Synjardy

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

empagliflozin, metformin

Available from:

Boehringer Ingelheim

ATC code:

A10BD20

INN (International Name):

empagliflozin, metformin

Therapeutic group:

Drugs used in diabetes

Therapeutic area:

Diabetes Mellitus, Type 2

Therapeutic indications:

Synjardy is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:in patients inadequately controlled on their maximally tolerated dose of metformin alone;in patients inadequately controlled with metformin in combination with other glucose-lowering medicinal products, including insulin;in patients already being treated with the combination of empagliflozin and metformin as separate tablets.

Product summary:

Revision: 26

Authorization status:

Authorised

Authorization date:

2015-05-27

Patient Information leaflet

66
B. PACKAGE LEAFLET
67
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SYNJARDY 5 MG/850 MG FILM-COATED TABLETS
SYNJARDY 5 MG/1,000 MG FILM-COATED TABLETS
SYNJARDY 12.5 MG/850 MG FILM-COATED TABLETS
SYNJARDY 12.5 MG/1,000 MG FILM-COATED TABLETS
empagliflozin/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 Synjardy is and what it is used for
2.
What you need to know before you take Synjardy
3.
How to take Synjardy
4.
Possible side effects
5.
How to store Synjardy
6.
Contents of the pack and other information
1.
WHAT SYNJARDY IS AND WHAT IT IS USED FOR
WHAT SYNJARDY IS
Synjardy contains two active substances empagliflozin and metformin.
Each belongs to a group of
medicines called “oral anti-diabetics”. These are medicines taken
by mouth to treat type 2 diabetes.
WHAT IS TYPE 2 DIABETES?
Type 2 diabetes is a disease that comes from both your genes and your
lifestyle. If you have type 2
diabetes, your pancreas does not make enough insulin to control the
level of glucose in your blood,
and your body is unable to use its own insulin effectively. This
results in high levels of glucose in your
blood which can lead to medical problems like heart disease, kidney
disease, blindness, and poor
circulation in your limbs.
HOW SYNJARDY WORKS
Empagliflozin belongs to a group of medicines called sodium glucose
co-transporter-2 (SGLT2)
inhibitors. It works by blocking the SGLT2 protein in your kidneys.
This causes blood sugar (glucose)
to be removed in your urine. Metformin

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Synjardy 5 mg/850 mg film-coated tablets
Synjardy 5 mg/1,000 mg film-coated tablets
Synjardy 12.5 mg/850 mg film-coated tablets
Synjardy 12.5 mg/1,000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Synjardy 5 mg/850 mg film-coated tablets
Each tablet contains 5 mg empagliflozin and 850 mg metformin
hydrochloride.
Synjardy 5 mg/1,000 mg film-coated tablets
Each tablet contains 5 mg empagliflozin and 1,000 mg metformin
hydrochloride.
Synjardy 12.5 mg/850 mg film-coated tablets
Each tablet contains 12.5 mg empagliflozin and 850 mg metformin
hydrochloride.
Synjardy 12.5 mg/1,000 mg film-coated tablets
Each tablet contains 12.5 mg empagliflozin and 1,000 mg metformin
hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Synjardy 5 mg/850 mg film-coated tablets
Yellowish white, oval, biconvex film coated tablets debossed with
“S5” and the Boehringer Ingelheim
logo on one side and “850” on the other side (tablet length: 19.2
mm, tablet width: 9.4 mm).
Synjardy 5 mg/1,000 mg film-coated tablets
Brownish yellow, oval, biconvex film coated tablets debossed with
“S5” and the Boehringer
Ingelheim logo on one side and “1000” on the other side (tablet
length: 21.1 mm, tablet width:
9.7 mm).
Synjardy 12.5 mg/850 mg film-coated tablets
Pinkish white, oval, biconvex film coated tablets debossed with
“S12” and the Boehringer Ingelheim
logo on one side and “850” on the other side (tablet length: 19.2
mm, tablet width: 9.4 mm).
Synjardy 12.5 mg/1,000 mg film-coated tablets
Dark brownish purple, oval, biconvex film coated tablets debossed with
“S12” and the Boehringer
Ingelheim logo on one side and “1000” on the other side (tablet
length: 21.1 mm, tablet width:
9.7 mm).
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Synjardy is indicated for the treatment of adults with type 2 diabetes
mellitus as an adjunct to diet and
exercise:

i