Jardiance - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Jardiance 10 mg film-coated tablets

Jardiance 25 mg film-coated tablets empagliflozin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – 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 signs of illness 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.

What is in this leaflet

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

• 2. What you need to know before you take Jardiance

• 3. How to take Jardiance

• 4. Possible side effects

• 5. How to store Jardiance

• 6. Contents of the pack and other information

1. What Jardiance is and what it is used for

What Jardiance is

Jardiance contains the active substance empagliflozin.

Jardiance is a member of a group of medicines called sodium glucose co-transporter-2 (SGLT2) inhibitors.

What Jardiance is used for

Type 2 diabetes mellitus

• Jardiance is used to treat type 2 diabetes in adult patients (aged 18 years and older) that cannot be controlled by diet and exercise alone.
• Jardiance can be used without other medicines in patients who cannot take metformin (another diabetes medicine).
• Jardiance can also be used with other medicines for the treatment of diabetes. These may be medicines taken by mouth or given by injection such as insulin.

Jardiance works by blocking the SGLT2 protein in your kidneys. This causes blood sugar (glucose) to be removed in your urine. Thereby Jardiance lowers the amount of sugar in your blood.

This medicine can also help prevent heart disease in patients with type 2 diabetes mellitus.

It is important that you continue with your diet and exercise plan as told by your doctor, pharmacist or nurse.

Heart failure

• Jardiance is used to treat heart failure in adult patients with symptoms due to a weak pump function of the heart.

What is type 2 diabetes?

Type 2 diabetes is a disease that comes from both your genes and your lifestyle. If you have type 2 diabetes, your pancreas does not make enough insulin to control the level of glucose in your blood, and your body is unable to use its own insulin effectively. This results in high levels of glucose in your blood which can lead to medical problems like heart disease, kidney disease, blindness, and poor circulation in your limbs.

What is heart failure?

This type of heart failure occurs when the heart is weak and cannot pump enough blood to the lungs and the rest of the body. This can lead to serious medical problems and need for hospital care. The most common symptoms of heart failure are feeling breathless, feeling tired or very tired all the time, and ankle swelling.

Jardiance helps protect your heart from getting weaker and improves your symptoms.

2. What you need to know before you take Jardiance

Do not take Jardiance

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

• section 6).

Warnings and precautions

Contact a doctor or the nearest hospital straight away:

Ketoacidosis

• if you experience rapid weight loss, feeling sick or being sick, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to your breath, a sweet or metallic taste in your mouth, or a different odour to your urine or sweat, contact a doctor or the nearest hospital straight away. These symptoms could be a sign of “ketoacidosis” – a rare, but serious, sometimes life-threatening problem you can get with diabetes because of increased levels of “ketone bodies” in your urine or blood, seen in tests. The risk of developing ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or 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 starts when you are young and your body does not produce any insulin. You should not take Jardiance to treat your type 1 diabetes.
• if you have serious kidney problems – your doctor may limit your dose to 10 mg once a day or

ask you to take a different medicine (see also section 3, ‘How to take Jardiance’).

• if you have serious liver problems – your doctor may ask you to take a different medicine.
• might be at risk of dehydration, for example:

o if you are being sick, have diarrhoea or fever, or if you are not able to eat or drink o if you are taking medicines that increase urine production [diuretics] or lower blood pressure

o if you are over 75 years old.

Possible signs are listed in section 4 under ‘dehydration’. Your doctor may ask you to stop taking Jardiance until you recover to prevent loss of too much body fluid. Ask about ways to prevent dehydration.

• if you are 85 years old or older as you should not start taking Jardiance due to limited therapeutic experience.
• if you have a serious infection of the kidney or the urinary tract with fever. Your doctor may ask you to stop taking Jardiance until you have recovered.

Talk to your doctor immediately if you develop a combination of symptoms of pain, tenderness, redness, or swelling of the genitals or the area between the genitals and the anus with fever or feeling generally unwell. These symptoms could be a sign of a rare but serious or even life-threatening infection, called necrotising fasciitis of the perineum or Fournier's gangrene which destroys the tissue under the skin. Fournier’s gangrene has to be treated immediately.

Foot care

Like for all diabetic patients it is important to check your feet regularly and adhere to any other advice regarding foot care given by your health care professional.

Kidney function

Your kidneys should be checked before you start taking and whilst you are on this medicine.

Urine glucose

Because of how this medicine works, your urine will test positive for sugar while you are taking this medicine.

Children and adolescents

Jardiance is not recommended for children and adolescents under 18 years, because it has not been studied in these patients.

Other medicines 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 medicines that increase urine production (diuretics). Your doctor may ask you

to stop taking Jardiance. Possible signs of losing too much fluid from your body 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 these other medicines, to prevent your blood sugar levels from getting too low (hypoglycaemia).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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 child. Do not use Jardiance if you are breast-feeding. It is not known if Jardiance passes into human breast milk.

Driving and using machines

Jardiance has minor influence on the ability to drive and use machines.

Taking this medicine in combination with medicines called sulphonylureas or with insulin can cause blood sugar levels to drop too low (hypoglycaemia), which may cause symptoms such as shaking, sweating and change in vision, 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

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.

Jardiance contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free’.

3. How to take Jardiance

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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 whether to increase your dose to 25 mg once a day, if needed to help to control your blood sugar.
• Your doctor may limit your dose to 10 mg once a day if you have a kidney problem.
• Your doctor will prescribe the strength that is right for you. Do not change your dose unless

your doctor has told 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 to remember to take it.

If you have type 2 diabetes mellitus, your doctor may prescribe Jardiance together with another diabetes medicine. Remember to take all medicines as directed by your doctor to achieve the best results for your health.

Appropriate diet and exercise help your body use its blood sugar better. It is important to stay on the diet and exercise program recommended by your doctor while taking Jardiance.

If you take more Jardiance than you should

If you take more Jardiance than you should, talk to a doctor immediately or go to a hospital immediately. Take the medicine pack with you.

If you forget to take Jardiance

What to do if you forget to take a tablet depends on how long it is until your next dose.

• If it is 12 hours or more until your 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 your 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 first consulting your doctor. If you have type 2 diabetes mellitus, your blood sugar levels may increase 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 everybody gets them.

Contact a doctor or the nearest hospital straight away if you have any of the following side effects:

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

Possible signs of severe allergic reaction may include:

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

Diabetic ketoacidosis, seen rarely (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 your urine or blood
• rapid weight loss
• feeling sick or being sick
• stomach pain
• excessive thirst
• fast and deep breathing
• confusion
• unusual sleepiness or tiredness
• a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your

urine or sweat.

This may occur regardless of blood glucose level. Your doctor may decide to temporarily or permanently stop your treatment with Jardiance.

Contact your doctor as soon as possible if you notice the following side effects:

Low blood sugar (hypoglycaemia), seen very commonly (may affect more than 1 in 10 people)

If you take Jardiance with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The signs of low blood sugar may include:

• shaking, sweating, feeling very anxious or confused, fast heart beat
• 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 signs above. If you have symptoms of low blood sugar, eat glucose tablets, a high sugar snack or drink fruit juice. Measure your blood sugar if possible and rest.

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

The signs of urinary tract infection are:

• burning sensation when passing urine
• urine that appears cloudy
• pain in the pelvis, or mid-back pain (when kidneys are infected)

An urge to pass urine or more frequent urination may be due to the way Jardiance works, but they can also be signs of urinary tract infection. If you note an increase in such symptoms, you should also contact your doctor.

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

The signs of dehydration are not specific, but may include:

• unusual thirst
• lightheadedness or dizziness upon standing
• fainting or loss of consciousness

Other side effects while taking Jardiance:

Common

• genital yeast infection (thrush)
• passing more urine than usual or needing to pass urine more often
• itching
• rash or red skin – this may be itchy and include raised bumps, oozing fluid or blisters
• thirst
• blood tests may show an increase in blood fat (cholesterol) levels in your blood
• constipation

Uncommon

• hives
• straining or pain when emptying the bladder
• blood tests may show a decrease in kidney function (creatinine or urea)
• blood tests may show increases in the amount of red blood cells in your blood (haematocrit)

Rare

• necrotising fasciitis of the perineum or Fournier's gan­grene, a serious soft tissue infection of the

genitals or the area between the genitals and the anus

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in. By reporting side effects you can help provide more information on the safety of this medicine.

5. 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 blister and the carton after ‘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 shows signs of tampering.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Jardiance contains

• – The active substance is empagliflozin.

– Each tablet contains 10 mg or 25 mg empagliflozin.

– The 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), iron oxide

yellow (E172)

What Jardiance looks like and contents of the pack

Jardiance 10 mg film-coated tablets are round, pale yellow, biconvex and bevel-edged. They have “S10” on one side and the Boehringer Ingelheim logo on the other side. The tablets are 9.1 mm in diameter.

Jardiance 25 mg film-coated tablets are oval, pale yellow and biconvex. They have “S25” on one side and the Boehringer Ingelheim 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/aluminium perforated unit dose blisters. The pack sizes are

• 7 × 1, 10 × 1, 14 × 1, 28 × 1, 30 × 1, 60 × 1, 70 × 1, 90 × 1, and 100 × 1 film-coated tablets.