Malvacid Oral Suspension 170 ml

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MALVACID^®

Marketing Authorization Number: LP-005750

International Nonproprietary or Grouping Name: Algeldrate + Magnesium Hydroxide

Brand Name: Malvacid^®

Dosage Form: oral suspension

Composition:

Composition per 15 ml of suspension:

Description:

Homogeneous white or almost white suspension.

Pharmacotherapeutic group: Antacid

ATC Code: A02AD01

Pharmacological properties

Pharmacodynamics

An antacid preparation containing aluminum hydroxide and magnesium hydroxide. The drug neutralizes free hydrochloric acid in gastric juice without causing secondary hypersecretion. Due to the increase in pH upon its intake, the activity of pepsin in gastric juice decreases. It also has adsorbing and enveloping properties, which reduce the impact of damaging factors on the mucous membrane of the esophagus and stomach.

Pharmacokinetics

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

Indications for use

Peptic ulcer of the stomach and duodenum in the acute phase.

Acute gastroduodenitis.

Chronic gastroduodenitis with normal or increased secretory function in the acute phase.

Hiatal hernia.

Reflux esophagitis.

Dyspeptic symptoms such as: discomfort, gastralgia (pain in the epigastric region), heartburn, acid reflux (after excessive consumption of ethanol, nicotine, coffee, intake of medications, including non-steroidal anti-inflammatory drugs (NSAIDs), glucocorticosteroids (GCS), as well as dietary indiscretions).

Contraindications

Hypersensitivity to the active substances or any of the inactive ingredients of the drug.

Severe renal failure.

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

Children and adolescents under 15 years of age.

Hypophosphatemia.

Precautions

In patients with porphyria on hemodialysis.

In renal failure of mild to moderate severity (see "Special Instructions" section).

During pregnancy and breastfeeding (see "Use in Pregnancy and Lactation" section).

In elderly individuals.

In patients at risk of developing phosphate deficiency, with long-term use.

In Alzheimer's disease.

Use in Pregnancy and Lactation

Pregnancy

Animal studies revealed no evidence of teratogenic effects for aluminum hydroxide and magnesium hydroxide. To date, no specific teratogenic effects have been identified with the intake of drugs containing aluminum and magnesium hydroxide during pregnancy; however, due to insufficient clinical experience of use during pregnancy, Malvacid^® can be taken only if the potential benefit to the mother justifies the potential risk to the fetus.

Lactation

When used according to recommendations, the absorption of the aluminum hydroxide and magnesium hydroxide combination in the mother is limited; therefore, the use of Malvacid^® during breastfeeding is possible.

Dosage and Administration

Orally. Before use, the suspension must be thoroughly homogenized by shaking the bottle or by thoroughly kneading and shaking the sachet. The contents of the sachet are taken undiluted.

Take 15 ml (1 sachet or 3 measuring spoons of 5 ml) 3-4 times a day, 1-2 hours after meals and at night, as well as when epigastric pain or heartburn occurs. The maximum dose should not exceed 90 ml of suspension per day (6 sachets or 18 measuring spoons of 5 ml).

For reflux esophagitis the drug is taken 30-60 minutes after meals.

For gastric ulcer the drug is taken 30 minutes before meals.

The course of treatment should not exceed 2-3 months.

For episodic use, for example, for discomfort after dietary indiscretions, take 15 ml (1 sachet or 3 measuring spoons of 5 ml) as a single dose.

Patients with impaired renal function. The use of the drug in high doses and/or for a long time should be avoided (see "Precautions" section).

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 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 by the kidneys. 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, atenolol, bisphosphonates, cefdinir, cefpodoxime, chloroquine, cyclines, dasatinib monohydrate, diflunisal, digoxin, eltrombopag olamine, ethambutol, fluoroquinolones, gabapentin, glucocorticoids,
indomethacin, iron salts, isoniazid, ketoconazole, levothyroxine, lincosamides, metoprolol, mycophenolate mofetil, phenothiazine neuroleptics, penicillamine, phenytoin, propranolol, raltegravir potassium, riociguat, rosuvastatin, sodium fluoride, tacrolimus and antiviral drugs (combination of tenofovir alafenamide fumarate / emtricitabine / bictegravir sodium).

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.

Due to the sorbitol content in Malvacid^® , the possibility of an additive effect should be considered when used concomitantly with food products containing sorbitol (or fructose), or when following a diet containing sorbitol (or fructose).

The sorbitol content in Malvacid^® may also affect the bioavailability of concomitantly administered oral drugs.

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 from 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 reduced 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 conducted under medical supervision.

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

If during treatment, gastrointestinal symptoms persist for more than 10 days or a worsening of the condition is observed, the diagnosis should be clarified and treatment adjusted.

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

Long-term use 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.

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.

The drug is radiolucent.

The drug contains sorbitol. A single dose of 15 ml (1 sachet or 3 measuring spoons of 5 ml) contains 214.35 mg of sorbitol; the maximum daily dose (90 ml) contains 1286.1 mg of sorbitol.

Sorbitol is a source of fructose. If you have an intolerance to certain sugars or if you have been diagnosed with hereditary fructose intolerance, a rare hereditary disease in which fructose entering the human body is not broken down in the GI tract, consult your doctor before starting the drug.

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

Oral suspension

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

170 ml in dark glass bottles or in polyethylene terephthalate bottles with a polyethylene cap.

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 above 25 °C. Do not freeze.

Keep out of reach of children.

Regulatory status:

Over-the-counter.

Shelf life:

For the bottle: 2 years. Opened bottle should be stored for no more than 6 months.

For the sachet: 2 years.

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

Manufacturer:

Production site address (all stages):

JSC "AVVA RUS", Russia, Kirov Region, Kirov, Luganskaya St., 53A.

Tel.: +7 (8332) 25-12-29; +7 (495) 956-75-54.

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 

Complaints should be sent to:

Mailing Address: Russia, 121614 Moscow,

Krylatskie Kholmy St., 30, building 9

Tel.: +7-913-927-76-52

Email: drug.safety@avva-rus.ru