Fertin 4 mg, tabletten

Riik: Holland

keel: hollandi

Allikas: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Toimeaine:

GLIMEPIRIDE 4 mg/stuk

Saadav alates:

Medochemie Limited Constantinopelstreet 1-10 3011 LIMASSOL (CYPRUS)

ATC kood:

A10BB12

INN (Rahvusvaheline Nimetus):

GLIMEPIRIDE 4 mg/stuk

Ravimvorm:

Tablet

Koostis:

INDIGOKARMIJN (E 132) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201), INDIGOKARMIJN (E 132) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POVIDON K 30 (E 1201),

Manustamisviis:

Oraal gebruik

Terapeutiline ala:

Glimepiride

Toote kokkuvõte:

Hulpstoffen: INDIGOKARMIJN (E 132); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); POVIDON K 30 (E 1201);

Loa andmise kuupäev:

2009-12-10

Infovoldik

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FERTIN 1 MG TABLETS
FERTIN 2 MG TABLETS
FERTIN 3 MG TABLETS
FERTIN 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 Fertin is and what it is used for
2.
What you need to know before you take Fertin
3.
How to take Fertin
4.
Possible side effects
5.
How to store Fertin
6.
Contents of the pack and other information
1.
WHAT FERTIN
IS AND WHAT IT IS USED FOR
Fertin is an orally active blood sugar lowering medicine. Fertin
contains glimepiride, which belongs
to to a blood sugar lowering group of medicines called sulfonylurea.
Fertin works by increasing the
amount of insulin released from your pancreas. The insulin then lowers
your blood sugar levels.
WHAT FERTIN IS USED FOR:
Fertin 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 FERTIN
DO NOT TAKE FERTIN 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).
-
have insulin dependent diabetes (type 1
diabetes mellitus).
-
have diabetic ketoacidosis (a complication of diabetes when your acid
level is raised in your body
and you may have some of the following signs: fatigue, feeling sick
(nausea),

Toote omadused

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fertin 1mg, tablets
Fertin 2mg, tablets
Fertin 3mg, tablets
Fertin 4mg, tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1mg, 2mg, 3mg or 4mg glimepiride.
Excipient with known effect: lactose monohydrate
Each tablet of Fertin 1mg contains 78.37mg of lactose monohydrate.
Each tablet of Fertin 2mg contains 156.6mg of lactose monohydrate.
Each tablet of Fertin 3mg contains 155.7mg of lactose monohydrate.
Each tablet of Fertin 4mg contains 154.75mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Fertin 1mg is pink, round, flat, scored on one side tablet with
diameter 6mm.
Fertin 2mg is green, oval, flat, scored on one side, embossed “MC”
on the other side tablet with
dimensions 5x10mm.
Fertin 3mg is pale yellow, oval, flat, scored on one side, embossed
“MC” on the other side tablet with
dimensions 5x10mm.
Fertin 4mg is blue, oval, flat, scored on one side, embossed “MC”
on the other side tablet with
dimensions 5x10mm.
The score line helps dividing the tablets in two equal halves.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Fertin is indicated for the treatment of type 2 diabetes mellitus,
when diet, physical exercise and
weight reduction alone are not adequate.
2
4.2.
POSOLOGY AND METHOD OF 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 cannot
compensate if the patient does not keep to
the recommended diet.
Posology
Dose is determined by the results of blood and urinary glucose
determinations.
The starting dose is 1 mg glimepiride per day. If good control is
achieved this dose should be used for
maintenance therapy.
For different dose regimens appropriate strengths are available.
If control is unsatisfactory the dose should be increased, based on
the glycaemic control, in a stepwise
manner with an interval of about 1 to 2 weeks