Pays: Canada
Langue: anglais
Source: Health Canada
BETAHISTINE HYDROCHLORIDE
SANIS HEALTH INC
N07CA01
BETAHISTINE
24MG
TABLET
BETAHISTINE HYDROCHLORIDE 24MG
ORAL
100
Prescription
MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS
Active ingredient group (AIG) number: 0103555004; AHFS:
APPROVED
2022-02-08
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 Lire le document complet
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 ................................................................................. Lire le document complet