Maalox Plus 4% + 3.5% + 0.5% 250 ml oral suspension lemon and mint

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Symptomatic treatment of hyperacidity (including burning and pain) even in case of esophagitis, and hyperacidity when accompanied by dyspepsia. Symptomatic treatment of gastro-intestinal swelling when accompanied by hyperacidity.

CONTRAINDICATIONS

-Hypersensitivity to the active substances or to any of the excipients, listed in paragraph 6.1; -Patients suffering from porphyria (see section 4.4); -Severe forms of renal failure (creatinine clearance less than 30 mL/min) (see section 4.4); -Contraindicated in pediatric age (see paragraph 4.2); -State of cachexia.

WARNINGS AND PRECAUTIONS FOR USE

Aluminum hydroxide can cause constipation and an overdose of magnesium salts can cause intestinal hypermotility (see section 4.8); high doses of this medicinal product may cause or aggravate intestinal and ileal obstruction in patients at higher risk, such as those with renal impairment, with underlying constipation, with impaired intestinal motility, in children (0 to 24 months), or elderly (see section 4.9). 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 on low phosphorus diets or in children (0 to 24 months), may lead to phosphate elimination (due to an aluminium-phosphate bond) accompanied by increased bone resorption and hypercalciuria with risk of osteomalacia (see section 4.8). It is advisable to monitor patients in case of long-term use or patients at risk of hypophosphatemia. In patients with renal impairment, plasma levels of aluminum and magnesium tend to increase, causing hyperaluminemia and hypermagnesemia, respectively. In these patients, long exposure to high doses of aluminum and magnesium salts can lead to encephalopathies, dementia, microcytic anemia or worsening of dialysis-induced osteomalacia. In the presence of mild and moderate forms of renal impairment, the medicine must be taken under medical supervision and prolonged use of the medicine must be avoided. The administration of this medicine in subjects suffering from severe forms of renal failure is contraindicated (see section 4.3). Aluminum hydroxide may be unsafe in porphyria patients undergoing hemodialysis; MAALOX PLUS is contraindicated in patients suffering from porphyria (see section 4.3). MAALOX PLUS, due to its composition, has no tendency to modify the behavior of the bird. However, in some particularly sensitive subjects and for high doses, an acceleration of intestinal transit may occur. This medicine contains 448 mg of sorbitol (E420) in 10 ml (2 teaspoons). Patients with hereditary fructose intolerance should not be given this medicine. This medicine contains 8.2 mg of ethanol in 10 ml (2 teaspoons). 10 ml of this medicine is equivalent to 0.2 ml of beer or 0.1 ml of wine. The small amount of alcohol in this medicine will not produce any noticeable effects. This medicine contains invert sugar and sucrose: Patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine. This medicine contains sulfur dioxide (E220): rarely it can cause serious hypersensitivity reactions and bronchospasm. This medicinal product contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially 'sodium-free'. Pediatric population In young children, the use of magnesium hydroxide can lead to hypermagnesemia, particularly if they have kidney damage or dehydration.

INTERACTIONS

Since Al and Mg salts reduce the gastrointestinal absorption of tetracyclines, it is recommended to avoid taking MAALOX PLUS during oral tetracycline therapy. The use of aluminum-containing antacids may reduce the absorption of drugs in particular H2-antagonists, atenolol, bisphosphonates, cefdinir, cefpodoxime, chloroquine, tetracyclines, dasatinib monohydrate, diflunisal, digoxin, dexamethasone, eltrombopag olamine, elvitegravir, ethambutol, fluoroquinolones, glucocorticoids, indomethacin, iron salts, isoniazid, ketoconazole, levothyroxine, lincosamides, metoprolol, nilotinib, phenothiazine neuroleptics, penicillamines, propranolol, raltegravir potassium, rilpivirine, riociguat, rosuvastatin, sodium fluoride and antiviral treatments in combination with tenofovir alafenamide fumarate/emtricitabine/sodium bictegravir. Since the use of magnesium hydroxide causes alkalinization of the urine, increased excretion of salicylates has been observed when administered simultaneously. Caution is advised when the medicinal product is taken together 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 can cause hyperaluminemia, especially in patients with renal impairment. The combination with the integrase inhibitors (dolutegravir, raltegravir, bictegravir) and MAALOX PLUS should be avoided (refer to the respective SmPCs for dose recommendations). As a precaution, allow at least 2 hours (4 for fluoroquinolones) to pass between taking any oral medication and MAALOX PLUS. Concomitant 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 failure. The alkalinization of the urine following the administration of magnesium hydroxide can modify the excretion of some drugs; therefore, increased excretion of salicylates was observed.

SIDE EFFECTS

The frequency of the side effects reported 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: 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: hyperaluminemia, hypophosphatemia, during prolonged use or at high doses or even at normal doses of the medicine in patients with low phosphorus diets or in children (0 to 24 months), which may cause increased bone resorption, hypercalciuria, osteomalacia (see section 4.4). Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance 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.