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What Jardiance is and what it is used for
Jardiance contains the active substance emfgliflozine that works by blocking a kidney protein called sodium-glucose cotransporter 2 (SGLT2). SGLT2 prevents urine glucose secretion by absorption of glucose into the bloodstream during blood filtration through the kidneys. By blocking this protein, the drug results in glucose (urine glucose) being released from the urine, and thus reduces blood glucose levels that are too high as a result of type 2 diabetes.
Your doctor has prescribed this medicine to lower your blood sugar.
Jardiance is used to treat type 2 diabetes mellitus in adult patients (18 years of age and older) who are not only controlled with diet and exercise;
Jardiance can be used without other medicines in patients who can not take metformin (another medicine for diabetes);
Jardiance can also be used with other medicines. These may be oral medicines or insulin injections.
It is important to continue with your diet and exercise, as your doctor, pharmacist or nurse has told you.
What is type 2 diabetes mellitus?
Type 2 diabetes mellitus is a disease that is due to your genes and your way of life. If you suffer from type 2 diabetes, your pancreas does not produce enough insulin to control the level of glucose in your blood and your body can not use your own insulin effectively. This leads to high blood glucose levels that can lead to health problems such as heart disease, kidney disease, blindness and poor blood circulation in the limbs.
2. What you need to know before you take Jardiance
Do not take Jardiance:
If you are allergic to emmglyflozine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Jardiance:
If you have Type 1 diabetes mellitus. This type of diabetes usually begins at a young age and your body does not synthesize insulin;
If you have elevated levels of ketone bodies in the urine or blood found in laboratory tests. This is a sign of diabetic ketoacidosis - a problem that you may encounter in diabetes and whose signs are rapid weight loss, nausea or vomiting, swallowing mouth, sweet or metallic taste in the mouth or strange smell of urine or sweat;
If you have severe kidney problems - your doctor may tell you to take another medicine;
If you are 75 years of age or older, increased urine output as a result of the medicine can affect the water-electrolyte balance in your body and increase the risk of dehydration. Possible signs are listed in section 4, "Possible side effects" in the "dehydration" sub-section;
If you are 85 years of age or older, because in this case you should not start taking Jardiance;
If you vomit, you have a disorder or fever or if you can not eat or drink. Such conditions can lead to dehydration. Your doctor may tell you to stop taking Jardiance until you recover to avoid the loss of too much fluid from the body;
If you have a serious kidney or urinary tract infection with fever. Your doctor may tell you to stop taking Jardiance until you recover.
Glucose in the urine
Due to the mechanism of action of this medicine, your urine sugar tests will be positive while you are taking this medicine.
Children and adolescents
Jardiance is not recommended for children and adolescents under 18 because it has not been studied in these patients.
Other medications and Jardiance
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is important to tell your doctor:
If you are taking a drainage medicine (diuretic). Your doctor may tell you to stop taking Jardiance. Possible signs of excessive fluid loss from the body are listed in section 4 "Possible side effects";
If you are taking other medicines that lower your blood sugar like insulin or a sulphonylurea. Your doctor may want to lower the dose of these medicines in order to avoid too much blood sugar (hypoglycaemia).
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Do not use Jardiance if you are pregnant. It is not known whether Jardiance is harmful to the fetus. Do not use Jardiance if you are breast-feeding. It is not known whether Jardiance passes into the mother's stern.
Driving and using machines
Jardiance has little influence on the ability to drive and use machines.
Taking this medicine in combination with a medicine called
How to take Jardiance
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
How much to take
Initial dose of Jardiance is one 10 mg tablet once a day. Your doctor will decide whether to increase your dose to 25 mg once a day;
Your doctor may limit your dose to 10 mg once a day if you have a kidney problem;
Your doctor will prescribe the right amount of active substance per dose for you. Do not change your dose unless your doctor has told you.
Taking this medicine
Swallow the tablet whole with water;
You can take the tablet with or without food;
You can take your tablet at any time of the day. Make sure you take it every day at the same time. This will help you think about taking it.
Your doctor may prescribe Jardiance with another anti-diabetes medicine. Remember that you should take all the medicines as directed by your doctor to get the best results for your health.
Diet and exercise can help your body better use blood sugar. It is important that you adhere to the diet and motor regimen 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, you should immediately consult a doctor or go to hospital immediately. Take the medicine pack with you.
If you forget to take Jardiance
What to do if you forget to take one tablet depends on how long it is until the next intake.
If you take 12 or more hours before taking the next dose, take Jardiance as soon as you remember. Then take the next dose at your usual time;
If the next dose remains less than 12 hours, skip the missed dose. Then take the next dose at your usual time;
Do not take a double dose of Jardiance to make up for the forgotten dose.
If you stop taking Jardiance
Do not stop taking Jardiance before consulting your doctor. Your blood sugar may rise when you stop taking Jardiance.
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 everyone gets them.
Contact your doctor as soon as possible if you notice any of the following side effects:
Low blood sugar (hypoglycaemia), very common (may affect more than 1 in 10 people)
If you take Jardiance with another medicine that can cause low blood sugar, such as sulphonylureas or insulin, the risk of getting low blood sugar is higher. The signs of low blood sugar may include:
Trembling, sweating, feeling of great anxiety or confusion, rapid heartbeat;
Very strong hunger, headache.
Your doctor will tell you how to correct your low blood sugar and what to do if you get any of the signs listed above. If you have symptoms of low blood sugar, eat lumps of sugar, a high sugar snack or drink fruit juice. If possible, measure your blood sugar and relax.
Urinary tract infection is common (may affect up to 1 in 10 people)
The signs of urinary tract infection are:
Burning sensation during urination;
Pain in the pelvis or in the middle of the back (when there is an infection of the kidneys).
Positive urination or urinary incontinence may be due to the way Jardiance works, but as there may be signs of urinary tract infection if you notice an increase in these symptoms, you should also contact your doctor.
Dehydration occurs uncommonly (may affect up to 1 in 100 people)
The signs of dehydration are not specific, but may include:
Vertigo or dizziness when standing up;
Seizure or loss of consciousness.
Other side effects during Jardiance:
Thrush or bacterial infection of the genitals;
More than usual urine output or more frequent urination urgency;
Tension or pain when emptying the bladder.
Reporting of side effects
If you get any side effects, tell your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. As you report side effects, you can contribute to getting more information about the safety of this medicine.
How to Store Jardiance
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after "EXP / EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice that the packaging is damaged or has a trace of opening.
Do not dispose of medicines in the sewer or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What Jardiance contains
The active substance is emagliflozin.
Each tablet contains 10 mg or 25 mg of emfaglifosin.
The other ingredients are:
Tablet core: lactose monohydrate (see end of point 2, "Jardiance contains lactose"), microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate;
Film coating: hypromellose, titanium dioxide (E171), talc, macrogol (400), yellow iron oxide (E172).
What Jardiance looks like and contents of the pack
Jardiance 10 mg film-coated tablets are round, pale yellow, biconvex, and bevelled edges. On one side are "S10", and on the other - Boehringer Ingelheim logo. The tablets have a diameter of 9.1 mm.
Jardiance 25 mg film-coated tablets are oval, pale yellow and biconvex. On one side are "S25", and on the other - the logo of Boehringer Ingelheim. The tablet is 11.1 mm long and has a width of 5.6 mm.
Jardiance tablets are available in perforated unit dose blisters of PVC / Aluminum. 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 packs may be marketed in your country.
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