Fordiab 50 mg/1000 mg filmomhulde tabletten

País: Holanda

Língua: holandês

Origem: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Ingredientes ativos:

METFORMINEHYDROCHLORIDE 1000 mg/stuk SAMENSTELLING overeenkomend met ; METFORMINE 779,6 mg/stuk ; SITAGLIPTINEHYDROCHLORIDE 1-WATER 56,7 mg/stuk SAMENSTELLING overeenkomend met ; SITAGLIPTINE 50 mg/stuk

DCI (Denominação Comum Internacional):

METFORMINEHYDROCHLORIDE 1000 mg/stuk SAMENSTELLING overeenkomend met ; METFORMINE 779,6 mg/stuk ; SITAGLIPTINEHYDROCHLORIDE 1-WATER 56,7 mg/stuk SAMENSTELLING overeenkomend met ; SITAGLIPTINE 50 mg/stuk

Forma farmacêutica:

Filmomhulde tablet

Composição:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; NATRIUMLAURILSULFAAT ; NATRIUMSTEARYLFUMARAAT ; POLYETHYLEENGLYCOL (E 1521) ; POLYVINYLALCOHOL (E 1203) ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMSTEARYLFUMARAAT ; POLYETHYLEENGLYCOL (E 1521) ; POLYVINYLALCOHOL (E1203) ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Via de administração:

Oraal gebruik

Data de autorização:

1900-01-01

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FORDIAB 50 MG/850 MG FILMOMHULDE TABLETTEN
FORDIAB 50 MG/1000 MG FILMUMHULDE TABLETTEN
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 is and what it is used for
2. What you need to know before you take
3. How to take
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1. WHAT IS AND WHAT IT IS USED FOR
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 ser

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Fordiab 50 mg/850 mg filmomhulde tabletten
Fordiab 50 mg/1000 mg filmumhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sitagliptin hydrochloride monohydrate equivalent
to 50 mg of sitagliptin
and 850 mg of metformin hydrochloride.
Excipient(s) with known effect
Each tablet contains 27.6 mg sodium and 13.7 mg lactose (as
monohydrate).
Each tablet contains sitagliptin hydrochloride monohydrate equivalent
to 50 mg of sitagliptin
and 1,000 mg of metformin hydrochloride.
Excipient(s) with known effect
Each tablet contains 32.5 mg sodium.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
Oval-shaped, biconvex, pink film-coated tablet of approximately 20.5
mm x 9.5 mm and with
“S476” debossed on one side.
Oval-shaped, biconvex, brown film-coated tablet of approximately 21.5
mm x 10 mm and with
“S477” debossed on one side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For adult patients with type 2 diabetes mellitus:
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.
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.
is indicated as triple combination therapy with a
peroxisome proliferator-
activated receptor gamma (PPARγ) 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 PPARγ agonist.
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 st