Sugarfree (Tablets) Instructions for Use

Marketing Authorization Holder

Cadila Healthcare Ltd. (India)

ATC Code

V06D (Other therapeutic nutrition products)

Active Substance

Aspartame (Rec.INN registered by WHO)

Dosage Form

Sugarfree

Tablets 18 mg: 100 or 300 pcs.

Dosage Form, Packaging, and Composition

100 pcs. – polyethylene containers.
300 pcs. – polyethylene containers.

Clinical-Pharmacological Group

Sugar substitute

Pharmacotherapeutic Group

Sugar substitute

Pharmacological Action

Sugar substitute. A methylated dipeptide consisting of 2 amino acids – aspartic and phenylalanine, which are found in significant quantities in ordinary food.

Indications

• Use as a sweetening agent for patients with diabetes mellitus to replace sugar in foods and beverages.

This product is intended for dietary management of conditions requiring sugar restriction.

ICD codes

Dosage Regimen

Individualize the dosage based on the patient’s dietary requirements and sweetness preference.

Adhere to a maximum daily dose of 40 mg per kg of body weight to ensure safe intake levels.

Use tablets to sweeten foods and beverages as needed, but do not exceed the established daily limit.

Adverse Reactions

Observe for allergic skin reactions, including urticaria, which occur rarely following use.

Monitor for paradoxical increase in appetite and migraine headaches, which have been reported in isolated cases.

Discontinue use immediately and seek medical attention if any signs of hypersensitivity or adverse effects develop.

Drug Interactions

No specific drug interactions have been formally established for this sweetening agent.

Exercise caution when using concurrently with other products containing phenylalanine due to potential additive effects.

Consult a healthcare professional regarding potential interactions with other medications or dietary supplements.

Contraindications

• Do not use in patients with homozygous phenylketonuria (PKU), a genetic disorder of phenylalanine metabolism.

• Contraindicated in individuals with a known hypersensitivity or allergy to aspartame or any component of the formulation.

Overdose

Symptoms of overdose may include gastrointestinal discomfort or effects related to excessive phenylalanine intake.

Immediately discontinue use and initiate symptomatic and supportive treatment if an overdose is suspected.

In cases of substantial ingestion, particularly in patients with phenylketonuria, seek immediate medical attention.

Special Precautions

It is not recommended for use by physically healthy individuals. The sweet taste disappears during prolonged heat treatment.

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

Rx Only

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.