Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
REBAMIPIDE; REBAMIPIDE
A. MENARINI SINGAPORE PTE. LTD.
REBAMIPIDE; REBAMIPIDE
100 Tablets
KOREA OTSUKA PHARMACEUTICAL CO LTD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ MUCOSTA TABLETS 100MG Rebamipide (100mg) WHAT IS IN THIS LEAFLET 1. What MUCOSTA is used for 2. How MUCOSTA works 3. Before you use MUCOSTA 4. How to use MUCOSTA 5. While you are using it 6. Side effects 7. Storage and Disposal of MUCOSTA 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT MUCOSTA IS USED FOR MUCOSTA is used to treat gastric ulcers and treatment of gastric mucosal lesions (erosion, bleeding, redness and edema) in the following conditions: acute gastritis (severe inflammation of the lining of the stomach caused by food poisoning, overeating or bacterial or viral infection) and acute exacerbation of chronic gastritis (an inflammation of the stomach lining that may occur repeatedly or continue over a period of time). HOW MUCOSTA WORKS Mucosta containing the active ingredient rebamipide. It has the preventive and healing effects in gastric ulcer. It can protect the mucosa from injury and it can also promote healing of the mucosal inflammation associated with gastritis (swelling or inflammation in the lining of the stomach). BEFORE YOU USE MUCOSTA _-When you must not use it _ You must not take MUCOSTA if you are: • hypersensitive to any ingredient of this drug. • Nursing a child _-Before you start use it _ Patients are advised: • To read the patient package insert for MUCOSTA carefully before starting therapy and to reread it each time therapy is renewed in case the information has changed. Please tell your doctor or pharmacist if you are pregnant or nursing a child. _-Taking other medicines _ Please inform your doctor or pharmacist drugs that you are taking including those you obtain form pharmacies without a prescription. HOW TO USE MUCOSTA _-How much to use _ The usual adult dosage of MUCOSTA is 100mg 3 times daily. _-When to use it _ MUCOSTA should be taken in the morning, in the evening and before at bedtime. _-How long to use it _ It is important to follow and finish up the prescribed dose by yo Baca dokumen lengkap
-ANTI-GASTRITIS AND ANTI -GASTRIC ULCER DRUG – MUCOSTA ® Tablets 100 < Rebamipide> Designated Drug and Prescription -only Drug Storage: Store below 30 ⁰C. Expiration date : Three years after the date of manufacture. (The expiration date is indicated on the package.) DESCRIPTION 1. Compos ition MUCOSTA Tablets 100: Each MUCOSTA Tablet contains 100 mg of rebamipide and the foll owing inactive ingredients: mi crocr ystalline cellulose, low substituted hydroxypropylcellulose , hvdroxypropylcellulose, magnesium stearate, hypromellose , ma crogol 6000, and titanium oxide. 2. Product Description MUCOSTA Tablets 100 are white f ilm -co ated tablets. INDICATION - Gastric ulcers - Trea tment of gastric mucosal lesions (erosion, bleeding, redness and edema) in the following cond iti ons: acute gast ritis and acute exacerbation of chronic gastritis. DOSAGE AND ADMINISTRATION • Gastric ulcers: The usual adult dosage of rebamipide is 100m g (1MUCOSTA Tablet) taken by the oral route thre e times dai ly, in the morning, in the evening, and before at bedtime. •Treatment of gastric mucosal lesions (erosion, bleeding, redness, and edema) in the following conditions; acute gastritis and acute ex acerbat ion of chronic gastritis: The usual adult dosage of rebamipide is 100 mg (1 MUCOSTA Tablet ) three times daily taken by t he oral route. PRECAUTIONS 1. Adverse Reac tions Of 10,047 patients treated, advers e reactions, including abnormal laboratory findings, we re reported in 54 patients (0.54%). Of 3,035 patients aged over 65 years, adverse reactions were noted i n 18 patients (0.59%). The nature and incidence of adverse reactions were not different between the same in elderly and younger patients. The following summary of data i ncludes adverse react ions voluntari1y reported after marketing (Figures are total cases reported at the time of a pproval and at the completion of reexamination of MUCOSTA Tablet 100) CONTRAINDICATIONS (MUCOSTA Tablets are contraindicated in the followi ng patients) Patients with a history of hype Baca dokumen lengkap