Lactasababy^® (Capsules) Instructions for Use

Marketing Authorization Holder

Alta Health LLC (Russia)

Manufactured By

National Enzyme Company (USA)

Dosage Form

Lactasababy^®

Capsules: 90 pcs.

Dosage Form, Packaging, and Product Composition

Capsules weighing 220 mg.

	1 caps.
Lactose (Lactase)	7 mg (700 U)

Excipients: maltodextrin, cellulose (capsule), anti-caking agent medium-chain triglycerides.

90 pcs. – bottles (1)

Therapeutic Category

Dietary supplement – source of lactase

Properties

A biologically active food supplement, a source of the lactase enzyme.

It is intended for use in children from birth to 7 years of age with lactase deficiency.

Scope of Application

As a biologically active food supplement – a source of the lactase enzyme.

Indications

For use as a dietary supplement to provide the lactase enzyme in individuals with lactase deficiency.
To assist in the digestion of lactose in milk and dairy products for children from birth to 7 years of age.
Intended for use in conditions associated with lactose malabsorption.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
E73.0	Congenital lactase deficiency
E73.1	Secondary lactase deficiency

ICD-11 code	Indication
5C61.61	Congenital lactase deficiency
5C61.62	Secondary lactase deficiency

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Add the contents of the capsule to expressed breast milk or infant formula for children who are breastfed or formula-fed.

For older children, add the contents of the capsule to any food containing milk or dairy products.

Use immediately after preparation. Do not store the prepared mixture.

The dosage is determined individually based on the volume of milk and the degree of lactase deficiency, as advised by a pediatrician.

Adverse Reactions

When used according to the recommended scheme, adverse reactions are typically not observed.

In cases of individual intolerance to the components, allergic reactions are possible.

Discontinue use immediately and consult a physician if any adverse effects occur.

Drug Interactions

No specific drug interactions have been reported.

As a general precaution, administer separately from other medications, if possible, to avoid any potential interaction.

Consult a pediatrician for concomitant use with other digestive enzyme preparations.

Contraindications

Individual intolerance to any component of the supplement.
Known hypersensitivity to lactase or any of the excipients, including maltodextrin or cellulose.
Not intended for use in individuals without lactase deficiency.

Overdose

Information on overdose is limited due to the product’s nature as a dietary supplement.

Exceeding the recommended dose is not advised and may lead to gastrointestinal discomfort.

In case of suspected overdose, discontinue use and seek medical attention if symptoms persist.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer