Malvacid® A Suspension

PACKAGE INSERT

FOR THE MEDICAL USE OF THE DRUG

Malvacid® A

Marketing Authorization Number: LP-006125

Brand Name: Malvacid® A

International Nonproprietary or Grouping Name: Algeldrate + Benzocaine + Magnesium Hydroxide

Dosage Form: oral suspension

Composition of the suspension:

Description:

A white or almost white suspension with a characteristic odor. Separation may occur during storage. Homogeneity is restored after homogenization.

Pharmacotherapeutic Group: Antacid + Local Anesthetic Agent.

ATC Code: A02AX.

Pharmacological properties

Pharmacodynamics:

Malvacid® A is a medicinal product representing a balanced combination of algeldrate (aluminum hydroxide), magnesium hydroxide, and benzocaine. It neutralizes free hydrochloric acid in the stomach, reduces pepsin activity, leading to decreased digestive activity of gastric juice. It has enveloping and adsorbing effects. It protects the gastric mucosa by stimulating the synthesis of prostaglandins (cytoprotective effect). This protects the mucosa from inflammatory and erosive-hemorrhagic lesions resulting from the use of irritating and ulcerogenic agents such as ethyl alcohol and non-steroidal anti-inflammatory drugs (e.g., indomethacin, diclofenac, aspirin, acetylsalicylic acid, corticosteroid drugs). The therapeutic effect occurs 3-5 minutes after administration. The duration of action depends on the gastric emptying rate. When taken on an empty stomach, the effect lasts up to 60 minutes. When taken one hour after a meal, the antacid effect may last up to 3 hours. It does not cause secondary gastric acid hypersecretion.

Benzocaine provides a local anesthetic effect in the presence of pronounced pain syndrome.

Pharmacokinetics:

Absorption - small amounts are resorbed, which practically do not change the concentration of aluminum salts in the blood.

Distribution - none.

Metabolism - none.

Excretion - excreted via the intestines.

Magnesium Hydroxide

Distribution - usually local.

Metabolism - none.

Excretion - excreted via the intestines

Benzocaine

Benzocaine is absorbed in minimal amounts and has practically no systemic effects on the body. Its local anesthetic effect occurs within 1-2 minutes after taking the suspension.

Indications for use

• 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 mucosa of the upper gastrointestinal tract;

• Acute pancreatitis, exacerbation of chronic pancreatitis;

• Heartburn and epigastric pain after dietary indiscretions, excessive consumption of ethanol, nicotine, coffee, intake of medications that irritate the gastric mucosa.

Contraindications

• Hypersensitivity to the active substances or to any of the inactive ingredients;

• Severe renal failure (due to the risk of hypermagnesemia and aluminum intoxication);

• Severely debilitated patients;

• Severe hypophosphatemia;

• Pregnancy and breastfeeding;

• Congenital fructose intolerance (the product contains sorbitol);

• Alzheimer's disease;

• Children under 15 years of age.

Use in Pregnancy and Lactation

Malvacid® A is not prescribed during pregnancy and breastfeeding because it contains benzocaine.

Dosage and Administration

For oral use.

Adults and children over 15 years.

5-10 ml (1-2 measuring spoons of 5 ml) or 10 ml (1 sachet) 3-4 times daily, 10-15 minutes before meals. The maximum duration of treatment is 7 days, after which therapy is switched to the drug Malvacid®.

Fluid intake is not recommended for 15 minutes after taking the drug.

Before use, the suspension must be thoroughly homogenized by shaking the bottle or kneading and shaking the sachet.

Adverse Reactions

Adverse reactions are listed according to the system organ class of the Medical Dictionary for Regulatory Activities (MedDRA). Adverse reactions are classified according to the World Health Organization (WHO): Very common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1000, <1/100); Rare (≥1/10000, <1/1000); Very rare (<1/10000); Frequency unknown (cannot be estimated from the available data).

Immune system disorders: Frequency unknown - allergic reactions such as bronchospasm, pruritus, urticaria, angioedema, and rapid-type anaphylactic reactions.

Metabolism and nutrition disorders: Very rare - hypermagnesemia (1); Frequency unknown - hyperaluminemia, hypophosphatemia (2), which may lead to increased bone resorption, hypercalciuria, osteomalacia (see "Special Instructions").

Gastrointestinal disorders: Uncommon - diarrhea or constipation; Frequency unknown - abdominal pain.

1.Observed with prolonged use of magnesium hydroxide in patients with renal insufficiency.

2.Observed with prolonged use of high doses, as well as with usual doses in patients with limited phosphate intake.

Overdose

A single dose exceeding the recommended amount typically shows no signs of overdose other than constipation, flatulence, and a metallic taste.

Prolonged use of high doses may lead to nephrocalcinosis, severe constipation, mild drowsiness, hypermagnesemia. Signs of metabolic alkalosis may also occur: mood or mental activity changes, muscle numbness or pain, irritability and fatigue, slowed breathing, unpleasant taste sensations.

Measures should be taken immediately to rapidly remove the medication from the body via gastric lavage (induction of vomiting, administration of activated charcoal).

Drug Interactions

Malvacid® A alters the acidity of gastric contents, which affects the absorption, maximum plasma concentration, bioavailability, and excretion of many drugs used concomitantly.

Aluminum-containing antacids reduce the absorption of H2-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. Reduced absorption of these drugs is associated with the formation of insoluble complexes and/or alkalinization of gastric contents. To avoid undesirable drug interactions, a 2-hour interval (4 hours for fluoroquinolones) should be maintained between taking these drugs and Malvacid® A.

Concomitant use with enteric-coated tablets may lead to faster dissolution of their coating due to increased gastric juice alkalinity and cause irritation of the stomach and duodenum.

Concomitant use with quinidine may increase plasma quinidine concentration and lead to quinidine overdose. Caution is advised when using Malvacid® A concomitantly with polystyrene sulfonate due to possible reduced potassium-binding resin efficacy; risk of metabolic alkalosis in patients with renal failure (associated with aluminum and magnesium hydroxide use) and risk of intestinal obstruction (associated with aluminum hydroxide use).

Concomitant use of aluminum hydroxide with citrates may lead to higher aluminum concentrations, especially in patients with impaired renal function.

Urine alkalinization due to magnesium hydroxide use may alter the excretion of some drugs, leading to increased excretion of salicylates.

Malvacid® A should not be taken simultaneously with sulfonamides, due to its benzocaine content. Being a derivative of para-aminobenzoic acid, benzocaine acts as an antagonist to the antibacterial activity of sulfonamides.

Malvacid® A may affect the results of some laboratory and functional tests: it reduces gastric secretion level during acidity determination; interferes with diverticula imaging tests and technetium (Tc99) bone scintigraphy; moderately and briefly increases serum gastrin levels, increases serum phosphorus levels, serum and urine pH.

Special Instructions

Aluminum hydroxide may cause constipation; overdose of magnesium salts may lead to reduced intestinal motility. In high-risk patients (those with renal failure or elderly), high doses of this drug may cause or worsen intestinal obstruction.

Aluminum hydroxide is absorbed minimally in the gastrointestinal tract, so systemic effects are rare in patients with normal renal function. However, prolonged use, very high doses, or use of standard doses in patients on a low-phosphate diet may lead to phosphate deficiency (due to aluminum binding with phosphates), accompanied by increased bone resorption, hypercalciuria, and risk of osteomalacia. Prolonged use or treatment of patients at risk of phosphate deficiency should be under medical supervision.

In patients with renal failure, increased plasma concentrations of aluminum and magnesium are possible. Prolonged use of high doses of aluminum and magnesium salts in these patients may cause encephalopathy, dementia, microcytic anemia, or worsen dialysis-induced osteomalacia.

Use of aluminum hydroxide in porphyria patients undergoing hemodialysis may be dangerous, as aluminum has been shown to disrupt porphyrin metabolism.

In elderly patients, worsening of bone and joint diseases and progression of Alzheimer's disease are possible. Prolonged use of antacids may mask symptoms of more serious conditions, such as ulcers and gastrointestinal cancer.

During treatment with Malvacid® A, consumption of alcohol and acids (lemon juice, vinegar, etc.) should be avoided due to the potential weakening of the local anesthetic effect of benzocaine.

Taking the drug causes numbness and anesthesia of the oral mucosa and tongue. This phenomenon is transient and does not require therapeutic measures.

The drug is sugar-free, allowing its use by diabetic patients. The drug contains sorbitol, which is contraindicated in congenital fructose intolerance.

Effect on Ability to Drive and Operate Machinery Malvacid® A does not affect the ability to drive vehicles or operate machinery.

Pharmaceutical Form

Oral suspension

10 ml in sachets made of multilayer packaging material (polyethylene terephthalate-polypropylene-aluminum-polyethylene or polyethylene terephthalate-aluminum-polyethylene).

170 ml in dark glass bottles with polyethylene caps. A self-adhesive label is affixed to the bottle.

10 or 20 sachets or 1 bottle, together with a polymer double-sided measuring spoon (2.5 ml on one side and 5 ml on the other) and the package insert, are placed in a cardboard carton.

Storage Conditions:

In the original packaging (carton) at a temperature not exceeding 25 °C. Do not freeze.

Keep out of reach of children.

Regulatory Status:

Over-the-counter.

Marketing Authorization Holder/Organization Accepting Consumer Complaints:

JSC "AVVA RUS", Russia, 121614, Moscow, Krylatskie Kholmy St., 30, building 9. Tel./Fax: +7 (495) 956-75-54.

avva-rus.ru

Manufacturer:

JSC "AVVA RUS", Russia, Kirov Region, Kirov, Luganskaya St., 53A. Tel.: +7 (8332) 25-12-29; +7 (495) 956-75-54.