Malhydrate (Tablets) Instructions for Use

Marketing Authorization Holder

Avva Pharmaceuticals, Ltd. (Cyprus)

Manufactured By

Avva Rus, JSC (Russia)

ATC Code

A02AX (Antacids in combination with other agents)

Active Substances

Magnesium hydroxide (Ph.Eur.)

Algeldrate (Rec.INN)

Dosage Form

Malhydrate

Chewable tablets 400 mg+400 mg: 12 or 24 pcs.

Dosage Form, Packaging, and Composition

Chewable tablets from white to almost white in color, round, flat-cylindrical, with a bevel, with a faint minty odor; marbling is allowed.

Excipients: xylisorb XTAB 240 [xylitol – 95%, dextrin – 5%] – 30 mg, povidone K25 – 21 mg, magnesium stearate – 6 mg, corn starch – 5.6 mg, mint flavor – 2.45 mg, sucralose – 0.6 mg, sorbitol – to obtain a tablet weighing 1200 mg.

6 pcs. – contour cell packs (2) – cardboard packs.
6 pcs. – contour cell packs (4) – cardboard packs.

Clinical-Pharmacological Group

Antacid drug

Pharmacotherapeutic Group

Acid-related disorder treatment agents; antacids; antacids, other combinations

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 use, 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 night; 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, the 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. Squeeze the contents of the sachet 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: children under 12 years of age, lactation period (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 conduct an acute pharmacological test (after administration of the suspension through a gastric tube and subsequent rinsing with 10 ml of water, the pH of the 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.