Sanofi Maalox Plus product 30 Chewable Tablets

NAME
MAALOX PLUS ORAL SUSPENSION / CHEWABLE TABLETS

PHARMACOTHERAPEUTIC CATEGORY
Associated antacids.

ACTIVE PRINCIPLES
100 ml of suspension contain: magnesium hydroxide; aluminum hydroxide; dimethicone. One tablet contains: magnesium hydroxide; aluminum oxide, hydrate; dimethicone.

EXCIPIENTS
Oral suspension 3.65% + 3.25% + 0.5%: methylcellulose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, carmellose, hydroxypropylcellulose, citric acid, sodium saccharin, non-crystallizable liquid sorbitol, lemon flavor, Swiss cream flavor, water purified Chewable tablets 200 mg + 200 mg + 25 mg: corn starch, citric acid, pregelatinised starch, glucose, mannitol, sucrose, sorbitol, non crystallizable liquid sorbitol, talc, magnesium stearate, sodium saccharin, lemon flavoring, flavoring Swiss cream, E 172.

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.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active ingredients or to any of the listed excipients; patients with porphyria; severe forms of renal insufficiency (creatinine clearance less than 30 mL / min); generally contraindicated in pediatric age; state of cachexia.

DOSAGE
Oral suspension 3.65% + 3.25% + 0.5%: do not exceed the maximum doses indicated unless on medical prescription. Ingest 2-4 teaspoons 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. Chewable tablets 200 mg + 200 mg + 25 mg: 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.

STORAGE
Oral suspension: Do not store below 4 degrees C. Bottle: keep the bottle tightly closed. Chewable Tablets: Store below 25 degrees C.

WARNINGS
Aluminum hydroxide can cause constipation and an overdose of magnesium salts can cause hypomotility of the intestine; high doses of this medicine can cause or aggravate intestinal obstruction and ileus in patients at higher risk, such as those with renal impairment, with basic constipation, with impaired intestinal motility, in children (0 to 24 months ), or the 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 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 supervision of a doctor. Prolonged use of the medicinal product should be avoided in these patients. Prolonged use of the medicinal product should be avoided in these patients. Aluminum hydroxide may not be safe in patients with porphyria undergoing hemodialysis. The drug, due to its composition, has no tendency to modify the behavior of the hive. However, in some particularly sensitive subjects for high dosages, it is possible to experience an acceleration of intestinal transit. Oral suspension contains: parahydroxybenzoates; sorbitol. Chewable Tablets: Contains sorbitol, sucrose and glucose.

INTERACTIONS
Since Al and Mg salts reduce the gastrointestinal absorption of etetracyclines, it is recommended to avoid taking the drug during oral tetracycline therapy. The use of aluminum-containing antacids can reduce the absorption of drugs such as H2 antagonists, atenolol, cefdinir, cefpodoxime, chloroquine, tetracyclines, diflunisal, digoxin, bisphosphonates, ethambutol, fluoroquinolones, sodium fluoride, glucocorticoids, indomethacin, isoniazid , ketoconazole, levothyroxine, lincosamides, metoprolol, phenothiazine neuroleptics, penicillamines, propranolol, rosuvastatin, iron salts. Polystyrene sulphonate (Kayexalate): caution is recommended when 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 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 the product to avoid interaction with other drugs. 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 insufficiency.

SIDE EFFECTS
The frequency of the undesirable 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. Disorders of the immune system. Frequency not known: angioedema, anaphylactic reactions, hypersensitivity reactions, urticaria, pruritus. Gastrointestinal disorders. Uncommon: diarrhea or constipation. Metabolism and nutrition disorders. Frequency not known: hypermagnesaemia, 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 an increase in bone resorption, hypercalciuria, osteomalacia. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.

PREGNANCY AND BREASTFEEDING
The medicine should be used only in case of need ', after evaluating the expected benefit to the mother in relation to the possible risk to the fetus or infant. Due to limited maternal absorption when taken according to the indicated dosage regimen, aluminum hydroxide and its combinations with magnesium salts are considered compatible with breastfeeding.