Ebymect (dapagliflozin propanediol monohydrate...) – Package leaflet - A10BD15

Package leaflet: Information for the patient

Ebymect 5 mg/850 mg film-coated tablets Ebymect 5 mg/1,000 mg film-coated tablets dapagliflozin/metformin hydrochloride

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What Ebymect is and what it is used for

2.What you need to know before you take Ebymect

3.How to take Ebymect

4.Possible side effects

5.How to store Ebymect

6.Contents of the pack and other information

1.What Ebymect is and what it is used for

This medicine contains two different substances called dapagliflozin and metformin. Both belong to a group of medicines called oral anti-diabetics.

This medicine is used for a type of diabetes called “type 2 diabetes” in adult patients (aged 18 years and older) and usually occurs when you are older. If you have type 2 diabetes, your pancreas does not make enough insulin or your body is not able to use the insulin it produces properly. This leads to a high level of sugar (glucose) in your blood. Dapagliflozin works by removing excess sugar from your body via your urine and lowers the amount of sugar in your blood. Metformin works mainly by inhibiting glucose production in the liver.

These are medicines taken by mouth for diabetes.

This medicine is taken in combination with diet and exercise.

This medicine is used if your diabetes cannot be controlled with other medicines used to treat diabetes, along with diet and exercise.

Your doctor may ask you to take this medicine on its own or together with other medicines to treat diabetes. This may be another medicine taken by mouth and/or a medicine given by injection, such as insulin or a GLP-1 receptor agonist.

If you are already taking both dapagliflozin and metformin as single tablets, your doctor may ask you to switch to this medicine. To avoid overdose, do not continue taking dapagliflozin and metformin tablets, if you are taking this medicine.

It is important to continue to follow the advice on diet and exercise given to you by your doctor, pharmacist or nurse.

2. What you need to know before you take Ebymect

Do not take Ebymect

if you are allergic to dapagliflozin, metformin or any of the other ingredients of this medicine (listed in section 6).

if you have ever had a diabetic coma.

if you have uncontrolled diabetes, with, for example severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis. Ketoacidosis is a condition in which substances called ‘ketone bodies’ accumulate in the blood and which can lead to a diabetic pre-coma. Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual fruity smell.

if you have severely reduced kidney function.

if you have a severe infection.

if you have lost a lot of water from your body (dehydration), e.g. due to long-lasting or severe diarrhoea, or if you have vomited several times in a row.

if you have recently had a heart attack or if you have heart failure or serious problems with your blood circulation or difficulties in breathing.

if you have problems with your liver.

if you drink large amounts of alcohol, either every day or only from time to time (please see section “Ebymect with alcohol”).

Do not take this medicine if any of the above apply to you.

Warnings and precautions Risk of lactic acidosis

Ebymect may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease).

If any of the above apply to you, talk to your doctor for further instructions.

Stop taking Ebymect for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal. Talk to your doctor for further instructions.

Stop taking Ebymect and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.

Symptoms of lactic acidosis include:

-vomiting

-stomach ache (abdominal pain)

-muscle cramps

-a general feeling of not being well with severe tiredness

-difficulty in breathing

-reduced body temperature and heartbeat

Lactic acidosis is a medical emergency and must be treated in a hospital.

Talk to your doctor, pharmacist or nurse before taking this medicine, and during treatment:

if you have “type 1 diabetes” – the type that 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 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 problems with your kidneys. Your doctor will check your kidney function.

if you have very high levels of glucose in your blood which may make you dehydrated (lose too much body fluid). Possible signs of dehydration are listed at the top of section 4. Tell your doctor before you start taking this medicine if you have any of these signs.

if you are taking medicines to lower blood pressure (anti-hypertensives) and have a history of low blood pressure (hypotension). More information is given below in ‘Other medicines and Ebymect’.

if you have a history of serious heart disease or if you have had a stroke.

if you often get infections of the urinary tract. This medicine may cause urinary tract infections and your doctor may want to monitor you more closely. Your doctor may consider temporarily changing your treatment if you develop a serious infection.

if you are 75 years old or older, you should not start taking this medicine. This is because you may be more prone to some side effects.

if you are taking another medicine for diabetes that contains “pioglitazone”, you should not start taking this medicine.

if you have an increase in the amount of red blood cells in your blood, seen in tests.

If you need to have major surgery, you must stop taking Ebymect during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Ebymect.

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.

If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking this medicine.

Kidney function

During treatment with Ebymect, your doctor will check your kidney function at least once every year or more frequently if you are elderly and/or if you have worsening kidney function.

Urine glucose

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

Children and adolescents

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

Other medicines and Ebymect

If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Ebymect before or at the time of the injection. Your doctor will decide when you must stop and when to restart your treatment with Ebymect.

Tell your doctor if you are taking, have recently taken or might take any other medicines. You may need more frequent blood glucose and kidney function tests, or your doctor may adjust the dosage of Ebymect. It is especially important to mention the following:

if you are taking medicines which increase urine production (diuretics). Your doctor may ask you to stop taking this medicine. Possible signs of losing too much fluid from your body are listed at the top of section 4 ‘Possible side effects’.

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 you from getting blood sugar levels that are too low (hypoglycaemia).

if you are taking cimetidine, a medicine used to treat stomach problems.

if you are using bronchodilators (beta-2 agonists) which are used to treat asthma.

if you are using corticosteroids, which are used to treat inflammation in diseases like asthma and arthritis.

if you are using medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib).

if you are using certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).

Ebymect with alcohol

Avoid excessive alcohol intake while taking Ebymect since this may increase the risk of lactic acidosis (see “Warnings and precautions”).

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. You should stop taking this medicine if you become pregnant, since it is not recommended during the second and third trimesters (the last six months) of pregnancy. Talk to your doctor about the best way to control your blood sugar while you are pregnant.

Talk to your doctor if you would like to or are breast-feeding before taking this medicine. You should not use this medicine if you are breast-feeding. It is not known if this medicine passes into human breast milk.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. Taking it with other medicines that lower the amount of sugar in your blood, such as insulin or a “sulphonylurea” medicine, can cause too low blood sugar levels (hypoglycaemia), which may cause symptoms such as weakness, dizziness, increased sweating, fast heart beat, change in vision or difficulties concentrating, and may affect your ability to drive and use machines. Do not drive or use any tools or machines, if you start to feel these symptoms.

3.How to take Ebymect

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 amount of this medicine that you will take varies depending on your condition and the doses you currently take of metformin and/or individual tablets of dapagliflozin and metformin. Your doctor will tell you exactly which strength of this medicine to take.

The recommended dose is one tablet twice a day.

Taking this medicine

Swallow the tablet whole with half a glass of water.

Take your tablet with food. This is to reduce the risk of side effects in the stomach.

Take your tablet twice daily, once in the morning (breakfast) and once in the evening (dinner).

Your doctor may prescribe this medicine together with other medicine(s) to lower the amount of sugar in your blood. These may be medicine(s) by mouth or given by injection, such as insulin or a GLP-1 receptor agonist. Remember to take these other medicine(s) as your doctor has told you. This will help get the best results for your health.

Diet and exercise

To control your diabetes, you still need to keep to diet and exercise, even when you are taking this medicine. So it is important to keep following the advice about diet and exercise from your doctor, pharmacist or nurse. In particular, if you are following a diabetic weight control diet, continue to follow it while you are taking this medicine.

If you take more Ebymect than you should

If you take more Ebymect tablets than you should, you may experience lactic acidosis. Symptoms of lactic acidosis include feeling or being very sick, vomiting, stomach ache, muscular cramps, severe tiredness or difficulty breathing. If this happens to you, you may need immediate hospital treatment, as lactic acidosis may lead to coma. Stop taking this medicine immediately and contact a doctor or the nearest hospital straight away (see section 2). Take the medicine pack with you.

If you forget to take Ebymect

Do not take a double dose of this medicine to make up for a forgotten dose.

If you stop taking Ebymect

Do not stop taking this medicine without talking to your doctor first. Your blood sugar may increase without this medicine.

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.

Stop taking Ebymect and see a doctor as soon as possible if you notice any of the following serious or potentially serious side effects:

Lactic acidosis, seen very rarely (may affect up to 1 in 10,000 people)

Ebymect may cause a very rare, but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this happens you must stop taking Ebymect and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.

Dehydration: loss of too much fluid from your body, seen uncommonly (may affect up to 1 in 100 people).

These are signs of dehydration:

-very dry or sticky mouth, feeling very thirsty

-feeling very sleepy or tired

-passing little or no water (urine)

-fast heart beat.

Urinary tract infection, seen commonly (may affect up to 1 in 10 people). These are signs of a severe infection of the urinary tract:

-fever and/or chills

-burning sensation when passing water (urinating)

-pain in your back or side.

Although uncommon, if you see blood in your urine, tell your doctor immediately.

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

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 Ebymect.

Contact your doctor as soon as possible if you have any of the following side effects:

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

people) - when taking this medicine with a sulphonylurea or other medicines that lower the amount of sugar in your blood, such as insulin.

These are the signs of low blood sugar:

-shaking, sweating, feeling very anxious, fast heart beat

-feeling hungry, headache, change in vision

-a change in your mood or feeling confused.

Your doctor will tell you how to treat low blood sugar levels and what to do if you get any of the signs above.

Other side effects include:

Very common (may affect more than 1 in 10 people)

nausea, vomiting

diarrhoea or stomach ache

loss of appetite

Common (may affect up to 1 in 10 people)

genital infection (thrush) of your penis or vagina (signs may include irritation, itching, unusual discharge or odour)

back pain

passing more water (urine) than usual or needing to pass water more often

changes in the amount of cholesterol or fats in your blood (shown in tests)

changes in the amount of red blood cells in your blood (shown in tests)

changes in taste

dizziness

rash

Uncommon (may affect up to 1 in 100 people)

thirst

constipation

discomfort when passing water (urine)

awakening from sleep at night to pass urine

dry mouth

weight decreased

changes in laboratory blood tests (creatinine or urea)

decrease in kidney function

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

decreased vitamin B12 levels in the blood

abnormalities in liver function tests, inflammation of the liver (hepatitis)

redness of the skin (erythema), itching or an itchy rash (hives)

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 Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store Ebymect

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 or 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 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 Ebymect contains

The active substances are dapagliflozin and metformin hydrochloride (metformin HCl).

Each Ebymect 5 mg/850 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 850 mg metformin hydrochloride.

Each Ebymect 5 mg/1,000 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1,000 mg metformin hydrochloride.

The other ingredients are:

tablet core: hydroxypropyl cellulose (E463), microcrystalline cellulose (E460(i)), magnesium stearate (E470b), sodium starch glycolate.

film-coating: polyvinyl alcohol (E1203), macrogol 3350 (E1520(iii)), talc (E553b), titanium dioxide (E171), iron oxides (E172).

What Ebymect looks like and contents of the pack

Ebymect 5 mg/850 mg are 9.5 x 20 mm oval, brown film-coated tablets. They have “5/850” on one side and “1067” on the other side.

Ebymect 5 mg/1,000 mg are 10.5 x 21.5 mm oval, yellow film-coated tablets. They have “5/1000” on one side and “1069” on the other side.

Ebymect 5 mg/850 mg film-coated tablets and Ebymect 5 mg/1,000 mg film-coated tablets are available in PVC/PCTFE/Alu blister. The pack sizes are 14, 28, 56 and 60 film-coated tablets in non-perforated blisters, 60x1 film-coated tablets in perforated unit dose blisters and multipack containing 196 (2 packs of 98) film-coated tablets in non-perforated blisters.

Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Manufacturer

AstraZeneca GmbH

Tinsdaler Weg 183

22880 Wedel

Germany

Bristol-Myers Squibb Company

Contrada Fontana del Ceraso

IT-03012 Anagni (FR)

Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.