Maalox 400 mg + 400 mg - antacid 40 chewable tablets

Product Description

Drug useful for the symptomatic treatment of occasional heartburn and hyperacidity of the stomach.

Therapeutic indications

Maalox chewable tablets is a drug based on magnesium hydroxide and hydrated aluminum oxide, two active ingredients that help reduce heartburn and acidity.

Composition

Active ingredients: magnesium hydroxide 400 mg; aluminum oxide hydrate 400 mg.

Excipients: Sucrose powder with starch, sorbitol, mannitol, magnesium stearate, mint flavoring powder, sodium saccharin, sucrose.

Dosage

Maalox 400 mg + 400 mg tablets should be taken as follows:
1–2 tablets 4 times a day, chewed or sucked well, 20–60 minutes after meals and before going to bed. They can be taken at any time. be followed by the ingestion of water or milk.

Administration of the medicine in pediatric age is not recommended.

Do not exceed the maximum indicated dose.

Contraindications

Hypersensitivity to the active substances or to any of the excipients. Patients with porphyria. Severe forms of renal insufficiency. Generally contraindicated in pediatric age. State of cachexia.

Warnings

Aluminum hydroxide can cause constipation and an overdose of magnesium salts can cause intestinal hypomotility; high doses of this medicine can cause or aggravate intestinal obstruction and ileus in patients at higher risk, such as those with renal impairment, with underlying constipation, with altered intestinal motility, in children (0 to 24 months), or in the elderly. Aluminum hydroxide is poorly absorbed from the gastrointestinal tract, and systemic effects are therefore rare in patients with normal renal function. However, excessive doses or long-term use, or even normal doses in patients with low-phosphorus diets or in children (0 to 24 months), can lead to phosphate excretion (due to an aluminum-phosphate bond) accompanied by increased bone resorption and hypercalciuria with the risk of osteomalacia. It is advisable to consult a doctor in case of long-term use or in patients at risk of hypophosphatemia. In patients with renal impairment, plasma aluminum and magnesium levels tend to increase, causing hyperaluminemia and hypermagnesemia, respectively. In these patients, prolonged exposure to high doses of aluminum and magnesium salts can lead to encephalopathy, dementia, microcytic anemia, or worsening of dialysis-induced osteomalacia. In the presence of mild to moderate forms of renal insufficiency, it is advisable to take the product under the direct supervision of a doctor. Prolonged use of the drug should be avoided in these patients. Aluminum hydroxide may not be safe in patients with porphyria undergoing hemodialysis. MAALOX 400 mg + 400 mg chewable tablets contain sorbitol and sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine.

Maalox in Pregnancy

During pregnancy, the medicine should be used only if necessary, under the direct supervision of a doctor, after evaluating the expected benefit for the mother in relation to the possible risk to the fetus or infant.

Due to the limited maternal absorption when taken according to the indicated dosage regimen, aluminum hydroxide and its combinations with magnesium salts are considered compatible with breastfeeding.

Side effects

The frequency of the side effects listed below is defined using the following conventions: common (≥ 1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated from the available data).

Immune system disorders: Frequency not known (frequency cannot be estimated from the available data): angioedema, anaphylactic reactions, hypersensitivity reactions, urticaria, pruritus.
Gastrointestinal disorders: Uncommon (>1/1,000, <1/100): diarrhoea or constipation.
Metabolism and nutrition disorders: Frequency not known (frequency cannot be estimated from the available data): hypermagnesemia, hyperaluminemia, hypophosphatemia, during prolonged use or at high doses or even at normal doses of the drug in patients on diets low in phosphorus or in children (0 to 24 months), which can cause increased bone resorption, hypercalciuria, osteomalacia.

Interactions

Since Al and Mg salts reduce the gastrointestinal absorption of tetracyclines, it is recommended to avoid taking Maalox during oral tetracycline therapy. The use of antacids containing aluminum may increase the risk of developing malaise. reduce the absorption of drugs such as H2 antagonists, atenolol, cefdinir, cefpodoxime, chloroquine, tetracyclines, diflunisal, digoxin, bisphosphonates, ethambutol, fluoroquinolones, sodium fluoride, glucocorticoids, indomethacin, isoniazid, ketoconazole, levothyroxine, lincosamides, metoprolol, phenothiazine neuroleptics, penicillamine, propranolol, rosuvastatin, iron salts. • Polystyrene sulfonate (Kayexalate) Caution is advised when taking this medicine with polystyrene sulfonate (Kayexalate) due to the potential risk of reduced potassium-binding efficacy of the resin, metabolic alkalosis in patients with renal impairment (reported with aluminum hydroxide and magnesium hydroxide), and intestinal obstruction (reported with aluminum hydroxide). Aluminum hydroxide and citrates may cause hyperaluminemia, especially in patients with renal impairment. Allow at least two hours (four hours for fluoroquinolones) to elapse before taking MAALOX to avoid interactions with other medications. Concomitant use of quinidine may increase serum quinidine levels and lead to quinidine overdose. Concomitant use of aluminum hydroxide and citrates may cause hyperaluminemia. lead to an increase in aluminum levels, particularly in patients with renal insufficiency.

Format

Pack containing 40 chewable tablets.