Kataria

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KATARIA (KATARIA®)

Composition:

Active substance: sodium citrate;

1 sachet (5.6 g of granules) contains 4 g of sodium citrate;

Excipients: sucrose, sodium saccharin, cranberry flavoring 191121.

Pharmaceutical form. Granules.

Main physico-chemical properties: white or almost white free-flowing granules with a pleasant odor.

Pharmacotherapeutic group.

Agents used in urology. ATC code G04BX.

Pharmacological Properties

Pharmacodynamics

Sodium citrate is metabolized to bicarbonate, which promotes the regression of dysuria observed in cystitis, reduces urine acidity, resulting in alkalinization.

Pharmacokinetics

The pharmacokinetics of sodium citrate corresponds to its natural pharmacokinetics in the body.

Clinical characteristics.

Indications.

Relief of cystitis symptoms in women.

Contraindications.

• Hypersensitivity to the active substance or to other components of the medicinal product.
• Diabetes mellitus.
• Heart disease.
• Arterial hypertension.
• Kidney disease.
• Low-sodium diet.
• Pregnancy, breastfeeding.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of sodium-containing medicinal products should be avoided in patients receiving lithium preparations, since sodium is predominantly absorbed by the kidneys, leading to increased lithium excretion and reduced plasma lithium levels.

Medicinal products promoting urine alkalinization, such as sodium citrate, should not be used simultaneously with methenamine, as methenamine is effective only in acidic urine.

The therapeutic effect of certain medicinal products may be decreased or increased due to urine alkalinization or reduction of gastric juice pH, which may occur as a result of sodium citrate action.

Special precautions for use.

If symptoms persist after two days of treatment, consult a physician. Do not exceed the recommended dose.

Excipients. The medicinal product contains sucrose. If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicinal product.

This medicinal product contains 40.8 mmol (939 mg)/dose of sodium. Caution should be exercised when administering to patients on a sodium-restricted diet.

Use during pregnancy or breastfeeding.

Contraindicated during pregnancy or breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

Not established.

Method of Administration and Dosage.

Women (adults)

Dissolve the contents of one sachet in 1 glass of water.

Take orally 1 sachet 3 times daily for 48 hours.

The prepared solution should be used immediately.

Men and children

Not recommended.

Children.

Not recommended.

Overdose.

Overdose is unlikely.

Symptoms: in case of excessive intake of sodium citrate, gastrointestinal discomfort and diarrhea may occur. Overdose of sodium salts may lead to hypernatremia and hyperosmolarity. Excessive intake of bicarbonates may result in hypokalemia and metabolic alkalosis, especially in patients with impaired renal function.

Treatment: symptomatic, including appropriate correction of fluid and electrolyte balance.

Side effects.

Immune system disorders: hypersensitivity reactions, including skin rashes.

Gastrointestinal disorders: abdominal pain.

Renal and urinary disorders: moderate increase in diuresis.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C in the original packaging.

Keep out of reach of children.

Packaging.

5.6 g of granules in a sachet. 6 sachets in a cardboard package.

Availability category.

Over-the-counter.

Manufacturer.

Kusum HealthCare Pvt Ltd/

Kusum Healthcare Pvt Ltd.

Manufacturer's address.

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

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

INSTRUCTIONS

for medical use of the medicinal product

KATARIYA

(KATARIA®)

Composition:

Active ingredient: sodium citrate;

1 sachet (5.6 g of granules) contains 4 g of sodium citrate;

Excipients: sucrose, sodium saccharin, flavoring agent cranberry 191121.

Pharmaceutical form. Granules.

Main physicochemical properties: white or almost white free-flowing granules with a pleasant odor.

Pharmacotherapeutic group.

Medicinal products used in urology. ATC code G04BX.

Pharmacological properties.

Pharmacodynamics.

Sodium citrate is metabolized to bicarbonate, which promotes the regression of dysuria observed in cystitis, reduces urine acidity, leading to alkalinization.

Pharmacokinetics.

The pharmacokinetics of sodium citrate corresponds to its natural pharmacokinetics in the body.

Clinical characteristics.

Indications.

Relief of cystitis symptoms in women.

Contraindications.

• Hypersensitivity to the active substance or to other components of the medicinal product.
• Diabetes mellitus.
• Heart disease.
• Arterial hypertension.
• Kidney disease.
• Low-sodium diet.
• Pregnancy, breastfeeding.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of sodium-containing medicinal products should be avoided in patients receiving lithium preparations, since sodium is predominantly absorbed by the kidneys, leading to increased lithium excretion and reduced lithium plasma levels.

Medicinal products promoting urine alkalization, such as sodium citrate, should not be used simultaneously with methenamine, as methenamine is effective only in acidic urine.

The therapeutic effect of certain medicinal products may be reduced or enhanced due to urine alkalization or decreased gastric juice pH, which may occur as a result of sodium citrate action.

Special precautions for use.

If symptoms persist after two days of treatment, consult a physician. Do not exceed the recommended dose.

Excipients. The medicinal product contains sucrose. If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicinal product.

This medicinal product contains 40.8 mmol (939 mg)/dose of sodium. Caution is advised when administering to patients on a sodium-restricted diet.

Use during pregnancy or breastfeeding.

Contraindicated during pregnancy or breastfeeding.

Ability to influence reaction speed when driving or operating machinery.

Not established.

Method of Administration and Dosage.

Women (adults)

Dissolve the contents of one sachet in one glass of water.

Take orally 1 sachet three times a day for 48 hours.

The prepared solution should be used immediately.

Men and children

Not recommended.

Children.

Not recommended.

Overdose.

Overdose is unlikely.

Symptoms: in case of excessive intake of sodium citrate, gastrointestinal discomfort and diarrhea may occur. Overdose of sodium salts may lead to hypernatremia and hyperosmolarity. Excessive intake of bicarbonates may lead to hypokalemia and metabolic alkalosis, especially in patients with impaired renal function.

Treatment: symptomatic, including appropriate correction of fluid and electrolyte balance.

Side effects.

Immune system: hypersensitivity reactions, including skin rashes.

Gastrointestinal tract: abdominal pain.

Kidneys and urinary system: mild increase in diuresis.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C in the original packaging.

Keep out of reach of children.

Packaging.

5.6 g of granules in a sachet. 6 sachets in a cardboard pack.

Supply category.

Over-the-counter.

Manufacturer.

Kusum Healthcare Pvt Ltd.

Manufacturer's address and place of business.

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