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Magaplon® (Tablets, Suspension) Instructions for Use

ATC Code

A02AX (Antacids in combination with other agents)

Active Substances

Magnesium hydroxide (Ph.Eur.)

Algeldrate (Rec.INN)

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 use, dietary errors); fermentative or putrefactive dyspepsia (as part of combination therapy).

ICD codes

ICD-10 code Indication
E83.3 Disorders of phosphorus metabolism and phosphatases
K21.0 Gastro-esophageal reflux disease with esophagitis
K25 Gastric ulcer
K26 Duodenal ulcer
K27 Peptic ulcer
K29 Gastritis and duodenitis
K30 Functional dyspepsia (digestive disorder)
K44 Diaphragmatic hernia
K85 Acute pancreatitis
K86.1 Other chronic pancreatitis
R10.1 Pain localized to the upper abdomen
R12 Heartburn
ICD-11 code Indication
5C64.3 Disorders of phosphorus or phosphatase metabolism
DA22.Z Gastro-esophageal reflux disease, unspecified
DA24.Z Unspecified esophagitis
DA42.Z Gastritis, unspecified
DA51.Z Duodenitis, unspecified
DA60.Z Gastric ulcer, unspecified
DA61 Peptic ulcer of unspecified site
DA63.Z Duodenal ulcer, unspecified
DA7Z Diseases of stomach or duodenum, unspecified
DC31.Z Acute pancreatitis, unspecified
DC32.0 Calcific pancreatitis
DC32.1 Paraduodenal pancreatitis
DC32.2 Hereditary chronic pancreatitis
DC32.4 Chronic idiopathic pancreatitis
DC32.5 Tropical pancreatitis
DC32.Z Chronic pancreatitis, unspecified
DC33 Autoimmune pancreatitis
DD50.0 Diaphragmatic hernia
DD90.0 Globus sensation
DD90.1 Functional dysphagia
DD90.3 Functional dyspepsia
DD90.Z Functional disorders of esophagus or gastroduodenal system, unspecified
GB90.48 Disorders of calcium or phosphate excretion
MD81.10 Pain localized in the upper abdomen
MD95 Heartburn

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets, Suspension

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.

For children from 4 to 12 months – 7.5 ml, for 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 should 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 failure: 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, ensure sufficient intake of phosphorus salts with food.

For adequate selection of a single dose, it is advisable to conduct an acute pharmacological test (after administering 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, a dose increase 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, rifampicin, 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 effect 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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Artelar, LLC (Russia)

Manufactured By

Avva Rus, JSC (Russia)

Dosage Form

Bottle OTC Icon Magaplon® Chewable tablets 400 mg+400 mg: 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.

1 tab.
Algeldrate in the form of dried aluminum hydroxide gel (calculated as aluminum hydroxide Al(OH)3) 493.28 mg (400 mg)
Magnesium hydroxide (calculated as 100% substance) 400 mg

Excipients: xylisorb XTAB 240 [xylitol – 95%, dextrin – 5%] – 30 mg, povidone K-25 – 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.

Marketing Authorization Holder

Artelar, LLC (Russia)

Manufactured By

Avva Rus, JSC (Russia)

Dosage Form

Bottle OTC Icon Magaplon® Oral suspension: bottle 170 ml with measuring spoon

Dosage Form, Packaging, and Composition

Oral suspension homogeneous, white or almost white in color.

15 ml
Algeldrate in the form of dried aluminum hydroxide gel (calculated as aluminum hydroxide) 525 mg
Magnesium hydroxide (calculated as 100% substance) 600 mg

Excipients: liquid non-crystallizing sorbitol – 214.35 mg, 10% hydrochloric acid – 79.233 mg, mannitol – 37.5 mg, citric acid – 9.825 mg, 30% hydrogen peroxide – 9.75 mg, peppermint flavor – 7.56 mg, sucralose – 4.2 mg, domiphen bromide – 0.633 mg, purified water – to obtain a suspension volume of 15 ml.

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

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