Synjardy

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  • Synjardy
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Staðsetning

  • Fáanlegt í:
  • Synjardy
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  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Drugs used in diabetes,
  • Lækningarsvæði:
  • Diabetes Mellitus, Type 2
  • Ábendingar:
  • 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. ,
  • Vörulýsing:
  • Revision: 13

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/H/C/003770
  • Leyfisdagur:
  • 26-05-2015
  • EMEA númer:
  • EMEA/H/C/003770
  • Síðasta uppfærsla:
  • 29-03-2019

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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

EMA/80370/2017

EMEA/H/C/003770

EPAR summary for the public

Synjardy

empagliflozin / metformin

This is a summary of the European public assessment report (EPAR) for Synjardy. It explains how the

Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is

not intended to provide practical advice on how to use Synjardy.

For practical information about using Synjardy, patients should read the package leaflet or contact

their doctor or pharmacist.

What is Synjardy and what is it used for?

Synjardy is a diabetes medicine used with diet and exercise to treat adults with type 2 diabetes. It

contains the active substances empagliflozin and metformin. Synjardy is used:

in patients whose diabetes is not sufficiently controlled by metformin alone;

in combination with other diabetes medicines in patients whose diabetes is not sufficiently

controlled on these medicines plus metformin;

in patients who are already taking metformin and empagliflozin as separate tablets.

How is Synjardy used?

Synjardy is available as tablets containing 5 or 12.5 mg of empagliflozin with 850 or 1,000 mg of

metformin, and can only be obtained with a prescription.

The recommended dose of Synjardy is one tablet twice a day with meals, and treatment is normally

started with a tablet that supplies the dose of metformin the patient is already taking, together with

the lowest dose (5 mg) of empagliflozin. Doses are adjusted as necessary.

Synjardy

EMA/80370/2017

Page 2/3

If Synjardy is used in combination with insulin or a sulphonylurea (a medicine that increases the body’s

production of insulin), the doses of these medicines may need to be lowered to avoid hypoglycaemia

(low blood sugar levels).

For further information, see the package leaflet.

How does Synjardy work?

In type 2 diabetes the body does not make enough insulin to control the level of glucose (sugar) in the

blood or the body is unable to use insulin effectively. This leads to a high level of glucose in the blood.

The two active substances in Synjardy, empagliflozin and metformin, work in different ways to lower

blood glucose, and thus to control symptoms of the disease.

Empagliflozin works by blocking a protein in the kidneys (called sodium-glucose co-transporter 2 or

SGLT2). As blood is filtered by the kidneys, SGLT2 stops glucose in the bloodstream from being passed

out into the urine. By blocking the action of SGLT2, empagliflozin causes more glucose to be removed

in the urine, thereby reducing the levels of glucose in the blood. Empagliflozin has been authorised in

the EU under the trade name Jardiance since 2014.

Metformin works mainly by reducing the production of glucose in the body and reducing its absorption

from the gut. Metformin has been available in the EU since the 1950s.

What benefits of Synjardy have been shown in studies?

The benefits of empagliflozin in combination with metformin have been shown in 3 main studies

involving 1,679 patients with type 2 diabetes whose blood sugar was not adequately controlled by

metformin, alone or combined with other diabetes medicines (such as pioglitazone or a type of

diabetes medicine called a sulphonylurea). The studies compared the effect of empagliflozin plus

metformin versus placebo (a dummy treatment) with metformin. The main measure of effectiveness

was the reduction in the level of a substance in the blood called glycosylated haemoglobin (HbA1c)

after 24 weeks of treatment. HbA1c gives an indication of how well the blood glucose is controlled.

The studies showed a greater reduction in HbA1c when empagliflozin plus metformin was given,

compared with placebo plus metformin. Overall, the additional reduction was 0.58 percentage points

with a combination providing 5 mg of empagliflozin twice daily, and 0.62 percentage points with the

12.5 mg dose, and these reductions were considered clinically relevant. Similar benefits were seen in

the studies regardless of the other diabetes medicines being taken. In addition, the results indicated

that the combination was associated with a beneficial decrease in body weight and blood pressure.

Supportive evidence was provided from several further studies. Some of these were continuations of

the main studies that suggested the benefits of the combination continued with longer therapy. Studies

also indicated Synjardy was as effective as empagliflozin and metformin taken separately, and that the

combination helped reduce HbA1c when added to treatment including insulin.

Another main study showed that adding empagliflozin (one of the active substances of Synjardy) to

usual treatment reduced adverse cardiovascular (heart and blood vessels) effects. The study involved

patients with type 2 diabetes who already had cardiovascular disease (such as angina, heart attack

and stroke). The main measure of effectiveness was the occurrence of one of three major

cardiovascular events: stroke, heart attack or death caused by cardiovascular disease. On average,

patients in the study were followed up for 3.1 years. In those receiving empagliflozin, cardiovascular

events occurred in 10.5% (490 out of 4,687) of patients compared with 12.1% (282 out of 2,333) of

patients receiving placebo. Among these, in patients who were also taking metformin (the other active

Synjardy

EMA/80370/2017

Page 3/3

substance in Synjardy), the three major cardiovascular events occurred in 9.9% (344 out of 3,459) of

patients receiving empagliflozin and in 10.9% (189 out of 1,734) of patients receiving placebo.

What are the risks associated with Synjardy?

The most common side effects with Synjardy are hypoglycaemia (low blood sugar levels) when the

medicine is taken with a sulphonylurea or insulin, infections of the urinary tract and genitals, and

increased urination. For the full list of all side effects reported with Synjardy, see the package leaflet.

Synjardy must not be used in patients with:

metabolic acidosis (when the body produces more acid than it gets rid of) or diabetic pre-coma

(dangerous complications of diabetes);

severely reduced kidney function or conditions that could affect the kidneys such as dehydration,

severe infection or a steep fall in blood pressure;

a condition that could reduce the supply of oxygen to body tissues (such as in patients with

worsening heart failure, recent heart attack, breathing difficulty or a steep fall in blood pressure);

liver impairment, or problems with alcoholism or alcohol intoxication.

For the full list of restrictions, see the package leaflet.

Why is Synjardy approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Synjardy’s

benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP

concluded that the medicine could help produce a clinically meaningful reduction in blood glucose in

patients with type 2 diabetes, and the benefits and risks were in line with those of the individual active

substances. Synjardy was also shown to reduce cardiovascular events in patients with type 2 diabetes

who already had cardiovascular disease. Because of concerns about the balance of benefit and risk in

patients with reduced kidney function taking the fixed-dose combination, the CHMP recommended

restricting its use in these patients.

What measures are being taken to ensure the safe and effective use of

Synjardy?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe

and effective use of Synjardy have been included in the summary of product characteristics and the

package leaflet.

Other information about Synjardy

The European Commission granted a marketing authorisation valid throughout the European Union for

Synjardy on 27 May 2015.

The full EPAR and risk management plan summary for Synjardy can be found on the Agency’s website:

ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more

information about treatment with Synjardy, read the package leaflet (also part of the EPAR) or contact

your doctor or pharmacist.

This summary was last updated in 02-2017.

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

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

This medicine is subject to additional monitoring. This will allow quick identification of new

safety information. You can help by reporting any side effects you may get. See the end of section 4

for how to report side effects.

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

What Synjardy is and what it is used for

What you need to know before you take Synjardy

How to take Synjardy

Possible side effects

How to store Synjardy

Contents of the pack and other information

1.

What Synjardy is and what it is used for

Synjardy is a diabetes medicine that contains two active substances called empagliflozin and

metformin.

Empagliflozin works by blocking a protein in the kidneys called sodium glucose co-transporter 2

(SGLT2). SGLT2 prevents glucose (blood sugar) from being lost in urine by absorbing glucose

back into the bloodstream as blood is being filtered in the kidneys. By blocking this protein, the

medicine causes blood sugar, sodium (salt) and water to be removed via the urine. Blood sugar

levels, which are too high because of your type 2 diabetes, are thereby reduced. This medicine can

also help prevent heart disease.

Metformin works in a different way to lower blood sugar levels, mainly by blocking glucose

production in the liver.

Synjardy is added to diet and exercise to treat type 2 diabetes in adult patients (aged 18 years and

older) whose diabetes cannot be controlled by adding metformin alone or metformin with other

medicines for diabetes.

Synjardy can also be combined with other medicines for the treatment of diabetes. These may be

medicines taken by mouth or given by injection such as insulin.

In addition, Synjardy can be used as an alternative to taking both empagliflozin and metformin as

single tablets. To avoid overdose, do not continue taking empagliflozin and metformin tablets

separately, if you are taking this medicine.

It is important that you continue with your diet and exercise plan as told by your doctor, pharmacist or

nurse.

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.

2.

What you need to know before you take Synjardy

Do not take Synjardy:

if you are allergic to empagliflozin, metformin or any of the other ingredients of this medicine

(listed in section 6);

if you have severely reduced kidney function;

if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose),

nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see ‘Risk of lactic acidosis’ below)

or ketoacidosis. Ketoacidosis is a condition in which substances called ‘ketone bodies’ accumulate

in the blood and which can lead to diabetic pre-coma. Symptoms include stomach pain, fast and

deep breathing, sleepiness or your breath developing an unusual fruity smell;

if you have had a diabetic pre-coma;

if you have a severe infection such as an infection affecting your lung or bronchial system or your

kidney. Severe infections may lead to kidney problems, which can put you at risk for lactic

acidosis (see 'Warnings and precautions');

if you have lost a lot of water from your body (dehydration), e.g. due to long-lasting or severe

diarrhoea, or if you have vomited several times in a row. Dehydration may lead to kidney

problems, which can put you at risk for lactic acidosis (see 'Warnings and precautions');

if you are treated for acute heart failure or have recently had a heart attack, have severe problems

with your circulation (such as shock) or have breathing difficulties. This may lead to a lack in

oxygen supply to tissue which can put you at risk for lactic acidosis (see section ‘Warnings and

precautions');

if you have problems with your liver;

if you drink alcohol to excess, either every day or only from time to time (see section “Synjardy

with alcohol”).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking this medicine, and during treatment:

about what you can do to prevent dehydration;

if you have “type 1 diabetes” – this type usually starts when you are young and your body does not

produce any insulin;

if you experience rapid weight loss, feeling sick or being sick, stomach pain, excessive thirst, fast

and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to your breath, a

sweet or metallic taste in your mouth, or a different odour to your urine or sweat, contact a doctor

or the nearest hospital straight away. These symptoms could be a sign of “diabetic ketoacidosis” –

a rare, but serious, sometines life-threatening problem you can get with diabetes because of

increased levels of “ketone bodies” in your urine or blood, seen in tests. The risk of developing

diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption,

dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or

serious illness;

if you are 75 years old or older, as increased passing of urine due to the medicine may affect fluid

balance in your body and increase your risk of dehydration. Possible signs are listed in section 4,

‘Possible side effects’, dehydration;

if you are 85 years old or older as you should not start taking Synjardy;

if you have a serious infection of the kidney or the urinary tract with fever. Your doctor may ask

you to stop taking Synjardy until you have recovered.

Risk of lactic acidosis

Synjardy may cause a very rare, but very serious side effect called lactic acidosis, particularly if your

kidneys are not working properly. The risk of developing lactic acidosis is also increased with

uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further

information below), liver problems and any medical conditions in which a part of the body has a

reduced supply of oxygen (such as acute severe heart diseases).

If any of the above apply to you, talk to your doctor for further instructions.

Stop taking Synjardy for a short time if you have a condition that may be associated with

dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to

heat or if you drink less fluid than normal. Talk to your doctor for further instructions.

Stop taking Synjardy and contact a doctor or the nearest hospital immediately if you experience

some of the symptoms of lactic acidosis, as this condition may lead to coma.

Symptoms of lactic acidosis include:

vomiting

stomach ache (abdominal pain)

muscle cramps

a general feeling of not being well with severe tiredness

difficulty in breathing

reduced body temperature and heartbeat

Lactic acidosis is a medical emergency and must be treated in a hospital.

If you need to have major surgery you must stop taking Synjardy during and for some time after the

procedure. Your doctor will decide when you must stop and when to restart your treatment with

Synjardy.

During treatment with Synjardy, your doctor will check your kidney function at least once a year or

more frequently if you are elderly and/or if you have worsening kidney function.

Foot care

Like for all diabetic patients it is important to check your feet regularly and adhere to any other advice

regarding foot care given by your health care professional.

Urine glucose

Because of how this medicine works, your urine will test positive for sugar while you are taking this

medicine.

Children and adolescents

This medicine is not recommended for use in children and adolescents under 18 years, because it has

not been studied in these patients.

Other medicines and Synjardy

If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for

example in the context of an X-ray or scan, you must stop taking Synjardy before or at the time of the

injection. Your doctor will decide when you must stop and when to restart your treatment with

Synjardy.

Tell your doctor if you are taking, have recently taken or might take any other medicines. You may

need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the

dosage of Synjardy. It is especially important to mention the following:

medicines which increase urine production (diuretic), as Synjardy may increase the risk of losing

too much fluid. Your doctor may ask you to stop taking Synjardy. Possible signs of losing too

much fluid from your body are listed in section 4 ‘Possible side effects’.

other medicines that lower the amount of sugar in your blood such as insulin or a “sulphonylurea”

medicine. Your doctor may want to lower the dose of these other medicines, to prevent your blood

sugar levels from getting too low (hypoglycaemia).

medicines that may change the amount of metformin in your blood, especially if you have reduced

kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine,

trimethoprime, vandetanib, isavuconazole, crizotinib, olaparib).

bronchodilators (beta-2 agonists) which are used to treat asthma.

corticosteroids (given by mouth, as an injection, or inhaled), which are used to treat inflammation

in diseases like asthma and arthritis.

medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen

and celecoxib).

certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II

receptor antagonists).

medicines that contain alcohol (see section ‘Synjardy with alcohol’).

iodinated contrast agents (medicines used during an X-ray, see section ‘Warnings and

precautions’.

Synjardy with alcohol

Avoid excessive alcohol intake while taking Synjardy since this may increase the risk of lactic acidosis

(see section ‘Warnings and precautions’).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor or pharmacist for advice before taking this medicine.

Do not take Synjardy if you are pregnant. It is unknown if this medicine is harmful to the unborn

child.

Metformin passes into human milk in small amounts. It is not known whether empagliflozin passes

into human breast milk. Do not take Synjardy if you are breast-feeding.

Driving and using machines

Synjardy has minor influence on the ability to drive and use machines.

Taking this medicine in combination with medicines called sulphonylureas or with insulin can cause

blood sugar levels to drop too low (hypoglycaemia), which may cause symptoms such as shaking,

sweating and change in vision, and may affect your ability to drive and use machines. Do not drive or

use any tools or machines if you feel dizzy while taking Synjardy.

3.

How to take Synjardy

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist

if you are not sure.

How much to take

The dose of Synjardy varies depending on your condition and the doses of diabetes medicines you

currently take. Your doctor will adjust your dose as necessary and tell you exactly which strength of

the medicine to take.

The recommended dose is one tablet twice a day. Your doctor will normally start Synjardy treatment

by prescribing the strength of tablet that supplies the same dose of metformin you are already taking

(850 mg or 1,000 mg twice a day), and the lowest dose of empagliflozin (5 mg twice a day). If you are

already taking both medicines separately, your doctor will start treatment with tablets of Synjardy that

will supply the same amount of both. If you have reduced kidney function, your doctor may prescribe

a lower dose.

Taking this medicine

Swallow the tablet whole with water.

Take the tablets with meals to lower your chance of an upset stomach.

Take the tablet twice daily by mouth.

Your doctor may prescribe Synjardy together with another diabetes medicine. Remember to take all

medicines as directed by your doctor to achieve the best results for your health. Your doctor may need

to adjust your doses to control your blood sugar.

Diet and exercise can help your body use its blood sugar better. It is important to stay on the diet and

exercise program recommended by your doctor while taking Synjardy.

If you take more Synjardy than you should

If you take more Synjardy tablets than you should have, you may experience lactic acidosis.

Symptoms of lactic acidosis are non-specific such as feeling or being very sick, vomiting, stomach

ache with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in

breathing. Further symptoms are reduced body temperature and heartbeat. If this happens to you, you

may need immediate hospital treatment, as lactic acidosis can lead to coma. Stop taking this

medicine immediately and contact a doctor or the nearest hospital straight away (see section 2).

Take the medicine pack with you.

If you forget to take Synjardy

If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your

next dose, skip the missed dose and go back to your regular schedule. Do not take a double dose of this

medicine.

If you stop taking Synjardy

Do not stop taking Synjardy without first consulting your doctor. Your blood sugar levels may increase

when you stop taking Synjardy.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact a doctor or the nearest hospital straight away if you have any of the following side

effects:

Lactic acidosis, seen very rarely (may affect up to 1 in 10,000 people)

Synjardy may cause a very rare but very serious side effect called lactic acidosis (see section

‘Warnings and precautions’). If this happens you must stop taking Synjardy and contact a doctor or

the nearest hospital immediately, as lactic acidosis may lead to coma.

Diabetic ketoacidosis, seen rarely (may affect up to 1 in 1,000 people)

These are the signs of diabetic ketoacidosis (see section 2, ‘Warnings and precautions’):

increased levels of “ketone bodies” in your urine or blood

rapid weight loss

feeling sick or being sick

stomach pain

excessive thirst

fast and deep breathing

confusion

unusual sleepiness or tiredness

a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your

urine or sweat.

This may occur regardless of blood glucose level. Your doctor may decide to temporarily or

permanently stop your treatment with Synjardy.

Contact your doctor as soon as possible if you notice the following side effects:

Low blood sugar (hypoglycaemia), seen very commonly (may affect more than 1 in 10 people)

If you take Synjardy with another medicine that can cause low blood sugar, such as a sulfonylurea or

insulin, your risk of getting low blood sugar is increased. The signs of low blood sugar may include:

shaking, sweating, feeling very anxious or confused, fast heart beat

excessive hunger, headache

Your doctor will tell you how to treat low blood sugar levels and what to do if you get any of the signs

above. If you have symptoms of low blood sugar, eat glucose tablets, a high sugar snack or drink fruit

juice. Measure your blood sugar if possible and rest.

Urinary tract infection, seen commonly (may affect up to 1 in 10 people)

The signs of urinary tract infection are:

burning sensation when passing urine

urine that appears cloudy

pain in the pelvis, or mid-back pain (when kidneys are infected)

An urge to pass urine or more frequent urination may be due to the way Synjardy works, but they can

also be signs of urinary tract infection. If you note an increase in such symptoms, you should also

contact your doctor.

Dehydration, seen uncommonly (may affect up to 1 in 100 people)

The signs of dehydration are not specific, but may include:

unusual thirst

lightheadedness or dizziness upon standing

fainting or loss of consciousness

Other side effects while taking Synjardy:

Very common

feeling sick (nausea), vomiting

diarrhoea or stomach ache

loss of appetite

Common

genital yeast infection (thrush)

passing more urine than usual or needing to pass urine more often

itching

rash or red skin– this this may be itchy and include raised bumps, oozing fluid or blisters

changes to the way things taste

thirst

blood tests may show changes in blood fat (cholesterol) levels in your blood

Uncommon

hives

straining or pain when emptying the bladder

blood tests may show changes related to kidney function (creatinine or urea)

blood tests may show increases in the amount of red blood cells in your blood (haematocrit)

Very rare

decreased vitamin B12 levels in the blood

abnormalities in liver function tests, inflammation of the liver (hepatitis)

redness of the skin (erythema)

Not known

severe allergic reaction (may include swelling of the face, lips, mouth, tongue, or throat that

may lead to difficulty breathing or swallowing)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side

effects not listed in this leaflet. You can also report side effects directly via the national reporting

system listed in Appendix V. By reporting side effects you can help provide more information on the

safety of this medicine.

5.

How to store Synjardy

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and the carton after ‘EXP’.

The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Synjardy contains

The active substances are empagliflozin and metformin.

Each Synjardy 5 mg/850 mg film-coated tablet (tablet) contains 5 mg empagliflozin and

850 mg metformin hydrochloride.

Each Synjardy 5 mg/1,000 mg film-coated tablet (tablet) contains 5 mg empagliflozin and 1,000 mg

metformin hydrochloride.

Each Synjardy 12.5 mg/850 mg film-coated tablet (tablet) contains 12.5 mg empagliflozin and 850 mg

metformin hydrochloride.

Each Synjardy 12.5 mg/1,000 mg film-coated tablet (tablet) contains 12.5 mg empagliflozin and

1,000 mg metformin hydrochloride.

The other ingredient(s) are:

Tablet core: maize starch, copovidone, colloidal anhydrous silica, magnesium stearate.

Film coating: hypromellose, macrogol 400, titanium dioxide (E171), talc.

Synjardy 5 mg/850 mg and Synjardy 5 mg/1,000 mg tablets also contain iron oxide yellow (E172).

Synjardy 12.5 mg/850 mg and Synjardy 12.5 mg/1,000 mg tablets also contain iron oxide black

(E172) and iron oxide red (E172).

What Synjardy looks like and contents of the pack

Synjardy 5 mg/850 mg film-coated tablets are yellowish white, oval, biconvex. They have “S5” and

the Boehringer Ingelheim logo on one side and “850” on the other. The tablet is 19.2 mm long and has

a width of 9.4 mm.

Synjardy 5 mg/1,000 mg film-coated tablets are brownish yellow, oval, biconvex. They have “S5” and

the Boehringer Ingelheim logo on one side and “1000” on the other. The tablet is 21.1 mm long and

has a width of 9.7 mm.

Synjardy 12.5 mg/850 mg film-coated tablets are pinkish white, oval, biconvex. They have “S12” and

the Boehringer Ingelheim logo on one side and “850” on the other. The tablet is 19.2 mm long and has

a width of 9.4 mm.

Synjardy 12.5 mg/1,000 mg film-coated tablets are dark brownish purple, oval, biconvex. They have

“S12” and the Boehringer Ingelheim logo on one side and “1000” on the other. The tablet is 21.1 mm

long and has a width of 9.7 mm.

The tablets are available in PVC/PVDC/aluminium perforated unit dose blisters. The pack sizes are

10 x 1, 14 x 1, 30 x 1, 56 x 1, 60 x 1, 90 x 1 and 100 x 1 film-coated tablets and multipacks containing

120 (2 packs of 60 x 1), 180 (2 packs of 90 x 1) and 200 (2 packs of 100 x 1) film-coated tablets.

Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Boehringer Ingelheim Ellas A.E.

5th km Paiania – Markopoulo

Koropi Attiki, 19400

Greece

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

SCS Boehringer Ingelheim Comm.V

Tél/Tel: +32 2 773 33 11

Lietuva

Boehringer Ingelheim RCV GmbH & Co KG

Lietuvos filialas

Tel.: +370 37 473 922

България

Бьорингер Ингелхайм РЦВ ГмбХ и Ко КГ -

клон България

Тел: +359 2 958 79 98

Luxembourg/Luxemburg

SCS Boehringer Ingelheim Comm.V

Tél/Tel: +32 2 773 33 11

Česká republika

Boehringer Ingelheim spol. s r.o.

Tel: +420 234 655 111

Magyarország

Boehringer Ingelheim RCV GmbH & Co KG

Magyarországi Fióktelepe

Tel.: +36 1 299 89 00

Danmark

Boehringer Ingelheim Danmark A/S

Tlf: +45 39 15 88 88

Malta

Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620

Deutschland

Boehringer Ingelheim Pharma GmbH & Co. KG

Tel: +49 (0) 800 77 90 900

Lilly Deutschland GmbH

Tel. +49 (0) 6172 273 2222

Nederland

Boehringer Ingelheim b.v.

Tel: +31 (0) 800 22 55 889

Eesti

Boehringer Ingelheim RCV GmbH & Co KG

Eesti filiaal

Tel: +372 612 8000

Norge

Boehringer Ingelheim Norway KS

Tlf: +47 66 76 13 00

Ελλάδα

Boehringer Ingelheim Ellas A.E.

Tηλ: +30 2 10 89 06 300

Österreich

Boehringer Ingelheim RCV GmbH & Co KG

Tel: +43 1 80 105-0

España

Boehringer Ingelheim España, S.A.

Tel: +34 93 404 51 00

Lilly S.A.

Tel: +34 91 663 50 00

Polska

Boehringer Ingelheim Sp.zo.o.

Tel.: +48 22 699 0 699

France

Boehringer Ingelheim France S.A.S.

Tél: +33 3 26 50 45 33

Lilly France SAS

Tél: +33 1 55 49 34 34

Portugal

Boehringer Ingelheim, Unipessoal, Lda.

Tel: +351 21 313 53 00

Lilly Portugal Produtos Farmacêuticos, Lda

Tel: +351 21 412 66 00

Hrvatska

Boehringer Ingelheim Zagreb d.o.o.

Tel: +385 1 2444 600

România

Boehringer Ingelheim RCV GmbH & Co KG

Viena - Sucursala Bucureşti

Tel: +40 21 302 28 00

Ireland

Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620

Eli Lilly and Company (Ireland) Limited

Tel: +353 1 661 4377

Slovenija

Boehringer Ingelheim RCV GmbH & Co KG

Podružnica Ljubljana

Tel: +386 1 586 40 00

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

Boehringer Ingelheim RCV GmbH & Co KG

organizačná zložka

Tel: +421 2 5810 1211

Italia

Boehringer Ingelheim Italia S.p.A.

Tel: +39 02 5355 1

Eli Lilly Italia S.p.A.

Tel: +39 055 42571

Suomi/Finland

Boehringer Ingelheim Finland Ky

Puh/Tel: +358 10 3102 800

Κύπρος

Boehringer Ingelheim Ellas A.E.

Tηλ: +30 2 10 89 06 300

Sverige

Boehringer Ingelheim AB

Tel: +46 8 721 21 00

Latvija

Boehringer Ingelheim RCV GmbH & Co KG

Latvijas filiāle

Tel: +371 67 240 011

United Kingdom

Boehringer Ingelheim Ltd.

Tel: +44 1344 424 600

Eli Lilly and Company Limited

Tel: +44 1256 315 000

This leaflet was last revised in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.