BONAMINE TABLET (IMMEDIATE RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MECLIZINE HYDROCHLORIDE

Available from:

MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC

ATC code:

R06AE05

INN (International Name):

MECLOZINE

Dosage:

25MG

Pharmaceutical form:

TABLET (IMMEDIATE RELEASE)

Composition:

MECLIZINE HYDROCHLORIDE 25MG

Administration route:

ORAL

Units in package:

100

Prescription type:

OTC

Therapeutic area:

ANTIHISTAMINES

Product summary:

Active ingredient group (AIG) number: 0107502001; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2019-07-31

Summary of Product characteristics

PRODUCT MONOGRAPH
BONAMINE
®
MECLIZINE HYDROCHLORIDE TABLETS 25 MG, USP
ANTIEMETIC AGENT
McNeil Consumer Healthcare,
division of Johnson & Johnson Inc.
Date of Revision: June 8, 2011
88 McNabb Street
Markham, Ontario L3R 5L2
Control No. 142964
©
2011 McNeil Consumer Healthcare, division of Johnson & Johnson Inc.
NAME OF DRUG
_ _
_BONAMINE_
_®_
_ TABLETS _
_ _
_2 _
BONAMINE
®
MECLIZINE HYDROCHLORIDE TABLETS 25 MG, USP
THERAPEUTIC CLASSIFICATION
Antiemetic Agent
ACTION AND CLINICAL PHARMACOLOGY
Meclizine hydrochloride has antihistaminic and anticholinergic
properties. The site and mechanism
of its action in controlling vertigo arising from various conditions
have not been clearly defined.
Pharmacological studies conducted with other antihistamines show that
the peripheral labyrinthine
structures may be the site of action. The efficacy of meclizine
hydrochloride in controlling the
symptoms of motion sickness has been demonstrated in several fields
studies, specifically in cases of
airsickness and seasickness. Generally, it has been shown to be
effective in over 80% of such cases,
a single dose providing protection for approximately 24 hours with
minimal side effects.
INDICATIONS
BONAMINE
®
(meclizine hydrochloride) is indicated for the prevention and relief
of nausea,
dizziness and vomiting associated with motion sickness. It is also
indicated for the symptomatic
management
of
radiation
sickness,
Meniere’s
syndrome,
labyrinthitis
and
other
vestibular
disturbances.
_ _
_BONAMINE_
_®_
_ TABLETS _
_ _
_3 _
CONTRAINDICATIONS
BONAMINE
®
(meclizine hydrochloride) is contraindicated in persons with known
hypersensitivity
to meclizine hydrochloride.
WARNINGS
Patients should be warned that BONAMINE
®
(meclizine hydrochloride) may occasionally cause
drowsiness and that they should take the necessary precautions against
driving or operating
dangerous machinery when taking it.
Patients suffering from glaucoma or prostatic enlargement should take
BONAMINE
®
(meclizine
hydrochloride) only under the direction of a physi