Ebymect
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
06-02-2024
Charakterystyka produktu
(SPC)
06-02-2024
Sprawozdanie z oceny publicznego
(PAR)
28-08-2019
Składnik aktywny:
dapagliflozin propanediol monohydrate, metformin hydrochloride
Dostępny od:
AstraZeneca AB
Kod ATC:
A10BD15
INN (International Nazwa):
dapagliflozin, metformin
Grupa terapeutyczna:
Drugs used in diabetes
Dziedzina terapeutyczna:
Diabetes Mellitus, Type 2
Wskazania:
Type 2 diabetes mellitusFor the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.as monotherapy when metformin is considered inappropriate due to intolerance.in addition to other medicinal products for the treatment of type 2 diabetes.For study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.Type 1 diabetes mellitusEdistride is indicated in adults for the treatment of insufficiently controlled type 1 diabetes mellitus as an adjunct to insulin in patients with BMI ≥ 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy.
Podsumowanie produktu:
Revision: 20
Status autoryzacji:
Authorised
Data autoryzacji:
2015-11-15
Ulotka dla pacjenta
56
B. PACKAGE LEAFLET
57
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EBYMECT 5 MG/850 MG FILM-COATED TABLETS
EBYMECT 5 MG/1,000 MG FILM-COATED TABLETS
dapagliflozin/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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ebymect is and what it is used for
2.
What you need to know before you take Ebymect
3.
How to take Ebymect
4.
Possible side effects
5.
How to store Ebymect
6.
Contents of the pack and other information
1.
WHAT EBYMECT IS AND WHAT IT IS USED FOR
Ebymect contains two different active substances called dapagliflozin
and metformin. Both belong to a
group of medicines called oral anti-diabetics. These are medicines
taken by mouth for diabetes.
Ebymect is used for a type of diabetes called “type 2 diabetes” in
adult patients (aged 18 years and older).
If you have type 2 diabetes, your pancreas does not make enough
insulin or your body is not able to use
the insulin it produces properly. This leads to a high level of sugar
(glucose) in your blood.
Dapagliflozin works by removing excess sugar from your body via your
urine and lowers the
amount of sugar in your blood. It can also help prevent heart disease.
Metformin works mainly by inhibiting glucose production in the liver.
To treat type 2 diabetes:
This medicine is taken in combination with diet and exercise.
This medicine is used if your diabetes cannot be controlled with other
medicines used to treat
diabetes.
Your doctor may ask you to take this medicine on its own or together
with ot
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ebymect 5 mg/850 mg film-coated tablets
Ebymect 5 mg/1,000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ebymect 5 mg/850 mg film-coated tablets
Each tablet contains dapagliflozin propanediol monohydrate equivalent
to 5 mg dapagliflozin and 850 mg
of metformin hydrochloride.
Ebymect 5 mg/1,000 mg film-coated tablets
Each tablet contains dapagliflozin propanediol monohydrate equivalent
to 5 mg dapagliflozin and
1,000 mg of metformin hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Ebymect 5 mg/850 mg film-coated tablets
Brown, biconvex, 9.5 x 20 mm oval, film-coated tablets engraved with
“5/850” on one side and “1067”
engraved on the other side.
Ebymect 5 mg/1,000 mg film-coated tablets
Yellow, biconvex, 10.5 x 21.5 mm oval, film-coated tablets engraved
with “5/1000” on one side and
“1069” engraved on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ebymect is indicated in adults for the treatment of type 2 diabetes
mellitus as an adjunct to diet and
exercise:
in patients insufficiently controlled on their maximally tolerated
dose of metformin alone
in combination with other medicinal products for the treatment of
diabetes in patients insufficiently
controlled with metformin and these medicinal products
in patients already being treated with the combination of
dapagliflozin and metformin as separate
tablets.
For study results with respect to combination of therapies, effects on
glycaemic control and cardiovascular
events, and the populations studied, see sections 4.4, 4.5 and 5.1.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults with normal renal function (glomerular filtration rate [GFR]
≥ 90 mL/min)_
The recommended dose is one tablet twice daily. Each tablet contains a
fixed dose of dapagliflozin and
metformin (see section 2).
_For patients insufficiently controlled on metformin monoth
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