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Riofast (Tablets, Suspension) Instructions for Use

ATC Code

A02AD02 (Magaldrate)

Active Substance

Magaldrate (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antacid drug

Pharmacotherapeutic Group

Antacid agent

Pharmacological Action

Antacid agent. It neutralizes hydrochloric acid in the stomach and reduces the activity of pepsin.

It has an adsorbing and enveloping effect. It prevents the influence of aggressive factors on the gastric mucosa and enhances its own protective mechanisms, does not change the physiology of digestion and does not cause reactive secretion of hydrochloric acid.

Pharmacokinetics

Absorption from the gastrointestinal tract is low.

Indications

Acute gastritis; chronic gastritis with increased and normal secretory function of the stomach (in the acute phase); acute duodenitis; gastric ulcer and duodenal ulcer (in the acute phase); symptomatic ulcers of various origins; erosions of the gastrointestinal mucosa; reflux esophagitis; hiatal hernia; gastralgia, heartburn (after excessive consumption of ethanol, nicotine, coffee, medication use, dietary errors); dyspepsia of neurotic origin.

ICD codes

ICD-10 code Indication
K21.0 Gastro-esophageal reflux disease with esophagitis
K25 Gastric ulcer
K26 Duodenal ulcer
K27 Peptic ulcer
K29 Gastritis and duodenitis
K30 Functional dyspepsia (digestive disorder)
K44 Diaphragmatic hernia
R10.1 Pain localized to the upper abdomen
R12 Heartburn
ICD-11 code Indication
DA22.Z Gastro-esophageal reflux disease, unspecified
DA24.Z Unspecified esophagitis
DA42.Z Gastritis, unspecified
DA51.Z Duodenitis, unspecified
DA60.Z Gastric ulcer, unspecified
DA61 Peptic ulcer of unspecified site
DA63.Z Duodenal ulcer, unspecified
DA7Z Diseases of stomach or duodenum, unspecified
DD50.0 Diaphragmatic hernia
DD90.0 Globus sensation
DD90.1 Functional dysphagia
DD90.3 Functional dyspepsia
DD90.Z Functional disorders of esophagus or gastroduodenal system, unspecified
MD81.10 Pain localized in the upper abdomen
MD95 Heartburn

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.

Determine the dosage individually based on the clinical presentation and gastric acidity.

For tablets, chew thoroughly or allow to dissolve in the mouth before swallowing.

For the suspension, shake the bottle vigorously immediately before each use to ensure uniform consistency.

Administer a single dose of 0.8 grams to 1.6 grams (equivalent to 800 mg to 1600 mg of magaldrate).

Take the medication 1 to 2 hours after each meal and at bedtime, typically 3 to 4 times per day.

For the management of nocturnal heartburn, a single dose at bedtime may be sufficient.

Do not exceed the maximum daily dose of 5.6 grams (5600 mg) of magaldrate.

The duration of treatment depends on the indication and therapeutic response; do not use for prolonged, continuous therapy without medical supervision.

For symptomatic relief of occasional heartburn or dyspepsia, use only as needed.

Maintain an interval of at least 2 hours between the intake of magaldrate and any other oral medication to prevent potential drug interactions.

Adverse Reactions

Possible nausea, vomiting, constipation, diarrhea.

With long-term use in high doses, possible hypophosphatemia, hypocalcemia, hypercalciuria, osteomalacia, osteoporosis, hypermagnesemia, hyperaluminemia, encephalopathy, nephrocalcinosis, impaired renal function.

In patients with concomitant renal failure, possible thirst, decreased blood pressure, decreased reflexes.

Contraindications

Chronic renal failure, Alzheimer’s disease, hypophosphatemia, pregnancy, hypersensitivity to magaldrate.

Use in Pregnancy and Lactation

Magaldrate is contraindicated for use during pregnancy.

During lactation (breastfeeding), Magaldrate should be used with caution.

Use in Renal Impairment

Contraindicated in chronic renal failure.

With long-term use of magaldrate in patients with impaired renal function, regular monitoring of plasma aluminum levels should be performed.

Pediatric Use

Use with caution in children under 12 years of age.

Special Precautions

With long-term use of magaldrate in patients with impaired renal function, regular monitoring of plasma aluminum levels should be performed.

Use with caution in children under 12 years of age.

Drug Interactions

With simultaneous oral administration, Magaldrate may impair the absorption of tetracyclines, iron preparations, bile acid preparations, digoxin, benzodiazepines, dicumarol, indomethacin, cimetidine, isoniazid, quinolone derivatives (ciprofloxacin, ofloxacin, norfloxacin).

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Nycomed GmbH (Germany)

Dosage Form

Bottle Rx Icon Riofast Chewable tablets 800 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Chewable tablets 1 tab.
Magaldrate 800 mg

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.

Marketing Authorization Holder

Nycomed GmbH (Germany)

Dosage Form

Bottle Rx Icon Riofast Oral suspension 800 mg/10 ml: sachets

Dosage Form, Packaging, and Composition

Oral suspension 10 ml
Magaldrate 800 mg

10 ml – sachets (10) – cardboard packs.
10 ml – sachets (20) – cardboard packs.

Marketing Authorization Holder

Nycomed GmbH (Germany)

Dosage Form

Bottle Rx Icon Riofast Oral suspension 1600 mg/10 ml: sachets

Dosage Form, Packaging, and Composition

Oral suspension 10 ml
Magaldrate 1600 mg

10 ml – sachets (10) – cardboard packs.
10 ml – sachets (20) – cardboard packs.

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