Betahistine 16mg tablets

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Betahistine dihydrochloride

から入手可能:

Arrow Generics Ltd

ATCコード:

N07CA01

INN（国際名）:

Betahistine dihydrochloride

投薬量:

16mg

医薬品形態:

Oral tablet

投与経路:

Oral

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 04060000

情報リーフレット

NO ARTWORK SUBMITTED TEXT APPROVED
BETAHISTINE DIHYDROCHLORIDE 8MG AND 16MG TABLETS
•
Please read this leaflet carefully before you start to take your
medicine.
•
It gives you important information about your medicine.
•
If you want to know more, or you are not sure about anything, ask your
pharmacist or doctor.
•
Keep the leaflet until you have finished the medicine.
WHAT'S IN YOUR MEDICINE
Betahistine dihydrochloride tablets come in two strengths. Each tablet
contains either 8mg or 16mg of the
active ingredient Betahistine dihydrochloride.
The tablets also contain: povidone, microcrystalline cellulose,
lactose monohydrate, colloidal anhydrous
silica, crospovidone and stearic acid.
Betahistine dihydrochloride tablets are available in pack sizes of:
60, 84, 168*
_only marketed pack size will appear _
Your tablets are manufactured by Catalent Germany Schorndorf GmbH,
Steinbeisstrasse 1-2, 73614
Schorndorf, Germany.
The Marketing Authorisation holder is Accord-UK Limited, Barnstaple,
EX32 8NS, UK.
ABOUT YOUR MEDICINE
Betahistine is one of a class of medicines known as ‘antivertigo
preparations’. It works by improving blood
flow to the inner ear, which reduces the build up of pressure. It is
this pressure within the ear which is
thought to cause the vertigo (dizziness), tinnitus (ringing in the
ears) and hearing loss suffered by people
with Ménière’s disease.
BEFORE TAKING YOUR MEDICINE
DO NOT TAKE BETAHISTINE DIHYDROCHLORIDE TABLETS IF:
•
you know, or have been told that you are hypersensative (allergic) to
betahistine dihydrochloride or any
of the ingredients of betahistine dihydrochloride tablets
•
your doctor has told you that you have phaeochromocytoma (high blood
pressure caused by an adrenal
tumour)
•
you are breast-feeding
TAKE SPECIAL CARE WITH BETAHISTINE DIHYDROCHLORIDE TABLETS IF:
•
you have a stomach ulcer (peptic ulcer), or have suffered from one in
the past
•
you have, or used to have, asthma
•
you suffer from skin rashes
•
you suffer from severe low blood pressure (faint

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Betahistine Dihydrochloride 16mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Betahistine dihydrochloride 16mg
Excipient(s) with known effect: Each tablet contains 100 mg lactose
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablets for oral administration.
Flat white tablets, with bevelled edge. Markings: R4 on one side
scoreline on the
reverse.
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 the treatment of vertigo, tinnitus and
hearing loss
associated with Ménière's syndrome.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
Adults _(including the elderly);_
Initially two tablets three times daily, taken preferably with meals.
Maintenance doses are
generally in the range 24-48mg daily.
Paediatric population: not recommended for use in children below 18
years due to insufficient
data on safety and efficacy.
Geriatric population: 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.
4.3
CONTRAINDICATIONS
Betahistine is contraindicated in patients with a phaeochromocytoma
and
hypersensitivity to betahistine dihydrochloride or 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 s