Repaglinide Teva

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

repaglinide

Saatavilla:

Teva Pharma B.V.

ATC-koodi:

A10BX02

INN (Kansainvälinen yleisnimi):

repaglinide

Terapeuttinen ryhmä:

Drugs used in diabetes

Terapeuttinen alue:

Diabetes Mellitus, Type 2

Käyttöaiheet:

Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type-2-diabetes patients who are not satisfactorily controlled on metformin alone.Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.

Tuoteyhteenveto:

Revision: 9

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2009-06-28

Pakkausseloste

25
_ _
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE USER
REPAGLINIDE TEVA 0.5 MG TABLETS
REPAGLINIDE TEVA 1 MG TABLETS
REPAGLINIDE TEVA 2 MG TABLETS
Repaglinide
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 Repaglinide Teva is and what it is used for
2.
What you need to know before you take Repaglinide Teva
3.
How to take Repaglinide Teva
5.
Possible side effects
5.
How to store Repaglinide Teva
6.
Contents of the pack and other information
1.
WHAT REPAGLINIDE TEVA IS AND WHAT IT IS USED FOR
Repaglinide Teva is an oral antidiabetic medicine containing
repaglinide which helps your pancreas
produce more insulin and thereby lower your blood sugar (glucose).
TYPE 2 DIABETES
is a disease in which your pancreas does not make enough insulin to
control the sugar
in your blood or where your body does not respond normally to the
insulin it produces.
Repaglinide Teva is used to control type 2 diabetes in adults as an
add-on to diet and exercise:
treatment is usually started if diet, exercise and weight reduction
alone have not been able to control
(or lower) your blood sugar. Repaglinide Teva can also be given with
metformin, another medicine for
diabetes.
Repaglinide has been shown to lower the blood sugar, which helps to
prevent complications from your
diabetes.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE REPAGLINIDE TEVA
DO NOT TAKE REPAGLINIDE TEVA
•
If you are
ALLERGIC
to repaglinide or any of the other ingredients in this medicine
(listed in
section 6).
•
If you have
TYPE 1 DIABETES

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Repaglinide Teva 0.5 mg tablets
Repaglinide Teva 1 mg tablets
Repaglinide Teva 2 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Repaglinide Teva 0.5 mg tablets
Each tablet contains 0.5 mg of repaglinide.
Repaglinide Teva 1 mg tablets
Each tablet contains 1 mg of repaglinide.
Repaglinide Teva 2 mg tablets
Each tablet contains 2 mg of repaglinide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Repaglinide Teva 0.5 mg tablets
Light blue to blue, capsule shaped tablet, debossed with "93" on one
side and “210” on the other side.
Repaglinide Teva 1 mg tablets
Yellow to light yellow, capsule shaped tablet, debossed with "93" on
one side and “211” on the other.
Repaglinide Teva 2 mg tablets
Mottled peach, capsule shaped tablet, debossed with "93" on one side
and “212” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Repaglinide is indicated in adults with type 2 diabetes mellitus whose
hyperglycaemia can no longer
be controlled satisfactorily by diet, weight reduction and exercise.
Repaglinide is also indicated in
combination with metformin in adults with type 2 diabetes mellitus who
are not satisfactorily
controlled on metformin alone.
Treatment should be initiated as an adjunct to diet and exercise to
lower the blood glucose in relation
to meals.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Repaglinide is given preprandially and is titrated individually to
optimise glycaemic control. In
addition to the usual self-monitoring by the patient of blood and/or
urinary glucose, the patient’s blood
glucose must be monitored periodically by the physician to determine
the minimum effective dose for
the patient. Glycosylated haemoglobin levels are also of value in
monitoring the patient’s response to
therapy. Periodic monitoring is necessary to detect inadequate
lowering of blood glucose at the
recommended maximum dose level (i.e. primary failure) and to detect
loss