AgiFlux^® (Tablets) Instructions for Use

Marketing Authorization Holder

Agio Pharmaceuticals, Ltd. (India)

ATC Code

A02AD01 (Simple combinations of salts)

Active Substances

Magnesium hydroxide (Ph.Eur.)

Algeldrate (Rec.INN)

Dosage Form

AgiFlux®

Chewable tablets 400 mg+400 mg: 20, 40, or 60 pcs.

Dosage Form, Packaging, and Composition

Chewable tablets white in color with possible presence of single dark inclusions, round, flat on both sides, with a minty odor.

* containing not less than 76.5% of aluminum oxide.

Excipients: sucrose – 40 mg, mannitol – 282.5 mg, povidone K30 – 21 mg, sorbitol – 16 mg, sodium saccharin – 5 mg.

Lubricant composition: colloidal silicon dioxide – 8 mg, peppermint leaf oil – 7.5 mg, magnesium stearate – 20 mg.

10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (4) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.

Clinical-Pharmacological Group

Antacid drug

Pharmacotherapeutic Group

Antacid agent

Pharmacological Action

A combined agent, the action of which is due to its constituent components: it has antacid, adsorbent, enveloping, carminative, and choleretic effects.

The laxative effect of magnesium hydroxide balances the effect of algeldrate, which has the opposite effect on intestinal motility.

It neutralizes free hydrochloric acid in the stomach and reduces the activity of gastric juice. The residence time in the stomach is about 1 hour.

Pharmacokinetics

Absorption is low.

Indications

Acute gastritis; hyperacid gastritis; acute duodenitis; gastric and duodenal ulcer (in the acute phase); symptomatic ulcerative lesions of the stomach and duodenum of various origins; erosions of the mucous membrane of the upper gastrointestinal tract; reflux esophagitis; hiatal hernia; acute pancreatitis; exacerbation of chronic pancreatitis; hyperphosphatemia; discomfort, gastralgia, heartburn (after excessive consumption of ethanol, nicotine, coffee, medication intake, dietary errors); fermentative or putrefactive dyspepsia (as part of combination therapy).

ICD codes

Dosage Regimen

Orally, 5-10 ml (suspension, gel) or 2-3 tablets 1-2 hours after meals and at bedtime; for gastric ulcer – 30 minutes before meals; if necessary, the single dose can be increased to 15 ml or 3-4 tablets.

After achieving the therapeutic effect – maintenance therapy with 5 ml or 1 tablet 3 times/day for 2-3 months.

Children from 4 to 12 months – 7.5 ml, children over 1 year – 15 ml 3 times/day.

For prevention, take 5-10 ml or 1-2 tablets before possible irritating effects on the gastrointestinal mucosa.

To increase effectiveness, tablets should be chewed or held in the mouth until completely dissolved.

The suspension or gel must be homogenized before use by shaking the bottle or thoroughly kneading the sachet between the fingers.

The contents of the sachet are squeezed into a spoon or into the mouth.

Adverse Reactions

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

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

In patients with concomitant renal insufficiency: thirst, decreased blood pressure, hyporeflexia.

Contraindications

Hypersensitivity to algeldrate and magnesium hydroxide; chronic renal failure; pregnancy; Alzheimer’s disease; hypophosphatemia.

With caution in children under 12 years of age, during lactation (breastfeeding).

Use in Pregnancy and Lactation

Use during pregnancy is contraindicated.

Use with caution during lactation (breastfeeding).

Use in Renal Impairment

Contraindicated in chronic renal failure.

Pediatric Use

Use with caution in children under 12 years of age.

Special Precautions

With long-term administration, sufficient intake of phosphorus salts with food should be ensured.

For adequate selection of a single dose, it is advisable to perform an acute pharmacological test (after administration of the suspension through a gastric tube and subsequent rinsing with 10 ml of water, the pH of gastric juice is assessed after 1 hour; if the pH is below 3.5, an increase in dose is necessary).

Drug Interactions

Reduces and slows the absorption of digoxin, indomethacin, salicylates, chlorpromazine, phenytoin, H₂-histamine receptor blockers, beta-blockers, diflunisal, ketoconazole and itraconazole, isoniazid, tetracycline antibiotics and quinolones (ciprofloxacin, norfloxacin, ofloxacin, enoxacin, grepafloxacin, etc.), azithromycin, cefpodoxime, pivampicillin, rifampin, indirect anticoagulants, barbiturates (they should be taken 1 hour before or 2 hours after taking antacids), fexofenadine, dipyridamole, zalcitabine, chenodeoxycholic and ursodeoxycholic acids, penicillamine and lansoprazole.

M-cholinoreceptor blockers, by slowing gastric emptying, enhance and prolong the action of the drug.

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

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.