Sella Sodium Bicarbonate 500mg Food Supplement 1000 Tablets

NAME
SODIUM BICARBONATE SADDLE 500 MG TABLETS

PHARMACOTHERAPEUTIC CATEGORY
Antacids.

ACTIVE PRINCIPLES
Sodium bicarbonate.

EXCIPIENTS
Hydrogenated vegetable oil, polyvinylpyrrolidone, crospovidone.

INDICATIONS
Short-term treatment of gastric hyperacidity.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active substance or to any of the excipients; severe kidney failure; respiratory alkalosis; hypocalcemia, 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.

DOSAGE
Adults: The usual dose in adults varies between 500 mg to 5 g per day. Adolescents (12-18 years): 1-2 tablets after meals and at bedtime. The medicine is not indicated for children under the age of 12 years.

STORAGE
Store in the original package, tightly closed to protect the medicine from humidity, as sodium bicarbonate decomposes slowly in the presence of humidity.

WARNINGS
Particular caution should be exercised in 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 gastric acid levels it is possible that the efficacy of sodium bicarbonate on stomach acid is lower. Furthermore, in such subjects there is the possibility of an increase in its absorption into the plasma with the possibility of undesirable 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 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 to elapse between the intake of sodium bicarbonate and that of other drugs.

INTERACTIONS
Sodium bicarbonate when administered orally at recommended doses is absorbed only in small amounts 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 cause a reduction in the absorption of acid drugs, with a 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 cause an increase in the absorption of basic drugs with a consequent increase in their toxicity. Sodium bicarbonate, alkalizing the urine, can decrease the elimination of basic drugs, increasing their duration of action and toxicity. This interaction has been found, for example, for: quinidine, amphetamines, ephedrine, pseudoephedrine, memantine, flecainide and mecamylamine. With the same mechanism, sodium bicarbonate can cause a greater elimination of some drugs, with a consequent decrease in their effect. This interaction has been found, for example, for: aspirin, chlorpropamide, lithium methenamine and tetracyclines (especially doxycycline). If sodium bicarbonate is used in combination with diuretics that promote potassium excretion such as bumetamide, ethacrynic acid, furosemide and thiazides, hypochloraemic alkalosis may occur. Since sodium bicarbonate can cause sodium retention, concomitant use with other drugs that cause an increase in sodium in the body, such as corticosteroids, can aggravate this effect.

SIDE EFFECTS
The following are the side effects of orally administered sodium bicarbonate, organized according to the MedDRA Organic System Classification. Insufficient data are available to determine 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 heart 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 may occur especially in hypocalcemic patients. Hypernatremia. Hyperosmolarity, with increased volume of liquids 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. Caution should be exercised when 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.