Symptomatic treatment of stomach ailments such as: heartburn, indigestion (dyspepsia), hyperacidity of gastric juice, epigastric pain, which are not related to gastrointestinal disease.
Composition:
1 tabl powl. contains 150 mg ranitidine.
Action:
A competitive histamine H receptor antagonist2. It inhibits the secretion of hydrochloric acid in the stomach, both basal and stimulated, e.g. histamine, pentagastrin and food. Under the influence of Ranitidine, the secretion of pepsin decreases and the volume of gastric juice decreases to a small extent. The bioavailability of Ranitidine is approximately 50% on average. Cmax in plasma is usually achieved after 2-3 h. The plasma protein binding is about 15%. Ranitidine is excreted by the kidneys within 24 hours: approx. 30% in unchanged form, up to 6% in the form of N-oxide and in a small amount in the demethylated form, S-oxide and furanecarboxylic acid analogue. T0,5 in the elimination phase, on average, it is about 2.3-3 h. In patients with renal insufficiency, this period is doubled or tripled.
Contraindications:
Hypersensitivity to the active substance or any of the excipients.
Precautions:
Reception of H receptor antagonists2 it can mask the symptoms of stomach cancer and, consequently, delay its diagnosis. Particularly cautiously use in patients with significant renal insufficiency (creatinine clearance <50 ml / min). It should not be used in patients with severe renal insufficiency (creatinine clearance <10 ml / min). Isolated cases indicate a relationship between the occurrence of acute porphyria and the admission of ranitidine. Patients who have a history of acute porphyria should not take ranitidine. In elderly patients with chronic lung disease, diabetes or immune disorders, there may be an increased risk of developing community-acquired pneumonia. Use with caution (patients in the following groups should consult a physician before taking the product) in patients with impaired kidney or liver function; in the medium or elderly with dyspeptic symptoms that have occurred for the first time or have recently changed; with unintentional weight loss associated with dyspeptic symptoms; taking NSAIDs, in particular with history of gastritis and intestinal ulcers. It is not recommended for use in children under 16 years of age.
Pregnancy and lactation:
Ranitidine should be used in pregnant or breast-feeding women only if clearly necessary. Ranitidine crosses the placenta barrier and into breast milk.
Side effects:
Uncommon: abdominal pain, constipation, nausea. Rare: skin rash, transient and reversible changes in liver enzymes, increased plasma creatinine, hypersensitivity reactions (eg eosinophilia, urticaria, fever, low blood pressure, angioneurotic edema, difficulty in swallowing, bronchospasm, chest pains) . Very rare: headache (sometimes severe), fatigue, dizziness, transient movement disorders - involuntary movements, transient entanglement, anxiety, hallucinations, depression, transient blurred vision, erythema multiforme, pruritus, alopecia, joint pain, muscle pain, rhabdomyolysis , hepatitis (cellular, tubular or mixed) with or without jaundice, severe pancreatitis, diarrhea, interstitial nephritis, tachycardia, bradycardia, atrioventricular block, vasculitis, usually transient decreases in the number of leukocytes and platelets, agranulocytosis or aplastic anemia sometimes with partial or complete bone marrow suppression, gynecomastia, galactorrhea in men, decreased libido, transient potency disorders, decreased libido, transient potency disorders, anaphylactic shock. Not known: circulatory collapse, pneumonia, shortness of breath.
Dosage:
Orally. Adults and children ≥16 years: 1 tabl. per day. The maximum dose is 2 tablets. daily (morning and evening).If the symptoms persist or worsen after 14 days of treatment, the patient should consult a doctor or pharmacist. In patients with severe renal insufficiency (creatinine clearance <50 ml / min): 1 tablet per day. The tablets should be swallowed whole with a sufficient amount of liquid (eg a glass of water), taken with or without food.
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