Sytena Plus 50 mg/850 mg film-coated tablets

国家: 马耳他

语言: 英文

来源: Medicines Authority

可用日期:

Farmak International Sp. z o.o. Aleja Jana Pawla II 22 00-133 Warsaw , Poland

ATC代码:

A10BD07

INN（国际名称）:

SITAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 850 mg

药物剂型:

FILM-COATED TABLET

组成:

SITAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 850 mg

处方类型:

POM

治疗领域:

DRUGS USED IN DIABETES

產品總結:

Licence number in the source country: NOT APPLICAPABLE

授权状态:

Withdrawn

授权日期:

2022-06-17

资料单张

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SYTENA PLUS 50 MG/850 MG FILM-COATED TABLETS
sitagliptin/metformin hydrochloride
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 Sytena Plus is and what it is used for
2.
What you need to know before you take Sytena Plus
3.
How to take Sytena Plus
4.
Possible side effects
5.
How to store Sytena Plus
6.
Contents of the pack and other information
1.
WHAT SYTENA PLUS IS AND WHAT IT IS USED FOR
Sytena Plus contains two different medicines called sitagliptin and
metformin.
•
sitagliptin belongs to a class of medicines called DPP-4 inhibitors
(dipeptidyl peptidase-4
inhibitors)
•
metformin belongs to a class of medicines called biguanides.
They work together to control blood sugar levels in adult patients
with a form of diabetes called ‘type
2 diabetes mellitus’. This medicine helps to increase the levels of
insulin produced after a meal and
lowers the amount of sugar made by your body.
Along with diet and exercise, this medicine helps lower your blood
sugar. This medicine can be used
alone or with certain other medicines for diabetes (insulin,
sulphonylureas, or glitazones).
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 medical problems
like heart disease, kidney dise

产品特点

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1.
NAME OF THE MEDICINAL PRODUCT
Sytena Plus 50 mg/850 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sitagliptin hydrochloride monohydrate equivalent
to 50 mg of sitagliptin and 850
mg of metformin hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Pink, oblong oval-shaped film-coated tablets with a scoreline on one
side and ‘SA’ on the other side.
Tablet diameter: 19.5 ± 0.5mm
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult patients with type 2 diabetes mellitus:
Sytena Plus is indicated as an adjunct to diet and exercise to improve
glycaemic control in patients
inadequately controlled on their maximal tolerated dose of metformin
alone or those already being
treated with the combination of sitagliptin and metformin.
Sytena Plus is indicated in combination with a sulphonylurea (i.e.,
triple combination therapy) as an
adjunct to diet and exercise in patients inadequately controlled on
their maximal tolerated dose of
metformin and a sulphonylurea.
Sytena Plus is indicated as triple combination therapy with a
peroxisome proliferator-activated
receptor gamma (PPAR

) agonist (i.e., a thiazolidinedione) as an adjunct to diet and
exercise in
patients inadequately controlled on their maximal tolerated dose of
metformin and a PPAR

agonist.
Sytena Plus is also indicated as add-on to insulin (i.e., triple
combination therapy) as an adjunct to
diet and exercise to improve glycaemic control in patients when stable
dose of insulin and metformin
alone do not provide adequate glycaemic control.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose of antihyperglycaemic therapy with Sytena Plus should be
individualised on the basis of the
patient’s
current
regimen,
effectiveness,
and
tolerability
while
not
exceeding
the
maximum
recommended daily dose of 100 mg sitagliptin.