Malvacid Chewable Tablets

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT

Malvacid®

Malvacid®

Marketing Authorization Number:  LP-005514

Brand Name: Malvacid®

International Nonproprietary Name: Algeldrate + Magnesium Hydroxide

Dosage Form: Chewable tablets

Composition per one tablet:

Active substances: algeldrate as dried aluminum hydroxide gel – 493.28 mg (calculated as aluminum hydroxide Al(OH)₃ – 400.00 mg), magnesium hydroxide (calculated as 100% substance) – 400.00 mg.

Inactive ingredients: Xylisorb XTAB 240 [xylitol – 95%; dextrin – 5%] - 30.00 mg, povidone K-25 - 21.00 mg, magnesium stearate - 6.00 mg, corn starch - 5.60 mg, mint flavor - 2.45 mg, sucralose - 0.60 mg, sorbitol to obtain a tablet weighing 1200.00 mg.

Description:

Round, flat-cylindrical tablets from white to almost white in color, with a beveled edge and a slight minty odor. Marbling is acceptable.

Pharmacotherapeutic group: Antacid.

ATC Code:  A02AD01.

Pharmacological Properties

Pharmacodynamics:

The drug neutralizes free hydrochloric acid without causing secondary hypersecretion of hydrochloric acid. Due to the increase in pH, its intake reduces the peptic activity of gastric juice. It also has adsorbing and enveloping properties, which reduce the impact of damaging factors on the mucous membrane.

Pharmacokinetics:

Magnesium and aluminum hydroxides are considered local-acting antacids, practically not absorbed when taken in recommended doses and, accordingly, not exerting systemic effects.

Indications for Use:

For the relief of dyspeptic symptoms (discomfort or pain in the epigastric region, heartburn, acid reflux).

Contraindications:

•   Severe renal failure.

•   Hypersensitivity to the active substances and other components of the drug.

•   Hypophosphatemia.

•   Fructose intolerance (due to the presence of sorbitol in the composition).

•   Children and adolescents under 15 years of age.

Precautions:

•   In patients with porphyria on hemodialysis.

•   During pregnancy.

•   In Alzheimer's disease.

•   In renal failure.

•   In elderly individuals.

Use in Pregnancy and Lactation:

Animal studies have not provided clear evidence of a teratogenic effect for aluminum hydroxide and magnesium hydroxide. To date, no specific teratogenic effects have been identified with the use of the drug during pregnancy; however, due to insufficient clinical experience, its use during pregnancy is only possible if the potential benefit to the mother justifies the potential risk to the fetus.

Prescribing the drug in high doses and for prolonged periods during pregnancy should be avoided.

When used according to recommendations, the absorption of aluminum hydroxide and magnesium salt combinations in the mother is limited; therefore, the drug is considered compatible with breastfeeding.

Dosage and Administration:

The tablets should be dissolved or chewed thoroughly.

Adults and adolescents over 15 years: 1-2 tablets 3-4 times a day, 1-2 hours after meals and at night. For reflux esophagitis, the drug is taken shortly after meals. The maximum number of doses per day is 6. Do not take more than 12 tablets per day. The course of treatment should not exceed 2-3 months. For episodic use (e.g., for discomfort after dietary indiscretions) - take 1-2 tablets as a single dose.

Adverse Reactions:

When the recommended dosage regimen is followed, side effects are minor.

The following WHO classification is used to indicate the frequency of adverse effects:

- Uncommon (≥ 0.1% and < 1%);

- Frequency unknown (cannot be estimated from the available data).

Immune system disorders:

Frequency unknown: hypersensitivity reactions such as pruritus, urticaria, angioedema, and anaphylactic reactions.

Gastrointestinal disorders:

Uncommon: diarrhea, constipation.

Metabolism and nutrition disorders:

Frequency unknown: hypermagnesemia, hyperaluminemia, hypophosphatemia (with long-term treatment or high doses, or with standard doses and low phosphate intake), which may lead to increased bone resorption, hypercalciuria, osteomalacia.

Overdose:

Symptoms

Symptoms of acute overdose with the combination of aluminum hydroxide and magnesium salts include diarrhea, abdominal pain, and vomiting.

In at-risk patients, high doses of the drug may cause or worsen intestinal obstruction (see "Precautions" section).

Treatment

Aluminum and magnesium are excreted in the urine. Treatment of acute overdose involves fluid replacement and forced diuresis. Patients with renal failure require hemodialysis or peritoneal dialysis.

Drug Interactions:

•   With quinidine:

Concomitant use with quinidine may increase serum quinidine concentrations and lead to quinidine overdose.

•   With H2-receptor blockers, propranolol, atenolol, cefdinir, cefpodoxime, metoprolol, chloroquine, prostacyclins, diflunisal, digoxin, bisphosphonates, ethambutol, isoniazid, fluoroquinolones, sodium fluoride, glucocorticosteroids (described for prednisolone and dexamethasone), indomethacin, ketoconazole, lincosamides, phenothiazine neuroleptics, penicillamine, rosuvastatin, iron salts, levothyroxine:

Concomitant administration with Malvacid® reduces the absorption of the listed drugs in the gastrointestinal tract.

A 2-hour interval between taking these drugs and Malvacid®, and a 4-hour interval between taking fluoroquinolones and Malvacid®, can mostly avoid this undesirable interaction.

•   With polystyrene sulfonate (calcium polystyrene sulfonate):

Caution is advised when using Malvacid® concomitantly with polystyrene sulfonate due to the possible risk of reduced potassium-binding efficacy of the resin and the development of metabolic alkalosis in patients with renal failure (for aluminum hydroxide and magnesium hydroxide) and intestinal obstruction (for aluminum hydroxide).

•   With citrates:

Concomitant use of aluminum hydroxide with citrates may increase plasma aluminum concentrations, especially in patients with renal failure.

Special Instructions:

Aluminum hydroxide may cause constipation; overdose of magnesium salts may lead to weakened intestinal peristalsis; in high-risk patients (those with renal failure, elderly individuals), high doses of the drug may cause or worsen intestinal obstruction. Aluminum hydroxide is poorly absorbed in the gastrointestinal tract, so systemic effects are rare in patients with normal renal function. However, long-term treatment, use of excessively high doses, or use of normal doses against a background of low dietary phosphate intake can lead to phosphate deficiency (due to aluminum binding with phosphate), which is accompanied by increased bone resorption and hypercalciuria with a risk of osteomalacia. Treatment of patients at risk of phosphate deficiency or long-term use of the drug should be under medical supervision.

A 2-hour interval should be observed between the use of Malvacid® and other drugs, and a 4-hour interval between taking Malvacid® and fluoroquinolones (see "Drug Interactions").

Long-term prescription of Malvacid® in renal failure should be avoided.

Although the drug is available without a prescription, consultation with a doctor is recommended before use during pregnancy and lactation (breastfeeding), as well as in adolescents.

In renal failure, increased plasma concentrations of magnesium and aluminum are possible. In these patients, long-term use of the drug in high doses may lead to encephalopathy, dementia, microcytic anemia, or worsening of dialysis-induced osteomalacia.

Aluminum hydroxide, with low dietary phosphate intake, can lead to phosphorus deficiency in the body. Therefore, when using aluminum hydroxide, especially long-term, sufficient phosphate intake with food should be ensured.

If symptoms of the disease worsen or persist for 10 days of treatment, a doctor should be consulted to determine the cause and possibly adjust treatment.

The drug is radiolucent.

Effect on Ability to Drive and Operate Machinery: Does not affect the ability to drive vehicles, operate machinery, or engage in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

Pharmaceutical Form:

Chewable tablets, 400 mg + 400 mg.

6 tablets in a blister pack made of polyvinyl chloride film or polyvinyl chloride/polyvinylidene chloride and printed lacquered aluminum foil.

2 or 4 blister packs, together with the package insert, are placed in a cardboard carton.

Storage Conditions:

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

Shelf Life:

2 years. Do not use after the expiration date printed on the packaging.

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.