Starlix

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

nateglinide

MAH:

Novartis Europharm Limited

ATC_code:

A10BX03

INN:

nateglinide

therapeutic_group:

Drugs used in diabetes

therapeutic_area:

Diabetes Mellitus, Type 2

therapeutic_indication:

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

leaflet_short:

Revision: 15

authorization_status:

Withdrawn

authorization_date:

2001-04-03

PIL

29
B. PACKAGE LEAFLET
Medicinal Product no longer authorised
30
PACKAGE LEAFLET: INFORMATION FOR THE USER
STARLIX 60 MG FILM-COATED TABLETS
STARLIX 120 MG FILM-COATED TABLETS
STARLIX 180 MG FILM-COATED TABLETS
nateglinide
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1.
What Starlix is and what it is used for
2.
What you need to know before you take Starlix
3.
How to take Starlix
4.
Possible side effects
5.
How to store Starlix
6.
Contents of the pack and other information
1.
WHAT STARLIX IS AND WHAT IT IS USED FOR
WHAT STARLIX IS
The active substance of Starlix, nateglinide, belongs to a group of
medicines called oral antidiabetics.
Starlix is used to treat adult patients with type 2 diabetes. It helps
to control the level of sugar in the
blood. Your doctor will prescribe Starlix together with metformin, if
inadequately controlled despite a
maximally tolerated dose of metformin.
HOW STARLIX WORKS
Insulin is a substance produced in the body by the pancreas. It helps
to decrease blood sugar levels,
especially after meals. If you have type 2 diabetes, your body may not
start producing insulin quickly
enough after meals. Starlix works by stimulating the pancreas to
produce insulin more quickly, which
helps to keep blood sugar levels under control after meals.
Starlix tablets start to act within a very short time after they are
swallowed and are eliminated from the
body rapidly.
Medicinal Product no longer authorised
31
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE STARLIX
Follow all instructions

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal Product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
STARLIX 60 mg film-coated tablets
STARLIX 120 mg film-coated tablets
STARLIX 180 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
STARLIX 60 mg film-coated tablets
Each film-coated tablet contains 60 mg nateglinide.
_Excipient with known effect _
Lactose monohydrate: 141.5 mg per tablet.
STARLIX 120 mg film-coated tablets
Each film-coated tablet contains 120 mg nateglinide.
_Excipient with known effect _
Lactose monohydrate: 283 mg per tablet.
STARLIX 180 mg film-coated tablets
Each film-coated tablet contains 180 mg nateglinide.
_Excipient with known effect _
Lactose monohydrate: 214 mg per tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
STARLIX 60 mg film-coated tablets
60 mg pink, round, bevelled-edge tablets with “STARLIX” marked on
one side and “60” on the other.
STARLIX 120 mg film-coated tablets
120 mg yellow, ovaloid tablets with “STARLIX” marked on one side
and “120” on the other.
STARLIX 180 mg film-coated tablets
180 mg red, ovaloid tablets with “STARLIX” marked on one side and
“180” on the other.
Medicinal Product no longer authorised
3
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
Posology
_Adults _
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 t