*Based on in vitro study and may not translate into clinical benefit. †Gelusil provides relief in 40 seconds. $Heartburn here refers to the “Clinical manifestations of hyperacidity e.g. heartburn References: 1. In Vitro Study to evaluate Time of Onset of Action of Non-systemic Antacid. Data on File. Pfizer India, 2018. 2. Adapted from LPD of GELUSIL Tablets/Liquid and GELUSIL (Xtra Cool) Liquid; LPDGEL082018.
Full prescribing information available on request. Issued in Public Interest by Pfizer. SUMMARY OF PRESCRIBING INFORMATION OF GELUSIL® Antacid/Antigas Chewable Tablets/Liquid GELUSIL®MPS Tablets/Liquid (Original-Mint/Xtracool-Mint Flavour) COMPOSITION: Each uncoated chewable tablet contains: Activated dimethicone lP 50 mg, magnesium hydroxide IP 250 mg, dried aluminium hydrioxide 250 mg IP, magnesium aluminium silicate hydrate 50 mg. Liquid- Each 5 ml (1 teaspoonful) contains: Activated dimethicone lP 50 mg, magnesium hydroxide IP 250 mg, dried aluminium hydroxide IP 250 mg, Sorbitol Solution (70%) IP 1.25g. POSOLOGY AND METHOD OF ADMINISTRATION: Chewable tablets and Oral liquid suspension. Gelusil tablets: 1-2 tablets to be chewed 30-60 min after meals or whenever symptoms are pronounced. Gelusil liquid oral: 1-2 teaspoonful (approximately 5-10 ml) 30-60 min after meals or whenever symptoms are pronounced for not more than two weeks. INDICATIONS: For relief of symptoms of hyperacidity (e.g., heartburn, epigastric discomfort, or their equivalents) that are often associated with dyspepsia, peptic ulcer, gastritis, peptic esophagitis, and hiatus hernia. It is also indicated for relief of flatulence (gas). CONTRAINDICATIONS Gelusil tablets/liquid should not be used in patients with known sensitivity to any of the ingredients. SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE: Antacid therapy is only recommended for the short-term relief of heartburn. Patients with persistent heartburn (after4 to 6 weeks of therapy), or symptoms of complicated reflux disease (e.g., regurgitation, dysphagia, odynophagia, or wheezing) warrant full medical examination. Gelusil should not be taken in excess of the label specified dosage (10 teaspoonful or 12 tablets) in a 24-hour period. USE IN SPECIAL POPULATION: In elderly patients, dosing needs to be adjusted to suit individual patient requirements and characteristics. Gelusil should be used with caution in patients with renal impairment. Antacids should not be given to young children (up to 6 years of age) unless prescribed by a physician. Use in pregnancy should be based on assessment of the risk/benefit ratio. UNDESIRABLE EFFECTS: Generally, well tolerated DRUG INTERACTIONS: Antacids have potentially important interactions with Beta-blocking agents, Cimetidine, Chloroquine, Digoxin, NSAIDs, Phenytoin, Tetracyclines, Iron preparations, Fluoroquinolones and Quinidine. Absorption of captopril, dasatinib, itraconazole, rosuvastatin, some tetracyclines including doxycycline, some quinolone antibiotics including ciprofloxacin, levofloxacin, norfloxacin, and ofloxacin, may be impaired in the presence of aluminum hydroxide. In general, patients should be advised not to take any other oral medication within 1 to 2 hours of consuming antacids. OVERDOSE: In the event of overdosage, symptomatic treatment, with supportive measures and gastric lavage, if necessary, is recommended. Keep out of reach of children. In the event of overdose, get medical help. STORAGE: Tablets: Store in a dry place away from sunlight. Liquid: Store away from sunlight. Shake well before use. Keep bottle tightly closed and avoid freezing. Adapted from LPD of GELUSIL® Tablets/Liquid and GELUSIL (Xtra Cool) Liquid; LPDGEL082018. Gelusil® Trademark of Warner-Lambert Company LLC, USA. Licensed User. Pfizer Limited, India.
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