Ukraine Product

Quanil Granules

Quanil Granules

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:
- Stroke, acute phase of cerebrovascular disorders and their consequences.
- Traumatic brain injury and its neurological consequences.
- Cognitive impairment and behavioral disorders, resulting from chronic diseases and degenerative brain disorders.

When you should consult your doctor?

You should consult your doctor if you experience any of the following:
Nervous system disorders: headache, dizziness (vertigo), tremor.
Mentality disorders: hallucinations, anxious arousal, paranoia, insomnia, depression, epilepsy.
Immune system disorders: allergic reactions, including: rash, purpura, pruritus, angioedema, anaphylactic shock.
Cardio-vascular system disorders: arterial hypertension, arterial hypotension, tachycardia.
Respiratory system disorders: shortness of breath (dyspnea), rhinitis, cough.
Intestinal system disorders: anorexia, nausea, vomiting, diarrhea, steatorrhea, constipation, stomach pain, hygrostomia, a slight change in parameters of liver function.
Skin disorders: increased sweating, hyperemia.
General disorders: increased body temperature, fever sensation, trembling, edema, growth impairment, "fishy smell" of the body.


WHAT TO DO IF YOU MISS A DOSE?

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise take it as soon as you remember and then go back to taking it as you would normally.

Things you MUST NOT DO while on this medicine?

Do not exceed the dose of 1000 mg per day in the case of sustained intracranial hemorrhage.
Quanil should be administered with caution to patients who suffer from trimethylaminuria, Parkinson's disease, epilepsy and patients with depression in anamnesis. Quanil should be administered with caution to patients with kidney or hepatic disorders.
If you have a known intolerance to some sugars, consult your doctor, before taking this medicinal product, as the drug contains sorbate (E 420).
The drug contains aspartame (E 951), a phenylalanine derivative, which is danger to patients with phenylketonuria.
As choline is a disintegration product of succinylcholine, it may cause the same side effects as succinylcholine, such as respiratory depression.

 

What to do if you accidentally take too much (overdose) of the medicine?

Experience with overdose has not been described.

Is it safe in pregnancy and breast-feeding?

 Drug should be used during pregnancy and lactation only if the expected benefit for the mother outweighs the potential risk for the child

Storage Conditions:

Store at temperature below 25oC.
Keep it out of reach of children.

Drug Description

Composition:
active substance: citicoline sodium;
1 sachet (1.5 g of granules) contains citicoline sodium equivalent to citicoline 500 mg;
excipients: sorbate (E 420), povidone,  citric acid anhydrous, aspartame (E 951), flavor Lemon Premium, polyethylene glycol 6000, sodium stearyl fumarate, sodium lauryl sulfate.

Pharmaceutical form. Granules.
Main physico-chemical properties: white or almost white granules with lemon flavor.

Indications and dosage.

Indications

  • Stroke, acute phase of cerebrovascular disorders and their consequences.
  • Traumatic brain injury and its neurological consequences.
  • Cognitive impairment and behavioral disorders, resulting from chronic diseases and degenerative brain disorders.

 Dosage:
Quanil is administered orally, after dissolving the granules in half a glass of water, regardless of the meal.
The recommended dose for adults is from 500 mg (1 sachet) to 2000 mg (4 sachets) per day, which is divided into 2-3 doses.
The doses of the drug and duration of treatment depend on the severity of brain damage and are adjusted individually by a doctor.
Elderly patients do not require dosage adjustment.
Children. There are no adequate data from the use of Quanil in children. Therefore the drug should be administered only when the expected therapeutic benefit is higher than any possible risk. 

Side effects and drug interactions.

Side effect
Nervous system disorders: headache, dizziness (vertigo), tremor.
Mentality disorders: hallucinations, anxious arousal, paranoia, insomnia, depression, epilepsy.
Immune system disorders: allergic reactions, including: rash, purpura, pruritus, angioedema, anaphylactic shock.
Cardio-vascular system disorders: arterial hypertension, arterial hypotension, tachycardia.
Respiratory system disorders: shortness of breath (dyspnea), rhinitis, cough.
Intestinal system disorders: anorexia, nausea, vomiting, diarrhea, steatorrhea, constipation, stomach pain, hygrostomia, a slight change in parameters of liver function.
Skin disorders: increased sweating, hyperemia.
General disorders: increased body temperature, fever sensation, trembling, edema, growth impairment, "fishy smell" of the body.

Drug interactions
Citicoline increases the effect of levodopa. It should not be simultaneously used at the same time with drugs, containing meclofenoxate.

Warnings and precautions

Do not exceed the dose of 1000 mg per day in the case of sustained intracranial hemorrhage.
Quanil should be administered with caution to patients who suffer from trimethylaminuria, Parkinson's disease, epilepsy and patients with depression in anamnesis. Quanil should be administered with caution to patients with kidney or hepatic disorders.
If you have a known intolerance to some sugars, consult your doctor, before taking this medicinal product, as the drug contains sorbate (E 420).
The drug contains aspartame (E 951), a phenylalanine derivative, which is danger to patients with phenylketonuria.
As choline is a disintegration product of succinylcholine, it may cause the same side effects as succinylcholine, such as respiratory depression.

Overdosage and Contraindications

Overdose
Experience with overdose has not been described.

Contraindication

    • Hypersensitivity to any component of the drug.
    • Hypersthenia of parasympathetic nervous system.

     

Clinical pharmacology.

Pharmacotherapeutic group.
Psychostimulants and nootropics.  АТС code N06B X06.

Pharmacological properties.
Pharmacodynamics.
Citicoline stimulates the biosynthesis of structural phospholipids in the neuronal membrane that improves functioning the membranes, ionic exchange pumps and neuroreceptors. Citicoline due to its membrane stabilizing activity has decongestants properties, and thus reduces brain edema. Research findings have shown that citicoline inhibits the activity of some phospholipases, preventing the residual formation of free radicals, avoiding the destruction of membranous systems and preserving antioxidant defense system.
Citicoline reduces the amount of damaged tissue, preventing cell death, acting on the mechanisms of apoptosis, and facilitates cholinergic transmission. Citicoline also has a prophylactic neuroprotective effect in focal cerebral stroke.
According to results of roentgenological studies, citicoline significantly increases the functional rehabilitation of patients with acute cerebrovascular disorders, reducing the ischemic brain tissue injury.
When traumatic brain injuries citicoline reduces the recovery period and reduces the intensity of post-traumatic syndrome.
Citicoline increases brain activity, reduces amnesia, improves condition in cognitive, sensitive and motor disorders, observed in cerebral ischemia.
Pharmacokinetics.
Citicoline is well absorbed after oral, intramuscular or intravenous administration. Plasma choline levels significantly increased after the drug administration. The drug is almost completely absorbed in oral administration. Studies have shown that the bioavailability in per oral and parenteral routes of administration was similar.
The drug is metabolized in the intestine and in the liver to choline and cytidine. After administration, citicoline is assimilated by cerebral tissues, while cholines act on phospholipids, cytidine – on cytidine nucleoids and nucleic acids. Citicoline quickly reaches the cerebral tissues and actively integrates into cell membranes, cytoplasm and mitochondria, activating an activity of phospholipids.
Only a minor part of administered dose is excreted with urine and feces (less than 3%). Approximately 12% of administered dose are excreted via respiratory tract. The drug excretion via urine and respiratory tract has two phases: first phase – rapid excretion (with urine – within the first 36 hours, via airways – within the first 15 hours), the second phase – slow excretion. Major part of the drug dose is included into the metabolic processes.

Shelf-life.
2 years.

Storage conditions.
Store at the temperature NMT 25oC.
Keep it out of reach of children.

Package.
1.5 g are in a sachet No 1, 10 or 30 sachets are in a carton package.

Conditions of supply.
By prescription.

Manufacturer.
KUSUM HELTHCARE PVT LTD.

Address.
SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India.

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare
D-158A, OKHLA,INDUSTRIAL AREA,
PHASE-I, NEW DELHI,
Pin 110020
INDIA
Tel: 011-41005147, 011-40514919
Fax: +91-11-40527575