Empagliflozin is a member of a group of medicines called sodium glucose
co-transporter-2 (SGLT2) inhibitors. Empagliflozin works by blocking the
SGLT2 protein in your kidneys. This causes blood sugar (glucose) to be
removed in your urine. Thereby Empagliflozin lowers the amount of sugar in
your blood. This medicine can also help prevent heart disease.
- Empaglin® film coated tablet is used to treat type 2 diabetes in adult patients (aged 10 years and older) that cannot be controlled by diet and exercise alone.
- Empaglin® film coated tablet can be used without other medicines in patients who cannot take metformin (another diabetes medicine).
- Empaglin® film coated tablet 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.
It is important that you continue with your diet and exercise plan as told by
your doctor, pharmacist or nurse.
Always take Empaglin® film coated tablet exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
How much to take
The starting dose of Empaglin® 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 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.
- Your doctor may prescribe Empaglin® film coated tablet 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 Empaglin®.
If you take more Empaglin® than you should
If you take more Empaglin® film coated tablet than you should, talk to a doctor immediately or go to a hospital immediately. Take the medicine pack with you.
- Each film coated tablet of Empaglin® 10 contains:
Empagliflozin 10 mg.
- Each film coated tablet of Empaglin® 25 contains:
Empagliflozin 25 mg.
Do not use Empaglin®.
- if you are allergic to empagliflozin or any of the other ingredients of this
medicine
- Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
- if you are taking medicines that increase urine production (diuretics)
- 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).
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 Empaglin® if you are pregnant. It is unknown if Empaglin® is harmful to the unborn child.
Do not use Empaglin® if you are breastfeeding. It is not known if
Empagliflozin passes into human breast milk.
Stop using the product and seek immediate medical attention if you
develop urticaria, rash, tightness of the chest, wheezing, hypotension.
Common side effects
- Low blood sugar (hypoglycaemia)
- Urinary tract infection
- 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
Uncommon side effects
- 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)
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.
- 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 “diabetic
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 diabetic 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.
- if you have serious kidney or liver problems – your doctor may ask you to
take a different medicine.
- might be at risk of dehydration, for example:
• if you are being sick, have diarrhoea or fever, or if you are not able to eat or
drink
• if you are taking medicines that increase urine production [diuretics] or lower
blood pressure or if you are over 75 years old.
- if you have a serious infection of the kidney or the urinary tract with fever.
Your doctor may ask you to stop taking Empaglin® 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 immediatelyChildren and adolescents: Empaglin® film coated tablet can be used in children aged 10 years and older for the treatment of type 2 diabetes. No data are available in children below 10 years of age
Empaglin® is not recommended for children and adolescents under 18 years of age for the treatment of heart failure or for the treatment of chronic kidney disease, because it has not been studied in these patients.
- Empaglin® 25: pack of 3 blisters, blister of 10 tablets.
- Empaglin® 10: pack of 3 blisters, blister of 10 tablets.
- Store in a dry place at temperature not exceeding 25ºC.
