Acarbose 100mg 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:

100mg

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: 5055132710711

Tờ rơi thông tin

This medicine is intended for long- term use.
Acarbose tablets should be chewed with the first
mouthful of food.
If you prefer not to chew the
tablets then swallow them whole with a little liquid
IMMEDIATELY BEFORE THE MEAL.
The scoreline is only there to help you break the
tablet if you have difficulty swallowing it whole and
not to divide into equal doses.
IF YOU TAKE MORE ACARBOSE THAN YOU SHOULD
If you do exceed the prescribed dose, or in the
event
of
an
overdose,
you
may
experience
diarrhoea and other intestinal symptoms such as
flatulence (wind) and abdominal pain.
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.
By not following with the prescribed diet, intestinal
side effects (e.g. diarrhoea, flatulence) may
intensify. In case you are complying with the
prescribed diabetic diet and these side effects
appear or get worse, you should contact your
doctor.
REPORTING OF SIDE EFFECTS
If you get any of the side effects talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard or search for
MHRA Yellow Card in the Google Play or Apple
App Store. By reporting side effects you can help
provide more information on the safety of this
medicine.
5.
HOW TO STORE ACARBOSE
Keep this medicine out of the sight and reach of
IF YOU FORGET TO TAKE ACARBOSE
children.
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 C

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Acarbose 100 mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 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
100 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 50 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 patient