EBYMECT 5 MG/1000 MG FILM-COATED TABLETS

2. What you need to know before taking Ebymect

Do not take Ebymect:

• if you are allergic to dapagliflozin, metformin, or any of the other components of this medication (listed in section 6).
• if you have recently had a diabetic coma.
• 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 disorder 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 function 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 blood circulation (shock).
• if you have a disease that causes significant problems for 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 blood circulation (shock).
• if you have liver problems.
• if you consume large amounts of alcohol daily or occasionally (see "Taking Ebymect with alcohol").

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

Warnings and precautions

Risk of lactic acidosis

Ebymect may cause a very rare but serious side effect called lactic acidosis, especially if your kidneys do not function properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting, or alcohol consumption, dehydration (see more information below), liver problems, and any medical condition in which a part of the body has a reduced oxygen supply (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 usual. Consult your doctor for further instructions.

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

The symptoms of lactic acidosis include:

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

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

Consult your doctor promptly if:

• You know you have a genetic disorder that affects the mitochondria (the energy-producing components within cells), such as MELAS syndrome (Mitochondrial Encephalomyopathy with 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 starting to take Ebymect and during treatment:

If any of the above situations apply to you (or you are unsure), talk to your doctor, pharmacist, or nurse before taking this medication.

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 discomfort. 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 should 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 to restart it.

Kidney function

Your kidneys should be checked before starting to take Ebymect. During treatment with this medication, 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 essential that you regularly monitor your feet and follow any other foot care advice provided by your healthcare professional.

Glucose in urine

Due to how this medication works, your urine will test positive for glucose while taking this medication.

Older adults(≥65years or older)

If you are an older adult, there may be a greater risk that your kidneys will function worse and that you will be treated with other medications (see also "Kidney function" above and "Taking Ebymect with other medications" below).

Children andadolescents

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

Other medications and Ebymect

If you need to be administered an injection of a contrast medium containing iodine into your bloodstream, for example, in the context of an X-ray or examination, 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 to restart it.

Tell your doctor if you are taking, have recently taken, or may need to take any other medication. 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:

Taking Ebymect with alcohol

Avoid excessive alcohol consumption while taking Ebymect, as this may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medication. You should stop taking this medication if you become pregnant, as it is not recommended for use 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 medication. You should not use this medication during breastfeeding. Metformin passes into breast milk in small amounts. It is not known if dapagliflozin passes into breast milk.

Driving and using machines

This medication has a negligible influence on the ability to drive or use machines. Taking it with other medications that lower blood sugar, such as insulin or a "sulfonylurea" type medication, may cause very low blood sugar levels (hypoglycemia), which can cause symptoms such as weakness, dizziness, increased sweating, rapid heartbeat, vision changes, 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 medication contains less than 1 mmol of sodium (23 mg) per dose, which is essentially "sodium-free".

3. How to take Ebymect

Follow the instructions for taking this medication exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

How much to take

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

How to take this medication

• Swallow the tablet whole with a half 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 medication along with another medication(s) to lower your blood sugar. These may be oral medication(s) or injectable medication(s), such as insulin or a GLP-1 receptor agonist. Remember to take these other medication(s) as instructed by your doctor. This will help you achieve the best results for your health.

Diet and exercise

To control your diabetes, you should continue with diet and exercise, even when taking this medication. Therefore, it is essential that you continue to follow the dietary and exercise recommendations provided by your doctor, pharmacist, or nurse. In particular, if you are following a weight control diet for diabetics, continue with it while taking this medication.

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 fatigue, 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 medication immediately and contact a doctor or the nearest hospital right away (see section 2). Bring the medication packaging with you.

If you forget to take Ebymect

If you forget 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 follow your regular schedule. Do not take a double dose of this medication to make up for missed doses.

If you stop taking Ebymect

Do not stop taking this medication without consulting your doctor first. Your blood sugar may increase without this medication.

If you have any further questions about the use of this medication, 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 severe 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 severe 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 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