Instructions for use Alphacholine oral solution 600mg 7ml No. 10
Composition
active ingredient: choline alfoscerate;
7 ml of the drug contain choline alfoscerate 600 mg;
excipients: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sodium saccharin, orange flavoring, purified water.
Dosage form
Oral solution.
Main physicochemical properties: clear colorless liquid.
Pharmacotherapeutic group
Agents affecting the nervous system. Parasympathomimetics. Choline alfoscerate.
ATX code N07AX02.
Pharmacological properties
Pharmacodynamics
Choline alfoscerate is a drug that belongs to the group of central cholinomimetics with a predominant effect on the central nervous system (CNS). Alphacholine® has a positive effect on memory function and cognitive abilities, as well as on indicators of emotional state and behavior, the deterioration of which was due to the development of involutional brain pathology.
Choline alfoscerate, as a choline carrier and precursor of phosphatidylcholine, has the potential to prevent and correct biochemical damage that is of particular importance among the pathogenic factors of psychoorganic involutional syndrome, i.e., it can affect reduced cholinergic tone and altered phospholipid composition of nerve cell membranes.
The composition of the drug includes 40.5% metabolically protected choline, which ensures the release of choline in the brain. The mechanism of action is based on the fact that when choline enters the body, alfoscerate is broken down by enzymes into choline and glycerophosphate: choline participates in the biosynthesis of acetylcholine - one of the main mediators of nerve impulse transmission; glycerophosphate is a precursor of phospholipids (phosphatidylcholine) of the neuronal membrane. Thus, it improves the transmission of nerve impulses in cholinergic neurons; it has a positive effect on the plasticity of neuronal membranes and the function of receptors.
Alphacholine® improves cerebral blood flow, enhances metabolic processes in the brain, activates the structures of the reticular formation of the brain, and promotes the restoration of consciousness in traumatic brain injury.
Pharmacokinetics
The drug is rapidly absorbed, on average about 88% of the administered dose of choline alfoscerate is absorbed, rapid distribution in organs and tissues is noted. Penetrates the blood-brain barrier. Alfacholine® accumulates mainly in the brain (45% of the drug concentration in blood plasma), in the lungs and liver. Renal excretion is about 10%.
Indication
Psychoorganic syndrome on the background of involutional and degenerative processes in the brain, consequences of cerebrovascular insufficiency or primary and secondary cognitive disorders in the elderly, characterized by memory impairment, confusion, disorientation, decreased motivation and initiative, decreased ability to concentrate. Behavioral and affective disorders in the elderly: emotional lability, increased irritability, indifference to the environment, pseudomelancholia.
Contraindication
Hypersensitivity to the components of the drug; pregnancy or breastfeeding; patient's age up to 18 years (due to lack of data); pronounced psychomotor agitation in patients with psychotic disorders.
Interaction with other medicinal products and other types of interactions
Clinically significant drug interactions with other drugs have not been established.
Application features
Nausea may occur due to dopaminergic activation. Efficacy and safety in children (under 18 years of age) have not been established.
Important information about excipients.
The presence of methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216) in the composition may cause allergic reactions (possibly delayed).
Ability to influence reaction speed when driving vehicles or other mechanisms
Caution should be exercised when driving or engaging in other activities that require increased concentration and/or quick reactions.
Use during pregnancy or breastfeeding
The drug is contraindicated for use during pregnancy or breastfeeding.
Method of administration and doses
Take 1 vial of oral solution 2 times a day.
The indicated dose may be increased by the doctor.
Children
There is no experience with use in children.
Overdose
Possible increase in the severity of dose-dependent side effects. Overdose may manifest as nausea, anxiety, agitation, insomnia. Treatment is symptomatic: taking adsorbing drugs, including taking activated charcoal. The effectiveness of dialysis has not been established.
Adverse reactions
As a rule, the drug is well tolerated even with long-term use.
Gastrointestinal: nausea (which is mainly a consequence of secondary dopaminergic activation), abdominal pain.
From the nervous system: short-term confusion (in this case, the dose must be reduced), headache.
From the cardiovascular system: decreased blood pressure.
On the part of the immune system: hypersensitivity reactions: skin redness, rash, itching, urticaria, angioedema.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after the marketing authorisation of a medicinal product is an important procedure. It allows for continued monitoring of the benefit-risk balance of the medicinal product in question. Healthcare professionals should report any suspected adverse reactions via the national reporting system.
Expiration date
1.5 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ° C. Do not freeze.
Keep out of reach of children.
Packaging
7 ml in a vial with a tamper-evident cap; 10 vials in a pack.
Vacation category
According to the recipe.
Producer
PrJSC "Pharmaceutical Company "Darnitsa".
Location of the manufacturer and its business address
Ukraine, 02093, Kyiv, Boryspilska St., 13.
