Rutacid^® (Tablets) Instructions for Use

Marketing Authorization Holder

Krka, D.D. (Slovenia)

ATC Code

A02AD04 (Hydrotalcite)

Active Substance

Hydrotalcite (Rec.INN registered by WHO)

Dosage Form

Rutacid®

Chewable tablets 500 mg: 20 or 60 pcs.

Dosage Form, Packaging, and Composition

Excipients: mannitol, sodium saccharin, sodium carboxymethyl starch, talc, magnesium stearate, mint flavor.

10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.

Clinical-Pharmacological Group

Antacid drug

Pharmacotherapeutic Group

Antacid agent

Pharmacological Action

Antacid agent. Hydrotalcite has a layered lattice structure with low aluminum and magnesium content.

It neutralizes hydrochloric acid, reduces the acidity of gastric juice; decreases the proteolytic activity of pepsin, binds bile acids. It has a protective effect on the gastric mucosa.

Pharmacokinetics

The release of magnesium and aluminum occurs gradually in the stomach depending on the pH level of the gastric juice. It is absorbed in the small intestine.

After oral administration, the plasma levels of magnesium and aluminum temporarily increase, but no penetration into nerve and bone tissues occurs (with normal renal function). The absorbed part is excreted by the kidneys.

Indications

Acute and chronic gastritis, acute and chronic duodenitis, gastric and duodenal ulcer, reflux esophagitis, discomfort or pain in the epigastrium, heartburn after excessive consumption of alcohol, nicotine, dietary errors, intake of medications.

ICD codes

Dosage Regimen

For adults, take 1 to 2 tablets (500 mg to 1 g) as a single dose.

Administer the dose after meals, at bedtime, or when symptoms occur.

Chew the tablets thoroughly. Do not swallow whole.

For children aged 6 to 12 years, administer half the adult single dose (1/2 to 1 tablet).

The maximum daily dose is 6 grams (12 tablets) for adults.

Adjust the frequency of administration and duration of treatment individually based on symptom severity and clinical response.

For short-term relief of heartburn or epigastric pain, use as needed.

For chronic conditions like peptic ulcer disease or reflux esophagitis, continue use as directed by a physician.

Do not use for more than two weeks for self-medication without medical consultation.

If symptoms persist or worsen, discontinue use and seek medical advice.

Adverse Reactions

Possible when used in high doses – belching, diarrhea.

Contraindications

Renal failure, children under 6 years of age, hypersensitivity to hydrotalcite.

Use in Pregnancy and Lactation

There are no confirmed data on the negative effects of hydrotalcite during pregnancy and lactation (breastfeeding).

Use in Renal Impairment

Contraindicated in renal failure. In case of impaired renal function, long-term use in high doses should be avoided.

Pediatric Use

Contraindicated in children under 6 years of age.

Special Precautions

In case of impaired renal function, long-term use in high doses should be avoided.

Drug Interactions

With simultaneous use, the absorption of tetracyclines, iron, fluoride, fluoroquinolones is reduced.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°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.