Maalox 400mg + 400mg 40 chewable tablets

Maalox 400mg + 400mg is an antacid drug in chewable tablets , formulated with magnesium hydroxide and aluminum hydroxide . Thanks to its double action, it quickly neutralizes excess acid in the stomach, providing rapid relief from heartburn, acidity and gastroesophageal reflux . It is indicated to combat occasional gastric disorders caused by stress, poor diet or consumption of irritating foods. The chewable tablets are practical and have a pleasant taste, ideal for immediate relief, anywhere and at any time.

ACTIVE INGREDIENTS

Active ingredients contained in Maalox 400mg + 400mg 40 chewable tablets - What is the active ingredient in Maalox 400mg + 400mg 40 chewable tablets?

100 ml of suspension contains : - Active ingredients: magnesium hydroxide 3.65 g aluminium hydroxide 3.25 g Excipient(s) with known effect: methyl parahydroxybenzoate, propyl parahydroxybenzoate, sorbitol. For the full list of excipients, see section 6.1. One tablet contains : - Active ingredients: magnesium hydroxide 400 mg aluminium oxide hydrate 400 mg Excipient(s) with known effect: sucrose powder with starch, sucrose, sorbitol, benzyl alcohol (contained in the excipient mint flavour powder) (see sections 4.4 and 4.6). For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Maalox 400mg + 400mg 40 chewable tablets - What does Maalox 400mg + 400mg 40 chewable tablets contain?

MAALOX 3.65% + 3.25% oral suspension Methyl parahydroxybenzoate, propyl parahydroxybenzoate, citric acid monohydrate, non-crystallizing liquid sorbitol, mannitol, mint essence, sodium saccharin, purified water. MAALOX 400 mg + 400 mg chewable tablets Sucrose powder with starch, sorbitol, mannitol, magnesium stearate, mint flavouring powder (contains benzyl alcohol), sodium saccharin, sucrose.

DIRECTIONS

Therapeutic indications Maalox 400mg + 400mg 40 chewable tablets - Why is Maalox 400mg + 400mg 40 chewable tablets used? What is it for?

Symptomatic treatment of occasional heartburn and hyperacidity of the stomach.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Maalox 400mg + 400mg 40 chewable tablets - When should Maalox 400mg + 400mg 40 chewable tablets not be used?

- Hypersensitivity to the active substances or to any of the excipients listed in paragraph 6.1. - Patients with porphyria. - Severe forms of renal insufficiency (see paragraph 4.4). - Generally contraindicated in pediatric age. - State of cachexia.

DOSAGE

Quantity and method of taking Maalox 400mg + 400mg 40 chewable tablets - How to take Maalox 400mg + 400mg 40 chewable tablets?

MAALOX 3.65% + 3.25% oral suspension Dosage Swallow 2 to 4 teaspoons (10-20 ml), 4 times a day, 20-60 minutes after meals and at bedtime. Method of administration Shake well before use. It can also be taken in water or milk. MAALOX 400 mg + 400 mg chewable tablets Dosage 1-2 tablets 4 times a day well chewed or sucked, 20-60 minutes after meals and at bedtime. 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 medicinal product in paediatric age is not recommended. Do not exceed the maximum indicated dose.

CONSERVATION

Storage Maalox 400mg + 400mg 40 chewable tablets - How to store Maalox 400mg + 400mg 40 chewable tablets?

MAALOX 3.65% + 3.25% oral suspension : Do not store below 4°C. Keep the bottle tightly closed. MAALOX 400 mg + 400 mg chewable tablets This medicinal product does not require any special storage conditions.

WARNINGS

Warnings Maalox 400mg + 400mg 40 chewable tablets - About Maalox 400mg + 400mg 40 chewable tablets it is important to know that:

Aluminium hydroxide may cause constipation and an overdose of magnesium salts may 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, with underlying constipation, with impaired intestinal motility, in children (0 to 24 months), or in the elderly. Aluminium 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 excretion (due to an aluminium-phosphate bond) accompanied by increased bone resorption and hypercalciuria with 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 levels of aluminium and magnesium tend to increase, causing hyperaluminemia and hypermagnesemia, respectively. In these patients, long-term exposure to high doses of aluminium and magnesium salts may 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. Prolonged use of the medicinal product should be avoided in these patients. Aluminium hydroxide may not be safe in patients with porphyria undergoing haemodialysis (see section 4.3). Paediatric population In young children, the use of magnesium hydroxide may lead to hypermagnesemia, particularly if they have renal impairment or dehydration. MAALOX 3.65% + 3.25% oral suspension contains : • parahydroxybenzoates : may cause allergic reactions (even delayed). • approximately 98 mg of sorbitol in 10 ml (2 teaspoons). Patients with hereditary fructose intolerance should not be given this medicine. • less than 1 mmol (23 mg) sodium per dose, that is to say essentially “sodium-free”. MAALOX 400 mg + 400 mg chewable tablets contain : • approximately 125 mg sorbitol per tablet. Patients with hereditary fructose intolerance should not be given this medicine. • Sucrose , patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. • less than 1 mmol (23 mg) sodium per dose, that is to say essentially “sodium-free”. • 0.000072 mg benzyl alcohol per tablet. Benzyl alcohol may cause allergic reactions. • Large volumes should be used with caution and only if necessary, during pregnancy and breastfeeding and in patients with hepatic or renal insufficiency, due to the risk of accumulation and toxicity (metabolic acidosis).

INTERACTIONS

Interactions Maalox 400mg + 400mg 40 chewable tablets - Which medicines or foods can modify the effect of Maalox 400mg + 400mg 40 chewable tablets?

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 antacids containing aluminum may 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, lincosamides, metoprolol, phenothiazine neuroleptics, penicillamine, propranolol, rosuvastatin, iron salts. • Polystyrene sulfonate (Kayexalate) Caution is advised when the medicinal product is taken 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 aluminium hydroxide and magnesium hydroxide), and intestinal obstruction (reported with aluminium hydroxide). • Aluminium hydroxide and citrates may cause hyperaluminemia, especially in patients with renal impairment. Allow at least two hours (4 hours for fluoroquinolones) to elapse before taking MAALOX to avoid interactions with other drugs. Concomitant use of quinidine may increase serum quinidine levels and lead to quinidine overdose. Concomitant use of aluminium hydroxide and citrates may increase aluminium levels, particularly in patients with renal insufficiency. Alkalinization of urine following administration of magnesium hydroxide may alter the excretion of some drugs; therefore, increased excretion of salicylates was observed.

SIDE EFFECTS

Like all medicines, Maalox 400mg + 400mg 40 chewable tablets can cause side effects - What are the side effects of Maalox 400mg + 400mg 40 chewable tablets?

The frequency of adverse reactions listed 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 (cannot be estimated from the available data). Immune system disorders. Frequency not known : angioedema, anaphylactic reactions, hypersensitivity reactions, urticaria, pruritus. Gastrointestinal disorders. Uncommon : diarrhoea or constipation (see section 4.4); Frequency not known : abdominal pain. Metabolism and nutrition disorders. Very rare : hypermagnesaemia, including observations after prolonged administration to patients with renal impairment; Frequency not known: hyperaluminaemia, hypophosphatemia, 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 may cause increased bone resorption, hypercalciuria, osteomalacia (see section 4.4). Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. 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

Maalox 400mg + 400mg 40 chewable tablets Overdose - What are the risks of Maalox 400mg + 400mg 40 chewable tablets in case of overdose?

Experience with deliberate overdose is very limited. Cases of overdose with aluminium salts are more likely to occur 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 aluminium hydroxide and in combination with magnesium salts include diarrhoea, 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 general supportive measures. Aluminium and magnesium are eliminated by urinary excretion; treatment of magnesium overdose includes rehydration and forced diuresis. In cases of renal insufficiency, haemodialysis or peritoneal dialysis is necessary.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Maalox 400mg + 400mg 40 chewable tablets.

Pregnancy The medicinal product should be used only in case of necessity, under the direct supervision of a doctor, after evaluating the expected benefit for the mother in relation to the possible risk for the foetus or the infant. Breastfeeding Due to the limited maternal absorption when taken according to the indicated dosage regimen (see section 4.2), aluminium 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 breastfeeding, due to the risk of accumulation and toxicity (metabolic acidosis) (see section 4.4).

DRIVING AND USE OF MACHINERY

Taking Maalox 400mg + 400mg 40 chewable tablets before driving or using machines - Does Maalox 400mg + 400mg 40 chewable tablets affect driving or using machines?

MAALOX does not alter the ability to drive vehicles or use machinery.