Sella Sodium Bicarbonate 500mg Food Supplement 50 Tablets

Sodium bicarbonate tablets.

Therapeutic indications

Sodium Bicarbonate Sella is used in the short-term treatment of gastric hyperacidity.

Dosage and Posology

The drug should be taken according to the following doses and methods:

• Adults: The usual dose in adults varies between 500 mg to 5 g per day.
• Teenagers (12-18 years): 1-2 tablets after meals and at bedtime.

The medicine is not suitable for children under 12 years of age

Overdose

Experience with deliberate overdose with 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. In this case, symptomatic treatment should be resorted to by adopting generic supportive measures.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients
• Severe kidney failure
• Respiratory alkalosis
• Hypocalcaemia, due to an increased risk of tetany
• Diuretic-induced hypochloremia
• Excessive loss of chlorine, due to vomiting or continuous gastrointestinal sucking, due to the increased risk of metabolic alkalosis
• Children under the age of 12.
• Generally contraindicated in pregnancy.

Side effects

The following are the undesirable effects of orally administered sodium bicarbonate, organized according to the MedDRA system organ class. Insufficient data are available to establish the frequency of the individual effects listed.

• Immune system disorders: Allergic manifestations 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 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 Disorders: Metabolic alkalosis, especially in patients with renal insufficiency; Symptoms include shortness of breath (for compensatory hyperventilation, which can last up to 48 hours), muscle weakness associated with potassium depletion, muscle hypertonus, muscle spasms and tetany which can occur especially in hypocalcemic patients. Hypernatremia. Hyperosmolarity, with increased fluid volume and pulmonary edema.
• Cardiac disorders: Decreased cardiac output.
• Vascular disorders: Hypotension. Cerebral edema. Intracranial hemorrhage.
• Respiratory, thoracic and mediastinal disorders: Hypercapnia

Pregnancy and breastfeeding

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 / fetal development, parturition or postnatal development (see section 5.3). Caution should be exercised in prescribing the medicine to pregnant women. Furthermore, it should be considered that the sodium contained in the medicine can worsen the oedematous states of pregnancy. Therefore, for the treatment of stomach acid, it is recommended to use alternative drugs that do not contain sodium.

The use of sodium bicarbonate is considered compatible with breastfeeding.

Special warnings

Particular care should be taken when administering sodium bicarbonate in case of:

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

The tablets contain sodium, therefore this must 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. Sodium bicarbonate should be used with caution in case of anuria or oliguria, due to the increased risk of sodium retention. In addition, caution should be exercised in oedematous conditions with sodium retention, such as liver cirrhosis, congestive heart failure, renal failure, toxemia or pregnancy. In patients with very low stomach acid levels, sodium bicarbonate may be less effective on stomach acid. Furthermore, in these subjects there is the possibility of an increase in its absorption into plasma with the possibility of undesirable systemic effects. In patients presenting 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 bowel 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 processes of absorption and elimination of many drugs.

It is advisable to allow at least 2 hours between taking sodium bicarbonate and taking other medications.

Expiry and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. Store in the original package, tightly closed to protect the medicine from humidity, as sodium bicarbonate decomposes slowly in the presence of humidity.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

One Sella Sodium Bicarbonate tablet contains:

Active principle

Sodium bicarbonate 500 mg

Excipients

Hydrogenated vegetable oil, polyvinylpyrrolidone, crospovidone