MUCOSTA 100mg f.c.tab.

Negara: Mesir

Bahasa: Inggris

Sumber: EDA (Egyptian Drug Authority)

Tersedia dari:

OTSUKA PHARMACEUTICAL-JAPAN

Dosis:

100 mg

Bentuk farmasi:

coated tablet

Unit dalam paket:

10 tablets

Diproduksi oleh:

OTSUKA EGYPT

Tanggal Otorisasi:

2006-06-13

Karakteristik produk

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