MAALOX PLUS*30CPR MAST

  • SANOFI Srl
  • 020702080

-For burning and gastric pain

-Even in case of swelling

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MAALOX PLUS*30CPR MAST

Therapeutic indications

Symptomatic treatment of hyperacidity (including burning and pain) also in the case of esophagitis, and of hyperacidity when accompanied by dyspepsia. Symptomatic treatment of gastrointestinal swelling when accompanied by hyperacidity.

Dosage and method of use

MAALOX PLUS 3.65% + 3.25% + 0.5% oral suspension. Dosage: Do not exceed the maximum doses indicated unless on medical prescription. Ingest 2-4 teaspoons (10-20ml) 4 times a day, 20-60 minutes after meals and at bedtime. Method of administration: Shake well before use. It can be diluted in water or milk. MAALOX PLUS 200 mg + 200 mg + 25 mg chewable tablets. Dosage: Do not exceed the maximum doses indicated unless on medical prescription. 2-4 tablets 4 times a day well chewed or sucked, 20-60 minutes after meals and before bedtime. Method of administration: The tablets should be well chewed or sucked. Their intake can be followed by ingestion of water or milk. Pediatric population: Pediatric administration of the drug is not recommended.

Contraindications

- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. - Patients with porphyria. - Severe forms of renal insufficiency (creatinine clearance less than 30 mL / min). - 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 (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: hypermagnesaemia, including observations after prolonged administration to patients with renal impairment; Frequency not known: hyperalluminaemia, hypophosphataemia, during prolonged use or at high doses or even at normal doses of the drug 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 reactions. Reporting 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 hypermotility 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 medical supervision. Prolonged use of antacids in patients with mild and moderate forms of renal insufficiency should be avoided. Administration of this medicinal product is contraindicated in subjects with severe forms of renal insufficiency (see section 4.3). Aluminum hydroxide may not be safe in patients with porphyria undergoing hemodialysis (see section 4.3). Maalox Plus, due to its composition, has no tendency to modify the behavior of the hive. However, in some particularly sensitive subjects and for high dosages, an acceleration of intestinal transit is possible. MAALOX PLUS 3.65% + 3.25% + 0.5% oral suspension contains: - parahydroxybenzoates: they can cause allergic reactions (even delayed). - 448 mg of sorbitol in 10 ml (2 tsp). Patients with hereditary fructose intolerance should not be given this medicine. - less than 1 mmol (23 mg) of sodium per dose, ie it is essentially “sodium-free”. MAALOX PLUS 200 mg + 200 mg + 25 mg chewable tablets contains: - about 15 mg of sorbitol, per tablet. The additive effect of co-administration of sorbitol (or fructose) containing medicinal products and the daily dietary intake of sorbitol (or fructose) must be considered. The content of sorbitol in oral medicinal products may modify the bioavailability of other co-administered oral medicinal products. - about 500 mg of glucose, per tablet: to be taken into consideration in people with diabetes mellitus, if more than 10 tablets are taken per day; Patients with rare glucose-galactose malabsorption problems should not take 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) of sodium per tablet, ie 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.

Pregnancy and breastfeeding

There are no data on the use of MAALOX PLUS in pregnant women. It is not possible to determine whether or not the use of MAALOX PLUS during pregnancy is safe. Pregnancy: 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. Feeding time: Due 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.

Expiry and retention

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

Interactions with other drugs

As 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 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, rosenotexine, methylaminol, neurotyruvamine, propensol-methylenol, neurotyruvine, propenol-methylenol, lincosamides iron salts. • Polystyrene sulphonate (Kayexalate): Caution is recommended when the medicinal product is taken together with polystyrene sulphonate (Kayexalate) due to the potential risk of reduced efficacy of the resin in binding potassium, of metabolic alkalosis in patients with renal impairment (reported with hydroxide of aluminum and magnesium hydroxide), and intestinal obstruction (reported with aluminum hydroxide). • Aluminum hydroxide and citrates can cause hyperalluminaemia, especially in patients with renal impairment. Since the use of magnesium hydroxide causes the urine to alkalize, increased excretion of salicylates has been observed when administered concurrently. 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 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.

Active principles

100 ml of suspension contain: Active principles: magnesium hydroxide 3.65 g; aluminum hydroxide 3.25 g; dimethicone 0.50 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 principles: magnesium hydroxide 200 mg; aluminum oxide, hydrate 200 mg; dimethicone 25 mg. Excipient (s) with known effect: glucose, sucrose, sorbitol. For the full list of excipients, see section 6.1.

Excipients

MAALOX PLUS 3.65% + 3.25% + 0.5% oral suspension: Methylcellulose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, carmellose, hydroxypropylcellulose, citric acid, sodium saccharin, non-crystallizable liquid sorbitol, lemon flavor, Swiss cream flavor, purified water. MAALOX PLUS 200 mg + 200 mg + 25 mg chewable tablets: Maize starch, citric acid, pregelatinised starch, glucose, mannitol, sucrose, sorbitol, non crystallizable liquid sorbitol, talc, magnesium stearate, sodium saccharin, lemon flavor, Swiss cream flavor, E 172.

SANOFI Srl
020702080
12 Items