Almax 500 Mg 18 Chewable Tablets

Almax (500 Mg 18 Chewable Tablets)

ACTION AND MECHANISM

- Antacid. Almagato is a derivative of aluminum and magnesium, which acts as a nonabsorbable antacid by neutralizing hydrochloric acid in the stomach. Increasing gastric pH also reduces pepsin formation and activity. In addition, it adsorbs the pepsin formed and adsorbs and neutralizes bile acids when they return to the stomach.

PHARMACOKINETICS

Orally:

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

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

INDICATIONS

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

POSOLOGY

"ALMAX"

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

- Children and adolescents <18 years:

* Adolescents from 12 years old: the same as adults.

* Children <12 years: not recommended.

- Elderly: does not require dosage adjustment. Avoid prolonged treatments or high doses.

Duration of treatment : avoid treatments longer than 14 days without medical recommendation.

Missed dose : administer the forgotten dose as soon as possible, unless there is a short time before the next one. Administer the next dose at the usual time. Do not double the next dose.

DOSAGE IN KIDNEY INSUFFICIENCY

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

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

DOSAGE IN LIVER INSUFFICIENCY

No specific dosage recommendations have been made.

RULES FOR CORRECT ADMINISTRATION

- Chewable tablets: chew or allow to dissolve in the mouth.

Administration with food: administer 30-60 min after meals.

CONTRAINDICATIONS

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

- [ALZHEIMER DISEASE]. Aluminum could have a certain relationship with the appearance of this disease.

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

- [HEMORROIDS].

- [EDEMA].

- [DIARRHEA]. Magnesium salts may promote diarrhea.

- Toxemia gravidarum.

PRECAUTIONS

- [RENAL INSUFFICIENCY]. Risk of accumulation of magnesium and aluminum in these patients. It is recommended to use with caution in case of mild to moderate insufficiency (CLcr 30-90 ml / min), and avoid it in severe insufficiency (CLcr <30 ml / min).

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

- [INTESTINAL MALABSORPTION]. Almagate could reduce phosphate absorption by forming insoluble complexes. Caution is recommended in patients with intestinal malabsorption processes, diets poor in phosphorus or in [CONVALENCE] due to the risk of hypophosphatemia.

ADVICE TO THE PATIENT

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

- Take the antacid away from any other oral medication 2-3 h.

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

* Blood in vomit or stool.

SPECIAL WARNINGS

- Evaluate patients who develop gastrointestinal bleeding of unknown origin.

INTERACTIONS

- Antiulcer. Increasing the pH could reduce the activation of PPIs (eg omeprazole) in the canaliculi of the parietal glands. Avoid association.

- Salicylates. Antacids could alkalize the urine, favoring the elimination of salicylate.

In addition to these interactions, it must be taken into account that antacids can interfere with the absorption of any drug administered orally by different mechanisms. It might be advisable to distance the shots 2-3 h.

The following interaction mechanisms have been described:

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

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

PREGNANCY

Animal safety : no data available.

Safety in humans : There are no adequate and well-controlled studies in humans. The administration of antacids is considered safe during pregnancy, although it is recommended not to administer at high doses or for long periods of time, due to the risk of systemic 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 performed in humans.

LACTATION

Animal safety: no data available.

Safety in humans: both aluminum and magnesium can be excreted in milk, but due to low intestinal absorption of almagate they are unlikely to appear in significant amounts. Compatible with breastfeeding as long as low doses are used and 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.

The use of antacids in children <12 years is not recommended as they could mask serious symptoms such as appendicitis. In addition, there is a risk of hypermagnesemia or aluminum poisoning in children treated with magnesium and aluminum salts.

SENIORS

Aluminum could interfere with the absorption of phosphorus and calcium, favoring the appearance of osteoporosis. It is therefore recommended to avoid high doses or prolonged treatments.

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

EFFECTS ON DRIVING

It does not appear to have significant effects.

ADVERSE REACTIONS

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

Adverse reactions are described according to each frequency range, being considered very common (> 10%), common (1-10%), uncommon (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 described. Interference with phosphate absorption is to be expected, hypophosphatemia and osteomalacia may appear, especially in chronic poisoning.

Measures to be taken: symptomatic treatment.

Almax 500 Mg Leaflet 18 Chewable Tablets