MAALOX OS SOSP 250ML 4%+3.5 %

MAALOX 4% + 3.5% ORAL SOSPENSION ONLY

active ingredients

100 ml of suspension contain: - Active ingredients: magnesium hydroxide 4,00 g hydroxide aluminum 3.5 g equivalent to aluminum oxide 2,3 g excipients with known effects: 10 ml contain 0.31 mg of sodium and 100.03 mg of sorbitol. For the full list of excipients, see paragraph 6.1.

Excellent

Hydrochloric acid (10%), citric acid (monhydrate), mint essence, mannitol (E421), domifene bromide, sodium pouch, sorbitol 70% non crystallized liquid (E420), hydrogen peroxide solution 30% and purified water.

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 (see paragraph 4.4). - Severe forms of kidney failure (see paragraph 4.4). - Contraindicated in pediatric age (see paragraph 4.2). - Cachesia state.

Population

Population Eating from 2 to 4 teaspoons (10-20 ml) oral suspension 4 times a day, 20-60 minutes after meals and before bedtime. Do not exceed the maximum indicated dose of 16 teaspoons. Pediatric population MAALOX is contraindicated in children and adolescents under 18 years of age (see paragraph 4.3). Method of administration For oral use. Shake well before use.

Conservation

Store at a temperature below 25°C. For storage conditions after first opening see paragraph 6.3.

Warnings

Hydroxide aluminum can cause constipation and overdose of magnesium salts can cause hypomotility of the intestine (see paragraph 4.8); 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 (see paragraph 4.9). 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 (see paragraph 4.8). It is recommended to monitor patients in case of long-term use or 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 renal impairment, the medicinal product must be taken under the control of the doctor and the prolonged use of the medicinal product must be avoided. The administration of this medicinal product in persons suffering from severe forms of kidney failure is contraindicated (see paragraph 4.3). Hydroxide aluminium may not be safe in patients with porphyry under hemodialysis. MAALOX is contraindicated in patients with porphyry (see paragraph 4.3). This medicine contains about 100 mg of sorbitol in 10 ml (2 teaspoons). Patients with hereditary fructose intolerance should not be given this medicine. This medicine contains less than 1 mmol (23 mg) of sodium by dose, that is, it is essentially “without sodium”. 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 intake of MAALOX during tetracyclinic therapy by mouth. The use of antacids containing aluminum can reduce the absorption of drugs such as H₂-antagonists, atenolol, cefdinir, cefpodoxima, chlorochina, tetracycline, diflunisal, digoxin, bisphosphonate, etambutol, fluoroquinolone, sodium fluoride, glucocorticoids, indometacin, isoniazide, ketoconazole, levotiroxin, linomycin. 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; Frequency not noted: hyperalluminemia, hypophosphateemia, during prolonged use or at high doses or even at normal doses of the drug 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 the following symptoms: encephalopathy, seizures and dementia, hypermagnesia. 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). Treatment should 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 paragraph 4.2), hydroxide aluminum and its combinations with magnesium salts are considered compatible with breastfeeding.

Source: Farmadati