Eprocliv

Leaflet accompanying the packaging: patient information

Eprocliv, 50 mg + 850 mg, film-coated tablets

Eprocliv, 50 mg + 1000 mg, film-coated tablets

Sitagliptin + Metformin hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet, you may need to read it again.
In case of any doubts, consult a doctor, pharmacist or nurse.
This medicine has been prescribed specifically for you. Do not pass it on to others.
The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist or nurse.
See section 4.

Table of contents of the leaflet:

• 1. What is Eprocliv and what is it used for
• 2. Important information before taking Eprocliv
• 3. How to take Eprocliv
• 4. Possible side effects
• 5. How to store Eprocliv
• 6. Contents of the pack and other information

1. What is Eprocliv and what is it used for

Eprocliv contains two different active substances called sitagliptin and metformin.
Sitagliptin belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors)
Metformin belongs to a group of medicines called biguanides.
The combined action of these medicines leads to the normalization of blood sugar levels in adult patients with diabetes known as "type 2 diabetes". This medicine helps to increase the amount of insulin released after a meal and reduce the amount of sugar produced by the body.
The medicine is used in combination with diet and exercise to reduce blood sugar levels.
This medicine may be used alone or in combination with certain other anti-diabetic 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 produced does not work as it should. The body may also produce too much sugar. If this happens, sugar (glucose) builds up in the blood. This can lead to serious health problems, such as heart disease, kidney disease, vision loss, and limb amputation.

2. Important information before taking Eprocliv

When not to take Eprocliv

if the patient is allergic to sitagliptin or metformin or to any of the other ingredients of this medicine (listed in section 6);
if the patient has significantly reduced kidney function,
if the patient has uncontrolled diabetes, such as severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or diabetic ketoacidosis. Diabetic ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and can lead to diabetic coma. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness or unusual fruity odor from the mouth.
if the patient has a severe infection or dehydration,
if the patient is scheduled to undergo a radiological examination with intravenous administration of a contrast agent. Eprocliv should be discontinued during the radiological examination and for at least 2 days or more, according to the doctor's recommendations, depending on the patient's kidney function.
if the patient has recently had a heart attack or has had 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 from time to time),
if the patient is breastfeeding.
Eprocliv should not be taken if any of the above contraindications are present.
A doctor should be consulted to determine other methods of controlling diabetes. In case of doubts, before taking Eprocliv, it should be discussed with a doctor, pharmacist or nurse.

Warnings and precautions

Patients taking Eprocliv have reported cases of pancreatitis (see section 4).
If the patient develops blisters on the skin, it may be a sign of a disease called pemphigoid blisters. The doctor may recommend that the patient stop taking Eprocliv.

Risk of lactic acidosis

Eprocliv may cause a very rare but very serious side effect called lactic acidosis, especially if the patient has kidney problems. The risk of lactic acidosis also increases in case of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see below), liver problems, and any conditions in which a part of the body is not sufficiently supplied with oxygen (e.g., acute severe heart disease). If any of the above situations apply to the patient, they should consult a doctor for more detailed instructions.
The patient should contact a doctor immediately for further instructions if:
they have a genetically inherited disease affecting the mitochondria (energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or inherited diabetes and deafness from their mother (MIDD, maternal inherited diabetes and deafness).
after starting metformin, they experience any of the following symptoms: seizures, decreased cognitive abilities, difficulty moving, symptoms indicating nerve damage (e.g., pain or numbness), migraine, or hearing loss.

The patient should temporarily stop taking Eprocliv if they experience a condition that may lead to dehydration

(significant loss of water from the body), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. The patient should consult a doctor for more detailed instructions.

The patient should stop taking Eprocliv and immediately contact a doctor or the nearest hospital if they experience any symptoms of lactic acidosis

, as this condition can lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell, combined with extreme fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires hospital treatment.
Before starting Eprocliv, the patient should discuss the following with their doctor or pharmacist:

• if the patient has or has had pancreatitis (e.g., pancreatitis).
• if the patient has or has had gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood. In such cases, the risk of pancreatitis (see section 4) may increase.
• if the patient has type 1 diabetes. It is sometimes called insulin-dependent diabetes.
• if the patient has currently or has had allergic reactions to sitagliptin, metformin, or Eprocliv (see section 4).
• if the patient is taking a sulfonylurea derivative or insulin, anti-diabetic medicines, at the same time as Eprocliv, as this may lead to hypoglycemia (low blood sugar). The doctor may reduce the dose of the sulfonylurea derivative or insulin.

If the patient is to undergo major surgery, they should not take Eprocliv during the surgery and for some time after it. The doctor will decide when the patient should stop and resume Eprocliv treatment.
In case of doubts, whether any of the above situations apply to the patient, before taking Eprocliv, they should discuss it with their doctor or pharmacist.
During Eprocliv treatment, the doctor will monitor the patient's kidney function at least once a year or more often if the patient is elderly and/or has worsening kidney function.

Children and adolescents

This medicine should 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 when used 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 examination or computed tomography, they should stop taking Eprocliv before or at the latest at the time of administration. The doctor will decide when the patient should stop and resume Eprocliv treatment.
The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient may need more frequent blood sugar checks and kidney function tests or dose adjustments of Eprocliv by their doctor. It is especially important to inform about the following medicines:
medicines (taken orally, inhaled, or injected) used to treat inflammatory diseases, 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),
contrast agents containing iodine or medicines containing alcohol,
certain medicines used to treat stomach disorders, such as cimetidine, ranitidine, a medicine used to treat angina pectoris,
dolutegravir, a medicine used to treat HIV infection,
vandetanib, a medicine used to treat a certain type of thyroid cancer (medullary thyroid cancer),
digoxin (used to treat heart rhythm disorders and other heart diseases). When taking Eprocliv with digoxin, the patient's digoxin levels should be monitored.

Eprocliv and alcohol

The patient should avoid consuming excessive amounts of alcohol while taking Eprocliv, as this may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. This medicine should not be taken during pregnancy or breastfeeding. See section 2, When not to take Eprocliv.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, dizziness and drowsiness have been reported during sitagliptin treatment, which may affect the ability to drive and use machines.
Taking this medicine with sulfonylurea derivatives or insulin may lead to hypoglycemia, which may affect the ability to drive and use machines or work without safe foot support.

Eprocliv contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is essentially "sodium-free".

3. How to take Eprocliv

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The patient should take one tablet:
twice a day, orally;
with meals to reduce the likelihood of stomach upset.
To control blood sugar levels, the doctor may increase the dose of Eprocliv.
If the patient has kidney problems, the doctor may prescribe a lower dose.
During Eprocliv treatment, the patient should continue to follow the diet and exercise recommended by their doctor.
It is unlikely that taking this medicine alone will lead to low blood sugar (hypoglycemia). Low blood sugar may occur when taking this medicine with a sulfonylurea derivative or insulin - in such cases, the doctor may reduce the dose of the sulfonylurea derivative or insulin.

Taking a higher dose of Eprocliv than recommended

In case of taking a higher dose of this medicine than recommended, the patient should immediately contact their doctor. The patient should go to the hospital if they experience symptoms of lactic acidosis, such as feeling cold or uncomfortable, severe nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps, or rapid breathing (see "Warnings and precautions").

Missing a dose of Eprocliv

In case of missing a dose, the patient should take it as soon as possible. If it is almost time for the next dose, the patient should skip the missed dose and continue taking the medicine as usual. The patient should not take a double dose to make up for the missed dose.

Stopping Eprocliv treatment

To maintain control of blood sugar levels, the patient should take this medicine for as long as their doctor recommends. The patient should not stop taking this medicine without consulting their doctor first.
Stopping Eprocliv treatment may lead to a recurrence of high blood sugar levels.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The patient should STOPtaking Eprocliv and immediately contact their doctor if they experience any of the following serious side effects:
Severe and persistent abdominal pain (in the stomach area), which may radiate to the back, with or without nausea and vomiting, as these may be symptoms of pancreatitis.
Eprocliv may very rarely cause (may occur less often than 1 in 10,000 people) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this occurs, the patient should STOPtaking Eprocliv and immediately contact their doctor or the nearest hospital, as lactic acidosis can lead to coma.
In case of a severe allergic reaction (frequency not known), including rash, hives, blisters on the skin, and (or) peeling of the skin, as well as swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing, the patient should stop taking Eprocliv and immediately contact their doctor. The doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes.
Some patients taking metformin after starting sitagliptin experienced the following side effects:
Common(may occur less often than 1 in 10 people): low blood sugar, nausea, bloating, vomiting
Uncommon(may occur less often than 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness
Some patients experienced diarrhea, nausea, bloating, constipation, stomach pain, or vomiting after starting sitagliptin treatment in combination with metformin (common).
Some patients taking this medicine in combination with a sulfonylurea derivative, such as glimepiride, experienced the following side effects:
Very common(may occur more often than 1 in 10 people): low blood sugar
Common(may occur less often than 1 in 10 people): constipation
Some patients taking this medicine in combination with pioglitazone experienced the following side effects:
Common(may occur less often than 1 in 10 people): swelling of the hands or feet
Some patients taking this medicine in combination with insulin experienced the following side effects:
Very common: low blood sugar
Uncommon: dry mouth, headache
In clinical trials, some patients taking sitagliptin (one of the active substances of Eprocliv) alone or after marketing authorization of Eprocliv or sitagliptin alone or with other anti-diabetic medicines experienced the following side effects:
Common: low blood sugar, headache, upper respiratory tract infection, stuffy nose or sore throat, and joint or limb pain
Uncommon: dizziness, constipation, itching
Rare: decreased platelet count
Frequency not known: kidney disease (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, pemphigoid blisters (a type of blisters on the skin
Some patients taking metformin alone experienced the following side effects:
Very common: nausea, vomiting, diarrhea, stomach pain, and loss of appetite. These symptoms may occur after starting metformin and usually disappear.
Common: metallic taste
Very rare: decreased vitamin B12 levels, liver inflammation (liver disease), hives, skin rash, or itching

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Eprocliv

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton, after "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Eprocliv contains

Active substancesare sitagliptin and metformin hydrochloride.

Eprocliv, 50 mg + 850 mg, film-coated tablets

Each film-coated tablet contains sitagliptin phosphate 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 phosphate monohydrate, equivalent to 50 mg of sitagliptin and 1000 mg of metformin hydrochloride.
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 "SM 2" embossed 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 "SM 3" embossed on one side.
The medicine is available in blisters of OPA/Aluminum/PVC/Aluminum or PVC/PE/PVDC/Aluminum and single-dose blisters of OPA/Aluminum/PVC/Aluminum or PVC/PE/PVDC/Aluminum, packed in a carton.
Packaging containing 56 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization 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 information about this medicine, please contact the local representative of the marketing authorization holder:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Estonia
Eprocliv
Greece
Eprocliv
Spain
Eprocliv 50 mg/850 mg comprimidos recubiertos con pelicula EFG
Eprocliv 50 mg/1.000 mg comprimidos recubiertos con pelicula EFG
Croatia
Eprocliv 50 mg/850 mg filmom obložene tablete
Eprocliv 50 mg/1000 mg filmom obložene tablete
Lithuania
Eprocliv 50 mg/850 mg plėvele dengtos tabletės
Eprocliv 50 mg/1000 mg plėvele dengtos tabletės
Latvia
Eprocliv 50 mg/850 mg apvalkotās tabletes
Eprocliv 50 mg/1000 mg apvalkotā tabletes
Netherlands
Eprocliv 50/850 mg, filmomhulde tabletten
Eprocliv 50/1000 mg, filmomhulde tabletten
Poland
Eprocliv
Romania
Eprocliv 50 mg/1000 mg Comprimate filmate
Slovenia
Eprocliv 50 mg/850 mg filmsko obložene tablete
Eprocliv 50 mg/1000 mg filmsko obložene tablete
Slovakia
Eprocliv 50 mg/850 mg filmom obalené tablety
Eprocliv 50 mg/1000 mg filmom obalené tablety
Date of last revision of the leaflet:03/2025
Sandoz logo