Trazec

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

nateglinide

Available from:

Novartis Europharm Ltd.

ATC code:

A10BX03

INN (International Name):

nateglinide

Therapeutic group:

Drugs used in diabetes

Therapeutic area:

Diabetes Mellitus, Type 2

Therapeutic indications:

Nateglinide is indicated for combination therapy with metformin in type 2 diabetic patients inadequately controlled despite a maximally tolerated dose of metformin alone.

Product summary:

Revision: 5

Authorization status:

Withdrawn

Authorization date:

2001-04-03

Patient Information leaflet

Medicinal product no longer authorised
36
B. PACKAGE LEAFLET
Medicinal product no longer authorised
37
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRAZEC 60 MGFILM-COATED TABLETS
TRAZEC 120 MG FILM-COATED TABLETS
TRAZEC 180 MG FILM-COATED TABLETS
Nateglinide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Trazec is and what it is used for
2.
Before you take Trazec
3.
How to take Trazec
4.
Possible side effects
5.
How to store Trazec
6.
Further information
1.
WHAT TRAZEC IS AND WHAT IT IS USED FOR
Trazec is a medicine to lower blood sugar (glucose), which is taken by
mouth (these medicines are
also known as oral anti-diabetics).
It is used by people with type 2 diabetes. (This kind of diabetes is
also called non-insulin-dependent
diabetes mellitus.)
Insulin is a substance produced by a body organ called the pancreas.
It helps to decrease blood sugar
levels, especially after meals. In patients with type 2 diabetes, the
body may not start producing insulin
quickly enough after meals. Trazec works by stimulating the pancreas
to produce insulin more
quickly. This helps to keep the blood sugar controlled after meals.
Your doctor will prescribe Trazec together with another oral
anti-diabetic containing metformin.
Trazec tablets start to act quickly after you take them and are
eliminated from the body rapidly.
2.
BEFORE YOU TAKE TRAZEC
Follow all instructions given to you by your doctor and pharmacist
carefully, even if they are different
from what is in this leaflet.
DO NOT TAKE TRAZEC
-
if you are allergic (hypersensitive) to nateglinide or any of the
other ingredients of Traz

Summary of Product characteristics

Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
TRAZEC 60 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 60 mg nateglinide.
Excipients:
Lactose monohydrate: 141.5 mg per tablet.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
60 mg pink, round, bevelled-edge tablets with “NVR” marked on one
side and “TS” on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nateglinide is indicated for combination therapy with metformin in
type 2 diabetic patients
inadequately controlled despite a maximally tolerated dose of
metformin alone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Nateglinide should be taken within 1 to 30 minutes before meals
(usually breakfast, lunch and dinner).
The dosage of nateglinide should be determined by the physician
according to the patient’s
requirements.
The recommended starting dose is 60 mg three times daily before meals,
particularly in patients who
are near goal HbA
1c
. This may be increased to 120 mg three times daily.
Dose adjustments should be based on periodic glycosylated haemoglobin
(HbA
1c
) measurements.
Since the primary therapeutic effect of Trazec is to reduce mealtime
glucose, (a contributor to HbA
1c
),
the therapeutic response to Trazec may also be monitored with 1–2
hour post-meal glucose.
The recommended maximum daily dose is 180 mg three times daily to be
taken before the three main
meals.
Specific patient groups
_Elderly _
The clinical experience in patients over 75 years of age is limited.
_Children and adolescents _
There are no data available on the use of nateglinide in patients
under 18 years of age, and therefore its
use in this age group is not recommended.
_Patients with hepatic impairment _
No dose adjustment is necessary for patients with mild to moderate
hepatic impairment. As patients
with severe liver disease were not studied, nateglinid