Quanil

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KVANIL (QUANIL®)

Composition:

Active substance: citicoline sodium;

One tablet contains citicoline sodium equivalent to 500 mg of citicoline;

Excipients: lactose monohydrate, microcrystalline cellulose, povidone, sodium croscarmellose, colloidal anhydrous silicon dioxide, magnesium stearate, Opadry 03F58750 white coating.

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: capsule-shaped, smooth, film-coated tablets, white in color.

Pharmacotherapeutic group. Psychostimulants. Medicinal products used in attention deficit hyperactivity disorder (ADHD) and nootropic agents.

ATC code N06BX06.

Pharmacological Properties

Pharmacodynamics

Citicoline stimulates the biosynthesis of structural phospholipids in neuronal membranes, as confirmed by magnetic resonance spectroscopy data. Due to this mechanism of action, citicoline enhances the function of ion-exchange pumps and receptors, the modulation of which is necessary for normal nerve impulse conduction. Thanks to its stabilizing effect on neuronal membranes, citicoline accelerates the reabsorption of brain edema and thus exhibits anti-edematous properties.

Citicoline inhibits the activation of certain phospholipases (A1, A2, C, and D), reduces the formation of free radicals, prevents the destruction of membrane systems, and preserves antioxidant defense systems such as glutathione.

Citicoline maintains neuronal energy reserves, inhibits apoptosis, and improves cholinergic transmission by stimulating acetylcholine synthesis. Citicoline also exerts a preventive neuroprotective effect in focal cerebral ischemia.

Citicoline significantly improves functional recovery outcomes in patients with acute ischemic cerebrovascular disorders, slowing the progression of ischemic brain tissue damage as demonstrated by neuroimaging data.

In traumatic brain injuries, citicoline accelerates recovery and reduces the duration and severity of post-traumatic syndrome.

Citicoline improves levels of attention and consciousness, alleviates cognitive and neurological deficits associated with cerebral ischemia, and helps reduce symptoms of amnesia.

Pharmacokinetics

Citicoline is well absorbed after oral administration. After drug intake, a significant increase in plasma choline levels is observed. The drug is almost completely absorbed following oral administration. Bioavailability after oral and parenteral administration is nearly equivalent.

The drug is metabolized in the intestine and liver, forming choline and cytidine. After administration, citicoline is taken up by brain tissues, where choline acts on phospholipids and cytidine acts on cytidine nucleotides and nucleic acids. Citicoline rapidly reaches brain tissue and is actively incorporated into cell membranes, cytoplasm, and mitochondria, stimulating phospholipid activity.

Only a small amount of the administered dose is excreted in urine and feces (less than 3%). Approximately 12% of the administered dose is excreted via the respiratory tract. Elimination of the drug in urine and through the respiratory tract occurs in two phases: the first phase—rapid elimination (in urine—within the first 36 hours, via respiratory tract—within the first 15 hours), the second phase—slow elimination.

Clinical characteristics.

Indications.

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

Contraindications.

• Hypersensitivity to citicoline or to any of the other components of the drug.
• Increased parasympathetic nervous system tone.

Interaction with other medicinal products and other forms of interactions.

Citicoline enhances the effect of levodopa. Should not be administered simultaneously with drugs containing meclofenoxate.

Special precautions for use.

The medicinal product contains lactose. If the patient has been diagnosed with an intolerance to certain sugars, consult a physician before taking this medicinal product.

Use during pregnancy or breastfeeding.

There is insufficient data on the use of citicoline in pregnant women. Citicoline should not be used during pregnancy except when clearly needed. The drug should be prescribed during pregnancy or breastfeeding only if the expected benefit to the mother outweighs the potential risk to the fetus or infant. Data regarding the passage of citicoline into breast milk and its effects on the infant are lacking.

Ability to influence the reaction rate when driving or operating machinery.

In individual cases, certain adverse reactions related to the central nervous system may affect the ability to drive or operate complex machinery.

Shelf life.

3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Packaging.

10 tablets in a blister; 1 blister in a cardboard package.

3 or 10 packages in a cardboard box № 30 (10×1×3) or № 100 (10×1×10).

Prescription status.

By prescription only.

Manufacturer.

LLC "GLEDPHARM LTD".

Manufacturer's address and location of business activity.

40020, Ukraine, Sumy region, city of Sumy, Davydovskoho Hryhorii Street, 54.

INSTRUCTIONS

for medical use of the medicinal product

KVANIL

(QUANIL®)

Composition:

Active substance: citicoline sodium;

1 tablet contains 500 mg of citicoline sodium calculated as citicoline;

Excipients: lactose monohydrate, microcrystalline cellulose, povidone, sodium croscarmellose, colloidal anhydrous silicon dioxide, magnesium stearate, Opadry 03F58750 white coating.

Pharmaceutical form. Film-coated tablets.

Main physico-chemical properties: capsule-shaped, smooth, film-coated tablets of white color.

Pharmacotherapeutic group. Psychostimulants. Medicinal products used in attention deficit hyperactivity disorder (ADHD) and nootropic agents.

ATC code N06BX06.

Pharmacological Properties

Pharmacodynamics

Citicoline stimulates the biosynthesis of structural phospholipids in neuronal membranes, as confirmed by magnetic resonance spectroscopy data. Due to this mechanism of action, citicoline enhances the function of ion-exchange pumps and receptors, the modulation of which is necessary for normal nerve impulse conduction. Owing to its stabilizing effect on neuronal membranes, citicoline accelerates the reabsorption of cerebral edema and thus exhibits anti-edematous properties.

Citicoline inhibits the activation of certain phospholipases (A1, A2, C, and D), reduces the formation of free radicals, prevents the destruction of membrane systems, and preserves antioxidant defense systems such as glutathione.

Citicoline preserves neuronal energy reserves, inhibits apoptosis, and improves cholinergic transmission by stimulating acetylcholine synthesis. Citicoline also exerts a preventive neuroprotective effect in focal cerebral ischemia.

Citicoline significantly improves functional recovery outcomes in patients with acute ischemic disturbances of cerebral circulation, slowing the progression of ischemic brain tissue damage as demonstrated by neuroimaging data.

In traumatic brain injuries, citicoline accelerates recovery and reduces the duration and severity of post-traumatic syndrome.

Citicoline improves levels of attention and consciousness, alleviates cognitive and neurological deficits associated with cerebral ischemia, and helps reduce symptoms of amnesia.

Pharmacokinetics

Citicoline is well absorbed after oral administration. After drug intake, a significant increase in plasma choline levels is observed. The drug is almost completely absorbed following oral administration. Bioavailability via oral and parenteral routes is nearly equivalent.

The drug is metabolized in the intestine and liver, forming choline and cytidine. After administration, citicoline is taken up by brain tissues, where choline acts on phospholipids and cytidine acts on cytidine nucleotides and nucleic acids. Citicoline rapidly reaches brain tissue and actively incorporates into cellular membranes, cytoplasm, and mitochondria, stimulating phospholipid activity.

Only a small fraction of the administered dose is excreted in urine and feces (less than 3%). Approximately 12% of the administered dose is excreted via the respiratory tract. Elimination of the drug in urine and through the respiratory tract occurs in two phases: the first phase—rapid elimination (in urine—within the first 36 hours, via respiratory tract—within the first 15 hours), the second phase—slow elimination.

Clinical characteristics.

Indications.

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

Contraindications.

• Hypersensitivity to citicoline or to any of the other components of the drug.
• 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 meclofenoxate.

Special precautions for use

The medicine contains lactose. If the patient has been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

Use during pregnancy or breastfeeding

There are insufficient data on the use of citicoline in pregnant women. Citicoline should not be used during pregnancy except in cases of urgent medical need. The medicine should be administered during pregnancy or breastfeeding only if the expected benefit to the mother outweighs the potential risk to the fetus or infant. Data on the passage of citicoline into breast milk and its effects on the infant are lacking.

Ability to affect reaction rate 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.

Shelf life.

3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 tablets in a blister; 1 blister in a cardboard package.

3 or 10 packages in a cardboard box № 30 (10×1×3) or № 100 (10×1×10).

Prescription status.

By prescription only.

Manufacturer.

KUSUM HEALTHCARE PVT LTD.

Manufacturer's address and place of business.

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

INSTRUCTIONS

for medical use of the medicinal product

KWANIL

(QUANIL®)

Composition:

Active substance: citicoline sodium;

One tablet contains citicoline sodium equivalent to 500 mg of citicoline;

Excipients: lactose monohydrate, microcrystalline cellulose, povidone, sodium croscarmellose, colloidal anhydrous silicon dioxide, magnesium stearate, coating Opadry 03F58750 white.

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: smooth, capsule-shaped, film-coated tablets of white color.

Pharmacotherapeutic group. Psychostimulants. Medicinal products 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, as confirmed by magnetic resonance spectroscopy data. Due to this mechanism of action, citicoline enhances the function of ion-exchange pumps and receptors, the modulation of which is necessary for normal nerve impulse conduction. Thanks to its stabilizing effect on neuronal membranes, citicoline accelerates the reabsorption of brain edema, thus exhibiting anti-edematous properties.

Citicoline inhibits the activation of certain phospholipases (A1, A2, C, and D), reduces the formation of free radicals, prevents the destruction of membrane systems, and preserves antioxidant defense systems such as glutathione.

Citicoline maintains neuronal energy reserves, inhibits apoptosis, and improves cholinergic transmission by stimulating acetylcholine synthesis. Citicoline also exerts a preventive neuroprotective effect in focal cerebral ischemia.

Citicoline significantly improves functional recovery outcomes in patients with acute ischemic cerebrovascular disorders, slowing the progression of ischemic brain tissue damage as demonstrated by neuroimaging data.

In traumatic brain injuries, citicoline accelerates recovery and reduces the duration and severity of post-traumatic syndrome.

Citicoline improves levels of attention and consciousness, alleviates cognitive and neurological deficits associated with cerebral ischemia, and helps reduce symptoms of amnesia.

Pharmacokinetics

Citicoline is well absorbed after oral administration. Following drug intake, a significant increase in plasma choline levels is observed. After oral administration, the drug is almost completely absorbed. Bioavailability via oral and parenteral routes is nearly equivalent.

The drug is metabolized in the intestine and liver, forming choline and cytidine. After administration, citicoline is taken up by brain tissues, where choline acts on phospholipids and cytidine acts on cytidine nucleosides and nucleic acids. Citicoline rapidly reaches brain tissue and is actively incorporated into cell membranes, cytoplasm, and mitochondria, activating phospholipid metabolism.

Only a small amount of the administered dose is excreted in urine and feces (less than 3%). Approximately 12% of the administered dose is excreted via the respiratory tract. Elimination of the drug in urine and through the respiratory tract occurs in two phases: the first phase—rapid elimination (in urine—within the first 36 hours; via respiratory tract—within the first 15 hours), the second phase—slow elimination.

Clinical characteristics.

Indications.

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

Contraindications.

• Hypersensitivity to citicoline or to any other components of the drug.
• 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 meclofenoxate.

Special precautions for use.

The medicinal product contains lactose. If the patient has been diagnosed with an intolerance to certain sugars, consult a physician before taking this medicinal product.

Use during pregnancy or breastfeeding.

There is insufficient data on the use of citicoline in pregnant women. Citicoline should not be used during pregnancy except in cases of urgent medical need. During pregnancy or breastfeeding, the medicinal product should be prescribed only when the expected benefit to the mother outweighs the potential risk to the fetus or infant. Data regarding the passage of citicoline into breast milk and its effects on the infant are lacking.

Ability to affect reaction speed when driving or operating machinery.

In individual cases, certain adverse reactions related to the central nervous system may impair the ability to drive or operate complex machinery.

Shelf life.

3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Packaging.

10 tablets in a blister pack; 1 blister pack in a cardboard package.

3 or 10 packages in a cardboard box № 30 (10×1×3) or № 100 (10×1×10).

Prescription status.

By prescription only.

Manufacturer.

LLC "KUSUM PHARM".

Manufacturer's address and place of business.

40020, Ukraine, Sumy region, Sumy, Skryabina St., 54.

INSTRUCTION

for medical use of the medicinal product

KVANIL

(QUANIL®)

Composition:

Active ingredient: citicoline sodium;

One tablet contains 500 mg of citicoline sodium calculated as citicoline;

Excipients: lactose monohydrate, microcrystalline cellulose, povidone, sodium croscarmellose, colloidal anhydrous silicon dioxide, magnesium stearate, coating Opadry 03F58750 white.

Pharmaceutical form. Film-coated tablets.

Main physicochemical characteristics: capsule-shaped, smooth, film-coated tablets of white color.

Pharmacotherapeutic group. Psychostimulants. Medicinal products used in attention deficit hyperactivity disorder (ADHD) and nootropic agents.

ATC code N06BX06.

Pharmacological Properties

Pharmacodynamics

Citicoline stimulates the biosynthesis of structural phospholipids in neuronal membranes, as confirmed by magnetic resonance spectroscopy data. Due to this mechanism of action, citicoline enhances the function of ion-exchange pumps and receptors, the modulation of which is necessary for normal nerve impulse conduction. Thanks to its stabilizing effect on neuronal membranes, citicoline accelerates the reabsorption of cerebral edema, thus exhibiting anti-edematous properties.

Citicoline inhibits the activation of certain phospholipases (A1, A2, C, and D), reduces the formation of free radicals, prevents the destruction of membrane systems, and preserves protective antioxidant systems such as glutathione.

Citicoline maintains neuronal energy reserves, inhibits apoptosis, and improves cholinergic transmission by stimulating acetylcholine synthesis. Citicoline also exerts a preventive neuroprotective effect in focal cerebral ischemia.

Citicoline significantly improves functional recovery rates in patients with acute ischemic cerebrovascular disorders, slowing the progression of ischemic brain tissue damage as demonstrated by neuroimaging.

In traumatic brain injuries, citicoline accelerates recovery and reduces the duration and severity of post-traumatic syndrome.

Citicoline improves levels of attention and consciousness, alleviates cognitive and neurological deficits associated with cerebral ischemia, and helps reduce symptoms of amnesia.

Pharmacokinetics

Citicoline is well absorbed after oral administration. After drug intake, a significant increase in plasma choline levels is observed. Following oral administration, the drug is almost completely absorbed. Bioavailability via oral and parenteral routes is nearly equivalent.

The drug is metabolized in the intestine and liver, forming choline and cytidine. After administration, citicoline is taken up by brain tissues, where choline acts on phospholipids and cytidine on cytidine nucleotides and nucleic acids. Citicoline rapidly reaches brain tissue and actively incorporates into cell membranes, cytoplasm, and mitochondria, activating phospholipid activity.

Only a small amount of the administered dose is excreted in urine and feces (less than 3%). Approximately 12% of the administered dose is excreted via the respiratory tract. Elimination of the drug in urine and through the respiratory tract occurs in two phases: the first phase—rapid elimination (in urine—within the first 36 hours; via respiratory tract—within the first 15 hours), the second phase—slow elimination.

Clinical characteristics.

Indications.

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

Contraindications.

• Hypersensitivity to citicoline or to any of the other components of the drug.
• 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 concurrently with medicinal products containing meclofenoxate.

Special precautions for use

The medicinal product contains lactose. If the patient has been diagnosed with intolerance to certain sugars, consult a physician before taking this medicinal product.

Use during pregnancy or breastfeeding

There are insufficient data on the use of citicoline in pregnant women. Citicoline should not be used during pregnancy except when clearly needed. The drug should be prescribed during pregnancy only if the expected benefit to the mother outweighs the potential risk. Data on the passage of citicoline into breast milk and its effects on the infant are unknown.

Ability to influence reaction rate 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.

Shelf life.

3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 tablets in a blister; 1 blister in a cardboard pack.

3 or 10 packs in a cardboard box № 30 (10×1×3) or № 100 (10×1×10).

Prescription status.

Prescription only.

Manufacturer.

KUSUM HEALTHCARE PVT LTD.

Manufacturer's address.

Plot No. M-3, Indore Special Economic Zone, Phase-II, Pithampur, Distt. Dhar, Madhya Pradesh, Pin 454774, India