MAALOX * S / Z 30CPR MAST400 + 400MG

MAALOX * S / Z 30CPR MAST400 + 400MG

Therapeutic indications

Symptomatic treatment of occasional heartburn and hyperacidity of the stomach.

Dosage and method of use

Dosage1-2 tablets 4 times a day well chewed or sucked, 20-60 minutes after meals and before bedtime.Method of administrationThe tablets should be well chewed or sucked. Their intake can be followed by the ingestion of water or milk.Pediatric populationPediatric administration of the drug is not recommended. Do not exceed the maximum indicated dose.

Contraindications

- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. - Patients with porphyria. - Severe forms of renal failure (see section 4.4). - 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,Disorders of the immune system. Frequency not known: angioedema, anaphylactic reactions, hypersensitivity reactions, urticaria, pruritus. Gastrointestinal disorders. Uncommon: diarrhea or constipation (see section 4.4);Frequency not known: abdominal pain. Metabolism and nutrition disorders. Very rare: hypermagnesemia, including observations after prolonged administration to patients with renal impairment;Frequency not known (frequency cannot be estimated from the available data): 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 (see section 4.4).Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

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 in 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 (see section 4.3).MAALOX chewable tablets red fruit flavor contains:- about 110 mg ofsorbitolper tablet emaltitol. Patients with hereditary fructose intolerance should not be given this medicine. - less than 1 mmol (23 mg) ofsodiumper tablet, ie it is essentially “sodium-free”.MAALOX chewable tablets lemon flavor contains:- about 110 mg ofsorbitolper tablet emaltitol. Patients with hereditary fructose intolerance should not be given this medicine. - less than 1 mmol (23 mg) ofsodiumper tablet, ie it is essentially “sodium-free”. - 0.000068 mg ofbenzyl alcoholper tablet. Benzyl alcohol can cause allergic reactions. Large volumes should be used with caution and only if necessary, during pregnancy and lactation and in patients with hepatic or renal insufficiency, due to the risk of accumulation and toxicity (metabolic acidosis).Pediatric populationIn young children, the use of magnesium hydroxide can lead to hypermagnesemia, particularly if they have kidney damage or dehydration.

Pregnancy and breastfeeding

PregnancyThe 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.Feeding timeDue to limited maternal absorption when taken according to the indicated dosage regimen (see section 4.2), aluminum hydroxide and its combinations with magnesium salts are considered compatible with breastfeeding. Large volumes of benzyl alcohol should be used with caution and only if necessary during pregnancy and lactation due to the risk of accumulation and toxicity (metabolic acidosis) (see section 4.4).

Expiry and retention

This medicine does not require any special storage conditions.

Interactions with other drugs

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 aluminum-containing antacids can reduce the absorption of drugs such as H.₂- antagonists, atenolol, cefdinir, cefpodoxime, chloroquine, tetracyclines, diflunisal, digoxin, bisphosphonates, ethambutol, fluoroquinolones, sodium fluoride, glucocorticoids, indomethacin, isoniazid, ketoconazole, levothyroxine, rosenotexin, propensol-methylenol, neurotropinol, methylaminol, neurotyruvamine, propenol-methylenol, neurotenol, methoprolamine, neurotenol iron salts. • Polystyrene sulphonate (Kayexalate) Caution is advised when the medicinal product is taken together with polystyrene sulphonate (Kayexalate) due to the potential risk of the resin's reduced efficacy in binding potassium, of 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 can cause hyperalluminaemia, especially in patients with renal impairment. Allow at least two hours (4 for fluoroquinolones) before taking MAALOX to avoid interaction with other drugs. Simultaneous use of quinidine may result in increased serum quinidine levels and lead to quinidine overdose. The simultaneous use of aluminum hydroxide and citrates can lead to an increase in aluminum levels, particularly in patients with renal insufficiency. Alkalinization of urine following administration of magnesium hydroxide can modify the excretion of some drugs; therefore, increased excretion of salicylates was observed.

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, using 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.

Active principles

One tablet contains:- Active principles:magnesium hydroxide 400 mg aluminum oxide, hydrate 400 mg Excipient (s) with known effect: - Chewable red fruit flavoring tablets: sorbitol and maltitol. - Lemon flavored chewable tablets: sorbitol, maltitol and benzyl alcohol (contained in the lemon flavored excipient) (see sections 4.4 and 4.6). For the full list of excipients, see section 6.1.

Excipients

MAALOX 400 mg + 400 mg chewable tablets lemon flavoredLiquid sorbitol (non-crystallizable), maltitol, glycerol (85 percent), sodium saccharin, lemon flavor (contains benzyl alcohol), talc, magnesium stearate.MAALOX 400 mg + 400 mg chewable tablets, red fruit flavorLiquid sorbitol (not crystallizable), maltitol, glycerol (85 percent), sodium saccharin, red fruit flavor, talc, magnesium stearate.