Страна: Египет
Език: английски
Източник: EDA (Egyptian Drug Authority)
OTSUKA PHARMACEUTICAL-JAPAN
100 mg
coated tablet
10 tablets
OTSUKA EGYPT
2006-06-13
Egypt Otsuka Pharmaceutical Co., 1 BODY SYSTEM/ FREQUENCY < 0.1% *INCIDENCE UNKNOWN HYPER- SENSITIVITY (NOTE 1) Rash, pruritus, drug-eruption-like eczema, other symptoms of hypersensitivity Urticaria NEURO- PSYCHIATRIC Numbness, dizziness, sleepiness GASTRO- INTESTINAL Constipation, feeling of abdomen enlarged, diarrhea, nausea, vomiting, heartburn, abdominal pain, belching, taste abnormality, etc. Thirst Revised: March 2016 (2nd version ) - ANTI-GASTRITIS AND ANTI-GASTRIC ULCER DRUG – MUCOSTA ® TABLETS 100 MG DESCRIPTION 1. COMPOSITION BRAND NAME ACTIVE INGREDIENT INACTIVE INGREDIENTS MUCOSTA TABLETS 100 MG Each tablet contains 100 mg of rebamipide Microcrystalline cellulose, Low substituted Hydroxypropyl cellulose, Hydroxypropyl cellulose, Magnesium stearate, Hydroxypropyl methyl cellulose 2910, macrogol 6000, and Titanium oxide 2. PRODUCT DESCRIPTION .Mucosta tablets 100 mg are round white film coated tablets APPEARANCE DIAMETER (MM) THICKNESS (MM) WEIGHT (MG) CODE 8.1 3.4 Approx 175 OG33 INDICATIONS • Gastric ulcers • Treatment of gastric mucosal lesions (erosion, bleeding, redness, and edema) in the following conditions; acute gastritis and acute exacerbation of chronic gastritis DOSAGE AND ADMINISTRATION • Gastric ulcers: The usual adult dosage of rebamipide is 100 mg (1 tablet of MUCOSTA TABLETS 100 MG ) taken by the oral route three times daily, in the morning, in the evening, and before bedtime. • Treatment of gastric mucosal lesions (erosion, bleeding, redness, and edema) in the following conditions; acute gastritis and acute exacerbation of chronic gastritis: The usual adult dosage of rebamipide is 100 mg (1 tablet of MUCOSTA TABLETS 100 MG three times daily taken by the oral route. PRECAUTIONS 1. ADVERSE REACTIONS Of 10,047 patients treated, adverse reactions, including abnormal laboratory findings, were reported in 54 patients (0.54%). Of 3,035 patients aged over 65 years, adverse reactions were noted in 18 patients (0.59%). The nature and incidence of adverse reactions showed no differenc Прочетете целия документ