Acarbose 50mg tablets

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Acarbose

Sẵn có từ:

Morningside Healthcare Ltd

Mã ATC:

A10BF01

INN (Tên quốc tế):

Acarbose

Liều dùng:

50mg

Dạng dược phẩm:

Oral tablet

Tuyến hành chính:

Oral

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: 06010203; GTIN: 5055132710704

Tờ rơi thông tin

diarrhoea and other intestinal symptoms such as
appear
or
get
worse,
you
should
contact
your
flatulence (wind) and abdominal pain.
doctor.
If you take more than the prescribed dose, or in
the
event
of
an
overdose,
avoid
the
intake
of
carbohydrate-containing food or drinks and seek
medical advice immediately. If possible, take your
tablets or the pack with you to show the doctor.
IF YOU FORGET TO TAKE ACARBOSE
If
you
forget
to
take
one
or
more
doses
of
Acarbose do not take the tablets between meals
but, instead, wait until your next scheduled dose
and meal and continue as before.
Do
not
take
a
double
dose
to
make
up
for
a
forgotten tablet.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects,
although not everybody gets them. The
following side effects have been observed during
treatment with acarbose.
VERY COMMON
SIDE
EFFECTS
_( _may _ affect more _
_than 1 in 10 people): _
•
wind _(flatulence)_
COMMON SIDE EFFECTS _ (may affect up to 1 _
_in 10 people): _
•
diarrhoea
•
stomach or abdominal pain
UNCOMMON SIDE EFFECTS _(may affect up to _
_1 in 100 people): _
•
feeling sick _(nausea)_
•
being sick _(vomiting)_
•
indigestion
increase
in
liver
enzymes
_(transaminases) _
in
the blood
RARE SIDE EFFECTS
(may _affect up to 1 in 1,000 people) _
•
s
welling
•
yellowing
of
the
whites
of
the
eyes
or
skin
_(jaundice)_
OTHER SIDE EFFECTS
_(Frequency _
_not _
_known: _
_frequency _
_cannot _
_be _
_estimated from the available data) _
•
a
decrease
in
the
number
of
blood
cells
necessary for clotting
•
allergic reaction, such as rash, redness of the
skin, skin eruptions, itching
•
a decrease in bowel activity
•
inflammation of the liver _(hepatitis)_
•
gas
pockets
in
the
bowel
_(pneumatosis_
_cystoides intestinalis)_
•
rash
with
pus
filled
pimples/blisters
_(acute_
_generalised exanthematous pustulosis)_
In
addition,
side
effects
like
liver
disorder,
abnormal liver function and liver injury have been
reported. Individual cases of a rapidly progressive
and
fatal
form
of
liv

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Acarbose 50 mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of acarbose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White or yellowish, plane, round tablets, scored on one 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
Acarbose is recommended for the treatment of type II diabetes mellitus
in
patients
inadequately
controlled
on
diet
alone,
or
on
diet
and
oral
hypoglycaemic agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
The recommended initial dose is 50 mg three times a day. However, some
patients may benefit from more gradual initial dose titration to
minimise
gastrointestinal side-effects. This may be achieved by initiating
treatment at 50
mg once or twice a day, with subsequent titration to a three times a
day
regimen.
If after six to eight weeks' treatment patients show an inadequate
clinical
response, the dosage may be increased to 100 mg three times a day. A
further
increase
in
dosage
to
a
maximum
of
200
mg
three
times
a
day
may
occasionally be necessary.
Patients receiving the maximum dose
_require careful monitoring (see Special warnings and precautions for
use, _
_Section 4.4)._
Acarbose is intended for continuous long-term treatment.
Elderly
No modification of the normal adult dosage regimen is necessary.
Paediatric population
The efficacy and safety of acarbose in children and adolescents have
not been
established. Acarbose is not recommended for patients under the age of
18
years.
Renal or hepatic impairment
See section 4.3.
Method of administration
Acarbose tablets are taken orally and should be chewed with the first
mouthful
of food, or swallowed whole with a little liquid directly before the
meal.
Owing to the great individual variation of glucosidase activity in the
intestinal
mucosa, there is no fixed dosage regimen, and patients