Onglyza

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

Saxagliptin

זמין מ:

AstraZeneca AB

קוד ATC:

A10BH03

INN (שם בינלאומי):

saxagliptin

קבוצה תרפויטית:

Drugs used in diabetes

איזור תרפויטי:

Diabetes Mellitus, Type 2

סממני תרפויטית:

Add-on combination therapyOnglyza is indicated in adult patients aged 18 years and older with type-2 diabetes mellitus to improve glycaemic control:as monotherapy:in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance;as dual oral therapy:in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control;in combination with a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate;in combination with a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate;as triple oral therapy:in combination with metformin plus a sulphonylurea when this regimen alone, with diet and exercise, does not provide adequate glycaemic control;as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

leaflet_short:

Revision: 22

מצב אישור:

Authorised

תאריך אישור:

2009-09-30

עלון מידע

34
B. PACKAGE LEAFLET
35
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ONGLYZA 2.5 MG FILM-COATED TABLETS
Saxagliptin
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 Onglyza is and what it is used for
2.
What you need to know before you take Onglyza
3.
How to take Onglyza
4.
Possible side effects
5.
How to store Onglyza
6.
Contents of the pack and other information
1.
WHAT ONGLYZA IS AND WHAT IT IS USED FOR
Onglyza contains the active substance saxagliptin, which belongs to a
group of medicines called ‘oral
anti-diabetics’. They work by helping to control the level of sugar
in your blood.
Onglyza is used for adult patients aged 18 years and older with
‘type 2 diabetes’, if the disease cannot
be adequately controlled with one oral anti-diabetic medicine, diet
and exercise. Onglyza is used alone
or together with insulin or other anti-diabetic medicines.
It is important to keep following the advice about diet and exercise
that you have been given by your
doctor or nurse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ONGLYZA
DO NOT TAKE ONGLYZA

if you are allergic to saxagliptin or any of the other ingredients of
this medicine (listed in
section 6).

if you have had a serious allergic reaction to any other similar
medicines that you take to control
your blood sugar. See section 4.
WARNINGS AND PRECAUTIONS:
Talk to your doctor or pharmacist before taking Onglyza:

if you are taking insulin. Onglyza should not be used in place of
insulin;

if you have type 1 diabetes (your

מאפייני מוצר

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Onglyza 2.5 mg film-coated tablets
Onglyza 5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Onglyza 2.5 mg film-coated tablets
Each tablet contains 2.5 mg saxagliptin (as hydrochloride).
Onglyza 5 mg film-coated tablets
Each tablet contains 5 mg saxagliptin (as hydrochloride).
Excipient(s) with known effect:
Each tablet contains 99 mg lactose (as monohydrate).
Onglyza contains less than 1 mmol sodium (23 mg) per dose, i.e. is
essentially ‘sodium-free’.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Onglyza 2.5 mg film-coated tablets
Onglyza 2.5 mg tablets are pale yellow to light yellow, biconvex,
round, film-coated tablets, with
“2.5” printed on one side and “4214” printed on the other
side, in blue ink.
Onglyza 5 mg film-coated tablets
Onglyza 5 mg tablets are pink, biconvex, round, film-coated tablets,
with “5” printed on one side and
“4215” printed on the other side, in blue ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Onglyza is indicated in adult patients with type 2 diabetes mellitus
as an adjunct to diet and exercise to
improve glycaemic control:

as monotherapy when metformin is inappropriate due to intolerance or
contraindications

in combination with other medicinal products for the treatment of
diabetes, including insulin,
when these do not provide adequate glycaemic control (see sections
4.4, 4.5 and 5.1 for
available data on different combinations).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Onglyza is 5 mg once daily. When Onglyza is
used in combination with
insulin or a sulphonylurea, a lower dose of the insulin or
sulphonylurea may be required to reduce the
risk of hypoglycaemia (see section 4.4).
The safety and efficacy of saxagliptin as triple oral therapy in
combination with metformin and a
thiazolidinedione have not been established.
3
Special populations
Elderly (≥ 65