EBYMECT 5 MG/850 MG FILM-COATED TABLETS

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 recently had diabetic ketoacidosis.
• if you have uncontrolled diabetes with, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, 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, which can lead to a pre-diabetic coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or if your breath develops an unusual fruity odor.
• if you have severe kidney impairment.
• if you have any condition that may worsen kidney function, such as:
• • loss of large amounts of body water (dehydration), e.g., due to prolonged or severe diarrhea or if you have vomited several times in a row.
  • severe infection.
  • serious problems with your blood circulation (shock).
• if you have a disease that causes significant problems for your blood to reach your organs, such as:
• • heart failure.
  • breathing difficulties due to acute heart or lung disease.
  • if you have recently had a heart attack.
  • any serious problem with your blood circulation (shock).
• if you have liver problems.
• if you consume large amounts of alcohol every day or only occasionally (see section “Taking Ebymect with alcohol”).

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

Warnings and precautions

Risk of lactic acidosis

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

If any of the above applies to you, consult your doctor for further instructions.

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

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

The symptoms of lactic acidosis include:

• vomiting.
• stomach pain (abdominal pain).
• muscle cramps.
• general feeling of being unwell, with intense tiredness.
• difficulty breathing.
• reduction in body temperature and heart rate.

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

Consult your doctor promptly if:

• You know you have a genetic disease that affects the mitochondria (the energy-producing components within cells), such as MELAS syndrome (Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like episodes) or Maternally Inherited Diabetes and Deafness (MIDD).
• You experience any of the following symptoms after starting treatment with metformin: seizure, cognitive impairment, difficulty with body movements, symptoms indicating nerve damage (e.g., pain or numbness), migraine, and hearing loss.

Consult your doctor, pharmacist, or nurse before you start taking Ebymect and during treatment:

• if you experience rapid weight loss, have nausea or vomiting, have stomach pain, excessive thirst, rapid and deep breathing, confusion, drowsiness, and unusual tiredness, sweet smell on your breath, a sweet or metallic taste in your mouth, or a different smell in your urine or sweat, contact a doctor or the nearest hospital immediately. These symptoms may be a sign of “diabetic ketoacidosis” – a rare but serious, potentially life-threatening problem that occurs with diabetes due to an increase in “ketone bodies” in your urine or blood, which is detected in laboratory tests. The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a greater need for insulin due to major surgery or serious illness.
• if you have “type 1 diabetes” your body does not produce any insulin. Ebymect should not be used to treat this condition.
• if you have very high blood sugar levels that can cause dehydration (losing too much body fluid). Possible signs of dehydration are included in section 4. Inform your doctor before you start taking this medicine if you have any of these signs.
• if you are taking medicines to lower your blood pressure (antihypertensives) or have a history of low blood pressure (hypotension). More information is included later in “Taking Ebymect with other medicines”.
• if you frequently have urinary tract infections. 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 severe infection.

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

Consult your doctor immediately if you experience a combination of symptoms of pain, pain on palpation, redness, or inflammation of the genitals or the area between the genitals and the anus, with fever or general feeling of being unwell. These symptoms could be a sign of a rare but serious, potentially life-threatening infection called necrotizing fasciitis of the perineum or Fournier's gangrene, which destroys tissue under the skin. Fournier's gangrene must be treated immediately.

Surgery

If you need to undergo major surgery, you should stop taking Ebymect during the procedure and for a period after it. Your doctor will decide when you should stop taking Ebymect and when you can restart it.

Kidney function

Your kidneys should be checked before you start taking Ebymect. During treatment with this medicine, your doctor will check your kidney function once a year or more frequently if you are an elderly person and/or if your kidney function is worsening.

Foot care

It is important that you regularly check your feet and follow any other foot care advice given to you by your healthcare professional.

Glucose in urine

Due to the way this medicine works, your urine will test positive for glucose while you are taking this medicine.

Elderly (≥ 65 years or older)

If you are elderly, there may be a greater risk that your kidneys will not work properly and that you will be treated with other medicines (see also “Kidney function” above and “Taking Ebymect with other medicines” below).

Children and adolescents

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

Other medicines and Ebymect

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

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 need to adjust the dose of Ebymect. It is especially important to mention the following:

• if you are taking a medicine used to remove fluid from the body (diuretic).
• if you are taking other medicines that lower the amount of sugar in the blood, such as insulin or a “sulfonylurea” type medicine. Your doctor may decide to reduce the dose of these medicines to avoid you having too low blood sugar levels (hypoglycemia).
• if you are taking lithium, as Ebymect may reduce the amount of lithium in your blood.
• if you are taking cimetidine, a medicine used to treat stomach problems.
• if you are using bronchodilators (beta-2 agonists) used to treat asthma.
• if you are using corticosteroids (used to treat inflammation in diseases such as asthma and arthritis) given orally, injected, or inhaled.
• if you are using medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib).
• if you are using certain medicines to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).

Taking Ebymect with alcohol

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

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

Consult your doctor if you want to breastfeed or are breastfeeding before taking this medicine. You should not use this medicine during breastfeeding. Metformin passes into human breast milk in small amounts. It is not known if dapagliflozin passes into 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 the blood, such as insulin or a “sulfonylurea” type medicine, may cause very low blood sugar levels (hypoglycemia), which can cause symptoms such as weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or difficulty concentrating, which can affect your ability to drive or use machines. Do not drive or use tools or machines if you start to feel these symptoms.

Ebymect contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is essentially “sodium-free”.

3. How to take Ebymect

Follow exactly the instructions for taking this medicine given to you by your doctor. If you are not sure, consult your doctor or pharmacist again.

How much to take

• The amount of this medicine you take will vary depending on your condition and the doses you are currently taking of metformin and/or separate dapagliflozin and metformin tablets. Your doctor will tell you exactly which strength of this medicine to take.
• The recommended dose is one tablet twice a day.

How to take this medicine

• Swallow the tablet whole with half a glass of water.
• Take the tablet with food. This is to reduce the risk of stomach side effects.
• Take your tablet twice a day, one in the morning (breakfast) and one in the evening (dinner).

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

Diet and exercise

To control your diabetes, you should continue with diet and exercise, even when taking this medicine. Therefore, it is important that you continue to follow the advice on diet and exercise given to you by your doctor, pharmacist, or nurse. In particular, if you are following a weight control diet for diabetics, continue with it while 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. The symptoms of lactic acidosis include having a lot of nausea or vomiting, stomach pain, muscle cramps, intense tiredness, or difficulty breathing. If this happens to you, you may need immediate hospital treatment, as lactic acidosis can lead to a coma. Stop taking this medicine immediately and contact a doctor or the nearest hospital right away (see section 2). Bring the medicine pack with you.

If you forget to take Ebymect

If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose of this medicine to make up for missed doses.

If you stop taking Ebymect

Do not stop taking this medicine without first talking to your doctor. Your blood sugar levels 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 Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Stop taking Ebymect and consult a doctor immediately if you notice any of these serious or potentially serious adverse effects:

• Lactic acidosis,occurs rarely (may affect up to 1 in 10,000 people)

Ebymect may cause a very rare but very serious adverse effect called lactic acidosis (see section 2 “Warnings and Precautions”). If this happens to you, you must stop taking Ebymect and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

Contact a doctor or the nearest hospital immediately if you experience any of the following adverse effects:

• Diabetic ketoacidosis, has been observed rarely (may affect up to 1 in 1,000 people)

These are the signs of diabetic ketoacidosis (see also section 2 “Warnings and Precautions”):

• increase in “ketone bodies” in your urine or blood
• rapid weight loss
• you have nausea or vomiting
• stomach pain
• excessive thirst
• rapid and deep breathing
• confusion
• unusual drowsiness and fatigue
• sweet smell in your breath, a sweet or metallic taste in your mouth, or a different smell in your urine or sweat.

This can occur despite blood glucose levels. Your doctor should decide whether to temporarily or permanently interrupt your treatment with Ebymect.

• Necrotizing fasciitis of the perineumor Fournier's gangrene, a serious infection of the soft tissues of the genitals or the area between the genitals and the anus, seen very rarely.

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

• Urinary tract infection, occurs frequently (may affect up to 1 in 10 people).

These are the signs of a serious urinary tract infection:

• fever and/or chills
• feeling of burning when urinating
• back pain or side pain.

Although it is rare, if you see blood in your urine, inform your doctor immediately.

Contact a doctor as soon as possible if you experience any of the following adverse effects:

• Decrease in blood sugar levels (hypoglycemia), is observed very frequently (may affect more than 1 in 10 people) – when taking this medicine with a sulfonylurea or other medicines that reduce blood sugar levels, such as insulin.

The signs of low blood sugar are:

• chills, sweating, feeling of great anxiety, rapid heartbeat
• feeling of hunger, headache, vision changes
• change in mood or feeling of confusion.

Your doctor will explain how to treat low blood sugar levels and what to do if you experience any of the above symptoms. If you have symptoms of low blood sugar, take glucose tablets, a sugary snack, or drink a fruit juice. Measure your blood sugar level, if possible, and rest.

Other adverse effects include:

Very frequent

• nausea, vomiting
• diarrhea or stomach pain
• loss of appetite

Frequent

• genital infections (candidiasis) of the penis or vagina (signs may include irritation, itching, and abnormal discharge or odor)
• back pain
• difficulty urinating, increased urination, or need to urinate more frequently
• changes in cholesterol or lipid levels in the blood (observed in laboratory tests)
• increase in the number of red blood cells in the blood (observed in laboratory tests)
• decrease in renal clearance of creatinine (observed in laboratory tests) at the start of treatment
• changes in taste
• dizziness
• rash
• low levels of vitamin B12 in the blood or decreased (symptoms may include extreme fatigue, red and painful tongue, numbness, or pale or yellowish skin). Your doctor may request some tests to find the cause of your symptoms because some of them can also be caused by diabetes or other health problems not related to the medicine.

Uncommon(may affect up to 1 in 100 people)

• excessive loss of body fluids (dehydration, signs may include very dry or sticky mouth, decreased or absent urination, or rapid heartbeat)
• fungal infection
• thirst
• constipation
• nocturnal awakenings due to need to urinate
• dry mouth
• weight loss
• increase in creatinine (observed in blood tests) at the start of treatment
• increase in urea (observed in blood tests)

Very rare

• abnormal liver function test results, liver inflammation (hepatitis)
• skin redness (erythema), itching, or pruritus (hives)
• kidney inflammation (tubulointerstitial nephritis)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Ebymect

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the blister or packaging after EXP/CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Ebymect Composition

• The active ingredients are dapagliflozin and metformin hydrochloride (HCl metformin).

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

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

• Other ingredients are:

• tablet core: hydroxypropylcellulose (E463), microcrystalline cellulose (E460(i)), magnesium stearate (E470b), sodium carboxymethylcellulose (type A).
• film coating: polyvinyl alcohol (E1203), macrogol (3350) (E1521), talc (E553b), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) (only Ebymect 5 mg/850 mg).

Product Appearance and Package Contents

• The film-coated tablets of Ebymect 5 mg/850 mg are brown, oval, 9.5 x 20 mm. They are engraved with “5/850” on one side and “1067” on the other.
• The film-coated tablets of Ebymect 5 mg/1,000 mg are yellow, oval, 10.5 x 21.5 mm. They are engraved with “5/1000” on one side and “1069” on the other.

Ebymect 5 mg/850 mg film-coated tablets and Ebymect 5 mg/1,000 mg film-coated tablets are available in PVC/PCTFE/Alu blisters. The package sizes are 14, 28, 56, and 196 (2 packages of 98) film-coated tablets in non-perforated calendar blisters of 14 tablets, 60 film-coated tablets in non-perforated blisters of 10 tablets, and 60x1 film-coated tablets in perforated unit-dose blisters.

Not all package sizes may be marketed in your country.

Marketing Authorization Holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Manufacturer

AstraZeneca AB

Gärtunavägen

SE-152 57 Södertälje

Sweden

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of the last revision of thisleaflet:

Other sources of information

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