Gastal mint tablets

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT GASTRAL PEPPERMINT TABLETS

Composition:

Active substances: sodium alginate, sodium hydrogen carbonate, calcium carbonate;

One tablet contains 250 mg of sodium alginate, 133.5 mg of sodium hydrogen carbonate, and 80 mg of calcium carbonate.

Excipients: mannitol (E 421); sorbitol (E 420); aspartame (E 951); potassium acesulfame; copovidone; povidone; magnesium stearate; flavouring "Peppermint extract with cooling effect" containing: flavouring extract (peppermint extract), natural flavouring substances, maltodextrin.

Pharmaceutical form. Chewable tablets.

Main physicochemical characteristics: tablets from almost white to white with brownish or greyish tinge, with small specks, round-shaped, with biconvex surface. A slight specific odour is permissible.

Pharmacotherapeutic group. Medicinal products for treatment of peptic ulcer and gastroesophageal reflux disease (GERD). ATC code A02B X13.

Pharmacological properties.

Pharmacodynamics.

After oral administration, GASTRAL MINT TABLETS rapidly interact with gastric juice, forming a layer of alginate gel on its surface, which has a pH close to neutral and effectively coats the gastric walls, preventing gastroesophageal reflux. In severe cases, this layer, distributed over the surface of gastric contents, rises into the esophagus and prevents its irritation.

Pharmacokinetics.

The mechanism of action of this medicinal product is physical and does not depend on absorption into the systemic circulation.

Clinical characteristics.

Indications.

Treatment of symptoms of gastroesophageal reflux disease, namely: heartburn; sour regurgitation; digestive disturbances related to reflux, including during pregnancy.

Contraindications.

This medicinal product is contraindicated in patients with known or suspected hypersensitivity to sodium alginate, sodium hydrogencarbonate, calcium carbonate, or to any of the excipients.

Interaction with other medicinal products and other forms of interaction.

At least 2 hours should elapse between the administration of GASTRAL MINT TABLETS and other medicinal products, especially tetracyclines, digoxin, fluoroquinolones, iron salts, ketoconazole, neuroleptics, thyroid hormones, penicillamine, beta-blockers (atenolol, metoprolol, propranolol), glucocorticoids, chloroquine, estramustine, and bisphosphonates.

Special precautions for use

One dose of the medicinal product (4 tablets) contains 257 mg (11.1 mmol) of sodium, which corresponds to 12.85% of the maximum daily sodium intake for adults recommended by the World Health Organization. The maximum daily dose of the medicinal product contains 51.4% of the maximum daily sodium intake recommended by the World Health Organization.

This medicinal product has a high sodium content, which should be taken into account by patients on a sodium-restricted diet, particularly those with kidney disease or congestive heart failure.

The dose of 4 tablets contains 320 mg (3.2 mmol) of calcium carbonate. Caution should be exercised when treating patients with hypercalcemia, nephrocalcinosis, or recurrent formation of calcium-containing kidney stones.

The medicinal product contains aspartame (E 951). Aspartame is a derivative of phenylalanine and may be harmful to patients with phenylketonuria.

The product contains sorbitol (E 420). If the patient has known intolerance to certain sugars, medical advice should be sought before taking this medicinal product.

If there is no improvement in symptoms after 7 days of treatment, the clinical situation should be re-evaluated.

Use during pregnancy or breastfeeding

Clinical studies involving more than 500 pregnant women, as well as extensive post-marketing experience, indicate no toxic effects of the active substances on the fetus or newborn, and no teratogenic potential. GASTRAL PEPPERMINT TABLETS may be used during pregnancy if clinically necessary.

Breastfeeding

Studies have shown no effects on newborns or infants breastfed by women taking this medicinal product. GASTRAL PEPPERMINT TABLETS may be used during breastfeeding.

Fertility

Clinical experience has demonstrated that therapeutic doses are unlikely to affect human fertility.

Effect on ability to drive and use machines

The medicinal product has no effect or has a negligible effect on the ability to drive or operate machinery.

Dosage and Administration.

The medicinal product is intended for oral administration. Tablets should be thoroughly chewed.

Adults and children aged 12 years and older: 2–4 tablets after meals and before bedtime.

Elderly patients: dose adjustment is not required for this age group.

Children. Clinical data on use in children under 12 years of age are lacking.

Not recommended for use in children under 12 years of age.

Overdose.

Symptoms. Symptoms may be mild; some abdominal discomfort may occur. Overdose may manifest as abdominal bloating.

Treatment. In case of overdose, symptomatic treatment should be administered.

Adverse reactions.

Adverse reactions are listed according to the following frequency classification: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), frequency not known (cannot be estimated from the available data):

Adverse reactions reporting. Reporting of adverse reactions after drug registration is of great importance. It allows monitoring of the benefit-risk balance associated with the use of this medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of drug efficacy through the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging. 10 tablets per blister, 1 or 2 blisters per carton.

Availability category. Over-the-counter (without prescription).

Manufacturer. Limited Liability Company "Pharmaceutical Company "Zdorovye".

Manufacturer's address and location of business operations. 22, Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.