Magion 40 tablets

Magion (450 Mg 40 Chewable Tablets)

Magaldrato

Magión belongs to a group of medicines called antacids. The active principle, magaldrate, is transformed into aluminum and magnesium salts in the stomach, regulating the acidity of the stomach.

It is indicated for the relief and symptomatic treatment of heartburn and heartburn in adults and children over 12 years of age.

ACTION AND MECHANISM

- Non-absorbable antacid. Derived from aluminum and magnesium. It works by neutralizing hydrochloric acid in the stomach, increasing gastric pH, which also reduces the formation and activity of pepsin. In addition, it adsorbs the pepsin formed.

PHARMACOKINETICS

- Absorption: The absorption of aluminum and magnesium cations is minimal from a standard dose of antacid. Only the part corresponding to the soluble compounds formed and the excess of which has not precipitated in the intestine is absorbed.

- Elimination: Unabsorbed magnesium and aluminum are mainly eliminated with faeces in the form of insoluble salts. The absorbed (minimal) part is eliminated in the urine.

- Renal insufficiency: In case of renal insufficiency, there could be a decrease in the elimination of magnesium and aluminum, with the consequent risk of hypermagnesemia and hypophosphatemia.

INDICATIONS

- Symptomatic treatment of [GASTRIC HYPERACIDITY].

POSOLOGY

"MAGION"

- Adults and adolescents> 12 years: 1-2 tablets, 3 times a day. In certain cases an additional dose may be necessary before bedtime. Maximum dose 8 g / 24 h.

- Children and adolescents <18 years: not recommended.

- Elderly: no specific dosage recommendations have been established.

RULES FOR CORRECT ADMINISTRATION

- Tablets: they can be chewed, swallowed or broken up in the mouth.

Administration with food : administer 1-2 h after the main meals.

CONTRAINDICATIONS

- Hypersensitivity to any component of the drug.

- Situations that could be aggravated by the laxative effect, such as [INTESTINAL OBSTRUCTION] or [INTESTINAL PERFORATION].

- Severe renal insufficiency (CLcr <30 ml / minute). Risk of hypermagnesemia and hypophosphatemia during prolonged treatments.

- [HYPOPHOSPHATEMIA]. Due to the aluminum content of this drug, there may be a decrease in phosphate absorption, with a risk of hypophosphatemia that causes anorexia, general malaise and muscle weakness, appearing especially in patients with a diet low in phosphates, diarrhea, malabsorption or transplantation. renal. Bimonthly determinations of serum phosphate levels are recommended, especially in patients undergoing hemodialysis.

PRECAUTIONS

- [RENAL INSUFFICIENCY]. In case of kidney failure, an accumulation of aluminum can occur in the body, which can lead to osteomalacia, osteodystrophy or encephalopathy. Magnesium build-up and hypermagnesemia can also occur.

- [HYPERMAGNESEMIA]. In case of prolonged administration of almagate, a build-up of magnesium may occur.

- Long-term treatment. Antacids eliminate symptoms related to acid diseases, which are common to those of malignant processes such as [STOMACH CANCER] or [ESOPHAGUS CANCER]. Therefore, there is a risk of delaying the diagnosis of these processes.

ADVICE TO THE PATIENT

- This medicine should not be used by patients with intestinal obstructions.

- When used as an antacid, it is recommended to take this medicine after meals or when discomfort occurs.

- Before taking the medicine, it is important to remove the envelope correctly, pressing it in different directions before opening it.

- The tablets should be chewed thoroughly before swallowing or allowed to dissolve in the mouth. Afterwards, then have a glass of water.

- Do not take with milk.

- If this preparation is used to relieve indigestion symptoms, it should not be taken for more than two weeks.

- It is advisable to promptly report symptoms such as a sensation of loss of appetite, weakness or unjustified general malaise, as well as the appearance of any symptoms that may indicate bleeding (eg: black stools).

SPECIAL WARNINGS

- Monitoring: During prolonged treatments, periodic controls of phosphate and calcium levels are recommended. Hypophosphatemia can increase serum calcium levels.

- It is important to monitor possible signs of hypophosphatemia (anorexia, muscle weakness and general malaise).

INTERACTIONS

- Emergency contraceptive based on ulipristal acetate: the increase in gastric pH can reduce the plasma concentrations of the contraceptive, reducing its effectiveness. Concomitant use is not recommended.

- NSAIDs (flufenamic or mefenamic acid, indomethacin): there are studies with some antacids (algeldrate, magnesium oxide, calcium carbonate) in which a decrease in their absorption has been recorded.

- Beta-blockers (propranolol, atenolol): there are studies with some antacids (algeldrate, magnesium hydroxide) in which a decrease in absorption has been recorded due to a decrease in the dissolution of the beta-blocker, so it is recommended to space its administration.

- Digitalis (digoxin, digitoxin): there are studies with some antacids (algeldrate, magnesium hydroxide) in which a decrease in the absorption of digitalis has been recorded, so it is recommended to space its administration 2 or 3 h.

- Eltrombopag: possible reduction of eltrombopag absorption due to the formation of insoluble chelates with polyvalent cations. Administer eltrombopag at least 4 hours before or after this medicine.

- Erlotinib: possible reduction in erlotinib levels, due to reduced absorption. Antacids increase gastric pH, which may decrease erlotinib's solubility, absorption, and therapeutic effects. It is recommended to administer at least 4 hours before or 2 hours after the daily dose of the antineoplastic.

- Gabapentin: a certain decrease in gabapentin levels has been observed when administered jointly or in the two hours after taking other antacids, due to an increase in pH. It is recommended to administer gabapentin two hours before an antacid.

- Isoniazid: there are studies in which a decrease in its absorption has been recorded due to a possible delay in gastric emptying, caused by aluminum, for which it is recommended to space the administration 2 or 3 h.

- Ketoconazole: there are studies in which a decrease in the absorption of ketoconazole has been recorded, due to the increase in pH that causes less solubilization of the drug.

- Lansoprazole: there are some studies in which a possible decrease in the absorption of lansoprazole has been registered.

- Iron chelators (deferasirox, deferiprone, deferoxamine): possible reduction of the antacid effect due to the formation of insoluble complexes with aluminum.

- Quinolones (ciprofloxacin, norfloxacin): there are studies with some antacids (algeldrate, almagate) in which a decrease in their absorption has been recorded due to the formation of insoluble, non-absorbable complexes at the intestinal level, so it is recommended to separate their administration 2 or 3 h.

- Iron salts (citrate, fumarate, iron sulfate): there are studies with some antacids (algeldrate, magnesium trisilicate) in which a decrease in absorption has been recorded due to the formation of poorly soluble complexes, so it is recommended to space the administration 2 or 3 h.

- Salicylates (acetylsalicylic acid): there are studies with some antacids (almagate, aluminum trisilicate) in which a decrease in salicylate levels has been recorded, due to greater excretion due to alkalinization of the urine, especially at high doses of salicylate. The administration of antacids derived from aluminum only seems advisable, given their probable lesser effect.

- Tetracyclines (chlortetracycline, demeclocycline, doxycycline): there are studies with some antacids (algeldrate, aluminum phosphate) in which possible formation of non-absorbable complexes at the gastrointestinal level has been recorded, thus reducing their absorption, so it is recommended to space the administration 2 or 3 h.

PREGNANCY

Animal safety : no data available.

Safety in humans : adequate and well-controlled studies in humans have not been performed; Therefore, it is convenient to take into account the possibility of the appearance of problems related to a decrease in the absorption of iron, fluorides and phosphates in prolonged treatments and / or high doses. This medication is not recommended during pregnancy unless the potential benefits outweigh the risks.

Effects on Fertility : No specific studies have been performed in humans.

LACTATION

With the use of antacids in general, small amounts of magnesium and aluminum can be excreted with breast milk, which do not seem to be enough to cause adverse effects in the newborn. Accepted use, recommending avoiding chronic and / or excessive use.

KIDS

The uncontrolled use of antacids in children under 6 years of age is not recommended as they could mask serious symptoms (appendicitis, etc.). In addition, with magnesium antacids there is a risk of hypermagnesemia in young children, especially if they have symptoms of dehydration or have kidney failure.

SENIORS

The prolonged use of aluminum antacids in the elderly can lead to the systemic absorption of aluminum, producing organic accumulation, which could aggravate the osteoporosis present in almost all the elderly due to the depletion of phosphorus and calcium, and the inhibition of the digestive absorption of fluorides. A possible accumulation of magnesium, which could cause hypermagnesemia and diarrhea, should also be considered. Chronic and / or excessive use is not recommended in the elderly, especially in patients with Alzheimer's disease, since a potential etiological role of aluminum in this disease has been suggested.

ADVERSE REACTIONS

The adverse effects of magaldrate are, in general, mild and transient. The most characteristic adverse reactions are:

-Exceptionally (<< 1%): [CONSTIPATION] or [DIARRHEA] when high doses are used. In prolonged treatment with high doses or in patients with low phosphate diets, it can induce [HYPOPHOSPHATEMIA] and cause [OSTEOMALACIA].

OVERDOSE

- Symptoms: Unknown. Its intestinal absorption is minimal, so overdose is very rare. In patients with severe renal insufficiency, there may be an increase in aluminum toxicity, manifested in the brain, bones and parathyroid glands.

Magion 40 tablets leaflet