MAALOX S/Z 30CPR LIMO400+400MG

MAALOX 400 MG + 400 MG STRUCTURAL FUNCTIONS

active ingredients

One tablet contains: - Active ingredients: magnesium hydroxide 400 mg aluminum oxide, idrate 400 mg excipient(s) with known effects: - Chewable aroma tablets red fruits: sorbitol and maltyt. - Chewable lemon aroma tablets: sorbitol, maltitol and benzilic alcohol (contained in the excipient lemon aroma) (see paragraphs 4.4 and 4.6). For the full list of excipients, see section 6.1.

Excellent

MAALOX 400 mg + 400 mg chewable lemon aroma tabletsLiquid Sorbitol (not crystallized), maltitol, glycerol (at 85 percent), sodium saccharin, lemon aroma (contains benzilic alcohol), talc, magnesium stearate. MAALOX 400 mg + 400 mg chewable aroma red fruits Liquid sorbitol (non-crystallizing), maltitol, glycerol (85 percent), sodium saccharin, red fruit flavoring, talc, magnesium stearate.

Therapeutic indications

Syntomatic treatment of burning and the hyperacidity of the occasional stomach.

Contraindications

- Hypersensitivity to active ingredients or any of the excipients listed in paragraph 6.1. - Patients with porphyry. - Severe forms of kidney failure (see paragraph 4.4). - Generally contraindicated in pediatric age. - Cachesia state.

Population

Population 1-2 tablets 4 times a day well chewed or sucked, 20-60 minutes after meals and before bedtime. Method of administration Tablets should be well chewed or sucked. Their intake may be followed by ingestion of water or milk. Pediatric population The administration of the medicinal product in pediatric age is not recommended. Do not exceed the maximum dose indicated.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Hydroxide aluminum can cause constipation and overdose of magnesium salts can cause hypomotility of the intestine; high doses of this medicine can cause or aggravate intestinal and ileo obstruction in patients at higher risk, such as those with kidney impairment, with basic stips, with alteration of intestinal motility, in children (from 0 to 24 months), or elderly. Hydroxide aluminium is not well absorbed by the gastrointestinal tract, and systemic effects are therefore rare in patients with normal kidney function. However, excessive doses or long-term use, or even normal doses in patients with poor phosphorus diets or in children (from 0 to 24 months), can lead to elimination of phosphate (due to an aluminum-phosphate bond) accompanied by an increase in bone reabsorption and hypercalciuria with risk of osteomalacia. It is recommended to consult your doctor in case of long-term use or in patients at risk of hypophosphateemia. In patients with renal impairment plasma levels of aluminum and magnesium tend to increase causing hyperalluminemia and hypermagnesiemia respectively. In these patients, long exposures at high doses of aluminum and magnesium salts can lead to encephalopathy, dementia, microcytic anemia or worsening of osteomalacia from dialysis. In the presence of mild and moderate forms of kidney failure it is recommended to take the product under the direct control of the doctor. In these patients, prolonged use of the medicine must be avoided. Hydroxide aluminium may not be safe in patients with porphyry under hemodialysis (see paragraph 4.3). MAALOX chewable tablets with red fruit flavour contains:- approximately 110 mg of sorbitol per tablet and maltitol. Patients with hereditary fructose intolerance should not be given this medicine. - less than 1 mmol (23 mg) of sodium by tablet, that is, it is essentially “without sodium”. MAALOX chewable tablets lemon aroma contains: - approximately 110 mg of sorbitol per tablet and maltitol. Patients with hereditary fructose intolerance should not be given this medicine. - less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially “sodium-free”.- 0.000068 mg of alcohol benzig 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). Pediatric population In small children the use of hydroxide magnesium can lead to hypermagnesemia, especially if they have kidney damage or dehydration.

Interactions

As Al and Mg salts reduce gastroenteric absorption of tetracyclines it is recommended to avoid taking Maalox during tetracycline therapy by mouth. The use of antacids containing aluminum can reduce the absorption of drugs such as H₂-antagonists, atenolol, cefdinir, cefpodoxime, chlorochina, tetracycline, diflunisal, digoxin, bisphosphonate, etambutol, fluoroquinolone, sodium fluoride, glucocorticoids, indometacin, isoniazide, ketoconazole, levotiroxin, linomycin. • Sulphonate polystyrene (Kayexalate) It is recommended caution when the medicine is taken along with sulphonate polystyrene (Kayexalate) due to the potential risk of reduced resin effectiveness in binding potassium, metabolic alkalosis in patients with kidney impairment (marked with aluminum hydroxide and magnesium hydroxide), and intestinal obstruction (marked with aluminum hydroxide). • Aluminium and citrate hydroxide can cause hyperalluminemia, especially in patients with renal impairment. Allow to spend at least two hours (4 for fluoroquinolone), before taking MAALOX to avoid interaction with other drugs. The contemporary use of chinidine can determine the increase of chinidine levels in serum and lead to overdose of chinidine. The contemporary use of hydroxide and citrates can lead to an increase in aluminium levels, particularly in patients with kidney failure. Alcalinization of urine after administration of hydroxide magnesium may change the excretion of certain drugs; therefore, a greater excretion of salicylates has been observed.

Effects

The frequency of the desired effects below is defined using the following conventions: common (≥1/100, Immune disorders. Frequency not known: angioedema, anaphylactic reactions, reactions of hypersensitivity, hives, itching. Gastrointestinal disease. Not common: diarrhea or stipsi (see paragraph 4.4); Frequency not known: abdominal pain. Disorders of metabolism and nutrition. Very rare: hypermagnesemia, including observations after prolonged administration to patients with kidney damage; Unknown frequency (frequency cannot be defined on the basis of available data): hyperalluminemia, hypophosphateemia, during prolonged use or at high doses or even at normal doses of the medicinal product in patients with poor phosphorus diets or in children (from 0 to 24 months), which may cause an increase in bone reabsorption, hypercalciuria, osteomalacia (see paragraph 4.4). Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

The experience on deliberate overdose is very limited. Overdose cases with aluminum salts can occur more easily in patients with chronic severe kidney impairment with following symptoms: encephalopathy, convulsions and dementia, hypermagnesiemia. The most frequently reported symptoms of acute overdose with hydroxide aluminum and in combination with magnesium salts include diarrhea, abdominal pain and vomiting. High doses of this medicine may cause or aggravate intestinal and ileo obstruction in risky patients (see paragraph 4.4). As in all cases of overdose the treatment must be symptomatic, adopting generic support measures. Aluminium and magnesium are eliminated by urinary excretion; the treatment of overdose from magnesium provides rehydration and forced diuresis. In case of kidney failure it is necessary hemodialysis or peritoneal dialysis.

Pregnancy

The medicine should only be used in case of need, under the direct control of the doctor, after evaluating the expected benefit for the mother in relation to the possible risk for the fetus or the infant.

Food

Following the limited maternal absorption when taken according to the indicated posological regime (see Section 4.2), hydroxide aluminum and its combinations with magnesium salts are considered compatible with breastfeeding. Large volumes of benzyl alcohol must be used with caution and only if necessary during pregnancy and lactation, due to the risk of accumulation and toxicity ( metabolic acidosis) (see paragraph 4.4).

Source: Farmadati