10 mg and 25 mg film-coated tablets
empagliflozin
What Jardiance is and what it is used for
What Jardiance is
Jardiance contains the active substance empagliflozin.
Jardiance belongs to the group of sodium-glucose co-transporter 2 (SGLT2) inhibitors.
What Jardiance is used for
Diabetes mellitus type 2
- Jardiance is used to treat type 2 diabetes in adult patients (18 years or older) who can not be controlled with diet and exercise alone.
- Jardiance can be used without other medicines by patients who cannot take metformin ( another medicine for diabetes).
- Jardiance can also be taken with other medicines to treat diabetes . It can be medicines that are taken by mouth or given as an injection , such as insulin .
Jardiance works by blocking the protein et SGLT2 in the kidneys. This causes blood sugar ( glucose ) to be removed through the urine. Jardiance thus lowers the amount of sugar in the blood.
This medicine may also help prevent heart disease in patients with type 2 diabetes mellitus.
You must continue with the diet and exercise programs recommended by your doctor, pharmacist, or nurse.
Heart failure
- Jardiance is used to treat heart failure in adult patients with symptoms of impaired pumping capacity of the heart.
What is type 2 diabetes?
Type 2 diabetes is a disease that is caused by both genes and lifestyle. If you have type 2 diabetes, your pancreas does not produce enough insulin to control the level of glucose in your blood, and your body is not able to use its insulin effectively. This causes high levels of glucose in the blood which can lead to medical problems such as heart disease, kidney disease, blindness, and poor circulation in the arms and legs.
What is heart failure?
This type of heart failure occurs when the heart is weak and can not pump enough blood to the lungs and the rest of the body. This can lead to serious medical problems and the need for hospital care. The most common symptoms of heart failure are shortness of breath, feeling tired or very tired all the time, and swollen ankles.
Jardiance helps prevent your heart from weakening and improves your symptoms.
What you need to know before taking Jardiance
Do not use Jardiance:
– if you are allergic to empagliflozin or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Contact a doctor or see your nearest hospital immediately:
Ketoacidosis
- if you experience rapid weight loss, nausea or vomiting, abdominal pain, severe thirst, rapid and deep breathing, confusion, unusual sleepiness or fatigue, a sweet breath, a sweet taste or metallic taste in the mouth or a different smell of sweat or urine, please contact doctor or nearest hospital immediately. These symptoms can be signs of “ketoacidosis” – a rare but serious, sometimes life-threatening, problem you can get in diabetes , due to elevated levels of “ketone bodies” in urine or blood, which can be detected in tests. The risk of developing ketoacidosis may increase with prolonged fasting, high alcohol consumption, dehydration, sudden decrease in insulin dose or a greater need for insulin. due to a major operation or a serious illness.
Talk to your doctor, pharmacist, or nurse before taking this medicine and during treatment:
- if you have “type 1 diabetes”. This type usually begins in adolescence and the body produces no insulin at all. You should not take Jardiance to treat your type 1 diabetes .
- if you have severe kidney problems – your doctor may limit your dose to one to 10 mg once a day or ask you to take another medicine (see also section 3, “How to take Jardiance”).
- if you have severe liver problems – your doctor may ask you to take another medicine.
- if you are at risk of dehydration, eg:
- if you vomit, have diarrhea or fever or if you can not eat or drink
- if you are taking medicines which increase urine production ( diuretics ) or that lowers blood pressure et
- if you are over 75 years old.
- if you are 85 years of age or older because you should not start taking Jardiance due to limited treatment experience.
- if you have a serious infection in the kidneys or urinary tract along with fever. Your doctor may ask you to stop taking Jardiance until you have recovered.
Talk to your doctor immediately if you experience a combination of symptoms such as pain, tenderness, redness, or swelling in the genitals or the area between the genitals and the rectum along with fever or general malaise. These symptoms can be a sign of a rare but serious and in the worst-case life-threatening infection called necrotizing fasciitis of the perineum or Fournier’s gangrene which destroys the tissue under the skin. Fournier’s gangrene must be treated immediately.
Chiropody
For all patients with diabetes, it is important to regularly check your feet and follow all other advice on foot care provided by healthcare professionals.
Renal function
Your kidneys should be checked before you start taking and while you are taking this medicine.
Uringlukos
Urine tests will give a positive answer for sugar while you are taking this medicine, due to the way this medicine works.
Children and young people
Jardiance is not recommended for use in children and adolescents below 18 years of age, as it has not been studied in these patients.
Other drugs and Jardiance
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must tell your doctor:
- if you are taking medicines that increase urine production ( diuretics ). Your doctor may ask you to stop taking Jardiance. Possible signs of losing too much fluid are listed in section 4.
- if you are taking other medicines that lower the amount of sugar in your blood, such as insulin or a ‘sulphonylurea’ medicine. Your doctor may want to lower the dose of one of these other medicines, to prevent your blood sugar levels from getting too low ( hypoglycaemia ).
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 use Jardiance if you are pregnant. It is unknown if Jardiance is harmful to the unborn baby. Do not use Jardiance if you are breastfeeding. It is not known if Jardiance passes into breast milk.
Driving and using machines
Jardiance has less effect on the ability to drive and use machines.
Taking this medicine in combination with medicines called sulphonylureas or with insulin may cause excessive blood sugar (hypoglycemia), it may cause symptoms such as tremors, sweating, and vision changes, and may affect your ability to drive and use machines. Do not drive or use any tools or machines if you feel dizzy while taking Jardiance.
Jardiance contains lactose and sodium
Jardiance contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free.
How to take Jardiance
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
How much to take
- The recommended dose of Jardiance is one 10 mg tablet once a day. If you have type 2 diabetes mellitus , your doctor will decide if your dose should be increased to 25 mg once daily if needed to control your blood sugar.
- Your doctor may limit the dose to one to 10 mg once a day if you have any kidney disease.
- Your doctor will prescribe the strength that is right for you. Do not change dose one unless your doctor tells you to.
Taking 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 the day. However, try to take it at the same time each day. This will help you remember to take it.
If you have type 2 diabetes mellitus, your doctor may prescribe Jardiance with another diabetes medicine. Remember to take all medicines according to your doctor’s instructions to achieve the best possible results for your health.
Proper diet and exercise will help your body make better use of your blood sugar. It is important to continue with the diet and exercise programs recommended by your doctor while you are taking Jardiance.
If you take more Jardiance than you should
If you take more Jardiance than you should, talk to a doctor immediately or seek medical advice immediately. Take the medicine pack with you.
If you forget to take Jardiance
What should be done if you forget to take a tablet depends on how long it takes until the next dose.
- If it is 12 hours or more until the next dose , take Jardiance as soon as you remember. Then take your next dose at the usual time.
- If it is less than 12 hours until the next dose , skip the missed dose . Then take your next dose at the usual time.
- Do not take a double dose of Jardiance to make up for a forgotten dose .
If you stop taking Jardiance
Do not stop taking Jardiance without discussing it with your doctor. If you have type 2 diabetes mellitus, your blood sugar levels may rise when you stop using Jardiance.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor or nearest hospital immediately if you get any of the following side effects:
Severe allergic reaction, uncommon (may affect up to 1 in 100 people)
Possible signs of a severe allergic reaction may include:
- swelling of the face, lips, mouth, tongue or throat and lead to difficulty breathing or swallowing.
Rare diabetic ketoacidosis (may affect up to 1 in 1,000 people)
These are the signs of diabetic ketoacidosis (see also section 2, “Warnings and precautions”):
- increased levels of “ketone bodies” in the urine or blood
- rapid weight loss
- nausea or vomiting
- abdominal pain
- strong thirst
- rapid and deep breathing
- confusion
- unusual drowsiness or fatigue
- a sweet smell on the breath, a sweet taste or metallic taste in the mouth or a different smell on sweat or urine
This can occur regardless of blood sugar levels. Your doctor may decide to temporarily or permanently discontinue your Jardiance treatment.
Contact your doctor as soon as possible if you notice any of the following side effects:
Low blood sugar (hypoglycemia), very common (may affect more than 1 in 10 people)
If you take Jardiance with another medicine that may cause low blood sugar, such as sulphonylurea or insulin, your risk of getting low blood sugar is higher. Signs of low blood sugar can be:
- tremors, sweating, strong feeling of anxiety or confusion, fast heartbeat
- excessive hunger, headache
Your doctor will tell you how to treat low blood sugar levels and what to do if you get any of the above signs. If you have symptoms of low blood sugar; eat glucose tablets, a sugary snack, or drink fruit juice. If possible, measure your blood sugar and rest.
Urinary tract infections, common (may affect up to 1 in 10 people)
Signs of urinary tract infection are:
- a burning sensation when urinating
- cloudy urine
- pain in the pelvis, or in the middle of the back (when the kidneys are infected)
Urinary incontinence or the need for urination more often may be due to the way Jardiance works, but may also be a sign of a urinary tract infection. If you notice an increase in these symptoms, consult your doctor.
Dehydration, very common (may affect more than 1 in 10 people)
Signs of dehydration are not specific, but may include:
- unusual thirst
- dizziness or dizziness when standing up
- fainting or unconsciousness
Other side effects when taking Jardiance:
Usual
- fungal infection around the genitals
- greater amount of urine than usual or having to urinate more often
- itching
- skin rash or redness of the skin – these may itch and include raised lumps, blisters or be exfoliating
- thirst
- blood tests may show an increase in blood fat levels ( cholesterol )
- constipation
Less common
- hives
- exertion or pain when emptying the bladder
- blood tests may show impaired kidney function ( creatinine or urea )
- blood tests may show increases in the number of red blood cells in the blood ( hematocrit )
Rare
- necrotizing fasciitis of the perineum or Fournier’s gangrene, a severe soft tissue infection of the genitals or the area between the genitals and the rectum
How to store Jardiance
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 and blister after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Do not use this medicine if the package is damaged or shows signs of being opened earlier.
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 to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is empagliflozin.
- Each tablet contains 10 mg or 25 mg empagliflozin.
Other ingredients are:
- tablet core : lactose monohydrate (see end of section 2 under “Jardiance contains lactose”), microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium (see end of section 2 under “Jardiance contains sodium”), colloidal anhydrous silica, magnesium stearate
- film coating : hypromellose, titanium dioxide (E171), talc, macrogol (400), yellow iron oxide (E172)
What the medicine looks like and contents of the pack
Jardiance 10 mg film-coated tablets are round, light yellow, biconvex with a beveled edge. They have “S10” on one side and Boehringer Ingelheim’s logo on the other side. The tablets have a diameter of 9.1 mm.
Jardiance 25 mg film-coated tablets are oval, light yellow, and biconvex. They have “S25” on one side and Boehringer Ingelheim’s logo on the other side. The tablet is 11.1 mm long and has a width of 5.6 mm.
Jardiance tablets are available in PVC / aluminum perforated unit dose blisters. Pack sizes of 7 x 1, 10 x 1, 14 x 1, 28 x 1, 30 x 1, 60 x 1, 70 x 1, 90 x 1 and 100 x 1 film-coated tablets.
Not all pack sizes may be marketed in your country.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Boehringer Ingelheim International GmbH
Binger Strasse 173
55216 Ingelheim am Rhein
Germany
Manufacturer
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Strasse 173
55216 Ingelheim am Rhein
Germany
Boehringer Ingelheim Ellas AE
5th km Paiania – Markopoulo
Koropi Attiki, 19400
Greece
Rottendorf Pharma GmbH
Ostenfelder Strasse 51 – 61
59320 Ennigerloh
Germany
Boehringer Ingelheim France
100-104 Avenue de France
75013 Paris
France
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