RISEK INSTA Sachet

- Omeprazole is contraindicated in patients with known hypersensitivity to any component of the formulation.

- Sodium bicarbonate is contraindicated with metabolic alkalosis and hypocalcemia.

Body as a whole

Allergic reactions, including, rarely anaphylaxis, fever, pain, fatigue, malaise and abdominal swelling.

Cardiovascular

Chest pain or angina, tachycardia, bradycardia, palpitation, elevated blood pressure, and peripheral edema.

Gastrointestinal

Pancreatitis (sometimes fatal), anorexia, irritable colon, flatulence, fecal discoloration, esophageal candidiasis, mucosal atrophy of the tongue, dry mouth, stomatitis. During treatment with omeprazole, gastric fundic gland polyps have been noted rarely. These polyps are benign and appear to be reversible when treatment is discontinued.

Hepatic

Mild and rarely, marked elevations of liver function tests [ALT(SGPT), AST(SGOT), ɤ-glutamyl transpeptidase, alkaline phosphatase, and bilirubin (jaundice)]. In rare instances, over liver disease has occurred, including hepatocellular, cholestatic, or mixed hepatitis, liver necrosis (sometimes fatal), hepatic failure (sometimes fatal), and hepatic encephalopathy.

Metabolic/ Nutritional

Hyponatremia, hypoglycemia, and weight gain.

Musculoskeletal

Muscle cramps, myalgia, muscle weakness, joint pain, and leg pain.

Nervous System/Psychiatric

Psychic disturbances including depression, agitation, aggression, hallucinations, confusion, insomnia, nervousness, tremors, apathy, somnolence, anxiety, dream abnormalities, vertigo, paresthesia and hemifacial dysesthesia.

Respiratory

Epistaxis, pharyngeal pain.

Skin

Rash and rarely, cases of severe generalized skin reactions including toxic epidermal necrolysis (TEN; sometimes fatal), Stevens-Johnson syndrome, and erythema multiforme (some severe); purpura and/or petechiae (sometimes with rechallenge); skin inflammation, urticaria, angioedema, pruritus, photosensitivity, alopecia, dry skin, and hyperhidrosis.

Special Senses

Tinnitus, taste perversion.

Ocular

Blurred vision, ocular irritation, dry eye syndrome, optic atrophy, anterior ischemic optic neuropathy, optic neuritis and double vision.

Urogenital

Interstitial nephritis (sometimes with positive rechallenge), urinary tract infection, microscopic pyuria, urinary frequency, elevated serum creatinine, proteinuria, hematuria, glycosuria, testicular pain, and gynecomastia.

Hematologic

Rare instances of pancytopenia, agranulocytosis (sometimes fatal), thrombocytopenia, neutropenia, leukopenia, anemia, leucocytosis, and hemolytic anemia have been reported.

Additional adverse reactions that could be caused by sodium bicarbonate include metabolic alkalosis, seizures, and tetany.

- diazepam, warfarin and phenytoin, drugs that are metabolized by oxidation in the liver, drugs metabolized via the cytochrome P-450 system (e.g., cyclosporine, Disulfiram, benzodiazepines).

- drugs where gastric pH is an important determinant of their bioavailability (e.g., ketoconazole, ampicillin esters, and iron salts).

- atazanavir

- tacrolimus

- clarithromycin

Pregnancy

There are no adequate and well controlled studies on the use of omeprazole in pregnant women. Omeprazole should be used during pregnancy only if the potential benefit to pregnant women justifies the potential risk to the fetus.

Nursing Mothers

Omeprazole is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from omeprazole; a decision should be made whether, to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. In addition, sodium bicarbonate should be used with caution in nursing mothers.

General:

- Symptomatic response to therapy with omeprazole does not preclude the presence of gastric malignancy.

- Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole.

- Omeprazole powder for oral suspension contains sodium in the form of sodium bicarbonate. This should be taken into consideration for patients on a sodium-restricted diet.

- Sodium bicarbonate should be used with caution in patients with Barter’s syndrome, hypokalemia, respiratory alkalosis, and problems with acid-bases balance. Long-term administration of bicarbonate with calcium or milk can cause milk-alkali syndrome.

RISEK INSTA (Omeprazole + Sodium bicarbonate) is a combination of omeprazole, a proton-pump inhibitor and sodium bicarbonate, an antacid. Risek insta contains immediate-release formulation of omeprazole and sodium bicarbonate. Sodium bicarbonate raises the gastric pH and thus protect omeprazole from acid degradation.

Omeprazole is substituted benzimidazole 5-methoxy-

Omeprazole reduces gastric acid secretion through a unique mechanism of action. Omeprazole belongs to a class of anti-secretory compounds – the substituted benzimidazoles that do not exhibit anti-cholinergic or H2 histamine antagonistic properties. It inhibits secretion of gastric acid by irreversibly blocking the enzyme system of hydrogen/potassium adenosine triphosphatase (H+/K+ATPase), the proton pump of the gastric perinatal cell. This effect is dose-related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus.