By-Vertin 8 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Betahistine dihydrochloride

Available from:

Fannin Limited

ATC code:

N07CA; N07CA01

INN (International Name):

Betahistine dihydrochloride

Dosage:

8 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Antivertigo preparations; betahistine

Authorization status:

Marketed

Authorization date:

2001-01-26

Patient Information leaflet

Version 2014/06
PACKAGE LEAFLET: INFORMATION FOR THE USER
BY-VERTIN 8MG TABLETS
BY-VERTIN 16MG TABLETS
Betahistine dihydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet See section 4.
WHAT IS IN THIS LEAFLET:
1. What By-Vertin is and what it is used for
2. What you need to know before you take By-Vertin
3. How to take By-Vertin
4. Possible side effects
5. How to store By-Vertin
6. Contents of the pack and other information
1. WHAT BY-VERTIN IS AND WHAT IT IS USED FOR
Betahistine is a medicine that is used to treat Ménière’s
syndrome, symptoms of which may
include dizziness, ringing in the ears, loss of hearing and nausea.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BY-VERTIN
DO NOT TAKE BETAHISTINE

if you are allergic to betahistine or any of the other ingredients of
this medicine (listed in

section 6)

if you have a phaeochromocytoma, a rare tumour of the adrenal gland

if you are under the age of 18
WARNINGS AND PRECAUTIONS

Talk to your doctor or pharmacist before taking Betahistine

if you suffer or if you have suffered from a stomach ulcer (peptic
ulcer)

if you have asthma

if you have nettle rash, skin rash or a cold in the nose caused by an
allergy, since these
complaints may be exacerbated.

if you have low blood pressure

if you are pregnant or planning to become

if you are breast-feeding
If you suffer from any of the above conditions, consult your doctor
about whether you may take
betahistine.
These groups of patients should be monitored by a doctor during
treatment.
OTHER MEDICINES AN

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
By-Vertin 8 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 8 mg betahistine dihydrochloride.
Each tablet contains 70 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Cylindrical, biplane white tablet with bevel-edges on both sides,
diameter 7 mm.
Embossed 'B8'
on one side, plain reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Betahistine is indicated for treatment of Ménière´s syndrome,
symptoms of which may include vertigo, tinnitus, hearing
loss and nausea.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Dosage_
Adults (including the elderly):
Initial oral treatment is 8 to 16 mg three times daily, taken with
food.
Maintenance doses are generally in the range 24 - 48 mg daily. Dosage
can be adjusted to suit individual patient needs.
_Paediatric population_: Betahistine tablets are not recommended for
use in children below 18 years due to insufficient
data on safety and efficacy.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
Phaeochromocytoma. As betahistine is a synthetic analogue of histamine
it may induce the release of catecholamines
from the tumor resulting in severe hypertension.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caution is advised in the treatment of patients with peptic ulcer or a
history of peptic ulceration, because of the
occasional dyspepsia encountered in patients on betahistine.
Patients with bronchial asthma and history of peptic ulcer need to be
carefully monitored during therapy.
Caution is advised in prescribing betahistine to patients with either
urticaria, rashes of allergic rhinitis, because of the
possibility of aggravating these symptoms.
Caution is advised in patients with severe hypotension.
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