Maalox plus 30 chewable tablets

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.

ACTIVE INGREDIENTS

100 ml of suspension contain: Active ingredients: magnesium hydroxide 3.65 g, aluminum hydroxide 3.25 g, dimethicone 0.50 g. Excipient(s) with known effects: methyl parahydroxybenzoate, propyl parahydroxybenzoate, ethanol, invert sugar, sucrose, sulfur dioxide (E 220), sorbitol (E420) 4.48 g/ 100ml (see section 4.4). For the full list of excipients, see section 6.1. One tablet contains: Active ingredients: magnesium hydroxide 200 mg, aluminum oxide, hydrate 200 mg, dimethicone 25 mg. Excipient(s) with known effects: glucose, sucrose, sorbitol (E420) 45 mg per tablet (see section 4.4). For the full list of excipients, see section 6.1.

EXCIPIENTS

MAALOX PLUS 3.65% + 3.25% + 0.5% oral suspension: Methyl cellulose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, carmellose, hydroxypropyl cellulose, citric acid, sodium saccharin, sorbitol (E420) non-crystallizable liquid, lemon flavor (containing ethanol), Swiss cream flavor (containing ethanol, invert sugar, sucrose, sulfur dioxide (E 220)), purified water. MAALOX PLUS 200 mg + 200 mg + 25 mg chewable tablets: Corn starch, citric acid, pregelatinized starch, glucose, mannitol, sucrose, sorbitol (E420), non-crystallizable liquid sorbitol, talc, magnesium stearate, sodium saccharin, lemon flavoring, Swiss cream flavoring, E 172.

CONTRAINDICATIONS AND SIDE EFFECTS

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

DOSAGE

MAALOX PLUS 3.65% + 3.25% + 0.5% oral suspension Dosage Do not exceed the maximum doses indicated unless prescribed by a doctor. Swallow 2-4 teaspoons (10-20 ml) 4 times a day, 20-60 minutes after meals and before bed. Method of administration Shake well before use. It can be diluted in water or milk. MAALOX PLUS 200 mg + 200 mg + 25 mg chewable tabletsDosage Do not exceed the maximum doses indicated unless prescribed by a doctor. 2-4 tablets 4 times a day, well chewed or sucked, 20-60 minutes after meals and before going to bed. Method of administration The tablets should be well chewed or sucked. Their intake can be followed by ingestion of water or milk. Pediatric population Administration of the medicine in pediatric age is not recommended.

CONSERVATION

Oral suspension: Do not store below 4°C. Bottle: keep the bottle tightly closed. Chewable tablets: Store below 25°C.

WARNINGS

Aluminum hydroxide can cause constipation and an overdose of magnesium salts can cause hypermotility of the intestine; high doses of this medicine may cause or aggravate intestinal and ileal obstruction in patients at higher risk, such as those with renal impairment, with underlying constipation, with alteration of intestinal 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 on low-phosphorus diets or in children (0 to 24 months), can lead to phosphate elimination (due to an aluminium-phosphate bond) accompanied by increased 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 hypophosphatemia. In patients with renal impairment, plasma levels of aluminum and magnesium tend to increase, causing hyperaluminemia and hypermagnesemia, respectively. In these patients, long exposures 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 failure it is advisable to take the product under the supervision of a doctor. Prolonged use of antacids in patients with mild and moderate forms of renal insufficiency should be avoided. The administration of this medicine is contraindicated in subjects suffering from severe forms of renal failure (see section 4.3). Aluminum hydroxide may be unsafe in porphyria patients undergoing haemodialysis (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. MAALOX PLUS 3.65% + 3.25% + 0.5% oral suspension contains: - parahydroxybenzoates: may cause allergic reactions (even delayed); - 448 mg of sorbitol (E420) in 10 ml (2 teaspoons). Patients with hereditary fructose intolerance should not be given this medicine; - ethanol: This medicine contains 9.5 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 significant effects; - sucrose and invert sugar: patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine; - sulfur dioxide (E 220): rarely can cause serious hypersensitivity reactions and bronchospasm; - less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially “sodium-free”. MAALOX PLUS 200 mg + 200 mg + 25 mg chewable tablets contains: - 45 mg of sorbitol, per tablet. The additive effect of co-administration of medicinal products containing sorbitol (or fructose) and daily dietary intake of sorbitol (or fructose) should be considered. The sorbitol content in oral medicinal products may modify the bioavailability of other co-administered oral medicinal products. Patients with hereditary fructose intolerance should not be given this medicine. - approximately 500 mg of glucose, per tablet: to be taken into consideration in people suffering from diabetes mellitus, if they take more than 10 tablets per day; Patients suffering from rare problems of glucose-galactose malabsorption should not take this medicine. - sucrose; Patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine. - less than 1 mmol (23 mg) of sodium per tablet, 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. • Polystyrene sulfonate (Kayexalate) 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). Since the use of magnesium hydroxide causes alkalinization of the urine, increased excretion of salicylates has been observed when administered simultaneously. 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 (frequency cannot be estimated from the available data): 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.

OVERDOSE

Experience with deliberate overdose is very limited. Cases of overdose with aluminum salts may occur more easily in patients with severe chronic 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 medicinal product may cause or aggravate intestinal and ileal obstruction in patients at risk (see section 4.4). As in all cases of overdose, treatment must be symptomatic, adopting general supportive measures. Aluminum and magnesium are eliminated through urinary excretion; treatment of magnesium overdose involves rehydration and forced diuresis. In case of renal failure, hemodialysis or peritoneal dialysis is required.

PREGNANCY AND BREASTFEEDING

There are no data on the use of MAALOX PLUS in pregnant women. It is not possible to establish whether or not the use of MAALOX PLUS during pregnancy is safe. Pregnancy The medicine must 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 for the fetus or infant. Breastfeeding Due to limited maternal absorption when taken according to the indicated dosing regimen (see section 4.2), aluminum hydroxide and its combinations with magnesium salts are considered compatible with breastfeeding.

EFFECTS ON DRIVING ABILITY

MAALOX PLUS does not alter the ability to drive and use machines.