Betahistine dihydrochloride 8 mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Azure Pharmaceuticals Ltd 12 Hamilton Drive, The Rock Road, Blackrock, Co. Louth A91 T997, Ireland

ATC code:

N07CA01

INN (International Name):

BETAHISTINE DIHYDROCHLORIDE 8 mg

Pharmaceutical form:

TABLET

Composition:

BETAHISTINE DIHYDROCHLORIDE 8 mg

Prescription type:

POM

Therapeutic area:

OTHER NERVOUS SYSTEM DRUGS

Authorization status:

Withdrawn

Authorization date:

2022-06-23

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 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 symptoms 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 Betahistine Tablets are and what they are used for
_2._
_ _
What you need to know before you take Betahistine Tablets
_ _
_3._
_ _
How to take Betahistine Tablets
_ _
4.
Possible side effects
_5._
_ _
How to store Betahistine Tablets
_ _
6.
Contents of the pack and other information
1. WHAT BETAHISTINE TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Betahistine Tablets. This medicine is
called a histamine analogue. It is
used to treat the following symptoms of Ménière's disease:
•
Dizziness (vertigo)
•
Ringing in the ears (tinnitus)
•
Hearing loss.
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 TABLETS
DO NOT TAKE BETAHISTINE TABLETS:
•
If you are allergic to betahistine or any of the other ingredients of
this medicine (listed in section
6).
•
If you have high blood pressure due to an adrenal tumour
(phaeochromocytoma).
If any of the above applies to you, do not take this medicine and talk
to your doctor.
WARNINGS AND PRECAUTIONS:
Talk to your doctor or pharmacist before taking Betahistine Tablets
if:
•
You have a stomach ulcer
•
You have asthma
•
You are pregnant or planning to become pregnant
•
You are breast-feeding.
Your doctor will t

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Betahistine dihydrochloride 8 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 8 mg betahistine dihydrochloride.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White to off-white, round, flat, bevel-edged tablet debossed ‘8’
on one side and ‘B’ on other side with
a diameter of 7 mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Betahistine dihydrochloride 8 mg tablet is indicated for vertigo,
tinnitus and hearing loss associated
with Ménière's syndrome.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults (including the elderly): _
The usual dose is 8 to 16 mg, three times daily taken preferably with
meals.
Maintenance doses are generally in the range 24-48 mg daily.
_Paediatric population: _
Betahistine should not be used in children aged below 18 years due to
insufficient data on safety and
efficacy.
_Elderly: _
Although there are limited data from clinical studies in this patient
group, extensive post marketing
experience suggests that no dose adjustment is necessary in this
patient population.
_Renal impairment: _
There are no specific clinical trials available in this patient group,
but according to post-marketing
experience no dose adjustment appears to be necessary.
_Hepatic impairment: _
There are no specific clinical trials available in this patient group,
but according to post-marketing
experience no dose adjustment appears to be necessary.
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Method of administration.
Oral use.
The tablets should be swallowed without being chewed with a glass of
water during meals.
4.3
CONTRAINDICATIONS
•
Phaeochromocytoma.
•
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caution is advised in the treatment of patients with a history of
peptic ulcer.
Clinical intolerance to betahistine dihydrochloride in bronchial
asthma patients has been shown in a
relatively f