MAALOX PLUS 30CPR MAST

MAALOX PLUS 30CPR MAST

047521036
2222 Items
€9.30 €11.90 -€2.60

€9.30

 

MAALOX PLUS

active ingredients

100 ml of suspension contain: Active ingredients: magnesium hydroxide 3,65 g, aluminum hydroxide 3,25 g, dimeticone 0.50 g. Excipient(s) with known effects: methyl parahydroxybenzoate, propile parahydroxybenzoate, ethanol, invert sugar, sucrose, sulphur dioxide (E 220), sorbitol (E420) 4,48 g/ 100ml (see paragraph 4.4). For the full list of excipients, see paragraph 6.1. One tablet contains: Active ingredients: magnesium hydroxide 200 mg, aluminum oxide, idrate 200 mg, dimeticone 25 mg. Excipient(s) with known effects: glucose, sucrose, sorbitol (E420) 45 mg per tablet (see paragraph 4.4). For the full list of excipients, see paragraph 6.1.

Excellent

MAALOX PLUS 3.65% + 3.25% + 0.5% oral suspension: Methylcellulose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, carmellose, hydroxypropylcellulose, citric acid, sodium saccharin, sorbitol (E420) non-crystallising liquid, lemon flavouring (containing ethanol), Swiss cream flavouring (containing ethanol, invert sugar, sucrose, sulphur dioxide (E 220)), purified water. MAALOX PLUS 200 mg + 200 mg + 25 mg chewable tablets: Corn starch, citric acid, pre-gelatinized starch, glucose, mannitol, sucrose, sorbitol (E420), non-clearable liquid sorbitol, talc, magnesium stearate, sodium sac, lemon aroma, Swiss cream aroma, E 172.

Therapeutic indications

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

Contraindications

- Hypersensitivity to active ingredients or any of the excipients listed in paragraph 6.1; - Patients with porphyry; - Severe forms of kidney failure (cancer of creatine less than 30 mL/min); - Generally contraindicated in pediatric age; - Cachesia state.

Population

MAALOX PLUS 3,65% + 3,25% + 0.5% oral suspension Population Do not exceed the maximum doses indicated if not on a prescription. Inger 2-4 teaspoons (10-20 ml) 4 times a day, 20-60 minutes after meals and before bedtime. Method of administration Shake well before use. It can be diluted in water or milk. MAALOX PLUS 200 mg + 200 mg + 25 mg chewing tabletsPopulation Do not exceed the maximum doses indicated if not on a prescription. 2-4 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.

Conservation

Oral suspension: Do not store below 4°C.Bottle: Keep the bottle tightly closed. Chewable tablets: Store at a temperature below 25°C.

Warnings

Hydroxide aluminum can cause constipation and overdose of magnesium salts can cause hypermotility 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 control of the doctor. Prolonged use of antacids in patients with mild and moderate forms of kidney failure should be avoided. The administration of this medicinal product is contraindicated in persons suffering from serious forms of kidney failure (see paragraph 4.3). Hydroxide aluminium may not be safe in patients with porphyry under hemodialysis (see paragraph 4.3). Maalox Plus, for its composition, has no tendency to change the behaviour of the alvo. However, in some particularly sensitive subjects and for high dosages, it is possible to accelerate intestinal transit. MAALOX PLUS 3,65% + 3,25% + 0.5% oral suspension contains:- parahydroxybenzos: may cause allergic reactions (also delayed); - 448 mg of sorbitol (E420) in 10 ml (2 teaspoons). Patients with hereditary intolerance to fructose should not be given this medicine; - ethanol: this medicine contains 9.5 mg of ethanol in 10 ml (2 teaspoons). 10 ml of this medicine are equivalent to 0.2 ml of beer or 0.1 ml of wine. The small amount of alcohol in this medicine will not produce significant effects; - sucrose and invert sugar: patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or sucrasis-isomaltasis failure, should not take this medicine; - sulphur dioxide (E 220): rarely can cause serious reactions of hypersensitivity and bronchospasm; - less than 1 mmol (23 mg) of sodium per dose, that is, it is essentially “sodium-free”. MAALOX PLUS 200 mg + 200 mg + 25 mg chewable tablets contains: - 45 mg of sorbitol, per tablet. The additive effect of co-administration of medicinal products containing sorbitol (or fructose) and the daily intake of sorbitol (or fructose) with the diet must be considered. The content of sorbitol in oral medicines may change the bioavailability of other oral medications co- administered. Patients with hereditary fructose intolerance should not be given this medicine. - about 500 mg glucose, per tablet: to be taken into account in people with diabetes mellitus, if more than 10 tablets per day were to be taken; patients suffering from rare glucose-galactose disease problems should not take this medicine. - sucrose; patients suffering from rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or isomaltase sucrasis failure, should not take this medicine. - less than 1 mmol (23 mg) of sodium by tablet, 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 taking Maalox Plus during oral tetracycline therapy. Phenol, phenylene. • 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. The combination with integrated inhibitors (dolutegravir, raltegravir, bictegravir) and MAALOX PLUS should be avoided (refer to their RCPs for dose recommendations). Since the use of hydroxide magnesium causes alkalinization of urine, a greater excretion of salicylates was observed if administered simultaneously. For precaution, let spend at least 2 hours (4 for fluoroquinolone), between taking any medication by mouth and MAALOX PLUS. 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 system disorders Frequency not known (frequency cannot be defined on the basis of available data): angioedema, anaphylactic reactions, hypersensitivity reactions, hives, itching. Gastrointestinal diseases 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 known: 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.

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

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047521036
2222 Items
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