MAALOX PLUS OS SOSP 4+3,5+0.5%

MAALOX PLUS 4% + 3.5% + 0.5% ORAL SOSPENSION AROMA LIMONE

active ingredients

100 ml of suspension contain: Active ingredients: magnesium hydroxide 4,0 g; hydroxide aluminum 3.5 g; aluminium oxide equivalent 2.3 g; symeticons 0.50 g. Excipients with known effects: 10 ml contain 0.348 mg of sodium and 448 mg of sorbitol. For the full list of excipients, see paragraph 6.1.

Excellent

Domifene bromuro, citric acid monohydrate, sodium pouch, , sorbitol 70% non crystallized liquid (E420), methylcellulose, hydroxypropylcellulose, microcrystalline cellulose and sodium carmellose, hydrogen peroxide solution 30%, lemon aroma, Swiss cream aroma and purified water.

Therapeutic indications

Symptomatic treatment of hyperacidity (including burning and pain) even in case of esophagitis, and hyperacidity when accompanied by dyspepsia. Symptomatic treatment of gastro-intestinal swelling when accompanied by hyperacidity.

Contraindications

- Hypersensitivity to active ingredients or any of the excipients listed in the paragraph 6.1. - Patients with porphyry (see paragraph 4.4). - Serious forms of kidney failure (cancers of creatine less than 30 mL/min) (see paragraph 4.4). - Contraindicated in pediatric age (see paragraph 4.2). - Cachesia state.

Population

Population Inger 2-4 teaspoons (10-20 ml) oral suspension 4 times a day, 20-60 minutes after meals and before bedtime. It can be diluted in water or milk. Do not exceed the maximum indicated dose of 16 teaspoons. Pediatric population MAALOX PLUS 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 30°C. For storage conditions after first opening see paragraph 6.3.

Warnings

Hydroxide aluminum can cause constipation and overdose of magnesium salts can cause hypermotility 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 PLUS is contraindicated in patients with porphyry (see paragraph 4.3). MAALOX PLUS, for its composition, has no tendency to change the behaviour of the egg. However, in some particularly sensitive subjects and for high dosages, it is possible to accelerate intestinal transit. This medicine contains 448 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, i.e. 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 MAALOX PLUS 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. Since the use of hydroxide magnesium causes alkalinization of urine, a greater excretion of salicylates was observed if administered simultaneously. 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 PLUS 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, hypersensitivity reactions, 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: hypermagnesiemia, 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 the address 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.

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

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