Sodium bicarbonate Sella 500 mg 50 tablets

Sodium bicarbonate Sella 500 mg 50 tablets is an over-the-counter medicine indicated for the treatment of gastric hyperacidity and related disorders, such as difficult digestion and heartburn . Thanks to its active ingredient, sodium bicarbonate , it acts quickly as an antacid , neutralizing excess acidity in the stomach and promoting rapid relief from symptoms. The 500 mg chewable tablets are convenient to take and ideal for short-term use , offering an effective solution for those who occasionally suffer from gastric disorders.

The package contains 50 tablets , designed to ensure prolonged coverage of daily needs. Sodium bicarbonate Sella is particularly suitable for adults who need rapid and safe support against stomach acidity, without the need for a medical prescription. Its formulation allows for timely intervention in moments of discomfort, improving the quality of life and digestive well-being. Choose Sodium bicarbonate Sella 500 mg for an effective and immediate antacid action, ideal for counteracting the symptoms of gastric hyperacidity and promoting more peaceful digestion.

ACTIVE INGREDIENTS

Active ingredients contained in Sodium bicarbonate Sella 500 mg 50 tablets - What is the active ingredient in Sodium bicarbonate Sella 500 mg 50 tablets?

Each tablet contains: Active substance: sodium bicarbonate 500 mg. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Sodium bicarbonate Sella 500 mg 50 tablets - What does Sodium bicarbonate Sella 500 mg 50 tablets contain?

Hydroxypropylcellulose, hydrogenated vegetable oil, crospovidone.

DIRECTIONS

Therapeutic indications Sodium bicarbonate Sella 500 mg 50 tablets - Why is Sodium bicarbonate Sella 500 mg 50 tablets used? What is it used for?

Short-term treatment of gastric hyperacidity.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Sodium bicarbonate Sella 500 mg 50 tablets - When should Sodium bicarbonate Sella 500 mg 50 tablets not be used?

- Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1; - severe renal insufficiency; - respiratory alkalosis; - hypocalcaemia, due to an increased risk of tetany; - diuretic-induced hypochloraemia (see paragraph 4.5); - excessive loss of chloride, due to vomiting or continuous gastrointestinal suction, due to the increased risk of metabolic alkalosis; - children under 12 years of age. Generally contraindicated in pregnancy (see paragraph 4.6).

DOSAGE

Quantity and method of taking Sodium bicarbonate Sella 500 mg 50 tablets - How to take Sodium bicarbonate Sella 500 mg 50 tablets?

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. The medicine is not indicated for children under 12 years of age.

CONSERVATION

Storage Sodium bicarbonate Sella 500 mg 50 tablets - How do you store Sodium bicarbonate Sella 500 mg 50 tablets?

Store in the original package, tightly closed to protect the medicine from moisture, since sodium bicarbonate decomposes slowly in the presence of moisture.

WARNINGS

Warnings Sodium bicarbonate Sella 500 mg 50 tablets - About Sodium bicarbonate Sella 500 mg 50 tablets it is important to know that:

Special caution should be exercised when administering sodium bicarbonate in case of: - history of congestive heart failure; - renal impairment; - hypertension; - liver cirrhosis; - concomitant use of corticosteroids (see section 4.5). The tablets contain sodium, therefore this should be taken into consideration in cases where a particularly low salt diet is recommended, for example in some cases of congestive heart failure, renal impairment, hypertension. This medicinal product contains 137 mg sodium per tablet, equivalent to 6.8% of the WHO recommended maximum daily intake of 2 g sodium for an adult. Sodium bicarbonate should be used with caution in case of anuria or oliguria, due to the increased risk of sodium retention. Furthermore, caution should be exercised in oedematous conditions with sodium retention, such as liver cirrhosis, congestive heart failure, renal insufficiency, toxaemia or pregnancy. In patients with very low levels of gastric acid, the effect of sodium bicarbonate on stomach acidity may be lower. Furthermore, in these subjects there is the possibility of an increase in its absorption into the plasma with the possibility of unwanted 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 drugs .

INTERACTIONS

Interactions Sodium bicarbonate Sella 500 mg 50 tablets - Which medicines or foods can modify the effect of Sodium bicarbonate Sella 500 mg 50 tablets?

Sodium bicarbonate, when administered orally at the recommended doses, is absorbed only in small quantities with minimal systemic effects. However, the possible interactions due to the presence of the drug in circulation are listed below. Sodium bicarbonate, by increasing the pH of the stomach, can determine a reduction in the absorption of acid drugs, with consequent decrease in their effect. This interaction has been found, for example, for: itraconazole, ketoconazole, atazanavir, cefpodoxime proxetil, dasatinib and iron. With the same mechanism, sodium bicarbonate can determine an increase in the absorption of basic drugs with consequent increase in their toxicity. Sodium bicarbonate, by alkalinizing the urine, can decrease the elimination of basic drugs, increasing their duration of action and toxicity. This interaction has been observed, for example, for: quinidine, amphetamines, ephedrine, pseudoephedrine, memantine, flecainide and mecamylamine. By the same mechanism, sodium bicarbonate can determine an increased elimination of some drugs, with consequent decrease in their effect. This interaction has been observed, for example, for: aspirin, chlorpropamide, lithium methenamine and tetracyclines (especially doxycycline). If sodium bicarbonate is used in association with diuretics that promote the excretion of potassium such as bumetamide, ethacrynic acid, furosemide and thiazides, hypochloraemic alkalosis may occur. Since sodium bicarbonate can cause sodium retention (see section 4.8 Undesirable effects), concomitant use with other drugs that cause an increase in sodium in the body, such as corticosteroids, may aggravate this effect.

SIDE EFFECTS

Like all medicines, Sodium bicarbonate Sella 500 mg 50 tablets can cause side effects - What are the side effects of Sodium bicarbonate Sella 500 mg 50 tablets?

The following are the undesirable effects of sodium bicarbonate administered orally, organized according to the MedDRA system organ classification. There are insufficient data to establish the frequency of the individual effects listed. Immune system disorders : Allergic reactions such as urticaria and bronchospasm, anaphylactic or anaphylactoid reactions. Gastrointestinal disorders : Stomach cramps, flatulence, vomiting and gastric lesions. Vascular disorders : Fluid 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 quantities with minimal systemic effects. However, the following are the adverse reactions due to a systemic effect of the drug. Metabolism and nutrition disorders : Metabolic 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 hypocalcaemic patients. Hypernatremia. Hyperosmolarity, with increased fluid volume and pulmonary oedema. Cardiac disorders : Decreased cardiac output. Vascular disorders : Hypotension. Cerebral oedema. Intracranial haemorrhage. Respiratory, thoracic and mediastinal disorders : Hypercapnia. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

OVERDOSE

Overdose Sodium bicarbonate Sella 500 mg 50 tablets - What are the risks of Sodium bicarbonate Sella 500 mg 50 tablets in case of overdose?

Experience with deliberate overdose of oral sodium bicarbonate is very limited. The only possible consequence of overdose is abdominal distension caused by excess carbon dioxide generated by the breakdown of sodium bicarbonate in the stomach. Symptomatic treatment with general supportive measures should be used.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Sodium bicarbonate Sella 500 mg 50 tablets.

Pregnancy: For sodium bicarbonate no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). Caution should be exercised when prescribing the medicinal product to pregnant women. Furthermore, it should be considered that the sodium contained in the medicinal product may worsen the oedematous states of pregnancy. Therefore, for the treatment of stomach acidity, it is advisable to use alternative drugs that do not contain sodium. Breastfeeding: The use of sodium bicarbonate is considered compatible with breastfeeding.

DRIVING AND USE OF MACHINERY

Taking Sodium bicarbonate Sella 500 mg 50 tablets before driving or using machines - Does Sodium bicarbonate Sella 500 mg 50 tablets affect driving or using machines?

Sodium bicarbonate does not alter the ability to drive vehicles or use machinery.