Malvacid^® A (Suspension) Instructions for Use

Marketing Authorization Holder

Avva Rus, JSC (Russia)

ATC Code

A02AB10 (Aluminum preparations in combination)

Active Substances

Magnesium hydroxide (Ph.Eur. European Pharmacopoeia)

Algeldrate (Rec.INN WHO Registered)

Benzocaine (Rec.INN WHO Registered)

Dosage Form

Malvacid® A

Oral suspension: pouch 10 ml 10 or 20 pcs., bottle 170 ml 1 pc.

Dosage Form, Packaging, and Composition

Oral suspension

10 ml – pouches (10 pcs.) – cardboard packs – Over-the-Counter
10 ml – pouches (20 pcs.) – cardboard packs – Over-the-Counter
170 ml – bottles – cardboard packs /complete with a double-sided measuring spoon/ – Over-the-Counter

Clinical-Pharmacological Group

Antacid drug in combination with a local anesthetic

Pharmacotherapeutic Group

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

Pharmacological Action

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

The laxative effect of magnesium hydroxide balances the effect of algeldrate, which has an inhibitory effect on intestinal motility. It neutralizes free hydrochloric acid in the stomach and reduces the activity of gastric juice. It does not cause secondary hypersecretion of gastric juice.

Benzocaine exerts a local anesthetic effect in the presence of severe pain syndrome.

Pharmacokinetics

Algeldrate is absorbed in small amounts, which practically do not change the concentration of aluminum salts in the blood. The absorption of magnesium is about 10% of the taken dose, which does not change the concentration of magnesium ions in the blood.

Benzocaine is absorbed in minimal amounts and practically has no systemic effects on the body. The components are not metabolized and are excreted through the intestines.

Indications

Acute gastritis, chronic gastritis with increased and normal secretory function of the stomach (in the acute phase), acute duodenitis, enteritis, colitis; peptic ulcer of the stomach and duodenum (in the acute phase); hiatal hernia, gastroesophageal reflux, reflux esophagitis, duodenogastric reflux; symptomatic ulcers of the gastrointestinal tract of various origins, erosions of the mucous membrane of the upper gastrointestinal tract; acute pancreatitis, exacerbation of chronic pancreatitis; heartburn and pain in the epigastrium after dietary errors, excessive consumption of ethanol, nicotine, coffee, intake of drugs that irritate the gastric mucosa.

ICD codes

Dosage Regimen

Administer the suspension orally, 3 to 4 times per day.

For adults and adolescents over 15 years, take one 10 ml pouch or one double-sided measuring spoon (10 ml) per dose.

Shake the bottle vigorously immediately before use to ensure a homogeneous suspension.

Take the dose between meals and at bedtime, or as directed by a physician for specific conditions.

For the management of nocturnal pain or heartburn, an additional dose at bedtime is recommended.

The maximum daily dosage should not exceed 80 ml (8 doses) without medical supervision.

For acute symptom relief, the duration of self-medication should not exceed two weeks without consulting a doctor.

In cases of severe pain unrelieved by the standard regimen, seek medical advice for evaluation and potential dosage adjustment.

Adverse Reactions

Immune system disorders frequency unknown – allergic reactions, such as bronchospasm, itching, urticaria, angioneurotic edema and rapid-type anaphylactic reactions.

Metabolism and nutrition disorders very rare – hypermagnesemia; frequency unknown – hyperaluminemia, hypophosphatemia, which can lead to increased bone resorption, hypercalciuria, osteomalacia.

Gastrointestinal disorders uncommon – diarrhea or constipation; frequency unknown – abdominal pain.

Contraindications

Hypersensitivity to the components of the combination; severe renal failure (risk of hypermagnesemia and aluminum intoxication); severely debilitated patients; severe hypophosphatemia; Alzheimer’s disease; children under 15 years of age; pregnancy, breastfeeding period; simultaneous use with sulfonamides.

With caution

Children over 15 years of age (the dosage form contains ethanol, and also due to the risk of methemoglobinemia), osteoporosis, mild or moderate renal failure, liver disease, hepatic insufficiency, alcoholism, elderly age over 65 years; bronchial asthma, epilepsy, traumatic brain injury, brain diseases, severe heart failure, irritable bowel syndrome.

Use in Pregnancy and Lactation

Due to the presence of benzocaine in this combination, use during pregnancy and breastfeeding is contraindicated.

Use in Hepatic Impairment

The drug is approved for use in hepatic impairment.

Use in Renal Impairment

Contraindicated in severe renal impairment, because there is a risk of hypermagnesemia and aluminum intoxication.

When using this combination in high doses in patients with renal failure, the occurrence or worsening of intestinal obstruction and ileus is possible.

Pediatric Use

Contraindicated for use in children under 15 years of age.

Geriatric Use

When using this combination in high doses in elderly patients, the occurrence or worsening of intestinal obstruction and ileus is possible.

Special Precautions

Caution is required when using the drug containing this combination (use only after consulting a doctor) in patients with severe constipation; with stomach pain of unclear origin and if acute appendicitis is suspected; in the presence of ulcerative colitis, diverticulosis, colostomy or ileostomy; with chronic diarrhea; acute hemorrhoids; with liver diseases; severe heart failure; with mild or moderate renal impairment.

Aluminum hydroxide can cause constipation; overdose of magnesium salts can lead to decreased intestinal motility. In patients at increased risk (patients with renal failure or elderly) high doses of this drug may cause or worsen intestinal obstruction and ileus.

Aluminum hydroxide is absorbed from the gastrointestinal tract to a small extent, so systemic effects are rarely observed in patients with normal renal function. However, long-term use, use in very high doses, or use in usual doses in patients on a low-phosphate diet can lead to phosphate deficiency (due to aluminum binding with phosphates), which is accompanied by increased bone resorption, hypercalciuria and the risk of osteomalacia. Long-term use or treatment of patients at risk of phosphate deficiency should be carried out under medical supervision.

In patients with renal failure, an increase in the concentration of aluminum and magnesium in plasma is possible. In these patients, long-term use of high doses of aluminum and magnesium salts can cause encephalopathy, dementia, microcytic anemia or worsen dialysis-induced osteomalacia.

The use of aluminum hydroxide in patients with porphyria undergoing hemodialysis may be dangerous, as it has been proven that aluminum can lead to disorders of porphyrin metabolism.

In elderly patients, worsening of bone and joint diseases, as well as progression of Alzheimer’s disease, is possible.

Long-term use of antacids may mask the symptoms of more serious diseases, such as ulcers or cancer of the gastrointestinal tract.

During treatment, it is necessary to avoid consumption of alcohol and acids.

When taking the drug, transient numbness and anesthesia of the oral mucosa and tongue occur, which does not require therapeutic measures.

Taking drugs containing this combination may affect the results of some laboratory and functional studies and tests, as it reduces the level of gastric secretion when determining its acidity; interferes with the imaging test of diverticula and bone scintigraphy using technetium (Tc₉₉); moderately and briefly increases serum gastrin levels, increases serum phosphorus levels, serum and urine pH.

Drug Interactions

This combination changes the acidity of the stomach contents, which affects the absorption, maximum plasma concentration and bioavailability, as well as the excretion of a large number of drugs used simultaneously with it.

Antacids containing aluminum reduce the absorption of H₂-histamine receptor blockers, atenolol, digoxin, cefdinir, cefpodoxime, chloroquine, tetracyclines, diflunisal, bisphosphonates, ethambutol, fluoroquinolones, sodium fluoride, glucocorticoids, indomethacin, isoniazid, polystyrene sulfonate, ketoconazole, lincosamides, metoprolol, neuroleptics, phenothiazines, penicillamine, propranolol, iron salts, vitamins. The reduced absorption of these drugs is associated with the formation of insoluble complexes and/or alkalinization of the stomach contents. To avoid undesirable drug interactions, a 2-hour interval should be observed between taking these drugs (4 hours for fluoroquinolones) and this fixed combination.

When taken simultaneously with enteric-coated tablets, increased alkalinity of gastric juice can lead to faster dissolution of their coating and cause irritation of the stomach and duodenum.

Simultaneous use with quinidine may lead to an increase in plasma quinidine concentration and lead to quinidine overdose.

Caution should be exercised when using this combination simultaneously with polystyrene sulfonate, as a decrease in the effectiveness of potassium binding to the resin is possible; due to the risk of metabolic alkalosis in patients with renal failure (associated with the use of aluminum hydroxide and magnesium hydroxide) and the risk of intestinal obstruction (associated with the use of aluminum hydroxide).

Simultaneous use of aluminum hydroxide with citrates may lead to a higher concentration of aluminum, especially in patients with impaired renal function.

Alkalinization of urine due to the use of magnesium hydroxide may alter the excretion of some drugs, resulting in increased excretion of salicylates.

This combination should not be taken simultaneously with sulfonamides, due to the presence of benzocaine in its composition. Being a derivative of para-aminobenzoic acid, Benzocaine acts as an antagonist of the antibacterial activity of sulfonamides.

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.