Maalox 400 mg + 400 mg - against stomach acid 30 chewable no-sugar tablets

Product Description

Symptomatic treatment of occasional heartburn and hyperacidity of the stomach.

Indications

Maalox 30 chewable tablets 400+400mg without sugar is indicated in cases of heartburn and hyperacidity of the stomach.

Composition

Active ingredients

Magnesium hydroxide 400 mg aluminum oxide, hydrated 400 mg.
Excipient(s) with known effect: sorbitol and maltitol.

Excipients

Maalox 400 mg + 400 mg chewable tablets lemon flavor Sorbitol liquid (non-crystallizing), maltitol, glycerol (85%), sodium saccharin, lemon flavor, talc, magnesium stearate.
Maalox 400 mg + 400 mg chewable tablets red fruit flavor Liquid sorbitol (non-crystallizing), maltitol, glycerol (85%), sodium saccharin, red fruit flavor, talc, magnesium stearate.

Directions for use and dosage

Dosage: 1–2 tablets 4 times a day, chewed or sucked well, 20–60 minutes after meals and before going to bed.
Method of administration: The tablets must be chewed or sucked well.
Their intake can be followed by the ingestion of water or milk.
Paediatric population: Administration of the medicine in pediatric age is not recommended.
Do not exceed the maximum indicated dose.

Warnings

Aluminum hydroxide can cause constipation, and an overdose of magnesium salts can cause intestinal hypomotility; high doses of this medicine may cause or worsen intestinal obstruction and ileus in patients at higher risk, such as those with renal impairment, underlying constipation, impaired intestinal motility, children (0 to 24 months), or the elderly.
Aluminum hydroxide is not well 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 diets low in phosphorus 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, long-term 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 and moderate forms of renal insufficiency, it is advisable to take the product under the direct supervision of a doctor.
In these patients, prolonged use of the medicine should be avoided.
Aluminum hydroxide may not be safe in patients with porphyria undergoing hemodialysis. Maalox contains sorbitol and maltitol.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.

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.

Interactions

Since Maalox is not recommended for children under 18 years of age, it is contraindicated in patients with porphyria. 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 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 the medicinal product is taken together with polystyrene sulfonate (Kayexalate) due to the potential risk of reduced effectiveness of the resin in binding potassium, 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 (4 for fluoroquinolones) before taking Maalox to avoid interactions with other drugs.
  Concomitant use of quinidine may cause increased serum quinidine levels and lead to quinidine overdose.

Concomitant use of aluminum hydroxide and citrates may lead to increased aluminum levels, particularly in patients with renal impairment.

Undesirable effects

The frequency of the following undesirable effects 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 may cause increased bone resorption, hypercalciuria, osteomalacia.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product.

Overdose

Experience with deliberate overdose is very limited.
Cases of overdose with aluminium salts may occur more frequently. easily in patients with chronic severe renal impairment with the following symptoms: encephalopathy, convulsions and dementia, hypermagnesemia.
The most frequently reported symptoms of acute overdose with aluminum hydroxide and in combination with magnesium salts include diarrhea, abdominal pain, and vomiting.
High doses of this medicine may cause or aggravate intestinal obstruction and ileus in patients at risk.
As in all cases of overdose, treatment should be symptomatic, with general supportive measures.
Aluminum and magnesium are eliminated by urinary excretion; treatment of magnesium overdose includes rehydration and forced diuresis.
In case of renal failure, hemodialysis or peritoneal dialysis is necessary.

Pregnancy and breastfeeding

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

Storage

This medicine does not require any special storage conditions.

Format

30 chewable tablets 400+400 mg