Glimeryl 4mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

GLIMEPIRIDE

Available from:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC code:

A10BB12

INN (International Name):

GLIMEPIRIDE 4 mg

Pharmaceutical form:

TABLET

Composition:

GLIMEPIRIDE 4 mg

Prescription type:

POM

Therapeutic area:

DRUGS USED IN DIABETES

Authorization status:

Withdrawn

Authorization date:

2005-12-20

Patient Information leaflet

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1
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PACKAGE LEAFLET: INFORMATION FOR THE USER
GLIMERYL 1 MG, 2 MG, 3 MG AND 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.
WHAT IS IN THIS LEAFLET
1.
What Glimeryl is and what it is used for
2.
What you need to know before you take Glimeryl
3.
How to take Glimeryl
4.
Possible side effects
5.
How to store Glimeryl
6.
Contents of the pack and other information
1.
WHAT GLIMERYL IS AND WHAT IT IS USED FOR
Glimeryl is a medicine taken by mouth to help lower blood sugar. It
belongs to a group of
medicines called sulfonylureas.
Glimeryl works by increasing the amount of insulin released from your
pancreas. The insulin then
lowers your blood sugar levels.
What Glimeryl is used for:
Glimeryl is used to treat a certain form of diabetes (type 2 diabetes
mellitus) when diet, physical
exercise and weight loss alone have not been able to control your
blood sugar levels.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GLIMERYL
DO NOT TAKE GLIMERYL IF
-
you are allergic to glimepiride, to other sulfonylureas (medicines
used to lower your
blood sugar such as glibenclamide) or sulfonamides (medicines for
bacterial infections
such as sulfamethoxazole) or to 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
acid level is raised in
your body and you may have some of the following symptoms: tiredness,
feeling sick
(nausea), frequent urination and muscular stiffness)
-
you have a severe

Summary of Product characteristics

PAGE 1 OF 11
1.
NAME OF THE MEDICINAL PRODUCT
Glimeryl 1 mg tablets
Glimeryl 2 mg tablets
Glimeryl 3 mg tablets
Glimeryl 4 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg glimepiride.
Excipient with known effect:
Each tablet contains 70.81 mg lactose monohydrate (see section 4.4).
Each tablet contains 2 mg glimepiride.
Excipients with known effect:
Each tablet contains 141.08 mg lactose monohydrate, 0.11 mg Sunset
Yellow FCF (E110) and
0.14 mg tartrazine (E102) (see section 4.4).
Each tablet contains 3 mg glimepiride.
Excipient with known effect:
Each tablet contains 140.71 mg lactose monohydrate (see section 4.4).
Each tablet contains 4 mg glimepiride.
Excipient with known effect:
Each tablet contains 139.60 mg lactose monohydrate (see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
The tablet is pink, flat, oblong, 8 mm x 4.1 mm in size, with bevelled
edges and a score on one side
and marked with “G” on the other side.
The tablet is green, flat, oblong, 10.1 mm x 5.1 mm in size, with
bevelled edges and a score on one
side and marked with “G” on the other side.
The tablet is yellow, flat, oblong, 10.1 mm x 5.1 mm in size, with
bevelled edges and a score on one
side and marked with “G” on the other side.
The tablet is blue, flat, oblong, 10.1 mm x 5.1 mm in size, with
bevelled edges and a score on one
side and marked with “G” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Glimeryl is indicated for the treatment of type 2 diabetes mellitus,
when diet, physical exercise and
weight reduction alone are not adequate.
PAGE 2 OF 11
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
The basis for successful treatment of diabetes is a good diet, regular
physical activity, as well as
routine checks of blood and urine. Tablets or insulin can not
compensate if the patient does not keep
to the recommended diet.
Dosage is determined by the results of blood and urinary glucose
determinations.
T