Maalox Sugar Free 400mg + 400mg Antacid Lemon Flavor 30 Chewable Tablets

Lemon flavored sugar-free chewable tablets based on magnesium hydroxide, aluminum hydroxide.

Therapeutic indications

Maalox Tablets 400 + 400 mg Sugar Free Lemon is used in the symptomatic treatment of occasional heartburn and hyperacidity of the stomach.

Dosage and Posology

The drug should be taken according to the following doses and methods: 1-2 tablets 4 times a day well chewed or sucked, 20-60 minutes after meals and before bedtime.

The tablets should be well chewed or sucked. Their intake can be followed by the ingestion of water or milk. Administration of the medicinal product in children is not recommended. Do not exceed the maximum indicated dose

Overdose

Experience with deliberate overdose is very limited. Cases of overdose with aluminum salts can occur more easily in patients with chronic severe renal impairment with the following symptoms: encephalopathy, convulsions and dementia, hypermagnesaemia. 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 medicinal product may cause or aggravate intestinal obstruction and ileus in patients at risk (see section 4.4). As in all cases of overdose, treatment should be symptomatic with generic supportive measures. Aluminum and magnesium are eliminated by urinary excretion; treatment of magnesium overdose involves rehydration and forced diuresis. In case of renal insufficiency, hemodialysis or peritoneal dialysis is required.

Contraindications

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

Side effects

The frequency of the undesirable effects listed below is defined using the following conventions: common (≥1 / 100, <1/10); uncommon (≥1 / 1,000 to <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 / 1000, <1/100): diarrhea or constipation

- Metabolism and nutrition disorders:

• Frequency not known (frequency cannot be estimated from the available data): hypermagnesaemia, hyperalluminaemia, hypophosphataemia, during prolonged use or at high doses or even at normal doses of the medicinal product in patients with low phosphorus diets or in children ( 0 to 24 months), which can cause increased bone resorption, hypercalciuria, osteomalacia

Pregnancy and breastfeeding

The medicine should only be used when needed, under the direct supervision of the doctor, after evaluating the expected benefit to the mother in relation to the possible risk to the fetus or infant.

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.

Special warnings

Aluminum hydroxide can cause constipation and an overdose of magnesium salts can cause hypomotility of the intestine; high doses of this medicine may cause or aggravate intestinal obstruction and ileus in patients at higher risk, such as those with renal impairment, with underlying constipation, with impaired bowel motility, in children (0 to 24 months) , or 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 low phosphorus diets or children (0 to 24 months), can lead to phosphate elimination (due to an aluminum-phosphate bond) accompanied by an increase in bone resorption and hypercalciuria with risk of osteomalacia. It is advisable to consult your doctor in case of long-term use or in patients at risk of hypophosphataemia. In patients with renal impairment, plasma levels of aluminum and magnesium tend to increase causing hyperalluminaemia and hypermagnesaemia, respectively. In these patients, long exposures to high doses of aluminum and magnesium salts can lead to encephalopathies, dementia, microcytic anemia or worsening of dialysis osteomalacia. In the presence of mild and moderate forms of renal insufficiency it is recommended to take the product under the direct supervision of the doctor. Prolonged use of the medicinal product 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.

Expiration and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

One tablet of Maalox Sugar Free 400mg + 400mg Lemon contains:

Active principle

Magnesium hydroxide 400 mg, aluminum oxide hydrate 400 mg.

Excipients

Non crystallizable liquid sorbitol, maltitol, glycerol 85 percent, sodium saccharin, lemon flavor, talc, magnesium stearate.