Sodium bicarbonate lfm 50 tablets 500 mg

Product Description

Drug for the treatment of gastric acidity

Indications

Sodium bicarbonate lfm is indicated as a short-term treatment of gastric hyperacidity.

Composition

Active ingredients

One tablet contains 500 mg of sodium bicarbonate.

Excipients

Cellulose powder, microcrystalline cellulose, PEG4000, magnesium stearate.

Directions for use and Dosage

Adults:The usual dose in adults varies between 500 mg and 5 g per day.

Adolescents (12-18 years):1-2 tablets after meals and at bedtime.

Paediatric population: The medicine Sodium Bicarbonate LFM is contraindicated in children under 12 years of age.

Warnings

Read the package leaflet carefully before starting treatment.

Particular caution is required when administering sodium bicarbonate in case of:

• history of congestive heart failure;
• renal impairment;
• hypertension;
• liver cirrhosis;
• concomitant use of corticosteroids.

The tablets contain sodium, therefore this should be taken into account. It should be considered in cases where a particularly low-salt diet is recommended, such as in some cases of congestive heart failure, renal impairment, and hypertension. Sodium bicarbonate should be used with caution in cases of anuria or oliguria, due to the increased risk of sodium retention. Furthermore, caution should be exercised in edematous conditions with sodium retention, such as liver cirrhosis, congestive heart failure, renal insufficiency, toxemia, or pregnancy.

In patients with very low gastric acid levels, the effectiveness of sodium bicarbonate on stomach acidity may be reduced. Furthermore, in these subjects, there is the possibility of increased absorption into plasma, with the potential for adverse systemic effects. In patients with potassium depletion, sodium bicarbonate should be administered with caution, and cardiac and electrolyte parameters should be monitored repeatedly. In patients with gastric and small intestinal inflammation or renal insufficiency, sodium bicarbonate increases the risk of excess blood sodium levels.

Sodium bicarbonate can cause changes in the pH of the stomach and urine, thus altering the absorption and elimination processes of many drugs (see section 4.5). It is advisable to allow at least 2 hours to elapse between taking sodium bicarbonate and other medications.

Contraindications and side effects

The following are the adverse reactions of orally administered sodium bicarbonate, organized according to the MedDRA system organ classification. There are insufficient data to establish the frequency of the individual effects listed.

• Immune system disordersAllergic reactions such as urticaria and bronchospasm, anaphylactic or anaphylactoid reactions.
• Gastrointestinal disordersStomach cramps, flatulence, vomiting, and gastric lesions.
• Vascular disordersFluid retention (edema), especially in elderly patients and in the presence of cardiac or renal insufficiency. Sodium bicarbonate, when administered orally at the recommended doses, is absorbed only in small amounts with minimal systemic effects. However, adverse reactions due to a systemic effect of the drug are listed below.
• Metabolism and nutrition disordersMetabolic alkalosis, especially in patients with renal insufficiency; Symptoms include shortness of breath (due to compensatory hyperventilation, which may last up to 48 hours), muscle weakness associated with potassium depletion, muscle hypertonicity, muscle spasms, and tetany, which may occur especially in hypocalcemic patients. Hypernatremia. Hyperosmolarity, with increased fluid volume and pulmonary edema.
• Cardiac disordersDecreased cardiac output. Vascular disordersHypotension. Cerebral edema. Intracranial haemorrhage.
• Respiratory, thoracic and mediastinal disordersHypercapnia.

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Pregnancy and breastfeeding

Storage

Do not store above 30°C. Store in the original package. Keep the bottle tightly closed to protect from moisture. Sodium bicarbonate decomposes slowly in the presence of moisture.

Format

50 tablets