Gelusil (Suspension) Instructions for Use

Marketing Authorization Holder

Hemofarm Koncern A.D. (Yugoslavia)

In Cooperation With

GOEDECKE, AG (Germany)

ATC Code

A02AD (Combined and complex preparations of aluminum, calcium and magnesium)

Active Substance

Simaldrate (Rec.INN registered by WHO)

Dosage Forms

	Gelusil	Suspension for oral administration 2.064 g/12 ml: sachets 20 pcs.
	Gelusil LAK	Tablets 500 mg: 40 pcs.

Dosage Form, Packaging, and Composition

12 ml – laminated paper sachets (20) – cardboard packs.
* – non-proprietary international name recommended by WHO; the international name adopted in the Russian Federation is simaldrate.

Gelusil lak

Tablets are yellowish-white in color, round, flat-cylindrical in shape, with a smooth surface, beveled on both sides, with a vanilla odor.

Excipients: dry milk, sucrose, magnesium stearate, vanilla flavor 39774, lactose monohydrate, vanilla tincture.

10 pcs. – blisters (4) – cardboard packs.

Clinical-Pharmacological Group

Antacid drug

Pharmacotherapeutic Group

Antacid agent

Pharmacological Action

Antacid drug. It neutralizes excess hydrochloric acid in the stomach and has an enveloping and adsorbing effect.

It prevents the influence of aggressive factors on the gastric and duodenal mucosa and has antitoxic properties.

It does not cause secondary hypersecretion and does not affect gastrointestinal motility.

Pharmacokinetics

Data on the pharmacokinetics of the drug are not provided.

Indications

• Acute gastritis with increased and normal secretion;
• Chronic gastritis with increased and normal secretion in the acute phase;
• Acute duodenitis;
• Gastric and duodenal ulcer in the acute phase;
• Hiatal hernia;
• Reflux esophagitis;
• Discomfort or pain in the epigastrium, heartburn, sour belching after excessive consumption of alcohol, nicotine, coffee, taking medications, dietary errors.

ICD codes

Dosage Regimen

Administer the drug orally.

For adults and children over 10 years of age, the typical dosage is 1 tablet or 1 sachet (12 ml) of suspension taken 3 to 6 times per day.

Chew or allow the tablets to dissolve in the mouth. Take tablets 1 hour after meals.

Take the oral suspension 1 to 2 hours after meals and at bedtime.

For episodic relief of symptoms such as heartburn or epigastric discomfort following dietary errors, take 1 tablet or 1 sachet of suspension as a single dose when needed.

Avoid long-term use in high doses without medical supervision.

Maintain an interval of at least 2 hours between taking Gelusil and any other oral medications to prevent reduced absorption.

Do not administer to children under 10 years of age.

Adverse Reactions

From the digestive system rarely – nausea, vomiting, constipation, diarrhea, change in taste sensations.

From the urinary system with long-term use in high doses – hypercalciuria, nephrocalcinosis, renal failure.

From the metabolism with long-term use in high doses – hypermagnesemia, hypocalcemia, hypercalciuria, hyperaluminemia.

Other rarely – allergic reactions; with long-term use in high doses – osteomalacia, osteoporosis, encephalopathy.

Contraindications

• Severe renal impairment;
• Hypersensitivity to the drug.

Use in Pregnancy and Lactation

The use of the drug during pregnancy and lactation (breastfeeding) is not recommended.

Use in Renal Impairment

The drug is contraindicated in severe renal impairment.

In patients with renal impairment, when prescribing Gelusil, serum magnesium levels should be regularly monitored and long-term use in high doses should be avoided.

Special Precautions

In patients with renal impairment, when prescribing Gelusil, serum magnesium levels should be regularly monitored and long-term use in high doses should be avoided.

When using the drug together with citrus juices (especially grapefruit), the likelihood of developing hypermagnesemia increases.

The interval between taking Gelusil and other drugs should be at least 2 hours.

Use in pediatrics

It is not recommended to prescribe the drug to children under 10 years of age.

Overdose

Data on overdose of Gelusil are not provided.

Drug Interactions

When taken simultaneously, Gelusil reduces the absorption of tetracyclines, propranolol, isoniazid, iron preparations, indomethacin, salicylates.

Storage Conditions

The drug in tablet form should be stored in a place protected from light and moisture, out of the reach of children, at a temperature between 15°C (59°F) and 25°C (77°F).

Shelf Life

Shelf life – 5 years.

The drug in the form of a suspension for oral administration should be stored out of the reach of children at a temperature between 15°C (59°F) and 25°C (77°F). Shelf life – 3 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.