Altacid (Tablets) Instructions for Use

Marketing Authorization Holder

Bosnalijek, JSC (Bosnia And Herzegovina)

ATC Code

A02AD01 (Simple combinations of salts)

Dosage Forms

	Altacid	Chewable tablets: 16 or 40 pcs.
		Oral suspension: 200 ml bottle with a measuring spoon

Dosage Form, Packaging, and Composition

Chewable tablets round, flat on both sides, white or white with a yellowish tint, with a smooth surface, with a menthol odor.

Excipients: mannitol, talc, povidone, macrogol 4000, mint flavor, magnesium stearate, sodium saccharin.

8 pcs. – blisters (2) – cardboard packs.
8 pcs. – blisters (5) – cardboard packs.

Oral suspension white in color, with a menthol odor.

Excipients: sorbitol 70% (non-crystalline), methylparahydroxybenzoate, mint flavor, propylparahydroxybenzoate, distilled water.

200 ml – dark glass bottles (1) complete with a measuring spoon – cardboard packs.

Clinical-Pharmacological Group

Antacid drug

Pharmacotherapeutic Group

Antacid agent

Pharmacological Action

A combined antacid drug.

It neutralizes free hydrochloric acid in the stomach and reduces the peptic activity of gastric juice.

It also has an adsorbing and enveloping effect, reducing the impact of damaging factors on the mucous membrane.

Indications

• Acute gastritis;
• Hyperacid gastritis;
• Acute duodenitis;
• Gastric and duodenal ulcer in the acute phase;
• Symptomatic ulcers of various origins;
• Erosions of the mucous membrane of the upper gastrointestinal tract;
• Hiatal hernia;
• Reflux esophagitis;
• Acute pancreatitis, exacerbation of chronic pancreatitis;
• Hyperphosphatemia;
• Epigastric pain and heartburn due to dietary errors, medication intake, excessive consumption of coffee, alcohol, nicotine;
• Fermentative and putrefactive dyspepsia.

ICD codes

Dosage Regimen

For adults administer 1-2 chewable tablets or 10-15 ml (2-3 teaspoons) of oral suspension.

Take the dose 4-6 times per day, one hour after meals and at bedtime.

For children aged 2 to 12 years administer half the adult dose.

Thoroughly chew the tablets before swallowing.

For the suspension, shake the bottle well before each use.

Administer the suspension directly or mix with a small amount of water or milk.

Do not exceed the recommended daily dosage.

For short-term symptomatic relief; consult a physician for use beyond two weeks.

Maintain a minimum 2-hour interval between taking Altacid and any other oral medication.

Ensure adequate dietary phosphorus intake during long-term therapy.

Adverse Reactions

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

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

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

Other: encephalopathy; with concomitant renal failure – thirst, decreased blood pressure, hyporeflexia.

Contraindications

• Chronic renal failure;
• Alzheimer’s disease;
• Hypophosphatemia;
• Pregnancy;
• Hypersensitivity to the drug components.

Use in Pregnancy and Lactation

The use of the drug is contraindicated during pregnancy.

Altacid should be used with caution during lactation (breastfeeding).

Use in Renal Impairment

Contraindicated in chronic renal failure.

Pediatric Use

Altacid should be prescribed with caution to children under 12 years of age.

For children aged 2 to 12 years half the adult dose is prescribed.

Special Precautions

A 2-hour interval should be observed between taking Altacid and other medicines.

With long-term use of Altacid, sufficient dietary phosphorus intake should be ensured.

Use in pediatrics

Altacid should be prescribed with caution to children under 12 years of age.

Overdose

Long-term use of the drug in high doses may lead to the development of intestinal dyskinesia, hypophosphatemia, osteomalacia, as well as the development of iron deficiency in the body, since aluminum phosphate binds iron.

Drug Interactions

When taken simultaneously with Altacid, the absorption of indomethacin, salicylates, chlorpromazine, phenytoin, histamine H₂-receptor blockers, beta-blockers, diflunisal, isoniazid, tetracycline antibiotics, indirect anticoagulants, barbiturates is reduced and slowed.

M-cholinoblockers, by slowing gastric emptying, enhance and prolong the action of Altacid.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 30°C (86°F).

Shelf Life

Shelf life – 2 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.