MERISLON 12mg Tablet
Country: Philippines
Language: English
Source: FDA (Food And Drug Administration)
Summary of Product characteristics
(SPC)
23-04-2024
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Active ingredient:
Betahistine mesilate
Available from:
Under License from: PT Eisai Co. Ltd.- Tokyo, Japan; Importer: HI-EISAI PHARMACEUTICAL, INC.; Distributor: Zuellig Pharma Corporation
INN (International Name):
Betahistine mesilate
Dosage:
12mg
Pharmaceutical form:
Tablet
Units in package:
Clear PVC/Aluminum foil blister pack x 10's in aluminum pouch (Box of 100's)
Manufactured by:
Pt. Eisai Indonesia, Indonesia
Authorization date:
2017-08-23
Summary of Product characteristics
Eisai Co., Ltd.
1
Revised: July 2009 (8th version)
Standard Commodity Classification No. of Japan
871339
- For relief vertigo and equilibrium disturbances -
- Betahistine mesilate tablets, JP -
MERISLON
Tablets 6mg
MERISLON
Tablets 12mg
Prescription drug
Caution : Use only as directed by a physician.
DESCRIPTION
1. COMPOSITION
TABLETS 6 MG:
Each white plain tablet contains 6 mg of betahistine me-
silate.
It also contains hydrated silicon dioxide, microcrystalline
cellulose, calcium stearate, talc, low substituted hydroxy-
propylcellulose and hydroxypropylcellulose as inactive in-
gredients.
TABLETS 12 MG:
Each white plain tablet contains 12 mg of betahistine
mesilate.
It also contains hydrated silicon dioxide, microcrystalline
cellulose, calcium stearate, talc, low substituted hydroxy-
propylcellulose and hydroxypropylcellulose as inactive in-
gredients.
2. PRODUCT DESCRIPTION
Brand
name
Dosage form
and identifi-
cation code
Appearance
Description
Face
Reverse
Lateral
MERISLON
Tablets 6 mg
Plain
tablets
White
Diameter
(mm)
6.1
Weight
(mg)
84
Thickness
(mm)
2.4
MERISLON
Tablets 12mg
Plain
tablets
White,
scored
Diameter
(mm)
7.1
Weight
(mg)
120
Thi
ckness
(mm)
2.7
INDICATIONS
Dizziness and feeling of dizziness resulting from the following
diseases:
Meniere’s disease, Meniere’s syndrome and vertigo
DOSAGE AND ADMINISTRATION
MERISLON TABLETS 6 MG:
The usual adult dosage for oral use is 1 - 2 tablets (6 - 12
mg of betahistine mesilate), three times daily after meals.
The dosage may be adjusted depending on the patient’s
age and symptoms.
MERISLON TABLETS 12 MG:
The usual adult dosage for oral use is 1 tablet (12 mg of
betahistine mesilate), three times daily after meals. Single
dose of betahistine mesilate is 6 - 12 mg.
PRECAUTIONS
1. CAREFUL
ADMINISTRATION
(MERISLON
SHOULD
BE
AD-
MINISTERED WITH CARE IN THE FOLLOWING PATIENTS.)
(1) Patients with a history of peptic ulcer or with an active
peptic ulcer
[Since MERISLON has a histamine-like action, it may
enhance gastric acid secretion through the interventi
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