Acarbose 100mg tablets

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Acarbose

Предлага се от:

Viatris UK Healthcare Ltd

АТС код:

A10BF01

INN (Международно Name):

Acarbose

дозиране:

100mg

Лекарствена форма:

Oral tablet

Начин на приложение:

Oral

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 06010203; GTIN: 5016695000053

Листовка

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Barcode Info
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Sign-offs
v1/May 2015
20 May 2016
1/2
11:12
Acarbose 50/100mg 90
Leaflet
898213
671958
898213
04569/1619,04569/1620
NA
50061535
4851
NA
281544
1
NA
UK
NA
NA
1
Black
Myriad Pro
170 x 360mm
9 pt
8 pt
50061535
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ACARBOSE 50 MG TABLETS
ACARBOSE 100 MG TABLETS
(acarbose)
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 Acarbose is and what it is used for
2.
What you need to know before you take Acarbose
3.
How to take Acarbose
4.
Possible side effects
5.
How to store Acarbose
6.
Contents of the pack and other information
1. WHAT ACARBOSE IS AND WHAT IT IS
USED FOR
Acarbose contains the active substance acarbose,
which belongs to a group of medicines called
glucosidase inhibitors.
Acarbose is used in the treatment of non-insulin
dependent (type II) diabetes mellitus in patients
inadequately controlled on diet alone, or on diet
and oral hypoglycaemic agents. Acarbose is for
adults aged over 18 years. This medicine has
been prescribed for you by your doctor to treat
your diabetes.
Acarbose will help to control your blood sugar levels.
This is because acarbose works by sl

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Acarbose 100mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg acarbose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White to off-white, round biconvex tablet intagliated with AB
breakline 100 on one
side and M on the reverse.
The score line is not intended for breaking the tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acarbose is indicated in adults and adolescents aged over 18 years.
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 _
Owing to the great individual variation of glucosidase activity in the
intestinal mucosa, there
is no fixed dosage regimen, and patients should be treated according
to clinical response and
tolerance of intestinal side-effects.
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.
If distressing complaints develop in spite of strict adherence to the
diet, the dose should not be
increased further, and if necessary should be reduced according to the
severity of the side-
effects and the clinical judgment of the prescriber.
The average dose is 300 mg Acarbose/day (corresponding to 3 x 2
tablets of 50 mg
Acarbose/day, or 3 x 1 tablet of 100 mg Acarbose/day).
Acarbose is intended for continuous long-term treatment.
_Elde