Acid Reducer Tablets - Ranitidine 75mg

02230507

24 months

Ranitidine hydrochloride 75mg

Microcrystalline cellulose, hydroxypropyl methylcellulose, polydextrose, croscarmellose sodium, titanium dioxide, magnesium stearate, polyethylene glycol, colloidal silicon dioxide, red ferric oxide, carnauba wax, vanillin and yellow ferric oxide.

Pink, shield shaped, biconvex film coated tablets. Engraved '75' on one side and plain on the other side.

Diameter: 0.3300 x 0.3494 shield
Thickness: 0.118" - 0.140"

Store at room temperature (15 to 30°C). Protect from light.

Relieves burning and discomfort of heartburn and acid indigestion. Reduces stomach acid for up to 9 hours, day or night.

Adults and children 16 years and older: take one tablet as needed. If symptoms return, take another tablet. Do not take more than 2 tablets during a 24 hour period. If symptoms persist for more than two consecutive weeks, consult your doctor.

If you are taking a prescription medicine for stomach ulcer, have difficulty swallowing or persistent abdominal discomfort, have kidney disease, or are pregnant or breast-feeding, consult your doctor before taking this product. Keep out of the reach of children.

Contraindicated in patients known to have hypersensitivity to any of the component of the preparation. Ranitidine may mask symptoms associated with carcinoma of the stomach and, therefore, may delay diagnosis of that condition. Ranitidine may precipitate acute porphyritic attacks, therefore it should be avoided in patients with a history of acute porphyria. Ranitidine is excreted via kidneys and, in the presence of severe renal impairment, plasma levels of ranitidine are increased and elimination prolonged. Concurrent administration of antacids and ranitidine may decrease absorption of ranitidine; therefore, antacids should not be taken within 1/2 - 1 hour of ranitidine ingestion.

Simultaneous administration of ketokonazole and ranitidine may result in reduction of the absorption of ketoconazole. Ranitidine should not be taken for at least for 2 hours after ketoconazole. High doses of sucralfate (2 grams) may reduce absorption of ranitidine. It is recommended to take sucralfate 2 hours after ranitidine administration.

The most common adverse events include headache, nausea, vomiting and diarrhea. It can also cause dizziness, vertigo, hallucinations (predominantly in severely ill elderly patients), premature ventricular beats, bradycardia, atrioventricular block, transient and reversible changes of liver function tests, hepatitis with or without jaundice. Rare cases of agranulocytosis and pancytopenia, sometimes with marrow hypoplasia or aplasia, rash, small increase in serum creatinine, and acute pancreatitis have been reported. Hypersensitivity reactions can occur including bronchospasm, anaphylaxis, hypotension and angioneurotic edema.

There is no experience to date with deliberate overdosage. The usual measures to remove unabsorbed drug from the gastrointestinal tract (including activated charcoal or syrup of ipecac), clinical monitoring and supportive therapy should be employed. Also, if need, the drug can be removed from the plasma by haemodialysis. Up to 6g per day has been administered without untoward effect.