Betahistine dihydrochloride 8mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Betahistine dihydrochloride

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

N07CA; N07CA01

INN (International Name):

Betahistine dihydrochloride

Dosage:

8 milligram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

Antivertigo preparations; betahistine

Authorization status:

Marketed

Authorization date:

2011-10-07

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BETAHISTINE DIHYDROCHLORIDE 8 MG TABLETS
BETAHISTINE DIHYDROCHLORIDE 16 MG TABLETS
Betahistine dihydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINTS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Betahistine dihydrochloride tablets is and what it is used for
2. What you need to know before you take Betahistine dihydrochloride
tablets
3. How to take Betahistine dihydrochloride tablets
4. Possible side effects
5. How to store Betahistine dihydrochloride tablets
6. Contents of the pack and other information
1. WHAT BETAHISTINE DIHYDROCHLORIDE TABLETS IS AND WHAT IT IS USED FOR
Betahistine is a
histamine analogue
medicine that is used to treat symptoms of Ménière’s
syndrome such as dizziness
(vertigo)
, ringing in the ears (tinnitus), loss of hearing and nausea.
This medicine works by improving blood flow in the inner ear. This
lowers the build up of
pressure.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BETAHISTINE DIHYDROCHLORIDE
TABLETS
DO NOT TAKE BETAHISTINE DIHYDROCHLORIDE TABLETS:
•
If you are allergic (hypersensitive) to betahistine dihydrochloride or
any of the other
ingredients of Betahistine dihydrochloride tablets (see section 6,
Contents of the pack and
other information).
•
if you have
high blood pressure due to adrenal tumour
(phaeochromocytoma), a rare tumour
of the adrenal gland.
WARNING AND PRECAUTIONS
•
if have 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, s

Summary of Product characteristics

HealthProductsRegulatoryAuthority
04March2019
CRN008NJC
Page1of5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betahistinedihydrochloride8mgtablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eachtabletcontains
Betahistinedihydrochloride8mg
Excipient(s)withknowneffect:
Eachtabletcontains50mglactosemonohydrate
Forthefulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
Tablet
White,round,flat,6.5.mmtabletswithbevellededgeswiththeinscription‘BE’ononesideandabreaklineontheotherside.
Thescorelineisonlytofacilitatebreakingforeaseofswallowingandnottodivideintoequaldoses.
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
Initialoraltreatmentis8to16mgthreetimesdaily,takenpreferablywithmeals.
Maintenancedosesaregenerallyintherange24-48mgdaily.Dailydoseshouldnotexceed48mg.Dosagecanbeadjusted
tosuitindividualpatientneeds.Sometimesimprovementcouldbeobservedonlyafteracoupleofweeksoftreatment.
Thereisnodataavailableforpatientswithhepaticimpairment.
Thereisnodataavailableforpatientswithrenalimpairment.
Thereislimiteddataintheelderly,betahistineshouldbeusedwithcautioninthispopulation.
Children and adolescents:
Betahistinetabletsarenotrecommendedforuseinchildrenand
adolescentsbelowage18duetolackofdataonsafetyand
efficacy.
4.3 CONTRAINDICATIONS