ACTION AND MECHANISM

- Antacid. Almagate is an aluminum and magnesium derivative that acts as a non-absorbable antacid by neutralizing hydrochloric acid in the stomach. Increased gastric pH also reduces the formation and activity of pepsin. It also adsorbs the pepsin formed and adsorbs and neutralizes bile acids when they reflux into the stomach.

SPECIAL WARNINGS

- Evaluate patients who develop gastrointestinal bleeding of unknown origin.

SENIORS

Aluminum may interfere with the absorption of phosphorus and calcium, promoting the development of osteoporosis. Therefore, it is recommended to avoid high doses or prolonged treatment.

Its use is contraindicated in cases of Alzheimer's disease, due to the possible relationship of this disease with aluminum.

PATIENT ADVICE

- If symptoms persist or worsen after 14 days of treatment, consult your doctor and/or pharmacist.

- Space the antacid intake with any other oral medication by 2-3 hours.

- Tell your doctor and/or pharmacist if you experience any of these symptoms:

* Blood in vomit or stool.

CONTRAINDICATIONS

- Hypersensitivity to almagate or any other component of the medication.

- [ALZHEIMER'S DISEASE]. Aluminum may have some connection with the onset of this disease.

- Patients with gastrointestinal bleeding of unknown cause (see Precautions; gastrointestinal bleeding).

- [HEMORRHOIDS].

- [EDEMA].

- [DIARRHEA]. Magnesium salts may promote diarrhea.

- Toxemia of pregnancy.

EFFECTS ON DRIVING

It does not appear to have significant effects.

PREGNANCY

Animal safety : no data available.

Human safety : Adequate and well-controlled studies in humans are lacking. Antacids are considered safe to use during pregnancy, although high doses or prolonged use are not recommended, due to the risk of systemic side effects.

Cases of tendon hyperreflexia have been reported in neonates of mothers who used aluminum and/or magnesium salts during pregnancy.

Effects on fertility : No specific studies have been conducted in humans.

PHARMACOKINETICS

Oral route:

- Absorption: the absorption of aluminum and magnesium is minimal.

- Excretion: absorbed metal ions are eliminated through the kidneys, while the remainder appear in feces.

INDICATIONS

- Symptomatic treatment of [GASTRIC HYPERACIDITY] in adults and adolescents from 12 years of age.

INTERACTIONS

- Antiulcer drugs. Increasing pH may reduce the activation of PPIs (e.g., omeprazole) in the canaliculi of the parietal glands. Avoid combination.

- Salicylates. Antacids may alkalize urine, promoting salicylate elimination.

In addition to these interactions, it should be noted that antacids can interfere with the absorption of any orally administered medication through various mechanisms. It may be advisable to space out doses by 2-3 hours.

The following interaction mechanisms have been described:

- Drugs with pH-dependent absorption. Antacids may affect the solubility and subsequent intestinal absorption of drugs for which gastric pH is a limiting factor. Thus, decreased absorption has been observed for drugs such as atenolol, azole antifungals, NSAIDs, digoxin, erlotinib, gabapentin, and ulipristal.

- Formation of insoluble chelates. Aluminum can form insoluble complexes with drugs such as quinolones, iron salts, or tetracyclines, reducing their absorption.

LACTATION

Animal safety: no data available.

Safety in humans: Both aluminum and magnesium can be excreted in milk, but due to the low intestinal absorption of almagate, they are unlikely to appear in significant quantities. Compatible with breastfeeding as long as low doses are used for a short period of time.

CHILDREN

Almagato can be used in adolescents from 12 years of age at the same doses as in adults.

Antacids are not recommended for children under 12 years of age, as they may mask serious symptoms such as appendicitis. Furthermore, there is a risk of hypermagnesemia or aluminum poisoning in children treated with magnesium and aluminum salts.

RULES FOR CORRECT ADMINISTRATION

- Chewable tablets: chew or let dissolve in the mouth.

POSOLOGY

"ALMAX"

- Adults: 1 g/8 h. If necessary, an additional dose may be administered at bedtime. Maximum dose: 8 g/24 h.

- Children and adolescents < 18 years:

* Teenagers from 12 years old: same as adults.

* Children < 12 years: not recommended.

- Elderly: No dosage adjustment is required. Avoid prolonged treatment or high doses.

Treatment duration : avoid treatments longer than 14 days without medical advice.

Missed dose : Administer the missed dose as soon as possible, unless it is almost time for the next dose. Administer the next dose at the regular time. Do not double the next dose.

DOSAGE IN LIVER FAILURE

No specific dosage recommendations have been made.

DOSAGE IN KIDNEY FAILURE

- Mild to moderate renal impairment (CLcr 30-90 ml/min): avoid high doses.

- Severe renal impairment (CLcr < 30 ml/min): not recommended.

PRECAUTIONS

- [RENAL FAILURE]. Risk of magnesium and aluminum accumulation in these patients. Caution is recommended in patients with mild to moderate impairment (CLcr 30–90 ml/min) and avoidance in patients with severe impairment (CLcr < 30 ml/min).

- [DIGESTIVE HEMORRHAGE]. Patients with gastrointestinal bleeding should be evaluated, as almagate may mask more serious conditions such as stomach cancer.

- [INTESTINAL MALABSORPTION]. Almagate may reduce phosphate absorption by forming insoluble complexes. Caution is recommended in patients with intestinal malabsorption, on low-phosphorus diets, or during [CONVALESCENCE] due to the risk of hypophosphatemia.

ADVERSE REACTIONS

The effects are mild, transient and infrequent due to its low intestinal absorption.

Adverse reactions are described according to each frequency interval, considering very frequent (>10%), frequent (1-10%), unfrequent (0.1-1%), rare (0.01-0.1%), very rare (<0.01%) or of unknown frequency (cannot be estimated from the available data).

- Digestive: frequency unknown [DIARRHEA].

OVERDOSE

Symptoms: No cases have been reported. Interference with phosphate absorption is expected, and hypophosphatemia and osteomalacia may occur, especially in chronic poisoning.

Measures to be taken: symptomatic treatment.