Glimepiride Aurobindo 2mg Tablets

Nazione: Malta

Lingua: inglese

Fonte: Medicines Authority

Principio attivo:

GLIMEPIRIDE

Commercializzato da:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

Codice ATC:

A10BB12

INN (Nome Internazionale):

GLIMEPIRIDE

Forma farmaceutica:

TABLET

Composizione:

GLIMEPIRIDE

Tipo di ricetta:

POM

Area terapeutica:

DRUGS USED IN DIABETES

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2013-08-07

Foglio illustrativo

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PACKAGE LEAFLET: INFORMATION FOR THE USER
GLIMEPIRIDE AUROBINDO 1 MG TABLETS
GLIMEPIRIDE AUROBINDO 2 MG TABLETS
GLIMEPIRIDE AUROBINDO 3 MG TABLETS
GLIMEPIRIDE AUROBINDO 4 MG TABLETS
glimepiride
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 Glimepiride Aurobindo is and what it is used for
2.
What you need to know before you take Glimepiride Aurobindo
3.
How to take Glimepiride Aurobindo
4.
Possible side effects
5.
How to store Glimepiride Aurobindo
6.
Contents of the pack and other information
1.
WHAT GLIMEPIRIDE AUROBINDO IS AND WHAT IT IS USED FOR
Glimepiride Aurobindo is a medicine taken by mouth to help lower blood
sugar. It belongs to a
group of medicines called sulfonylurea. Glimepiride Aurobindo works by
increasing the amount
of insulin released from your pancreas. The insulin then lowers your
blood sugar levels.
WHAT GLIMEPIRIDE AUROBINDO IS USED FOR:
•
Glimepiride Aurobindo is used to treat a certain form of diabetes
(type 2 diabetes mellitus)
when diet, physical exercise and weight reduction alone have not been
able to control your
blood sugar levels
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GLIMEPIRIDE AUROBINDO
DO NOT TAKE GLIMEPIRIDE AUROBINDO AND TELL YOUR DOCTOR IF:
•
If you are allergic to: glimepiride or other sulfonylureas (medicines
used to lower your blood
sugar such as glibenclamide) or sulfonamides (medicines for bacterial
infections such as
sulfamethoxazole) or any of the other ingredients of this medicine
(listed in Section 6 )
•
You have insulin

Scheda tecnica

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Glimepiride Aurobindo 1 mg tablets
Glimepiride Aurobindo 2 mg tablets
Glimepiride Aurobindo 3 mg tablets
Glimepiride Aurobindo 4 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1mg, 2mg, 3mg or 4mg of glimepiride.
Excipients with known effect: 1mg, 2mg, 3mg and 4mg tablets also
contain 158.45 mg, 157.50 mg,
156.45 mg and 155.35 mg lactose monohydrate per tablet respectively.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
_Glimepiride Aurobindo 1mg Tablets: _
Pink coloured, flat faced, oblong uncoated tablets with notched sides
at double bisect, debossed
with “X” and “76” on either side of the bisect on one face,
and plain on the other face. The size is
10 mm X 5 mm.
The tablet can be divided into equal doses.
_Glimepiride Aurobindo 2mg Tablets: _
White to off white coloured, flat faced, oblong uncoated tablets with
notched sides at double bisect,
debossed with “Y” and “32” on either side of the bisect on one
face, and plain on the other face.
The size is 10 mm X 5 mm.
The tablet can be divided into equal doses.
_Glimepiride Aurobindo 3mg Tablets: _
Light yellow coloured, flat faced, oblong uncoated tablets with
notched sides at double bisect,
debossed with “Y” and “33” on either side of the bisect on one
face, and plain on the other face.
The size is 10 mm X 5 mm.
The tablet can be divided into equal doses.
_Glimepiride Aurobindo 4mg Tablets: _
Light blue to blue coloured, flat faced, oblong uncoated tablets with
notched sides at double bisect,
debossed with “Y” and “34” on either side of the bisect on one
face, and plain on the other face.
The size is 10 mm X 5 mm
The tablet can be divided into equal doses.
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4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Glimepiride Aurobindo is indicated for the treatment of type 2
diabetes mellitus, when diet,
physical exercise and weight reduction alone are not adequate.
4.2
POSOLOGY AND