Glimepiride Denk 3 tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

glimepiride

Available from:

Denk Pharma GmbH & Co. KG

ATC code:

A10BB12

INN (International Name):

glimepiride

Dosage:

3mg

Pharmaceutical form:

tablets

Units in package:

(30/3x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-01-10

Patient Information leaflet

_Glimepiride Denk 3_
Tablet – oral use
Antidiabetic agent
Active substance: glimepiride
Package leaflet: Information for the patient
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 DENK 3 IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GLIMEPIRIDE DENK 3
3.
HOW TO TAKE GLIMEPIRIDE DENK 3
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE GLIMEPIRIDE DENK 3
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
What Glimepiride Denk 3 is and what it is used for
Glimepiride Denk 3 is an orally active blood sugar lowering drug. This
drug
belongs to a blood sugar lowering group of medicines called
sulfonylureas.
Glimepiride Denk 3 works by increasing the amount of insulin released
from
your pancreas. The insulin then lowers your blood sugar levels.
Glimepiride Denk 3 is used to treat a certain form of diabetes (type 2
diabe
-
tes 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
Denk 3
Do not take Glimepiride Denk 3 and tell your doctor if
•
you are allergic to glimepiride or certain 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 dependent diabetes (type 1 diabetes mellitus)
•
you have diabetic ketoacidosis (a complication of diabetes when your

Summary of Product characteristics

1
S
UMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Glimepiride Denk 3
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: glimepiride
Each tablet contains 3 mg glimepiride.
Excipients with known effect:
Glimepiride Denk 3 contains lactose monohydrate and less than 1 mmol
sodium (23 mg) per
tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Yellow coloured, oblong, flat, uncoated tablet with facet and with
breakline on one side.
The tablets can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Glimepiride 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 METHOD OF ADMINISTRATION
For oral administration.
The basis for successful treatment of diabetes is a suitable diet,
regular physical activity as well
as routine checks of blood and urine values. Antidiabetic agents or
insulin cannot compensate
if the patient does not keep to the recommended diet.
POSOLOGY
The dose is determined by the results of blood and urinary glucose
determinations.
The starting dose is 1 mg glimepiride a day. If sufficient metabolic
control is achieved, this
dose should be used for maintenance therapy.
For the different dose regimens appropriate strengths are available.
If metabolic control is unsatisfactory, the dose should be increased
gradually, based on
glycaemic situation, to 2, 3 or 4 mg glimepiride per day at intervals
of about 1 to 2 weeks.
A dose of more than 4 mg glimepiride per day gives better results only
in exceptional cases.
The maximum recommended dose is 6 mg glimepiride a day.
2
If patient’s metabolism is not adequately controlled with the
maximum daily dose of metformin
alone, concomitant therapy with glimepiride can be initiated. While
maintaining the metformin
dose, the glimepiride therapy is started with a low dose, and is then
titrated up depending on
the desired level of metabolic control up to the maximum daily dose.
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