Empelic

Package leaflet: Information for the patient

Empelic, 10 mg, coated tablets
Empelic, 25 mg, coated tablets
Empagliflozin
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• 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. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

1. What Empelic is and what it is used for
Empelic contains the active substance empagliflozin.
Empelic belongs to a group of medicines called sodium-glucose cotransporter 2 (SGLT2) inhibitors.

What Empelic is used for
Type 2 diabetes

• Empelic is used to treat type 2 diabetes in adults and children aged 10 years and older whose condition cannot be controlled by diet and exercise alone.
• Empelic may be used alone in patients who cannot take metformin (another antidiabetic medicine).
• Empelic may also be used together with other medicines used to treat diabetes, which may be taken orally or administered by injection, such as insulin.

Empelic works by blocking the SGLT2 protein in the kidneys. This causes the body to remove sugar (glucose) through the urine. As a result, Empelic lowers blood glucose levels.
This medicine may also help prevent heart disease in patients with type 2 diabetes.
It is important to continue following the diet and exercise plan recommended by your doctor, pharmacist, or nurse.

Heart failure

• Empelic is used to treat heart failure in adult patients with symptoms of impaired heart function.

Chronic kidney disease

• Empelic is used to treat chronic kidney disease in adult patients.

What is type 2 diabetes
Type 2 diabetes is a disease influenced by both genetics and lifestyle. In patients with type 2 diabetes, the pancreas does not produce enough insulin to control blood glucose levels, and the body cannot effectively use the insulin it produces. This leads to high blood glucose levels, which may cause complications such as heart disease, kidney disease, vision problems, and poor circulation in the limbs.

What is heart failure
Heart failure occurs when the heart is too weak or stiff to function properly. This may lead to serious health problems and the need for hospital care. The most common symptoms of heart failure are shortness of breath, persistent or severe fatigue, and swelling of the ankles.
Empelic helps protect the heart from further weakening and reduces symptoms of the disease.

What is chronic kidney disease
Chronic kidney disease is a long-term condition. It may be caused by other diseases such as diabetes and high blood pressure, or even by the body's own immune system attacking the kidneys. In chronic kidney disease, the kidneys gradually lose their ability to properly clean and filter the blood. This may lead to serious health problems, such as leg swelling, heart failure, or the need for hospital treatment.
Empelic helps protect the kidneys from losing their function.

2. Important information before taking Empelic

When not to take Empelic

• if you are allergic to empagliflozin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Contact your doctor or nearest hospital immediately:
Ketoacidosis

• if you experience rapid weight loss, nausea or vomiting, abdominal pain, excessive thirst, rapid and deep breathing, confusion, unusual drowsiness or fatigue, sweet-smelling breath, sweet or metallic taste in the mouth, or a change in the smell of your urine or sweat, contact your doctor or nearest hospital immediately. These symptoms may indicate "ketoacidosis" — a rare but serious, sometimes life-threatening complication caused by increased levels of "ketone bodies" in the blood or urine, which can be detected in laboratory tests. The risk of ketoacid游戏副本

3. How to use Empelic

This medicine should always be used exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

What dose should be used

• The recommended dose of Empelic is one 10 mg tablet once daily. For patients with type 2 diabetes, your doctor may decide to increase the dose to 25 mg once daily if necessary to control blood sugar levels.
• Your doctor may reduce the dose to 10 mg once daily if you have kidney disease.
• Your doctor will prescribe the dose appropriate for you. Do not change the prescribed dose unless your doctor instructs you to do so.

How to take this medicine

• Swallow the tablet whole with water.
• The tablet may be taken with or without food.
• The tablet may be taken at any time of day, but it is advisable to take it at approximately the same time each day. This helps you remember to take your next dose.

For patients with type 2 diabetes, your doctor may prescribe Empelic to be used together with another antidiabetic medicine. All medicines should be taken exactly as directed by your doctor to achieve the best possible treatment outcome.
Following an appropriate diet and engaging in regular physical exercise helps your body use sugar more effectively. It is important that, while taking Empelic, you continue to follow the diet and exercise program recommended by your doctor.

If you take more Empelic than you should
If you take more Empelic than prescribed, contact your doctor or go to a hospital immediately. Take the medicine pack with you.

If you forget to take Empelic
What you should do if you miss a dose depends on how much time remains until your next scheduled dose.

• If 12 hours or more remain before your next dose, take the missed tablet as soon as you remember. Then take your next dose at the usual time.
• If less than 12 hours remain before your next dose, skip the missed dose. Take your next dose at the usual time.
• Do not take a double dose to make up for a missed dose.

Stopping Empelic
Do not stop taking Empelic without first consulting your doctor, unless you suspect you may have ketoacidosis (see "Ketoacidosis" in section "Warnings and precautions").
In patients with type 2 diabetes, stopping Empelic may lead to increased blood sugar levels.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should consult a doctor or the nearest hospital immediately if the patient
experiences any of the following adverse reactions:
Severe allergic reaction, observed not commonly (may occur in up to 1 in 100 patients)
Possible symptoms of a severe allergic reaction may include:

• swelling of the face, lips, mouth, tongue or throat, which may lead to difficulty breathing or swallowing.

Ketoacidosis, observed not commonly (may occur in up to 1 in 100 patients)
Symptoms of ketoacidosis (see also section 2 "Warnings and precautions"):

• increased concentration of "ketone bodies" in urine or blood,
• rapid weight loss,
• nausea or vomiting,
• abdominal pain,
• excessive thirst,
• rapid and deep breathing,
• confusion,
• unusual drowsiness or fatigue,
• sweet breath odour, sweet or metallic taste in the mouth, or change in the smell of urine or sweat.

This may occur regardless of blood glucose concentration. The doctor may decide to suspend or discontinue treatment with Empelic.
If any of the following adverse reactions occur, the doctor should be informed as soon as possible:
Low blood sugar (hypoglycaemia), observed very commonly (may occur in more than 1 in 10 patients)
When taking Empelic together with another medicine that may lower blood sugar levels, such as a sulfonylurea derivative or insulin, there is an increased risk of low blood sugar. Symptoms of low blood sugar may include:

• trembling, sweating, strong feeling of anxiety or confusion, rapid heartbeat,
• intense hunger, headache.

The doctor will inform the patient how to treat low blood sugar and what to do if any of the above symptoms occur. If symptoms of low blood sugar occur, the patient should eat glucose tablets, a sweet snack, or drink fruit juice. Blood sugar should be measured if possible, and the patient should rest.
Urinary tract infection, observed commonly (may occur in up to 1 in 10 patients)
Symptoms of urinary tract infection include:

• burning sensation during urination,
• cloudy appearance of urine,
• pelvic pain or pain in the mid-back (if the kidneys are affected).

Urgent need to urinate or more frequent urination may be caused by the mechanism of action of Empelic, but these may also be symptoms of a urinary tract infection. If such symptoms worsen, contact the doctor.
Dehydration, observed very commonly (may occur in more than 1 in 10 patients)
Symptoms of dehydration are non-specific but may include:

• unusual thirst,
• feeling dizzy or lightheaded upon standing,
• loss of consciousness or fainting.

Other adverse reactions occurring during treatment with Empelic:
Common

• fungal infection of the genital organs (candidiasis),
• passing larger amounts of urine or more frequently than usual,
• itching,
• skin rash or redness – may be accompanied by itching, raised bumps, oozing fluid or blisters,
• thirst,
• blood tests may show increased levels of fats (cholesterol) in the blood,
• constipation.

Not common

• urticaria,
• difficulty or pain when emptying the bladder,
• blood tests may show impaired kidney function (increased creatinine or urea levels),
• blood tests may show increased number of red blood cells in the blood (haematocrit).

Rare

• necrotizing fasciitis of the perineum, also known as Fournier's gangrene, a serious infection of the soft tissues of the external genital organs or the area between the genitals and the anus.

Very rare

• kidney inflammation (tubulointerstitial nephritis).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Empelic

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the EXP.
The expiry date refers to the last day of the stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot/LOT indicates the batch number.
There are no special storage instructions for this medicine.
Do not use this medicine if you notice that the packaging is damaged or tampered with.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Empelic contains

• The active substance is empagliflozin. Each coated tablet contains 10 mg or 25 mg of empagliflozin.
• The other ingredients are:
  • tablet core: mannitol, pregelatinized maize starch, microcrystalline cellulose (type 101, type 102), hydroxypropylcellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate;
  • tablet coating: hypromellose type 2910 (6 mPa·s), titanium dioxide (E 171), polyethylene glycol 8000, talc (Empelic 25 mg, coated tablets), iron oxide yellow (E 172), iron oxide red (Empelic 10 mg, coated tablets).

What Empelic looks like and contents of the pack
Empelic 10 mg, coated tablets – are round, biconvex, yellow coated tablets,
with the number "10" embossed on one side (tablet diameter: 5.8 mm – 6.3 mm).
Empelic 25 mg, coated tablets – are elongated, biconvex, light yellow coated tablets,
with the number "25" embossed on one side (tablet length: 12.4 mm – 12.9 mm,
width: 5.9 mm – 6.5 mm).
Empelic tablets are supplied in aluminium//PVC/PVDC blisters in a cardboard carton or
in unit-dose containers made of HDPE closed with a child-resistant cap made of polypropylene,
with a moisture-absorbing agent, packed in a cardboard carton.
Blister packs: the pack contains 14, 28, 30, 60, 90 or 100 coated tablets.
Container: the pack contains 30 or 90 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel.: +48 22 364 61 01
This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic: Empelic, 10 mg, 25 mg, potahované tablety