Package leaflet: Information for the patient

Eprocliv, 50 mg + 850 mg, film-coated tablets
Eprocliv, 50 mg + 1000 mg, film-coated tablets
Sitagliptin + Metformin hydrochloride
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.
Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others.
It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse.
See section 4.
Leaflet contents:

What Eprocliv is and what it is used for
What you need to know before taking Eprocliv
How to take Eprocliv
Possible side effects
How to store Eprocliv
Contents of the pack and other information

1. What Eprocliv is and what it is used for

Eprocliv contains two different active substances called sitagliptin and metformin.
Sitagliptin belongs to a group of medicines known as DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors).
Metformin belongs to a group of medicines known as biguanides.
The combined action of these medicines helps regulate blood glucose levels in adult patients with diabetes known as "type 2 diabetes". This medicine helps increase the amount of insulin released after meals and reduces the amount of glucose produced by the body.
Used together with diet and physical exercise, this medicine helps lower blood glucose levels.
This medicine may be used as the only antidiabetic treatment or in combination with certain other antidiabetic medicines (insulin, sulfonylurea derivatives, or glitazones).

What is type 2 diabetes?
In type 2 diabetes, the body does not produce enough insulin, and the insulin that is produced does not work properly. The body may also produce too much glucose. When this happens, sugar (glucose) accumulates in the blood. This can lead to serious health problems, such as heart disease, kidney disease, vision loss, and limb amputations.

2. Important information before using Eprocliv

When not to use Eprocliv
if the patient is allergic to sitagliptin or metformin, or to any of the other
components of this medicine (listed in section 6);
if the patient has significantly reduced kidney function,
if the patient has uncontrolled diabetes, for example severe hyperglycaemia (high
blood glucose levels), nausea, vomiting, diarrhoea, sudden 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 may lead to diabetic pre-coma. Symptoms
include: abdominal pain, rapid and deep breathing, drowsiness or an unusual fruity odour on the breath.
if the patient has severe infection or dehydration,
if the patient is scheduled for a radiological examination with intravascular administration of a contrast agent. The use of Eprocliv must be discontinued during the radiological examination and for 2 or more days afterwards, as recommended by the physician, depending on the patient's kidney function.
if the patient has recently had a heart attack or has experienced severe circulatory disorders, such as shock or breathing difficulties,
if the patient has liver disease,
if the patient consumes excessive amounts of alcohol (either daily or occasionally),
if the patient is breastfeeding.
Eprocliv must not be taken if any of the above contraindications apply.
Consult a doctor to determine alternative methods of diabetes control. In case of
doubt, discuss this with your doctor, pharmacist, or nurse before using Eprocliv.
Warnings and precautions
Cases of pancreatitis have been reported in patients taking Eprocliv (see section 4).
If the patient develops blisters on the skin, this may be a symptom of a disease known as bullous pemphigoid. The doctor may advise the patient to discontinue taking Eprocliv.
Risk of lactic acidosis
Eprocliv may cause a very rare but serious adverse effect called lactic
acidosis, especially if the patient has impaired kidney function. The risk of lactic acidosis is also increased in cases of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see further information below), impaired liver function, or any medical condition in which part of the body is inadequately supplied with oxygen (e.g. acute severe heart disease). If any of the above situations apply to the patient, consult a doctor for further instructions.
Contact a doctor immediately for further guidance if:
the patient has a genetically inherited disorder affecting mitochondria (cellular energy-producing structures), such as MELAS (mitochondrial encephalopathy, myopathy, lactic acidosis and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
after starting metformin, the patient develops any of the following symptoms:
seizures, worsening cognitive function, difficulty moving, symptoms indicating nerve damage (e.g. pain or numbness), migraine, or deafness.
Temporarily discontinue Eprocliv if the patient has a medical condition that may be associated with dehydration (significant loss of water from the body), such as
severe vomiting, diarrhoea, fever, exposure to high temperatures, or if the patient is drinking less fluid than usual. Consult a doctor for further instructions.
Discontinue Eprocliv and contact a doctor or the nearest hospital immediately if the patient experiences any symptoms of lactic acidosis,
as this condition may lead to coma.
Symptoms of lactic acidosis include:

vomiting,
abdominal pain,
muscle cramps,
general malaise combined with severe fatigue,
difficulty breathing,
decreased body temperature and slowed heart rate.

Lactic acidosis is an acute, life-threatening condition requiring hospital treatment.
Before starting Eprocliv, discuss the following with your doctor or pharmacist:

if the patient has or has had pancreatic disease (e.g. pancreatitis).
if the patient has or has had gallstones, alcohol dependence, or very high blood triglyceride levels (a type of fat). In such cases, the risk of pancreatitis may be increased (see section 4).
if the patient has been diagnosed with type 1 diabetes. This is sometimes referred to as insulin-dependent diabetes.
if the patient currently has or has previously experienced allergic reactions to sitagliptin, metformin, or Eprocliv (see section 4).
if the patient is taking a sulphonylurea derivative or insulin, antidiabetic medicines, together with Eprocliv, as this may lead to excessively low blood sugar levels (hypoglycaemia). The doctor may reduce the dose of the sulphonylurea derivative or insulin.

If the patient is scheduled for major surgery, Eprocliv must not be taken during the procedure and for some time afterwards. The doctor will decide when the patient should stop and restart treatment with Eprocliv.
If in doubt whether any of the above situations apply to the patient, discuss this with the doctor or pharmacist before using Eprocliv.
While being treated with Eprocliv, the doctor will monitor the patient's kidney function at least once a year, or more frequently if the patient is elderly and/or has worsening kidney function.
Children and adolescents
This medicine must not be used in children and adolescents under 18 years of age. This medicine is not effective in children and adolescents aged 10 to 17 years. It is not known whether this medicine is safe and effective for use in children under 10 years of age.
Eprocliv and other medicines
If the patient is to receive an intravenous contrast agent containing iodine, for example for an X-ray or CT scan, the patient must stop taking Eprocliv before or at the latest at the time of such injection. The doctor will decide when the patient should stop and restart treatment with Eprocliv.
Inform the doctor or pharmacist about all medicines currently used, recently taken, or planned for use. The patient may require more frequent monitoring of blood glucose levels and kidney function assessments, or dose adjustments of Eprocliv by the doctor. It is particularly important to inform about the following medicines:
medicines (taken orally, by inhalation, or by injection) used to treat inflammatory conditions such as asthma or arthritis (corticosteroids),
medicines that increase urine production (diuretics),
medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib),
certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists),
specific medicines used to treat asthma (β-sympathomimetics),
iodinated contrast agents or medicines containing alcohol,
some medicines used to treat gastrointestinal disorders, such as cimetidine,
ranolazine, a medicine used to treat angina,
dolutegravir, a medicine used to treat HIV infection,
vandetanib, a medicine used to treat a specific type of thyroid cancer (medullary thyroid cancer),
digoxin (used to treat heart rhythm disorders and other heart conditions). Blood digoxin levels should be monitored during concomitant use of Eprocliv and digoxin.
Eprocliv and alcohol
Avoid consuming excessive amounts of alcohol while taking Eprocliv, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. This medicine must not be used during pregnancy or while breastfeeding. See section 2, When not to use Eprocliv.
Driving and operating machinery
This medicine has no effect or negligible effect on the ability to drive and operate machinery. However, dizziness and drowsiness have been reported during treatment with sitagliptin, which may affect the ability to drive or operate machinery.
Taking this medicine together with medicines called sulphonylurea derivatives or with insulin may lead to hypoglycaemia, which in turn may affect the ability to drive and operate machinery or work without secure foot support.
Eprocliv contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Eprocliv

This medicine should always be taken as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Take one tablet:
twice daily, orally;
with meals to reduce the likelihood of stomach upset.
To control blood sugar levels, your doctor may increase the dose of this medicine.
If you have impaired kidney function, your doctor may prescribe a lower dose.
While taking this medicine, you should continue the diet recommended by your doctor and pay attention
to evenly distributing carbohydrate intake throughout the day.
It is unlikely that taking this medicine alone would lead to abnormally low blood sugar (hypoglycaemia).
Low blood sugar may occur when this medicine is taken together with a sulphonylurea derivative or insulin –
in such a case, your doctor may reduce the dose of the sulphonylurea derivative or insulin.
Taking more Eprocliv than prescribed
If you take more than the prescribed amount of this medicine, contact your doctor immediately.
You should go to hospital if symptoms of lactic acidosis occur, such as feeling cold or discomfort, severe
nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps or rapid breathing (see section
"Warnings and precautions").
Missing a dose of Eprocliv
If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed
dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed
dose.
Stopping Eprocliv
To maintain control of blood sugar levels, take this medicine for as long as your doctor recommends.
Do not stop taking this medicine without first consulting your doctor.
Stopping treatment with Eprocliv may cause blood sugar levels to rise again.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You should STOP taking Eprocliv and contact your doctor immediately
if any of the following serious adverse reactions occur:
Severe and persistent abdominal pain (in the stomach area), possibly radiating to the back,
with or without nausea and vomiting, as these may be symptoms of pancreatitis.
Eprocliv may very rarely cause (may occur in fewer than 1 in 10,000 people)
a very serious adverse reaction known as lactic acidosis (see section “Warnings and precautions”).
If lactic acidosis occurs in a patient, STOP taking Eprocliv and contact your doctor or the nearest
hospital immediately, as lactic acidosis may lead to coma.
If a severe allergic reaction occurs (frequency unknown), including rash, hives, skin blisters and (or)
skin peeling, and swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or
swallowing, stop using the medicine and contact your doctor immediately.
Your doctor may prescribe medication to treat the allergic reaction and another medicine for diabetes.
In some patients taking metformin, the following adverse reactions occurred after starting
sitagliptin:
Common (may occur in fewer than 1 in 10 people): low blood sugar, nausea, bloating, vomiting
Uncommon (may occur in fewer than 1 in 100 people): stomach pain, diarrhoea, constipation, drowsiness
Some patients experienced diarrhoea, nausea, bloating, constipation, stomach pain, or vomiting
after starting treatment with sitagliptin in combination with metformin (common).
In some patients using this medicine together with a sulfonylurea derivative, such as glimepiride,
the following adverse reactions occurred:
Very common (may occur in more than 1 in 10 people): low blood sugar
Common (may occur in fewer than 1 in 10 people): constipation
In some patients using this medicine together with pioglitazone, the following adverse reactions occurred:
Common (may occur in fewer than 1 in 10 people): swelling of hands or feet
In some patients using this medicine together with insulin, the following adverse reactions occurred:
Very common: low blood sugar
Uncommon: dry mouth, headache
In clinical trials, in some patients using sitagliptin alone (one of the active substances in Eprocliv) or
after marketing authorization of Eprocliv or sitagliptin alone or in combination with other antidiabetic
medicines, the following adverse reactions occurred:
Common: low blood sugar, headache, upper respiratory tract infection, stuffy nose or runny nose and
sore throat, bone and joint pain, pain in arms or legs
Uncommon: dizziness, constipation, itching
Rare: decreased platelet count
Frequency unknown: kidney disorders (sometimes requiring dialysis), vomiting, joint pain, muscle pain,
back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister)
In some patients using metformin alone, the following adverse reactions occurred:
Very common: nausea, vomiting, diarrhoea, stomach pain, and loss of appetite. These symptoms may
occur after starting metformin and usually resolve over time.
Common: metallic taste, reduced or low blood levels of vitamin B12 (symptoms may include extreme
tiredness (fatigue), sore and red tongue (glossitis), tingling (paraesthesia), or pallor or yellowing of the skin).
Your doctor may order certain tests to determine the cause of these symptoms, as some of them may also
be caused by diabetes or other unrelated health conditions.
Very rare: hepatitis (liver disease), urticaria, skin redness (rash), or itching
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor,
pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse
Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and
Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Eprocliv

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the outer carton, following "EXP". The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Eprocliv contains
The active substances are sitagliptin and metformin hydrochloride.
Eprocliv, 50 mg + 850 mg, film-coated tablets
Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg
of sitagliptin and 850 mg of metformin hydrochloride.
Eprocliv, 50 mg + 1000 mg, film-coated tablets
Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg
of sitagliptin and 1000 mg of metformin hydrochloride.
The other ingredients are:
Tablet core: povidone (K30), sodium lauryl sulfate, microcrystalline cellulose, sodium
croscarmellose, sodium stearyl fumarate.
Coating: hypromellose (type 2910), hydroxypropyl cellulose, triethyl citrate, titanium dioxide
(E 171), talc, yellow iron oxide (E 172), red iron oxide (E 172).

What Eprocliv looks like and contents of the pack
Eprocliv, 50 mg + 850 mg, film-coated tablets
Light orange, oval, biconvex film-coated tablet (approximately 10 x 20 mm)
with the imprint “SM 2” on one side.
Eprocliv, 50 mg + 1000 mg, film-coated tablets
Light red, oval, biconvex film-coated tablet (approximately 10.5 x 21 mm)
with the imprint “SM 3” on one side.
The medicine is available in blisters made of OPA/Aluminum/PVC/Aluminum or
PVC/PE/PVDC/Aluminum, or in unit dose blisters made of OPA/Aluminum/PVC/Aluminum
or PVC/PE/PVDC/Aluminum, packed in a cardboard carton.
Pack containing 56 film-coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria

Manufacturer
Lek d.d., PE PROIZVODNJA LENDAVA
Trimlini 2D
9220 Lendava
Slovenia
Lek S.A.
ul. Podlipie 16, 95-010 Stryków
Poland

For more detailed information about this medicine, please contact the local representative of the
Marketing Authorisation Holder:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Estonia Eprocliv
Greece Eprocliv
Spain Eprocliv 50 mg/850 mg film-coated tablets EFG
Eprocliv 50 mg/1.000 mg film-coated tablets EFG
Croatia Eprocliv 50 mg/850 mg film-coated tablets
Eprocliv 50 mg/1000 mg film-coated tablets
Lithuania Eprocliv 50 mg/850 mg film-coated tablets
Eprocliv 50 mg/1000 mg film-coated tablets
Latvia Eprocliv 50 mg/850 mg coated tablets
Eprocliv 50 mg/1000 mg coated tablets
Netherlands Eprocliv 50/850 mg, film-coated tablets
Eprocliv 50/1000 mg, film-coated tablets
Poland Eprocliv
Romania Eprocliv 50 mg/1000 mg Film-coated tablets
Slovenia Eprocliv 50 mg/850 mg film-coated tablets
Eprocliv 50 mg/1000 mg film-coated tablets
Slovakia Eprocliv 50 mg/850 mg film-coated tablets
Eprocliv 50 mg/1000 mg film-coated tablets