BICARB 20CPR 500MG

SODIUM BICARBONATE ZETA 500 MG INCLUDED

active ingredients

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

Excellent

Microcrystalline cellulose, talc, magnesium stearate, silicon dioxide.

Therapeutic indications

Short-term treatment of gastric hyperacidity.

Contraindications

- Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1; - severe kidney failures; - respiratory alkalosis; - hypocalcemia, for an increase in risk of tetania; - hypochloremia induced by diuretics (see paragraph 4.5); - excessive loss of chlorine, due to continuous gastrointestinal vomiting or suction, due to the increased risk of metabolic alkalosis; - children under 12 years of age. Generally contraindicated in pregnancy (see paragraph 4.6).

Population

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 medicinal product is not indicated for children under 12 years of age.

Conservation

Store in the original packaging, well closed to repair the medicine from light and moisture, since in the presence of moisture the sodium bicarbonate is slowly decomposed.

Warnings

Particular caution is needed in administering sodium bicarbonate in case of: - history of congestive heart failure; - renal compromise; - hypertension; - hepatic cirrhosis; - concomitant use of corticosteroids (see paragraph 4.5). Tablets contain sodium, therefore this must be taken into account in cases where a particularly poor diet of salt is recommended, for example in some cases of congestive heart failure, kidney impairment, hypertension. Bicarbonate sodium should be used with caution in case of watermelon or oliguria, due to increased risk of sodium retention. In addition, you should pay attention in edematose conditions with sodium retention, such as liver cirrhosis, congestive heart failure, kidney failure, toxemia or pregnancy. In patients with very low levels of gastric acid it is possible that the effectiveness of bicarbonate sodium on stomach acid is lower. In addition, in such subjects there is the possibility of an increase in its absorption in plasma with the possibility of unwanted systemic effects. In patients who have potassium depletion, the administration of bicarbonate sodium should take place with caution and the cardiac and electrolytic parameters should be repeatedly monitored. In patients with gastric inflammation and small intestines or kidney failure, sodium bicarbonate increases the risk of excess blood levels of sodium. Bicarbonate sodium can determine changes in the pH of the stomach and urine, thus altering the processes of absorption and elimination of many drugs (see paragraph 4.5). It is advisable to spend at least 2 hours between taking baking soda and other medicines.

Interactions

Bicarbonate sodium when administered orally at the recommended doses is only absorbed in small quantities with minimal systemic effects. The following are the possible interactions due to the presence of the drug in circulation. Bicarbonate sodium, increasing the pH of the stomach, can determine a reduction in the absorption of acid drugs, resulting in a decrease in their effect. This interaction has been found, for example, for: itraconazole, ketoconazole, atazanavir, cefpodoxima proxetile, dasatinib and iron. With the same mechanism the sodium bicarbonate can determine an increase in the absorption of basic drugs resulting in increased toxicity. Bicarbonate sodium, alkalinizing urine, can decrease the elimination of basic drugs by increasing the duration of action and toxicity. This interaction has been found, for example, for: chinidine, amphetamine, ephedrine, pseudo ephedrine, memantine, phlecainide and mecamilamine. With the same mechanism the sodium bicarbonate can determine a greater elimination of certain drugs, resulting in a decrease in their effect. This interaction was found, for example, for: aspirin, chlorpropamide, lithium methylamine and tetracycline (especially doxycycline). If bicarbonate sodium is used in association with diuretics that promote potassium excretion such as bumetamide, etacrine acid, furosemide and thiazides, hypochlorhemic alkalosis may occur. Since sodium bicarbonate can determine sodium retention (see paragraph 4.8 Undesirable effects) concomitant use with other drugs that cause an increase in sodium in the body, such as corticosteroids, can aggravate this effect.

Effects

Below are the undesirable effects of bicarbonate sodium administered by mouth, organized according to the systemic and organic classification MedDRA. No sufficient data is available to determine the frequency of the individual effects listed. Immune system disorders Allergic manifestations such as hives and bronchospasm, anaphylactic or anaphylactic reactions. Gastrointestinal diseases Stomach cracks, flatulence, vomiting and gastric injuries. Vascular diseases Water retention (edema), especially in elderly patients and in the presence of heart or kidney failure. Bicarbonate sodium when administered orally at the recommended doses is only absorbed in small quantities with minimal systemic effects. The following are however listed adverse reactions due to a systemic effect of the drug. Disorders of metabolism and nutrition Metabolic alkalosis, especially in patients with kidney failure; symptoms include fatigued breathing (for compensatory hyperventilation, which can last even 48 hours), muscle weakness associated with potassium depletion, muscle hypertonin, muscle spasms and tetany that can occur especially in hypocalcemic patients. Hypernatriemia. Hyperosmolarity, with increased volume of liquids and pulmonary edema. Heart disease Reduced heart rate. Vascular diseases Hypotension. Brain edema. Intracranial bleeding. Respiratory, chest and mediastinic pathologies Hypercapnia. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa

Overdosing

The experience on deliberate overdose with bicarbonate sodium by mouth is very limited. The only possible consequence of overdose is abdominal distension caused by excess carbon dioxide generated by the melting of the sodium bicarbonate in the stomach. In this case, use of symptomatic treatment by taking generic support measures.

Pregnancy

Clinical data relating to exposed pregnancy are not available for bicarbonate sodium. Animal studies indicate no direct or indirect harmful effects on pregnancy, embryo/fetal development, birth or post-natal development (see paragraph 5.3). it is necessary to be prudent in prescribing the medicine to pregnant women. In addition, it should be considered that the sodium contained in the medicinal product may worsen the edematosis states of pregnancy. Therefore, for the treatment of stomach acid, it is recommended to use alternative drugs that do not contain sodium.

Food

The use of bicarbonate sodium is considered compatible with breastfeeding.

Source: Farmadati