Empelic

Package Leaflet: Information for the Patient

Empelic, 10 mg, Film-Coated Tablets

Empelic, 25 mg, Film-Coated Tablets

Empagliflozin

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

• You should 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 symptoms 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.

Table of Contents of the Package Leaflet

• 1. What is Empelic and what is it 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 is Empelic and what is it used for

Empelic contains the active substance empagliflozin.
Empelic belongs to a group of medicines called sodium-glucose cotransporter 2 (SGLT2) inhibitors.

What is Empelic used for

Type 2 diabetes

• Empelic is used to treat type 2 diabetes in adults aged 18 and older, when diet and exercise alone do not provide adequate control.
• Empelic can be used alone in patients who cannot take metformin (another diabetes medicine).
• Empelic can also be used with other diabetes medicines that are taken orally or injected, such as insulin.

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

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

What is type 2 diabetes

Type 2 diabetes is a condition that depends on both genes and lifestyle. In a patient with type 2 diabetes, the pancreas does not produce enough insulin to control blood glucose levels, and the body is unable to effectively use the insulin produced. This leads to high blood glucose levels, which can cause complications such as heart disease, kidney disease, vision loss, and poor blood circulation in the limbs.

What is heart failure

Heart failure occurs when the heart is too weak or stiff to work properly. This can lead to serious health problems and the need for hospital care. The most common symptoms of heart failure are shortness of breath, persistent tiredness or extreme tiredness, and swelling of the ankles.
Empelic helps protect the heart from further weakening and relieves symptoms of the disease.

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

Seek medical help immediately if you experience:

Ketoacidosis

• if you experience rapid weight loss, nausea or vomiting, abdominal pain, excessive thirst, rapid and deep breathing, confusion, unusual sleepiness or tiredness, sweet breath odor, sweet or metallic taste in the mouth, or a change in the smell of urine or sweat, seek medical help immediately. These symptoms may indicate "ketoacidosis" - a rare but serious and potentially life-threatening complication resulting from increased levels of "ketone bodies" in the urine or blood, as determined by laboratory tests. The risk of ketoacidosis may increase with prolonged fasting, excessive alcohol consumption, dehydration, sudden reduction in insulin dose, or increased insulin requirements due to major surgery or severe illness.

Before starting and while taking this medicine, discuss with your doctor, pharmacist, or nurse:

• if you have "type 1 diabetes". This type of diabetes usually appears at a young age and is characterized by the body's inability to produce enough insulin. Do not take Empelic if you have type 1 diabetes.
• if you have severe kidney disease - your doctor may limit the dose to 10 mg once daily or recommend taking a different medicine (see also section 3 "How to take Empelic").
• if you have severe liver disease - your doctor may prescribe a different medicine for you.
• if you are at risk of dehydration, for example:
• if you have vomiting, diarrhea, or fever, or are unable to eat or drink
• if you are taking medicines that increase urine production (diuretics) or lower blood pressure
• if you are 75 years or older. Possible symptoms are listed in section 4 under "Dehydration". Your doctor may recommend stopping Empelic until these symptoms resolve to prevent excessive fluid loss. Ask your doctor about ways to prevent dehydration.
• if you have a severe kidney or urinary tract infection with fever. Your doctor may recommend stopping Empelic until you recover.

If you experience a combination of symptoms such as pain, tenderness, redness, or swelling of the external genital area or the area between the genitals and anus, with fever or general feeling of being unwell, seek medical help immediately.
This may be a sign of a rare but serious or potentially life-threatening infection called necrotizing fasciitis of the perineum or Fournier's gangrene, which can cause tissue damage.
Foot care
For all patients with diabetes, it is essential to regularly check the condition of your feet and follow any foot care recommendations provided by your doctor.
Kidney function
Before starting and while taking this medicine, your kidney function should be monitored.
Blood glucose levels in urine
Due to the action of Empelic, urine tests for glucose may be positive while taking this medicine.

Children and adolescents

Empelic is not recommended for use in children and adolescents under 18 years of age, as its use in this age group has not been studied.

Empelic and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Be sure to inform your doctor:

• if you are taking medicines that increase urine production (diuretics). Your doctor may recommend stopping Empelic. Possible symptoms of excessive fluid loss are listed in section 4.
• if you are taking other diabetes medicines that lower blood sugar, such as insulin or sulfonylurea derivatives. Your doctor may recommend reducing the dose of these medicines to prevent excessive lowering of blood sugar (hypoglycemia).
• if you are taking lithium, as Empelic may decrease lithium levels in the blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 Empelic if you are pregnant. It is not known whether Empelic is harmful to unborn babies. Do not take Empelic if you are breastfeeding. It is not known whether Empelic passes into breast milk.

Driving and using machines

Empelic has a minor influence on the ability to drive and use machines.
Taking this medicine in combination with sulfonylurea derivatives and/or insulin may cause excessive lowering of blood sugar (hypoglycemia), which can lead to symptoms such as trembling, sweating, anxiety, or confusion, and may affect your ability to drive and use machines. If you experience dizziness while taking Empelic, do not drive or use any tools or machines.

Empelic contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Empelic

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

What dose to take

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

How to take this medicine

• Swallow the tablet whole with water.
• You can take the tablet with or without food.
• You can take the tablet at any time of day, but try to take it at the same time each day. This will help you remember to take your next dose.

For patients with type 2 diabetes, your doctor may recommend taking Empelic with another diabetes medicine. Take all medicines as directed by your doctor to get the best results from treatment.
A suitable diet and exercise will help your body make better use of sugar. It is important that you continue to follow the diet and exercise plan recommended by your doctor while taking Empelic.

If you take more Empelic than you should

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

If you forget to take Empelic

The action to take if you miss a dose depends on how much time is left before your next dose.

• If it is 12 hours or more before your next dose, take the Empelic tablet as soon as you remember. Take your next dose at the usual time.
• If it is less than 12 hours 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 forgotten dose.

If you stop taking Empelic

Do not stop taking Empelic without first talking to your doctor.
In patients with type 2 diabetes, stopping Empelic may increase blood sugar levels.
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.

Seek medical help immediately if you experience any of the following side effects:

Severe allergic reaction, uncommon (may affect up to 1 in 100 people)

Signs 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, uncommon (may affect up to 1 in 100 people)

Signs of ketoacidosis (see also section 2 "Warnings and precautions"):

• increased levels of "ketone bodies" in urine or blood,
• rapid weight loss,
• nausea or vomiting,
• abdominal pain,
• excessive thirst,
• rapid and deep breathing,
• confusion,
• unusual sleepiness or tiredness,
• sweet breath odor, sweet or metallic taste in the mouth, or a change in the smell of urine or sweat.

This may occur regardless of blood glucose levels. Your doctor may decide to stop or discontinue Empelic.

If you experience any of the following side effects, contact your doctor as soon as possible:

Low blood sugar (hypoglycemia), very common (may affect more than 1 in 10 people)

If you are taking Empelic with another medicine that can lower blood sugar, such as a sulfonylurea derivative or insulin, there is an increased risk of low blood sugar. Signs of low blood sugar may include:

• trembling, sweating, anxiety, or confusion, rapid heartbeat,
• excessive hunger, headache.

Your doctor will inform you how to treat low blood sugar and what to do if you experience any of these symptoms. If you experience symptoms of low blood sugar, eat glucose tablets, a sweet snack, or drink fruit juice. Measure your blood sugar levels if possible and rest.

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

Signs of a urinary tract infection may include:

• pain while urinating,
• cloudy urine,
• abdominal pain or back pain (if the infection affects the kidneys).

Urgent need to urinate or more frequent urination may be caused by the action of Empelic, but they can also be symptoms of a urinary tract infection. If you experience worsening of these symptoms, contact your doctor.

Dehydration, very common (may affect more than 1 in 10 people)

Signs of dehydration are not specific but may include:

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

Other side effects that may occur when taking Empelic:

Common (may affect up to 1 in 10 people):

• yeast infection of the genital area (thrush),
• increased urine production or more frequent urination than usual,
• itching,
• rash or redness of the skin - may be accompanied by itching, hives, fluid-filled bumps, or blisters,
• thirst,
• blood tests may show increased levels of fats (cholesterol) in the blood,
• constipation.

Uncommon (may affect up to 1 in 100 people)

• hives,
• difficulty or pain when urinating,
• blood tests may show impaired kidney function (creatinine or urea levels),
• blood tests may show increased red blood cell count (hematocrit).

Rare (may affect up to 1 in 1,000 people)

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

Very rare (may affect up to 1 in 10,000 people)

• kidney infection (pyelonephritis).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the national reporting system listed below.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Empelic

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 carton after EXP. The expiry date refers to the last day of that month.
The packaging is marked with the expiry date and batch number.
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. These measures will help protect the environment.

6. Contents of the pack and other information

What Empelic contains

• The active substance is empagliflozin. Each film-coated tablet contains 10 mg or 25 mg of empagliflozin.
• The other ingredients are: tablet core: mannitol, maize starch, microcrystalline cellulose (type 101, type 102), hydroxypropyl cellulose, sodium carboxymethylcellulose, silica colloidal anhydrous, zinc stearate;
• tablet coating: hypromellose (type 2910 (6mPas)), titanium dioxide (E 171), macrogol 8000, talc (Empelic 25 mg, film-coated tablets), yellow iron oxide (E 172), red iron oxide (Empelic 10 mg, film-coated tablets).

What Empelic looks like and contents of the pack

Empelic 10 mg, film-coated tablets – are round, biconvex, yellow tablets with "10" engraved on one side, (tablet diameter: 5.8 mm – 6.3 mm).
Empelic 25 mg, film-coated tablets – are oval, biconvex, light yellow tablets with "25" engraved on one side (tablet length: 12.4 mm – 12.9 mm, width: 5.9 mm – 6.5 mm).
Empelic tablets are available in aluminum/PVC/PVDC blisters, in a cardboard box or in HDPE containers with a child-resistant polypropylene screw cap, in a cardboard box.
Blisters: the pack contains 14, 28, 30, 60, 90, or 100 film-coated tablets.
Container: the pack contains 30 or 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

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

Czech Republic: Empelic, 10 mg, 25 mg, film-coated tablets

Date of last revision of the package leaflet: