Glucobay 50mg tablets

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Acarbose

Հասանելի է:

Bayer Plc

ATC կոդը:

A10BF01

INN (Միջազգային անվանումը):

Acarbose

Դոզան:

50mg

Դեղագործական ձեւ:

Oral tablet

Կառավարման երթուղին:

Oral

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF: 06010203; GTIN: 5010605048012

Տեղեկատվական թերթիկ

85959069
PMR 85959069 (AB/01-C_MU-201709656) Pantone: Black, Orange 021
0
Glucobay
®
50mg tablets
ACARBOSE
PACKAGE LEAFLET: INFORMATION FOR THE USER
0
Glucobay
®
50mg 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 GLUCOBAY IS AND WHAT IT IS USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
GLUCOBAY
3
HOW TO TAKE GLUCOBAY
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE GLUCOBAY
6
CONTENTS OF THE PACK AND OTHER
INFORMATION
1
What Glucobay is and
what it is used for
The active ingredient in this medicine is
acarbose. This belongs to a group of medicines
called_ glucosidase inhibitors._
GLUCOBAY IS USED TO TREAT NON-INSULIN
DEPENDENT DIABETES.
It helps to control your blood sugar levels.
It works by slowing down the digestion of
carbohydrates_ (complex sugars)_ which reduces
the abnormally high blood sugar levels in your
body after each meal.
Glucobay can be used to treat diabetes when a
restricted diet alone or a restricted diet plus other
sugar-lowering drugs do not work well enough.
2
What you need to know
before you take Glucobay
Do not take Glucobay:
s
IF YOU ARE ALLERGIC to acarbose or any of
the other ingredients of this medicine (listed
in section 6).
s
IF YOU ARE PREGNANT OR BREAST-FEEDING.
s
IF YOU HAVE INFLAMMATION OR ULCERATION
OF THE BOWEL, for example ulcerative colitis
or Crohn’s disease.
s
IF YOU HAVE AN OBSTRUCTION IN YOUR
INTESTINES, or are likely to get this.
s
IF YOU HAVE A SEVERE LIVER DISORDER
.
s
IF YOU HAVE AN INTESTINE DISEASE where
you do not digest or absorb food proper

Ապրանքի հատկությունները

OBJECT 1
GLUCOBAY 50MG TABLETS
Summary of Product Characteristics Updated 10-Oct-2017 | Bayer plc
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Glucobay 50 mg tablets
2. Qualitative and quantitative composition
GLUCOBAY 50 MG TABLETS:
1 tablet contains 50 mg acarbose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet for oral administration.
White to yellow-tinged round, convex tablets of 7 mm diameter and 10
mm radius of curvature with 'G50'
on one side and the BAYER-cross on the other side.
4. Clinical particulars
4.1 Therapeutic indications
INDICATIONS
Glucobay is recommended for the treatment of non-insulin dependent
(NIDDM) diabetes mellitus in
patients inadequately controlled on diet alone, or on diet and oral
hypoglycaemic agents.
MODE OF ACTION
Glucobay is a competitive inhibitor of intestinal alpha-glucosidases
with maximum specific inhibitory
activity against sucrase. Under the influence of Glucobay, the
digestion of starch and s