effect on the neuronal membrane, protects and preserves the energy reserve of the neuron, inhibits apoptosis and stimulates the synthesis of acetylcholine.
It has been experimentally established that citicoline exerts a neuroprotective effect in a model of focal cerebral ischemia.
Clinical trial data indicate that citicoline significantly improves functional evolution in patients with acute cerebrovascular accident, accelerates recovery in patients with brain trauma, and reduces the duration and severity of post-concussive syndrome.
It improves the level of attention and consciousness, has a beneficial effect on amnesia and cognitive and neurological disorders associated with cerebral ischemia.
5.2. Pharmacokinetic properties
Absorption
Citicoline is absorbed almost completely after oral administration, with its bioavailability being approximately the same as after intravenous administration. It is metabolized in the intestinal wall and liver to choline and cytidine, with plasma choline levels increasing significantly after its administration.
Distribution
It is distributed to a significant extent in brain structures, with rapid incorporation of choline into structural phospholipids and cytidine into cytidine nucleotides and nucleic acids.
In brain tissue, citicoline actively binds to the cell, cytoplasmic and mitochondrial membranes, as a component of structural phospholipids.
Biotransformation
It is metabolized in the intestinal wall and liver to choline and cytidine.
Excretion
A small portion of the administered dose is found in the urine, and about 12% of it is eliminated via CO2 excretion.
The process of elimination with urine is biphasic: a first phase, lasting about 36 hours, in which the elimination rate decreases rapidly, and a second phase, in which the rate decreases significantly more slowly. The dynamics of excretion with CO2 are similar - the elimination rate decreases rapidly during the first 15 hours after administration, and then slows down significantly in the following.
5.3. Preclinical safety data
No significant toxic effects were observed in a chronic 6-month experiment in dogs and a 3-month study in mice. In dogs treated with citicoline for three months, toxic manifestations (diarrhea and sialorrhea) were observed immediately after administration.
When administered to rabbits during the period of organogenesis, citicoline did not show embryo-fetal toxicity. A slight delay in cerebral osteogenesis was observed in 10% of the fetuses.
6. Pharmaceutical data
6.1. List of excipients
Saccharin sodium
Sorbitol, liquid (crystallizing)
Glycerol
Methyl parahydroxybenzoate
Propyl parahydroxybenzoate
Sodium citrate
Potassium sorbate
Citric acid, anhydrous
Strawberry flavor 1487 S (liquid)
Purified water
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
Shelf life after first opening the vial - 1 month.
6.4. Special storage conditions
Store in the original packaging at a temperature below 25°C.
6.5. Nature and contents of packaging
Colourless glass vial containing 30 ml or 60 ml of solution, closed with a polyethylene screw cap.
One vial together with a 5 ml dosing syringe, graduated every 0.5 ml, and a leaflet, placed in a single folding carton.
6.6. Special precautions for disposal and handling
The solution is dosed using the supplied syringe as follows:
1. The dosing syringe is immersed in the solution with the plunger pressed to the bottom.
2. The prescribed dose is withdrawn from the vial by pulling the plunger back up so that the liquid in the syringe corresponds exactly to the prescribed amount.
3. The medicinal product is taken alone or dissolved in half a glass of water (approximately 120 ml).
The dosing syringe should be washed with water after each administration.
7. MARKETING AUTHORISATION HOLDER
DANSON-BG Ltd.
26 Otets Paisii Street
2400 Radomir
Bulgaria
8. MARKETING AUTHORISATION NUMBER
Registration No. 20240018
9. DATE OF FIRST AUTHORISATION
Date of first authorisation: 16.01.2024
10. DATE OF TEXT UPDATE
January, 2024
