Sodium Alginate + Sodium Bicarbonate + Calcium Carbonate

Sodium Alginate + Sodium Bicarbonate + Calcium Carbonate is indicated in-

Gastric reflux

Heartburn

Indigestion

Flatulence associated with gastric reflux

Heartburn of pregnancy

All cases of epigastric and retrosternal distress where the underlying cause is gastric reflux.

This is the combination of two antacids (Calcium carbonate and Sodium bicarbonate) and an alginate (Sodium alginate). The suspension work in two ways-

Neutralizing excess stomach acid to relieve the pain & discomfort

Forming a protective barrier over the stomach contents to soothe the burning pain in your chest.

The mode of action of the product is physical and does not depend on absorption into the systemic circulation. The product is a combination of two antacids (Calcium Carbonate and Sodium Bicarbonate) and an Alginate. On ingestion, the medicinal product reacts rapidly with gastric acid to form a raft of Alginic Acid gel having a near neutral pH and studies have shown that the raft interacts with and caps the acid pocket in the stomach, reducing esophageal acid exposure. The raft floats on the stomach contents effectively impeding gastro-esophageal reflux, for up to 4 hours, and protecting the esophagus from Acid, Pepsin and Bile.In severe cases the raft itself may be refluxed into the esophagus, in preference to the stomach contents, and exert a demulcent effect. In addition in vitro evidence has shown that the raft has a secondary action and is able to entrap bile and pepsin within it structure, further protecting the esophagus from these gastric components. Calcium Carbonate neutralizes gastric acid to provide fast relief from indigestion and heartburn.This effect is increased by the addition of Sodium Bicarbonate which also has a neutralizing action.

For oral suspension:

Adult and children over 12 years:10-20 mL after meals and at bedtime, up to four times a day.

Children 6 to 12 years: 5-10 mL after meals and at bedtime, up to four times a day.

Children under 6 years: Not recommended.

Elderly: No dose modifications necessary.

Chewable Tablet should be taken in oral route after being thoroughly chewed. Recommended dose:

Adults and children 12 years and over: Take two to four tablets after meals and at bedtime, up to four times a day.

Children under 12 years: Tablets should be given only on medical advice.

Hepatic Impairment: No dose modification necessary.

Renal Insufficiency: Caution if highly restricted salt diet is necessary.

A time-interval of 2 hours should be considered between Sodium Alginate + Sodium Bicarbonate + Calcium Carbonate intake and the administration of other medicinal products, especially Tetracyclines, Digoxine, Fluoroquinolone, Iron salt, Ketoconazole, Neuroleptics, Thyroid Hormones, Penicillamine, beta-blockers (Atenolol, Metoprolol, Propranolol), Glucocorticoid, Chloroquine and Biphosphonates (diphosphonates) and Estramustine.

This product is contraindicated in patients with known or suspected hypersensitivity to the active ingredients or to any of the excipients.

In addition to the desired effect of the drug, some side effects may appear such as: constipation, flatulence, stomach cramp or belching. In these cases consult a physician. If too big dose has been taken, there might appear a sensation of swelling. In this case, it is advisable to consult a physician.

Pregnancy: Clinical studies in more than 500 pregnant women, as well as a large amount of data from post-marketing experience, indicate no malformative nor feto/neonatal toxicity of the active ingredients. This drug can be used during pregnancy, if clinically needed.

Breastfeeding: No effects of the active substances have been shown in breastfed newborns/infants of treated mothers. This drug can be used during breastfeeding.

Fertility: Pre-clinical investigations have revealed Alginate has no negative effect on parental or offspring fertility or reproduction. Clinical data do not suggest that this drug has an effect on human fertility.

Each 20 ml of dose has a sodium content of 254.5 mg (11.06 mmol). This should be taken into account when a highly restricted salt diet is recommended, e.g. in some cases of congestive cardiac failure and renal impairment.

Each 20 ml contains 260 mg (6.5 mmol) of calcium. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis, and recurrent calcium containing renal calculi.

Treatment of children younger than 12 years of age is not generally recommended, except on medical advice.

Sodium Alginate + Sodium Bicarbonate + Calcium Carbonate is considered high in sodium. This should be taken into account when a highly restricted salt diet is recommended, e.g., in some cases of congestive cardiac failure and renal impairment. Each tablet contains 75 mg of calcium. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi. Due to its aspartame content Sodium Alginate + Sodium Bicarbonate + Calcium Carbonate should not be given to patients with phenylketonuria. If symptoms persist, or treatment is required for more than 7 days continuously, medical advice should be sought. Taking Sodium Alginate + Sodium Bicarbonate + Calcium Carbonate can mask the symptoms of other more serious, underlying medical conditions. It should not be used in patients with impaired renal function/insufficiency and with hypophosphatemia. This may cause allergic reactions.

In the event of over dosage symptomatic treatment should be given. The patient may notice abdominal distension.

Antacids

Store in a cool (below 30°C) and dry place, away from light. Keep out of the reach of children. Do not refrigerate or freeze.

What is Sodium Alginate + Sodium Bicarbonate + Calcium Carbonate (500 mg+267 mg+160 mg)/10 ml Suspension, and how does it work?Sodium Alginate + Sodium Bicarbonate + Calcium Carbonate (500 mg+267 mg+160 mg)/10 ml Suspension is a medication used to treat symptoms of gastroesophageal reflux, including acid regurgitation, heartburn, and indigestion. It works by forming a thick protective layer, or "raft," on top of the stomach contents when it comes into contact with stomach acid. This raft acts as a physical barrier, preventing stomach acid from rising into the esophagus, which can cause irritation and discomfort. By keeping the acid and stomach contents in place, Sodium Alginate + Sodium Bicarbonate + Calcium Carbonate (500 mg+267 mg+160 mg)/10 ml Suspension helps alleviate symptoms associated with acid reflux and provides relief to patients experiencing digestive discomfort.What are the indications for using Sodium Alginate + Sodium Bicarbonate + Calcium Carbonate (500 mg+267 mg+160 mg)/10 ml Suspension?Sodium Alginate + Sodium Bicarbonate + Calcium Carbonate (500 mg+267 mg+160 mg)/10 ml Suspension is primarily indicated for the treatment of symptoms caused by gastroesophageal reflux disease (GERD), such as acid regurgitation, heartburn, and indigestion. It is particularly useful for patients who experience these symptoms after meals, during pregnancy, or due to reflux esophagitis. This medication provides relief by neutralizing stomach acid and preventing it from irritating the esophagus. Sodium Alginate + Sodium Bicarbonate + Calcium Carbonate (500 mg+267 mg+160 mg)/10 ml Suspension is also beneficial for individuals suffering from acid-related digestive issues, helping to improve their overall comfort and well-being.How should Sodium Alginate + Sodium Bicarbonate + Calcium Carbonate (500 mg+267 mg+160 mg)/10 ml Suspension be taken, and what is the recommended dosage?The recommended dosage of Sodium Alginate + Sodium Bicarbonate + Calcium Carbonate (500 mg+267 mg+160 mg)/10 ml Suspension varies based on age. For adults and children over 12 years, the advised dose is 10-20 mL, four times daily, taken after meals and at bedtime. For children under 12 years, the medication should only be used upon medical advice. Patients should follow the prescribed dosage and avoid exceeding the recommended amount without consulting a healthcare professional. It is essential to take the medication as directed to achieve the best results and ensure effective relief from symptoms.Are there any contraindications or precautions to consider before taking Sodium Alginate + Sodium Bicarbonate + Calcium Carbonate (500 mg+267 mg+160 mg)/10 ml Suspension?Sodium Alginate + Sodium Bicarbonate + Calcium Carbonate (500 mg+267 mg+160 mg)/10 ml Suspension is contraindicated in patients with known hypersensitivity to its active ingredients, including Sodium Alginate, Sodium Bicarbonate, and Calcium Carbonate. Additionally, this medication should be used with caution in individuals with renal impairment or congestive cardiac failure, as it may affect electrolyte balance. Patients with pre-existing medical conditions should consult their healthcare provider before using Sodium Alginate + Sodium Bicarbonate + Calcium Carbonate (500 mg+267 mg+160 mg)/10 ml Suspension. It is always recommended to inform the doctor about any ongoing medications to prevent potential drug interactions.What are the possible side effects of Sodium Alginate + Sodium Bicarbonate + Calcium Carbonate (500 mg+267 mg+160 mg)/10 ml Suspension?While Sodium Alginate + Sodium Bicarbonate + Calcium Carbonate (500 mg+267 mg+160 mg)/10 ml Suspension is generally well-tolerated, some patients may experience mild side effects. These can include skin rashes and breathing difficulties in individuals who are sensitive to its components. If any allergic reactions occur, such as swelling of the face, lips, or throat, or difficulty breathing, immediate medical attention should be sought. Although serious side effects are rare, patients should monitor their reactions to the medication and report any unusual symptoms to their physician. Proper medical supervision can help manage any adverse effects effectively.Can Sodium Alginate + Sodium Bicarbonate + Calcium Carbonate (500 mg+267 mg+160 mg)/10 ml Suspension be used during pregnancy, lactation, and in children?Sodium Alginate + Sodium Bicarbonate + Calcium Carbonate (500 mg+267 mg+160 mg)/10 ml Suspension is considered safe for use during pregnancy and lactation. However, pregnant or breastfeeding women should consult a doctor before using this medication to ensure it is appropriate for their condition. For children and adolescents, Sodium Alginate + Sodium Bicarbonate + Calcium Carbonate (500 mg+267 mg+160 mg)/10 ml Suspension should be used only under medical supervision. Since children may have different tolerances and reactions to medications, a healthcare provider’s guidance is essential in determining the correct dosage and ensuring safe administration.