ACARBOSE TECNIMEDE 50 Milligram Tablets

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

ACARBOSE

可用日期:

Multigeneris GmbH

INN（国际名称）:

ACARBOSE

剂量:

50 Milligram

药物剂型:

Tablets

处方类型:

Product subject to prescription which may be renewed (B)

授权状态:

Withdrawn

授权日期:

2014-01-31

资料单张

 
1
PACKAGE LEAFLET: INFORMATION FOR THE USER 

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 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. 

WHAT IS IN THIS LEAFLET 

1. What  is and what it is used for 
2. What you need to know before you take  
3. How to take  
4. Possible side effects 
5. How to store  
6. Contents of the pack and other information 

1. WHAT IS AND WHAT IT IS USED FOR 

Acarbose is used in the treatment of non-insulin dependent
diabetes mellitus in 
patients inadequately controlled on diet alone, or on diet and
oral hypoglycaemic 
agents. 
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 slowing down the digestion of carbohydrates (complex sugars)
from your diet, and 
this reduces the abnormally high blood sugar levels that occur after
each meal.  

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE  

DO NOT TAKE  

-  if you are allergic to acarbose or any of the other ingredients
of this medicine 
(listed in section 6). If you are unsure about this ask your
doctor. 
-  if you suffer from inflammation or ulceration of the bowel, e.g.
ulcerative colitis 
or Crohn's disease. 
-  if you have, or are susceptible to, an obstruction in your
intestines.  
-  if you have a liver disorder. 
-  if you have an intestin

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Acarbose Tecnimede 50 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of Acarbose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, circular, plain 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
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 should be treated according to clinical response and tolerance of
intestinal side effects.
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 tre