Alfasoxx (Solution) Instructions for Use

Marketing Authorization Holder

Alfasigma S.p.A. (Italy)

Manufactured By

Biofarma, S.r.l. (Italy)

Or

Apharm, S.r.L. (Italy)

Contact Information

ALPHASIGMA RUS LLC (Russia)

Dosage Forms

	Alfasoxx	Oral solution: 10 ml sachet 20 pcs.
		Oral solution: 200 ml bottle 1 pc.

Dosage Form, Packaging, and Product Composition

Oral solution as a clear amber-yellow liquid with a fruity odor.

Composition sodium hyaluronate, sodium chondroitin sulfate, xylitol C, poloxamer 407, polyvinylpyrrolidone, sodium benzoate, potassium sorbate, flavor, water.

PH 5.00±0.2.
Density 1.10±0.05.
Viscosity 0-150 c/s.

10 ml – sachets (20) – cardboard packs.
200 ml – bottles (1) with a measuring cup – cardboard packs.

Therapeutic Category

Esophagoprotector

Properties

The medical device Alfasoxx acts mechanically, providing rapid relief of symptoms caused by gastroesophageal reflux disease (GERD).

Gastroesophageal reflux disease (GERD) is characterized by symptoms such as heartburn, acid reflux or non-acid (mixed, alkaline) reflux, cough, and dysphonia, which may be associated with the presence of erosive defects in the esophageal mucosa. The severity of GERD symptoms often increases in the supine position, so patients’ condition worsens at night.

The combination of hyaluronic acid and chondroitin sulfate provides protection for the gastric and esophageal mucosa. The presence of Poloxamer 407 in Alfasoxx, which has high bioadhesive properties, ensures reliable contact of the hyaluronic acid-chondroitin sulfate complex with the esophageal wall surface, promoting its protection from the aggressive effects of gastric hydrochloric acid. Chondroitin sulfate also promotes the restoration of the esophageal and gastric mucosa. Alfasoxx helps reduce inflammation and heal mucosal erosions in esophagitis and gastroduodenitis.

Scope of Application

Of the product Alfasoxx

• Treatment of gastroesophageal reflux disease.

ICD codes

Dosage Regimen

Take orally 10 ml (1 sachet or 1 dose of the measuring cup) after main meals and before bedtime or as directed by a physician.

Shake the bottle contents before use. Measure the dose (10 ml) using the measuring cup provided in the package.

Contraindications

• Hypersensitivity to any component of the product;
• Pregnancy;
• Breastfeeding period.

Use during pregnancy and lactation

It is not recommended to use Alfasoxx in pregnant and breastfeeding women, as relevant studies have not been conducted.

Special instructions

The recommended dose should not be exceeded.

If GERD symptoms persist or adverse events are noted, the patient should consult a physician.

The product should be disposed of with household waste.

Drug Interactions

There are no known interactions with oral medications.

Dispensing Status

Available without a prescription.

Storage Conditions

The product should be stored out of the reach of children at a temperature between 5°C (41°F) and 30°C (86°F); do not freeze.

Shelf Life

Shelf life – 36 months. Do not use after the expiration date printed on the packaging.

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.