Combodiab 50 mg/1000 mg film-coated tablets

البلد: مالطا

اللغة: الإنجليزية

المصدر: Medicines Authority

العنصر النشط:

SITAGLIPTIN, METFORMIN HYDROCHLORIDE

متاح من:

Galenicum Health, S.L.U Calle Sant Gabriel, 50 Esplugues de Llobregat 08950 Barcelona, Spain

ATC رمز:

A10BD07

INN (الاسم الدولي):

SITAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 1000 mg

الشكل الصيدلاني:

FILM-COATED TABLET

تركيب:

SITAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 1000 mg

نوع الوصفة الطبية :

POM

المجال العلاجي:

DRUGS USED IN DIABETES

ملخص المنتج:

Licence number in the source country: NOT APPLICAPABLE

الوضع إذن:

Authorised

تاريخ الترخيص:

2020-11-10

نشرة المعلومات

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COMBODIAB 50 MG/1000 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 Combodiab is and what it is used for
2.
What you need to know before you take Combodiab
3.
How to take Combodiab
4.
Possible side effects
5.
How to store Combodiab
6.
Contents of the pack and other information
1.
WHAT COMBODIAB IS AND WHAT IT IS USED FOR
Combodiab 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 disease, blindne

خصائص المنتج

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1.
NAME OF THE MEDICINAL PRODUCT
Combodiab 50 mg/1000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sitagliptin hydrochloride monohydrate equivalent
to 50 mg of sitagliptin and
1,000 mg of metformin hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Red to brown, oblong oval-shaped film-coated tablets with a scoreline
in between ‘S’ and ‘B’ on one
side and with a scoreline on the other side.
Tablet diameter: 21.3 ± 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:
Combodiab 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.
Combodiab 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.
Combodiab 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.
Combodiab 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 Combodiab should be
individualised on the basis of the
patient’s
current
regimen,
effectiveness,
and
tolerability
while
not
exceeding
the
maximum
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recommended daily dose of 100 mg sitagliptin