Patient leaflet - Synjardy 5 mg/850 mg film-coated tablets
1. What Synjardy is and what it is used for
What Synjardy is
Synjardy contains two active substances empagliflozi metformin. Each belongs to a group of medicines cal anti-diabetics”. These are medicines taken by mouth type 2 diabetes.
What is type 2 diabetes?
Type 2 diabetes is a disease that comes from both yo and your lifestyle. If you have type 2 diabetes, your p does not make enough insulin to control the level of in your blood, and your body is unable to use its own
n and
led “oral to treat
ur genes ancreas glucose 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 works in a different way to lower blood sugar levels, mainly by blocking glucose production in the liver.
Thereby Synjardy lowers the amount of su medicine can also help prevent heart disea
What Synjardy is used for
Synjardy is added to diet and exercise t
diabetes in adult patients and children older whose diabetes cannot be contro metformin alone or metformin with oth
gar in your blood. This se.
o treat type 2
aged 10 years and lled by adding
er medicines for
diabetes.
Synjardy can also be combined with ot
treatment of diabetes. These may be m mouth or given by injection such as ins
In addition, Synjardy can be used as an
both empagliflozin and metformin as si avoid overdose, do not continue taking metformin tablets separately, if you are
It is important that you continue with your plan as told by your doctor, pharmacist or
her medicines for the edicines taken by ulin.
alternative to taking ngle tablets. To
empagliflozin and taking this medicine.
diet and exercise nurse.
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 uncontrolled diabetes, with, for example, severe
hyperglycaemia (very 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 serious kidney problems. Your doctor may limit
your daily dose or ask you to take a different medicine (see also section 3, ‘How to take Synjardy’).
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
e.g. due to long-lasting or sev vomited several times in a ro kidney problems, which can (see ‘Warnings and precautio
if you are treated for acute h
a heart attack, have severe p (such as shock) or have breat to a lack in oxygen supply to for lactic acidosis (see sectio
- if you have problems with yo
if you drink large amounts of
only from time to time (see s
from your body (dehydration), ere diarrhoea, or if you have w. Dehydration may lead to put you at risk for lactic acidosis ns’);
eart failure or have recently had roblems with your circulation hing difficulties. This may lead tissue which can put you at risk n ‘Warnings and precautions’); ur liver;
alcohol, either every day or ection “Synjardy with alcohol”).
Warnings and precautions
Risk of lactic acidosis
Synjardy may cause a very rare, called lactic acidosis, particularl properly. The risk of developing with uncontrolled diabetes, serio or alcohol intake, dehydration (s liver problems and any medical the body has a reduced supply o heart diseases).
If any of the above apply to you, instructions.
but very serious side effect y if your kidneys are not working lactic acidosis is also increased us infections, prolonged fasting ee further information below), conditions in which a part of f oxygen (such as acute severe
talk to your doctor for further
Stop taking Synjardy for a short that may be associated with deh
body fluids) such as severe vomi to heat or if you drink less fluid t for further instructions.
Stop taking Synjardy and contac hospital immediately if you exp of lactic acidosis, as this conditi Symptoms of lactic acidosis incl
- vomiting
- stomach ache (abdominal pa
- muscle cramps
a general feeling of not being
time if you have a condition ydration (significant loss of ting, diarrhoea, fever, exposure han normal. Talk to your doctor
t a doctor or the nearest erience some of the symptoms
on may lead to coma.
ude:
in)
well with severe tiredness
- difficulty in breathing
- reduced body temperature and heartbeat
Talk to your doctor promptly for further instructions
if you are known to suffer from a genetically inherited
disease affecting mitochondria (the energy-producing components within cells) such as MELAS syndrome (Mitochondrial Encephalopathy, myopathy, Lactic acidosis and Stroke-like episodes) or Maternal inherited diabetes and deafness (MIDD).
if you have any of these symptoms after starting metformin:
seizure, declined cognitive abilities, difficulty with body movements, symptoms indicating nerve damage (e.g. pain or numbness), migraine and deafness.
Lactic acidosis is a medical emergency and must be treated in a hospital.
Talk to your doctor, pharmacist or nurse before taking this medicine, and during treatment:
if you experience rapid weight loss, feeling sick or being
sick, stomach pain, excessive thirst, fast and deep breathing,
confusion, unusua to your breath, a s a different odour t or the nearest hos medicine until furt symptoms could b but serious, somet with diabetes beca in your urine or blo diabetic ketoacido fasting, excessive reductions in insul major surgery or s
if you have “type 1
l sleepiness or tiredness, a sweet smell weet or metallic taste in your mouth, or
o your urine or sweat, contact a doctor pital straight away and stop taking this her advice from your doctor. These e a sign of “diabetic ketoacidosis” – a rare, imes life-threatening problem you can get use of increased levels of “ketone bodies” od, seen in tests. The risk of developing sis may be increased with prolonged alcohol consumption, dehydration, sudden in dose, or a higher need of insulin due to erious illness;
diabetes” – this type usually starts when
you are young and You should not tak
might be at risk of
o if you are being
not able to eat
o if you are takin
[diuretics] or lo
o if you are 75 ye Possible signs are l
Your doctor may a recover to prevent ways to prevent de
if you have a serio
tract with fever. Yo
your body does not produce any insulin. e Synjardy if you have type 1 diabetes; dehydration, for example:
sick, have diarrhoea or fever, or if you are or drink
g medicines that increase urine production wer blood pressure
ars old or older.
isted in section 4 under ‘dehydration’. sk you to stop taking Synjardy until you loss of too much body fluid. Ask about hydration.
us infection of the kidney or the urinary ur doctor may ask you to stop taking
Synjardy until you
if you need to und
contrast agents (su given below in “Ot
Talk to your doctor im of symptoms of pain, genitals or the area be fever or feeling genera a sign of a rare but se called necrotising fasc gangrene which destr gangrene has to be tre
have recovered;
ergo an examination with iodination ch as X-ray or scan). More information is her medicines and Synjardy”.
mediately if you develop a combination tenderness, redness, or swelling of the tween the genitals and the anus with lly unwell. These symptoms could be rious or even life-threatening infection, iitis of the perineum or Fournier’s oys the tissue under the skin. Fournier’s ated immediately.
Surgery
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.
Kidney function
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
Synjardy can be used in children aged 10 years and older for the treatment of type 2 diabetes mellitus.
Due to limit
ed data caution is recommended when used in children ag
ed between 10 and 12 years.
No data are
available in children below 10 years of age.
Other medi
cines and Synjardy
If you need
to have an injection of a contrast medium that contains io
dine into your bloodstream, for example in the context of a
n X-ray or scan, you must stop taking Synjardy before or at
the time of the injection. Your doctor will decide when you m
ust stop and when to restart your treatment with
Synjardy.
Tell your do
ctor if you are taking, have recently taken or might take any ot
her medicines. You may need more frequent blood glucose and
kidney function tests, or your doctor may need to adjust th
e dosage of Synjardy. It is especially important to mention th
e following:
medicin
es which increase urine production (diuretics), as
Synjardy
may increase the risk of losing too much fluid. Your doctor
may ask you to stop taking Synjardy. Possible signs of losing to
o much fluid from your body are listed in section 4.
other m
edicines that lower the amount of sugar in your blood su
ch as insulin or a “sulphonylurea” medicine. Your doctor
may want to lower the dose of these other medicines, to preve
nt your blood sugar levels from getting too low
(hypogly
caemia).
medicin
es that may change the amount of metformin in your blood, e
specially if you have reduced kidney function (such as verapam
il, rifampicin, cimetidine, dolutegravir, ranolazine, trimetho
prim, vandetanib, isavuconazole, crizotinib, olaparib
).
broncho
dilators (beta-2 agonists) which are used to treat asthma.
corticos
teroids (given by mouth, as an injection, or inhaled), which ar
e used to treat inflammation in diseases like asthma and arth
ritis.
medicin
es used to treat pain and inflammation (NSAID and
COX-2-i
nhibitors, such as ibuprofen and celecoxib).
certain
medicines for the treatment of high blood pressure
(ACE inh
ibitors and angiotensin II receptor antagonists).
medicin
es that contain alcohol (see section ‘Synjardy with alcohol’
).
- iodinated contrast agents (medicines used during an X-ray, see section ‘Warnings and precautions’).
- if you are taking lithium because Synjardy can lower the amount of lithium in your blood.
Synjardy with alcohol
Avoid excessive alcohol intake while taking Synjardy since this may increase the risk of lactic acidosis (see section ‘Warnings and precautions’).
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
Package leaflet: Information for the patient
Synjardy® 5 mg/850 mg
film-coated tablets Synjardy® 5 mg/1 000 m
g
film-coated tablets Synjardy
®
12.5 mg/850
mg
film-coated tablets Synjardy® 12.5 mg/1 00 film-coated tablets
empagliflozin/metformin hydrochl
Read all of this leaflet carefully before you start takin
- Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor,
0 mg
oride
g this medicine because it contains important informatio
pharmacist or nurse.
n for you.
This medicine has been prescribed for you only. D
the same as yours.
If you get any side effects, talk to your doctor, pha
leaflet. See section 4.
o not pass it on to others. It may harm them, even if thei
rmacist or nurse. This includes any possible side effects
r signs of illness are
not listed in this
abcd
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
abcd
abcd 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 a
nd 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 sym
ptoms such
as shaking, sweating and change in vision, and may a
ffect 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 tol
d you.
Check with your doctor or pharmacist if you are not sur
e.
How much to take
The dose of Synjardy varies depending on your condi
tion and
the doses of diabetes medicines you currently take. Y
our doctor
will adjust your dose as necessary and tell you exactl
y which
strength of the medicine to take.
The recommended dose is one tablet twice a day. You
r doctor
will normally start Synjardy treatment by prescribing t
he
strength of tablet that supplies the same dose of metf
ormin
you are already taking (850 mg or 1 000 mg twice a d
ay), and
the lowest dose of empagliflozin (5 mg twice a day). If
you
are already taking both medicines separately, your do
ctor will
start treatment with tablets of Synjardy that will supp
ly the
same amount of both. If you have reduced kidney fun
ction,
your doctor may prescribe a lower dose or decide to u
se an
alternative medicine.
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 an
other
diabetes medicine. Remember to take all medicines a
s directed
by your doctor to achieve the best results for your he
alth. Your
doctor may need to adjust your doses to control your blood sugar.
Appropriate diet and exercise 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 c doctor, unless you suspect you have diabet acidosis, or if you have a condition that m dehydration (see section 2 “warnings and blood sugar levels may increase when you
If you have any further questions on the us ask your doctor, pharmacist or nurse.
4. Possible side effects
onsulting your
ic ketoacidosis, lactic ay be associated with precautions”). Your stop taking Synjardy.
e of this medicine,
Like all medicines, this medicine can cause although not everybody gets them.
Contact a doctor or the nearest hospital st have any of the following side effects:
Severe allergic reaction, seen with uncom (may affect up to 1 in 100 people)
Possible signs of severe allergic reaction m
swelling of the face, lips, mouth, tongu
lead to difficulty breathing or swallowin
Lactic acidosis, seen very rarely (may affec 10 000 people)
side effects,
raight away if you
mon frequency
ay include:
e, or throat that may g
t up to 1 in
Synjardy may cause a very rare but very se called lactic acidosis (see section 2). If this stop taking Synjardy and contact a doctor hospital immediately, as lactic acidosis ma
Diabetic ketoacidosis, seen rarely (may aff 1 000 people)
These are the signs of diabetic ketoacidosi
- increased levels of “ketone bodies” in y
- rapid weight loss
- feeling sick or being sick
- stomach pain
- excessive thirst
fast and deep breathing
rious side effect happens you must or the nearest
y lead to coma.
ect up to 1 in
s (see section 2): our urine or blood
- 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 t and what to do if you get any of symptoms of low blood sugar, e snack or drink fruit juice. Measu and rest.
Urinary tract infection, seen co 10 people)
The signs of urinary tract infecti
- burning sensation when pass
- urine that appears cloudy
pain in the pelvis, or mid-bac
infected)
reat low blood sugar levels the signs above. If you have at glucose tablets, a high sugar re your blood sugar if possible
mmonly (may affect up to 1 in
on are:
ing urine
k pain (when kidneys are
An urge to pass urine or more fr the way Synjardy works, but the tract infection. If you note an inc should also contact your doctor.
Dehydration, seen uncommonly 100 people)
The signs of dehydration are not
- unusual thirst
- lightheadedness or dizziness
- fainting or loss of consciousn
Other side effects while taking
equent urination may be due to y can also be signs of urinary rease in such symptoms, you
(may affect up to 1 in
specific, but may include:
upon standing
ess
Synjardy:
Very common
- feeling sick (nausea), vomitin
- diarrhoea or stomach ache
- loss of appetite
Common
- genital yeast infection (thrus
passing more urine than usu
often
- itching
rash or red skin – this may b
bumps, oozing fluid or bliste
- changes to the way things ta
thirst
g
h)
al or needing to pass urine more
e itchy and include raised rs
ste
blood tests may show an increase in blood fat (cholesterol)
levels in your blood
- constipation
decreased or low vitamin B12 levels in the blood (symptoms
may include extreme tiredness (fatigue), a sore and red tongue (glossitis), pins and needles (paraesthesia) or pale or yellow skin). Your doctor may arrange some tests to find out the cause of your symptoms because some of these may also be caused by diabetes or due to other unrelated health problems.
Uncommon
- hives
- straining or pain when emptying the bladder
blood tests may show a decrease in kidney function
(creatinine or urea)
- blood tests may show increases in the amount of red blood cells in your blood (haematocrit)
Rare
- necrotising fasciitis of the perineum or Fournier’s gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the anus
Very rare
abnormalities in liv
liver (hepatitis)
- redness of the skin
- inflammation of th
Reporting of side effe
If you get any side eff nurse. This includes a leaflet. You can also r below). By reporting s information on the sa
er function tests, inflammation of the
(erythema)
e kidneys (tubulointerstitial nephritis)
cts ects, talk to your doctor, pharmacist or ny possible side effects not listed in this eport side effects directly (see details ide effects you can help provide more fety of this medicine.
Yellow Card Scheme Website: www.mhra.g Yellow Card in the Go
5. How to store Sy
Keep this medicine ou
Do not use this medic on the blister and the to the last day of that
This medicine does n
ov.uk/yellowcard or search for MHRA ogle Play or Apple App Store njardy t of the sight and reach of children.
ine after the expiry date which is stated carton after ‘EXP’. The expiry date refers month.
ot require any special storage conditions.
Do not use this medic damaged or shows sig
Do not throw away an waste. Ask your pharm you no longer use. Th environment.
6. Contents of the
What Synjardy contai
The active substances Each Synjardy 5 mg/8
ine if you notice that the packaging is ns of tampering.
y medicines via wastewater or household acist how to throw away medicines ese measures will help protect the pack and other information ns are empagliflozin and metformin. 50 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, biconv logo on one long and ha Synjardy 5 yellow, oval Ingelheim l is 21.1 mm Synjardy 12 oval, biconv logo on one long and ha Synjardy 12 brownish p Boehringer
ex. They have “S5” and the Boehringer Ingelheim side and “850” on the other. The tablet is 19.2 mm s a width of 9.4 mm.
mg/1 000 mg film-coated tablets are brownish , biconvex. They have “S5” and the Boehringer ogo on one side and “1000” on the other. The tablet long and has a width of 9.7 mm.
.5 mg/850 mg film-coated tablets are pinkish white, ex. They have “S12” and the Boehringer Ingelheim side and “850” on the other. The tablet is 19.2 mm s a width of 9.4 mm.
.5 mg/1 000 mg film-coated tablets are dark urple, oval, biconvex. They have “S12” and the Ingelheim logo on one side and “1000” on the other.
The tablet i
The tablets unit dose bl 56 × 1, 60 × multipacks 90 × 1) and
Not all pack
Marketing
Boehringer Binger Stras 55216 Ingel
s 21.1 mm long and has a width of 9.7 mm.
are available in PVC/PVDC/aluminium perforated isters. The pack sizes are 10 × 1, 14 × 1, 30 × 1, 1, 90 × 1 and 100 × 1 film-coated tablets and containing 120 (2 packs of 60 × 1), 180 (2 packs of 200 (2 packs of 100 × 1) film-coated tablets.
sizes may be marketed.
Authorisation Holder
Ingelheim International GmbH se 173 heim am Rhein
Germany
Manufactur
Dragenoph Göllstraße 84529 Tittm Germany
For any info local repres
United King
Boehringer Tel: +44 134
er arm Apotheker Püschl GmbH
1 oning rmation about this medicine, please contact the entative of the Marketing Authorisation Holder:
dom
Ingelheim Ltd.
4 424 600