Sitagliptin Teva Tablet, film coated 100mg

Страна: Мальта

Язык: английский

Источник: Medicines Authority

Активный ингредиент:

SITAGLIPTIN

Доступна с:

Teva B.V. Swensweg 5, 2031 GA Haarlem, Netherlands

код АТС:

A10BH01

ИНН (Международная Имя):

SITAGLIPTIN 100 mg

Фармацевтическая форма:

FILM-COATED TABLET

состав:

SITAGLIPTIN 100 mg

Тип рецепта:

POM

Терапевтические области:

DRUGS USED IN DIABETES

Статус Авторизация:

Withdrawn

Дата Авторизация:

2016-09-02

тонкая брошюра

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PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SITAGLIPTIN TEVA 100 MG FILM-COATED TABLETS
Sitagliptin
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 Sitagliptin Teva is and what it is used for
2.
What you need to know before you take Sitagliptin Teva
3.
How to take Sitagliptin Teva
4.
Possible side effects
5.
How to store Sitagliptin Teva
6.
Contents of the pack and other information
1.
WHAT SITAGLIPTIN TEVA IS AND WHAT IT IS USED FOR
Sitagliptin Teva contains the active substance sitagliptin which is a
member of a class of medicines called
DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood
sugar levels in adult patients with type
2 diabetes mellitus.
This medicine helps to increase the levels of insulin produced after a
meal and decreases the amount of
sugar made by the body.
Your doctor has prescribed this medicine to help lower your blood
sugar, which is too high because of your
type 2 diabetes. This medicine can be used alone or in combination
with certain other medicines (insulin,
metformin, sulphonylureas, or glitazones) that lower blood sugar,
which you may already be taking for your
diabetes together with a food and exercise plan.
What is type 2 diabetes?
Type 2 diabetes is a condition in which your body does not make enough
insulin, and the insulin that your
body produces does not work as well as it should. Your body can also
make too much sugar. When this
happens, sugar (glucose) builds up in the blood. This can lead to
serious med

Характеристики продукта

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Sitagliptin Teva 100 mg Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sitagliptin malate, equivalent to 100 mg
sitagliptin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Brown to orange, round shaped film-coated tablet. One side is scored
and debossed with “S|100”. The other
side is scored. Dimensions: Diameter approx. 9.7 mm.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_For adult patients with type 2 diabetes mellitus,_ Sitagliptin Teva_
is indicated 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 diet and exercise plus metformin alone do not provide
adequate glycaemic control.

a sulphonylurea when diet and exercise plus maximal tolerated dose of
a sulphonylurea alone do not
provide adequate glycaemic control and when metformin is inappropriate
due to contraindications or
intolerance.

a peroxisome proliferator-activated receptor gamma (PPARγ) agonist
(i.e. a thiazolidinedione) when use
of a PPARγ
agonist is appropriate and when diet and exercise plus the PPARγ
agonist alone do not
provide adequate glycaemic control.
as triple oral therapy in combination with

a sulphonylurea and metformin when diet and exercise plus dual therapy
with these medicinal products
do not provide adequate glycaemic control.

a PPARγ
agonist and metformin when use of a PPARγ
agonist is appropriate and when diet and exercise
plus dual therapy with these medicinal products do not provide
adequate glycaemic control.
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Sitagliptin Teva is also indicated as add-on to insulin (with or
without metformin) when diet and exercise
plus stable dose of insulin do not provide adequate glycaemic control.
4.2
PO