BETAHISTINE TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

BETAHISTINE HYDROCHLORIDE

Disponible des:

SANIS HEALTH INC

Codi ATC:

N07CA01

Designació comuna internacional (DCI):

BETAHISTINE

Dosis:

24MG

formulario farmacéutico:

TABLET

Composición:

BETAHISTINE HYDROCHLORIDE 24MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0103555004; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2022-02-08

Informació per a l'usuari

IMPORTANT: PLEASE READ
_BETAHISTINE Product Monograph _
_Page 19 of 20_
PART III: CONSUMER INFORMATION
Pr
BETAHISTINE
BETAHISTINE DIHYDROCHLORIDE TABLETS, HOUSE STANDARD
READ THIS CAREFULLY BEFORE YOU START TAKING BETAHISTINE
AND EACH TIME YOU GET A REFILL. THIS LEAFLET IS A SUMMARY AND
WILL NOT TELL YOU EVERYTHING ABOUT BETAHISTINE. TALK TO
YOUR DOCTOR, NURSE, OR PHARMACIST ABOUT YOUR MEDICAL
CONDITION AND TREATMENT AND ASK IF THERE IS ANY NEW
INFORMATION ABOUT BETAHISTINE.
ABOUT THIS MEDICATION
WHAT THE MEDICATION IS USED FOR:
BETAHISTINE is used for reducing the episodes of recurrent
vertigo (dizziness) associated with Ménière’s disease.
WHAT IT DOES:
BETAHISTINE is a type of medicine called a histamine-
analogue. It is thought to work by helping the blood flow in your
inner ear, which lowers the build up of pressure. It is this build
up of pressure in the ear which is thought to cause feelings of
dizziness (vertigo), feelings of being sick (nausea and vomiting),
ringing in the ears (tinnitus), and hearing loss or hearing
difficulty suffered by people with Ménière’s disease.
WHEN IT SHOULD NOT BE USED:
Do not use BETAHISTINE if:

you are allergic (hypersensitive) to betahistine
dihydrochloride or to any of the non-medicinal ingredients
in the product.

you have a peptic (stomach) ulcer or have a history of this
condition.

your doctor has told you that you have an adrenal gland
tumour (called pheochromocytoma).
WHAT THE MEDICINAL INGREDIENT IS:
Betahistine dihydrochloride
WHAT THE NON-MEDICINAL INGREDIENTS ARE:
Colloidal Anhydrous Silica, Crospovidone, Lactose
Monohydrate, Microcrystalline Cellulose, Povidone and Stearic
Acid
WHAT DOSAGE FORMS IT COMES IN:
Tablets: 16 mg and 24 mg.
WARNINGS AND PRECAUTIONS
BEFORE YOU USE BETAHISTINE TALK TO YOUR DOCTOR, NURSE
OR PHARMACIST IF YOU:

have or have had health problems in the past.

you are taking medications, including ones you can take
without a doctor’s prescription e.g., natural or herbal
remedies.

suffer from bronchial asthma, sinc

Fitxa tècnica

PRODUCT MONOGRAPH
PR BETAHISTINE
Betahistine Dihydrochloride Tablets
8 MG, 16 MG AND 24 MG
Manufacturer’s standard
ANTI-VERTIGO AGENT
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Control Number: 260285
Date of
Preparation:
February 8, 2022
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
4
DRUG INTERACTIONS
...................................................................................................
6
DOSAGE AND ADMINISTRATION
...............................................................................
6
OVERDOSAGE
.................................................................................................................
7
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 7
STORAGE AND STABILITY
.........................................................................................
10
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 10
PART II: SCIENTIFIC INFORMATION
..............................................................................
11
PHARMACEUTICAL INFORMATION
.........................................................................
11
CLINICAL TRIALS
.........................................................................................................
12
DETAILED PHARMACOLOGY
.................................................................................