Maalox^® mini (Suspension) Instructions for Use

Marketing Authorization Holder

Opella Healthcare France, SAS (France)

Manufactured By

A. Nattermann and Cie., GmbH (Germany)

ATC Code

A02AX (Antacids in combination with other agents)

Active Substances

Magnesium hydroxide (Ph.Eur.)

Algeldrate (Rec.INN)

Dosage Forms

	Maalox® mini	Oral suspension (black currant flavor) 460 mg+400 mg/4.3 ml: mini-sachets 6, 10, 20, 30 or 40 pcs.
		Oral suspension (lemon flavor) 460 mg+400 mg/4.3 ml: mini-sachets 6, 10, 20, 30 or 40 pcs.

Dosage Form, Packaging, and Composition

Oral suspension (lemon flavor) from white to pale yellow, homogeneous.

Excipients: sucrose solution 64% – 4913 mg, liquid sorbitol (non-crystallizing) – 200 mg, xanthan gum – 2.4 mg, guar – 5.6 mg, natural lemon-lime flavor – 13.2 mg, sodium chloride – 4.8 mg.

4.3 ml (6 g) – mini-sachets made of aluminum foil (6) – cardboard packs.
4.3 ml (6 g) – mini-sachets made of aluminum foil (10) – cardboard packs.
4.3 ml (6 g) – mini-sachets made of aluminum foil (20) – cardboard packs.
4.3 ml (6 g) – mini-sachets made of aluminum foil (30) – cardboard packs.
4.3 ml (6 g) – mini-sachets made of aluminum foil (40) – cardboard packs.

Oral suspension (black currant flavor) from white to pale yellow, homogeneous.

Excipients: sucrose solution 64% – 4913 mg, liquid sorbitol (non-crystallizing) – 200 mg, xanthan gum – 2.4 mg, guar – 5.6 mg, black currant flavor – 13.2 mg, sodium chloride – 4.8 mg.

4.3 ml (6 g) – mini-sachets made of aluminum foil (6) – cardboard packs.
4.3 ml (6 g) – mini-sachets made of aluminum foil (10) – cardboard packs.
4.3 ml (6 g) – mini-sachets made of aluminum foil (20) – cardboard packs.
4.3 ml (6 g) – mini-sachets made of aluminum foil (30) – cardboard packs.
4.3 ml (6 g) – mini-sachets made of aluminum foil (40) – cardboard packs.

Clinical-Pharmacological Group

Antacid drug

Pharmacotherapeutic Group

Antacid agent

Pharmacological Action

An antacid drug that does not have a systemic effect. Its antacid capacity is 20 mEq H⁺ per mini-sachet (in vitro determination by the Rossett-Rice method). The drug neutralizes free hydrochloric acid without causing secondary hypersecretion of hydrochloric acid. Due to the increase in pH upon its intake, the peptic activity of gastric juice decreases.

It also has adsorbent and enveloping effects, due to which the impact of damaging factors on the gastric and duodenal mucosa is reduced.

Maalox^® mini is capable of eliminating or reducing heartburn for several hours. Due to the balanced composition regarding the effect on gastrointestinal motility, Maalox^® mini usually does not cause constipation. Magnesium hydroxide and Algeldrate are radiolucent to X-rays.

Pharmacokinetics

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

Indications

• Heartburn;
• Acid regurgitation.

ICD codes

Dosage Regimen

Adults and children over 15 years

The contents of 1-2 mini-sachets are taken orally 1-1.5 hours after meals or when heartburn occurs. If necessary, an additional dose of the drug can be taken 2 hours after the previous intake. The maximum daily dose is 12 mini-sachets. The course of treatment is no more than 2-3 months.

For episodic use, for example, for discomfort after dietary indiscretions, take 1-2 mini-sachets as a single dose.

For mild renal impairment the maximum daily dose is 8 mini-sachets. For moderate renal impairment the maximum daily dose is 6 mini-sachets.

Before opening the mini-sachet, its contents should be gently mixed by thoroughly kneading the sachet between the fingers. Squeeze the contents of the sachet into a spoon or into the mouth (take the suspension without prior dilution).

Adverse Reactions

When following the recommended dosage regimen, side effects are rare.

Definition of adverse effect frequency (according to WHO classification): infrequent (≥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: infrequent – diarrhea, constipation.

Metabolism and nutrition disorders: frequency unknown – hypermagnesemia, hyperaluminemia, hypophosphatemia (during long-term treatment or high-dose intake, or standard dose intake with low phosphate content in food), which may lead to increased bone resorption, hypercalciuria, osteomalacia.

Contraindications

• Hypersensitivity to the active substances and other components of the drug;
• Severe renal failure;
• Hypophosphatemia;
• Sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption (due to the presence of sorbitol and sucrose in the drug composition);
• Children and adolescents under 15 years of age.

With caution

• Aluminum hydroxide may cause constipation, overdose of magnesium salts may lead to weakened intestinal peristalsis; in patients at increased risk (patients with renal failure, elderly persons) intake of high doses of the drug may cause or worsen intestinal obstruction and ileus.
• Aluminum hydroxide is poorly absorbed from the gastrointestinal tract, so systemic exposure rarely occurs in patients with normal renal function. Long-term treatment, use of the drug in excessively high doses, or use of the drug in standard doses against a background of reduced dietary phosphate intake may lead to phosphate deficiency (due to aluminum binding with phosphate), which is accompanied by increased bone resorption and hypercalciuria with the risk of osteomalacia. Treatment of patients at risk of phosphate deficiency or long-term use of the drug should be carried out under medical supervision.
• In case of impaired renal function (when taking Maalox^® mini in such patients, an increase in plasma concentrations of magnesium and aluminum is possible, and with long-term use of Maalox^® mini in high doses, including high therapeutic doses, the development of encephalopathy, dementia, microcytic anemia or worsening of dialysis-induced osteomalacia is possible.
• In patients with porphyria on hemodialysis.
• In Alzheimer’s disease.
• In diabetes mellitus (due to the sucrose content in the drug composition).
• During pregnancy.

Use in Pregnancy and Lactation

To date, no specific teratogenic effects have been identified with the use of Maalox^® mini during pregnancy, however, due to insufficient clinical experience, its use during pregnancy is possible only in low doses, for a short duration and in cases where the potential therapeutic benefit for the mother justifies the potential risk to the fetus.

When using the drug in accordance with the dosage regimen, the absorption of aluminum hydroxide and magnesium salt combinations in the mother’s body is limited, therefore Maalox^® mini is considered compatible with breastfeeding.

In experimental studies in animals, no clear data on the teratogenic effect of aluminum hydroxide and magnesium hydroxide were obtained.

Use in Renal Impairment

Contraindicated in severe renal failure.

Use with caution in patients with impaired renal function (an increase in plasma concentrations of magnesium and aluminum is possible; with long-term use of Maalox^® mini in high doses, including high therapeutic doses, the development of encephalopathy, dementia, microcytic anemia is possible).

For mild renal impairment the maximum daily dose is 8 mini-sachets. For moderate renal impairment the maximum daily dose is 6 mini-sachets.

Pediatric Use

Contraindicated in children and adolescents under 15 years of age.

Special Precautions

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 Maalox^® mini and other drugs and a 4-hour interval between taking Maalox^® mini and fluoroquinolones.

Although the drug is available without a prescription, it is recommended to consult a doctor before using the drug during pregnancy and lactation (breastfeeding), as well as in adolescents over 15 years of age and patients with mild and moderate renal impairment.

Long-term prescription of Maalox^® mini should be avoided in cases of impaired renal function. When prescribing Maalox^® mini to patients with mild and moderate renal impairment, plasma concentrations of aluminum and magnesium should be carefully monitored, and if they increase, the use of the drug should be discontinued immediately.

Algeldrate, with low phosphate content in food, can lead to the development of phosphorus deficiency in the body. Therefore, during its use, especially long-term, sufficient intake of phosphates with food should be ensured.

One mini-sachet of the drug contains 3.15 g of sucrose and 0.2 g of sorbitol, respectively, the maximum daily dose contains 37.80 g of sucrose and 2.4 g of sorbitol.

Effect on ability to drive vehicles and operate machinery

The drug does not affect the ability to drive vehicles and operate machinery.

Overdose

Symptoms: diarrhea, abdominal pain and vomiting are possible. In patients at risk, taking the drug in high doses may cause or worsen intestinal obstruction or ileus.

Treatment: aluminum and magnesium are excreted in the urine. Fluid loss replacement and forced diuresis are performed. Patients with renal failure require hemodialysis or peritoneal dialysis.

Drug Interactions

With simultaneous use with quinidine, an increase in serum quinidine concentrations and the development of quinidine overdose are possible.

With simultaneous intake with Maalox^® mini, the absorption from the gastrointestinal tract of the following medicinal products is reduced: histamine H₂-receptor blockers, propranolol, atenolol, cefdinir, cefpodoxime, metoprolol, chloroquine, prostacyclins, diflunisal, digoxin, bisphosphonates, ethambutol, isoniazid, fluoroquinolones, sodium fluoride, corticosteroids (described for prednisolone and dexamethasone), indomethacin, ketoconazole, lincosamides, phenothiazine-derived antipsychotics, penicillamine, rosuvastatin, iron salts, levothyroxine. In case of a 2-hour interval between taking these drugs and Maalox^® mini and a 4-hour interval between taking fluoroquinolones and Maalox^® mini, this undesirable interaction can be avoided in most cases.

When using Maalox^® mini concomitantly with polystyrene sulfonate (kayexalate), caution should be exercised due to the possible risk of reduced potassium binding efficiency 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).

When combining aluminum hydroxide with citrates, an increase in plasma aluminum concentrations is possible, especially in patients with renal failure.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is available without a prescription.

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.