Betahistine 16mg tablets

Country: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Betahistine dihydrochloride

Доступно од:

Milpharm Ltd

АТЦ код:

N07CA01

INN (Међународно име):

Betahistine dihydrochloride

Дозирање:

16mg

Фармацеутски облик:

Oral tablet

Пут администрације:

Oral

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 04060000; GTIN: 8901175023066

Информативни летак

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 Betahistine is and what it is used for
2.
What you need to know before you take Betahistine
3.
How to take Betahistine
4.
Possible side effects
5.
How to store Betahistine
6.
Contents of the pack and other information
1.
WHAT BETAHISTINE IS AND WHAT IT IS USED FOR
Betahistine is a type of medicine called a “histamine
analogue”.
Betahistine is used for:
Ménière’s disease – the signs of this include:
•
feeling dizzy (vertigo)
•
ringing in the ears (tinnitus)
•
hearing loss or hearing difficulty
How this medicine works
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
DO NOT TAKE BETAHISTINE
•
if you are allergic to betahistine or to any of the other
ingredients of this medicine (listed in section 6)
•
if you have a pheochromocytoma, a rare tumour of the
adrenal gland
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking
Betahistine.
•
if you have or have had 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
•
Betahistine dihydrochloride is not the appropriate
treatment for the following forms of vertigo:
• attacks of benign positional vertigo,
• dizziness related to a disease of the central
nervous system.
•
if you are pregnant or planning

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Betahistine 16 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 16 mg Betahistine dihydrochloride
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White to off-white round (diameter 8.5 mm), uncoated tablets debossed
with ‘X’ and
a break line on one side and ‘88’ on the other side.
The tablet can be divided 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. The
daily dose should
be given in 2 or 3 divided doses throughout the day. 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. The best
results are
sometimes obtained after a few months. There are indications that
treatment from the
onset of the disease prevents the progression of the disease and/or
the loss of hearing
in later phases of the disease.
Betahistine 8 mg/16 mg:
8 mg tablets
16 mg tablets
1 - 2 tablets
3 times/day
½ - 1 tablet
3 times/day
Betahistine 24 mg:
The recommended starting dose is 24 mg betahistine.
If the maximum daily dose of 48 mg is indicated adults take one 24 mg
tablet twice
daily (in the morning and in the evening).
24 mg tablets
1 tablet
2 times/day
_ _
_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.
_Elderly population