Risek/Risek Insta

Risek/Risek Insta Adverse Reactions

omeprazole

Manufacturer:

Getz Pharma

Distributor:

Getz Bros
Full Prescribing Info
Adverse Reactions
Risek: Risek is well-tolerated and the adverse reactions have generally been mild and reversible.
Central and Peripheral Nervous System: Common: Headache. Uncommon: Dizziness, paresthesia, somnolence, insomnia, vertigo. Rare: Reversible mental confusion, agitation, aggression, depression and hallucinations, predominantly in severely ill patients.
Gastrointestinal: Common: Diarrhea, constipation, abdominal pain, nausea, vomiting and flatulence. Rare: Dry mouth, stomatitis and gastrointestinal candidiasis.
Hepatic: Uncommon: Increased liver enzymes.
Endocrine: Rare: Gynecomastia.
Hematological: Rare: Leukopenia, thrombocytopenia, agranulocytosis and pancytopenia.
Skin: Uncommon: Rash and/or pruritus, urticaria.
Others: Uncommon: Malaise.
Gastroduodenal carcinoids have been reported in patients with Zollinger-Ellison syndrome on long-term treatment with omeprazole.
Risek Insta: The following adverse reactions were reported: Body as a Whole: Allergic reactions eg, 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 and 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), g-glutamyl transpeptidase, alkaline phosphatase and bilirubin (jaundice)]. In rare instances, overt 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 and leg pain.
Nervous System/Psychiatric: Psychic disturbances eg, depression, agitation, aggression, hallucinations, confusion, insomnia, nervousness, tremors, apathy, somnolence, anxiety, dream abnormalities, vertigo, paresthesia and hemifacial dysesthesia.
Respiratory: Epistaxis and pharyngeal pain.
Skin: Rash and rarely, cases of severe generalized skin reactions eg, 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 hyperhydrosis.
Special Senses: Tinnitus and 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, leukocytosis and hemolytic anemia have been reported.
Additional adverse reactions that could be caused by sodium bicarbonate, include metabolic alkalosis, seizures and tetany.
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