SINVIA PLUS 50 mg/850 mg film-coated tablets

Ország: Málta

Nyelv: angol

Forrás: Medicines Authority

Beszerezhető a:

Elpen Pharmaceutical Co. Inc. 95 Marathonos Ave., 190 09 Pikermi, Attica, Greece

ATC-kód:

A10BD07

INN (nemzetközi neve):

SITAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 850 mg

Gyógyszerészeti forma:

FILM-COATED TABLET

Összetétel:

SITAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 850 mg

Recept típusa:

POM

Terápiás terület:

DRUGS USED IN DIABETES

Termék összefoglaló:

Licence number in the source country: NOT APPLICAPABLE

Engedélyezési státusz:

Withdrawn

Engedély dátuma:

2022-06-16

Betegtájékoztató

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SINVIA 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 SINVIA PLUS is and what it is used for
2.
What you need to know before you take SINVIA PLUS
3.
How to take SINVIA PLUS
4.
Possible side effects
5.
How to store SINVIA PLUS
6.
Contents of the pack and other information
1.
WHAT SINVIA PLUS IS AND WHAT IT IS USED FOR
SINVIA 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

Termékjellemzők

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1.
NAME OF THE MEDICINAL PRODUCT
SINVIA 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 not intended for breaking the tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult patients with type 2 diabetes mellitus:
SINVIA 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.
SINVIA 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.
SINVIA 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.
SINVIA 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 SINVIA 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.
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_ADULTS WITH NORMAL RENAL FUNCTION (