MANTI

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MANTI (MANTI®)

Composition:

Active substances: 1 chewable tablet contains aluminum hydroxide 200 mg, magnesium hydroxide 200 mg, simethicone 25 mg;

Excipients: stearic acid, sodium croscarmellose, magnesium stearate, peppermint flavor SD #297, aspartame (E 951), green colorant "Green Color (Lake Blend LB-1334)" [FD&C Yellow #10 (E 104), FD&C Blue #1 (E 133)], sorbitol (E 420).

Pharmaceutical form. Chewable tablets.

Main physicochemical properties: round, flat chewable tablets with beveled edges, light green in color, with specks of white and dark color, with a faint mint odor and embossing "Manti" on one side.

Pharmacotherapeutic group.

Antacids. Combinations of simple salts and antiflatulents (anti-foaming agents). ATC code A02AF02.

Pharmacological properties.

Pharmacodynamics.

Manti contains magnesium hydroxide, aluminum hydroxide, and simethicone. The action of the medicinal product is based on neutralizing hydrochloric acid in the stomach, reducing pepsin activity, and binding (i.e., adsorbing) bile acids and lysolecithin.

Simultaneous use of magnesium hydroxide and aluminum hydroxide makes the medicinal product mostly free of undesirable effects typical for the individual components when used separately (e.g., diarrhea after administration of magnesium compounds or constipation after administration of aluminum compounds).

Aluminum hydroxide and magnesium hydroxide react with hydrochloric acid to form salts (chlorides). This reaction increases the pH of gastric juice and reduces the harmful effect of hydrochloric acid on the gastric mucosa.

Aluminum hydroxide neutralizes hydrochloric acid in the stomach, forming aluminum chloride. Under the influence of the alkaline intestinal environment, the latter is converted into alkaline aluminum salts, which are poorly absorbed and are excreted in feces. With normal kidney function, serum aluminum levels remain practically unchanged.

Pharmacokinetics.

Approximately 10% of magnesium from magnesium hydroxide is absorbed from the intestine. Magnesium hydroxide neutralizes hydrochloric acid in the stomach and is converted into magnesium carbonate, with the concentration of magnesium ions in the blood remaining almost unchanged.

In patients with chronic renal insufficiency, levels of aluminum and magnesium ions may rise to toxic levels due to impaired excretion.

Simethicone, included in the formulation, helps relieve flatulence.

Simethicone is a stable silicone compound that is not absorbed from the gastrointestinal tract, promotes natural release of gases, and their absorption by intestinal walls.

Simethicone is biologically inert, practically not absorbed in the gastrointestinal tract, and is excreted unchanged in feces.

Clinical characteristics.

Indications.

Symptomatic treatment of gastrointestinal disorders associated with increased gastric acidity and excessive gas formation, such as gastric and duodenal ulcers, gastritis, hiatal hernia. Also used for dyspepsia, heartburn, and discomfort due to excessive gas formation.

Contraindications.

Hypersensitivity to the components of the medicinal product. Severe renal impairment (due to the risk of developing hypermagnesemia and elevated serum aluminum concentrations), osteoporosis, hypophosphatemia, disaccharidase deficiency, phenylketonuria, Alzheimer's disease, constipation, chronic diarrhea, intestinal obstruction, suspected appendicitis, gastrointestinal bleeding of unknown origin, severe abdominal pain of unclear etiology, ulcerative colitis, and conditions causing disturbances in water-electrolyte balance.

Interaction with other medicinal products and other types of interactions.

Manti interacts with certain other orally administered medicinal products. Reduced absorption from the gastrointestinal tract may occur when drugs are taken concomitantly. As a precautionary measure, an interval should be maintained between administration of antacids and other medicinal products.

Plasma concentrations of penicillamine, sotalol, propranolol, phenytoin, cefpodoxime, and fexofenadine may decrease when used concomitantly with antacid preparations. The effect of calcium polystyrene sulfonate may be reduced when used simultaneously with antacids.

The following should be taken 2 hours before or 2 hours after administration of Manti: H2-histamine blockers, antituberculosis drugs, ethambutol, isoniazid (oral), atenolol, metoprolol, propranolol, chloroquine, tetracyclines, diflunisal, digoxin, bisphosphonates, fexofenadine, iron (salts), fluoroquinolones, sodium fluoride, glucocorticosteroids (interaction described with prednisolone and dexamethasone), indomethacin, kayexalate, ketoconazole, lansoprazole, lincosamides, phenothiazine neuroleptics, penicillamine, phosphorus (supplements), thyroxine.

It should be noted that when used concomitantly with salicylates, renal excretion of salicylates is enhanced due to urinary alkalinization.

Manti may reduce absorption of: tetracycline antibiotics (e.g., tetracycline, doxycycline); quinolones (e.g., ciprofloxacin, norfloxacin, ofloxacin); bisphosphonate derivatives (e.g., clodronate, alendronate, risedronate); protease inhibitors (atazanavir, tipranavir, fosamprenavir); ketoconazole, itraconazole; rosuvastatin; allopurinol, diflunisal, gabapentin, iron, mycophenolate mofetil; levothyroxine; dasatinib; strontium ranelate.

Manti may increase absorption of: oral antidiabetic drugs of the sulfonylurea group (glipizide, glyburide, chlorpropamide, tolbutamide), coumarin derivatives, nifedipine, amoxicillin, pentoxifylline, and pseudoephedrine.

By occasionally increasing urinary pH, the drug may: reduce the effectiveness of treatments aimed at acidifying urine (e.g., ascorbic acid, ammonium chloride, sodium or potassium phosphate), reduce urinary excretion of amphetamine and mecamylamine, reduce solubility of fluoroquinolones, causing crystalluria.

The product should not be used simultaneously with quinolines.

Manti may cause disturbances in quinidine excretion, leading to manifestations of quinidine toxicity, especially in patients with renal insufficiency.

Concomitant use with cholinergic agents reduces their effectiveness.

When used with citrates, systemic alkalosis may occur, absorption of aluminum may increase, and aluminum toxicity may develop, especially in patients with renal insufficiency.

Use of Manti together with medicinal products having enteric coating may lead to faster dissolution of the coating and irritation of the stomach and duodenum.

The medicinal product may reduce absorption of folic acid.

Concomitant use with salicylates causes a significant reduction in serum salicylate levels. When used in combination with levothyroxine, a reduction in its hormonal effect is possible. Pirenzepine enhances and prolongs the effect of Manti.

Special precautions for use

The medicinal product contains aspartame (a derivative of phenylalanine, which poses a risk for patients with phenylketonuria); therefore, patients with phenylketonuria should not use this medicinal product (see section "Contraindications").

This medicinal product contains sorbitol. If you have been diagnosed with intolerance to certain sugars, consult your physician before taking this medicinal product.

Aluminium hydroxide may cause constipation, and magnesium hydroxide may lead to intestinal hypokinesia; the use of this medicinal product in high doses may cause or exacerbate intestinal obstruction and intestinal impaction, especially in patients at increased risk of such complications, for example, patients with renal impairment or elderly patients.

Patients should consult a physician if:

• weight loss occurs;
• difficulty in swallowing or persistent discomfort in the abdomen develops;
• digestive disturbances occur for the first time or there is a change in the course of pre-existing digestive disorders;
• renal impairment is present.

Aluminium salts are generally poorly absorbed in the gastrointestinal tract, and therefore systemic effects in patients with normal renal function are rare. However, administration of excessive doses of the drug, prolonged use, or even use of normal doses in patients whose diet is low in phosphorus may lead to decreased phosphate levels in the body, accompanied by enhanced bone resorption processes and the development of hypercalciuria, increasing the risk of osteomalacia (due to binding of aluminium with phosphate).

In patients with renal impairment, elevated plasma concentrations of both aluminium and magnesium may occur. In such patients, prolonged use of high doses of aluminium and magnesium salts may lead to the development of encephalopathy, dementia, microcytic anemia, or may worsen the course of dialysis-induced osteomalacia.

Aluminium hydroxide may be hazardous for patients with porphyria who are undergoing hemodialysis.

The use of this medicinal product is not recommended in patients with Alzheimer's disease (aluminium accumulates in neural fibrillary tangles in brain tissue and may lead to complications).

The use of magnesium hydroxide in children may cause hypermagnesemia, especially if they have renal impairment or dehydration.

If symptoms persist for more than 10 days or the patient's condition worsens during treatment, the treatment regimen should be re-evaluated.

The drug should not be taken for longer than 2 weeks without appropriate medical advice.

Concomitant intake of citrus fruit juice may increase aluminium absorption.

Use during pregnancy or breastfeeding

The drug is contraindicated during pregnancy. Breastfeeding should be discontinued during treatment with this drug.

Ability to influence reaction rate while driving or operating machinery

There are no data regarding negative effects on the ability to drive or operate machinery.

Method of Administration and Dosage.

For adults and children aged 14 years and older: 1–3 tablets between meals (1 hour after eating), in the evening before bedtime, and when symptoms appear. Do not exceed 12 tablets per day.

The tablets should be thoroughly dissolved or chewed.

The treatment course should not exceed 2 weeks.

Children.

For use in children aged 14 years and older.

Overdose.

Symptoms: increased fatigue, facial flushing, exhaustion, muscle weakness, mental disturbances; bone pain, constipation, loss of taste, dizziness, nausea or vomiting may also occur, as well as signs of metabolic alkalosis: mood changes or altered mental activity, numbness or muscle pain, nervousness, respiratory depression, unpleasant taste sensations.

Prolonged use of Manty may lead to hypermagnesemia, despite the fact that the drug is poorly absorbed from the gastrointestinal tract.

Treatment. In case of suspected overdose or appearance of clinical signs of overdose, discontinue the medication and take measures for rapid elimination of the drug from the gastrointestinal tract (administer activated charcoal, perform gastric lavage, and other procedures to reduce absorption of aluminum and magnesium ions).

Treatment of magnesium overdose: rehydration, forced diuresis. Calcium gluconate may be administered intravenously. In case of renal insufficiency, hemodialysis or peritoneal dialysis is required. Symptomatic therapy.

Adverse Reactions

Possible reduction in phosphorus levels in the body during prolonged use of the drug, use at high doses, or even use of standard doses in patients whose diet is low in phosphorus; increased bone resorption processes, hypocalcemia, hypercalciuria, osteomalacia, osteoporosis due to the presence of aluminium in this product (see section "Special Precautions"), hypermagnesemia, hyperaluminemia.

Elevated plasma concentrations of both aluminium and magnesium have been observed in patients with renal insufficiency. In such patients, prolonged use of high doses of aluminium and magnesium salts may lead to the development of encephalopathy, dementia, microcytic anemia, or may worsen dialysis-induced osteomalacia. For patients with renal insufficiency, the dose of the drug should be reduced or the dosing interval increased depending on the severity of renal impairment. In patients in this group, plasma concentrations of aluminium and magnesium should be monitored.

Aluminium hydroxide may be hazardous for patients with porphyria undergoing hemodialysis.

Adverse reactions are categorized by frequency as follows: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,000), very rare (< 1/10,000), frequency not known (cannot be estimated from available data).

Immune system disorders. Frequency not known: allergic reactions such as pruritus, urticaria, angioneurotic edema, and anaphylactic reactions, bronchospasm.

Metabolism and nutrition disorders. Very rare: hypermagnesemia (observed after prolonged use of magnesium hydroxide in patients with renal insufficiency).

Nervous system disorders. Frequency not known: aluminium and/or magnesium intoxication, predominantly in patients with renal insufficiency, dementia, worsening of Alzheimer's disease.

Gastrointestinal disorders. Uncommon: taste disturbances (chalky taste). Very rare: diarrhea. Frequency not known: constipation, abdominal pain, nausea, vomiting, change in stool color, excessive gas formation, bloating.

If any adverse effects or unusual reactions occur, consult your doctor regarding further use of the medicinal product.

Shelf life. 2 years.

Storage conditions.

Store at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging. 10 tablets per blister, 1 or 3 blisters per cardboard box. 8 tablets per blister, 1, 2, 3, or 4 blisters per cardboard box.

Prescription status. Over-the-counter.

Manufacturer.

TOV US Farmatsiya / US Pharmacia Sp. z o.o.

Manufacturer's address.

ul. Ziebicka 40, 50-507 Wroclaw, Poland.

Marketing Authorization Holder.

Unilab, LP.

Address of Marketing Authorization Holder.

966 Hungerford Drive, suite 3B, Rockville, MD 20850, USA.