Ebymect 5 mg/850 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ebymect 5mg/850mg film-coated tablets

Ebymect 5mg/1.000mg film-coated tablets

dapagliflozin/metformin hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Ebymect is and what it is used for
2. What you need to know before taking 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

Ebymect contains two different active substances called dapagliflozin and metformin. Both belong to a group of medicines known as “oral antidiabetics”. These are medicines taken by mouth for diabetes.

Ebymect is used for a type of diabetes called “type 2 diabetes” in adult patients (18 years of age or older). If you have type 2 diabetes, your pancreas does not produce enough insulin or your body is unable to use the insulin it produces effectively. This leads to high levels of sugar (glucose) in your blood.

• Dapagliflozin works by removing excess sugar from your body through the urine, thereby reducing the amount of sugar in your blood. It may also help prevent heart disease.
• Metformin works mainly by inhibiting glucose production in the liver.

To treat type 2 diabetes:

• This medicine should be taken together with diet and exercise.
• This medicine is used when your diabetes cannot be controlled with other medicines used to treat diabetes.
• Your doctor may ask you to take this medicine alone or together with other medicines for diabetes. These may include another medicine taken by mouth and/or a medicine given by injection.
• If you are already taking dapagliflozin and metformin as separate tablets, your doctor may ask you to switch to this medicine. To avoid overdose, do not continue taking separate dapagliflozin and metformin tablets if you are taking Ebymect.

It is important that you continue to follow the dietary and exercise advice provided by your doctor, pharmacist, or nurse.

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 medicine (listed in section 6).
• if you have recently experienced diabetic coma.
• if you have uncontrolled diabetes with, for example, severe hyperglycemia (high blood glucose), 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” build up in the blood, which may lead to pre-diabetic coma. Symptoms include stomach pain, rapid deep breathing, drowsiness, or fruity-smelling breath.
• if you have severe kidney function impairment.
• if you have any condition that may worsen your kidney function, such as:
  • significant loss of body fluids (dehydration), e.g., due to prolonged or severe diarrhea, or if you have vomited repeatedly
  • severe infection
  • serious problems with your blood circulation (shock).
• if you have a disease causing poor blood supply to your organs, such as:
  • heart failure
  • breathing difficulties due to acute heart or lung disease
  • recent myocardial infarction
  • serious circulatory problems (shock).
• if you have liver problems.
• if you consume large amounts of alcohol daily or intermittently (see section “Taking 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 serious adverse effect called lactic acidosis, especially if your kidneys are not functioning properly. The risk of developing lactic acidosis is also increased in uncontrolled diabetes, severe infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems, and any medical condition in which part of the body receives reduced oxygen supply (such as severe acute heart or lung disease).

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

Stop taking Ebymect temporarily if you develop a condition that may lead to dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or reduced fluid intake. 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 may lead to coma.

Symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general feeling of discomfort with profound fatigue
• difficulty breathing
• reduced body temperature and heart rate

Lactic acidosis is a medical emergency and requires hospital treatment.

Contact your doctor promptly for guidance if:

• You are known to have a genetic mitochondrial disorder (components responsible for energy production within cells), such as MELAS syndrome (Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like episodes) or Maternally Inherited Diabetes and Deafness (MIDD).
• You develop any of the following symptoms after starting metformin treatment: seizures, cognitive decline, movement difficulties, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Consult your doctor, pharmacist, or nurse before starting Ebymect, and during treatment:

• if you experience rapid weight loss, nausea or vomiting, stomach pain, excessive thirst, rapid deep breathing, confusion, drowsiness, unusual fatigue, sweet-smelling breath, a sweet or metallic taste in the mouth, or unusual odor in urine or sweat, contact a doctor or the nearest hospital immediately. These symptoms may indicate “diabetic ketoacidosis” – a rare but serious, sometimes life-threatening condition occurring in diabetes due to increased “ketone bodies” in blood or urine, detectable by laboratory tests. The risk of developing diabetic ketoacidosis may increase with prolonged fasting, excessive alcohol consumption, dehydration, sudden reduction in insulin dose, or increased insulin requirement due to major surgery or serious illness.
• if you have “type 1 diabetes,” your body produces no insulin. Ebymect should not be used to treat this condition.
• if you have very high blood glucose levels that may cause dehydration (loss of excessive body fluids). Possible signs of dehydration are listed in section 4. Inform your doctor before starting 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). Further information is provided below in “Taking Ebymect with other medicines.”
• if you frequently suffer from urinary tract infections. This medicine may cause urinary tract infections, and your doctor may wish to monitor you more closely. Your doctor may consider temporarily changing your treatment if you develop a serious infection.

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

Seek immediate medical attention if you develop a combination of symptoms such as pain, tenderness, redness, or swelling in the genital area or the region between the genitals and the anus, accompanied by fever or general malaise. These symptoms could indicate a rare but serious, potentially fatal infection called necrotizing fasciitis of the perineum or Fournier’s gangrene, which destroys tissue beneath the skin. Fournier’s gangrene requires immediate treatment.

Surgery

If you require major surgery, you must stop taking Ebymect during the procedure and for a period afterward. Your doctor will decide when to interrupt and when to restart Ebymect treatment.

Kidney function

Your kidneys should be evaluated before starting Ebymect. During treatment with this medicine, your doctor will check your kidney function once a year, or more frequently if you are elderly and/or if your kidney function is declining.

Foot care

It is important to regularly check your feet and follow any foot care advice provided by your healthcare professional.

Glucose in urine

Due to the mechanism of action of this medicine, your urine will test positive for glucose while taking this medicine.

Elderly (≥65 years or older)

If you are elderly, there may be an increased risk of impaired kidney function and concomitant use of other medications (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 receive an intravenous iodine-containing contrast agent, for example during an X-ray or scan, you must stop taking Ebymect before or at the time of the injection. Your doctor will decide when to interrupt and when to restart Ebymect treatment.

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines. You may require more frequent blood glucose and kidney function tests, or your doctor may need to adjust your Ebymect dose. 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 blood sugar, such as insulin or a sulfonylurea-type medicine. Your doctor may decide to reduce the dose of these medicines to prevent low blood sugar (hypoglycemia).
• if you are taking lithium, as Ebymect may reduce blood lithium levels.
• 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 conditions such as asthma and arthritis), whether taken orally, injected, or inhaled.
• if you are using medicines for 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 consumption 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 plan to become pregnant, consult your doctor or pharmacist before taking this medicine. You should stop taking this medicine if you become pregnant, as its use is not recommended during the second and third trimesters of pregnancy (the last six months). Consult your doctor about the best way to manage blood glucose during pregnancy.

Consult your doctor if you are planning to breastfeed or are currently breastfeeding before taking this medicine. You should not use this medicine while breastfeeding. Metformin passes into human milk in small amounts. It is unknown whether dapagliflozin passes into breast milk.

Driving and using machines

This medicine has no or negligible influence on the ability to drive or use machines. However, taking it with other medicines that lower blood sugar, such as insulin or sulfonylurea-type medicines, may cause very low blood sugar (hypoglycemia), leading to symptoms such as weakness, dizziness, increased sweating, rapid pulse, vision disturbances, or difficulty concentrating, which may affect your ability to drive or use machines. Do not drive or operate tools or machinery if you experience these symptoms.

Ebymect contains sodium

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

3. How to take Ebymect

Follow exactly the instructions for using this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

How much to take

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

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-related adverse effects.
• 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 your blood sugar levels. These may be oral medicines or injections, such as insulin or a GLP‑1 receptor agonist. Remember to take these other medicines as instructed by your doctor. This will help you achieve the best health outcomes.

Diet and exercise

To manage your diabetes, you must continue with diet and exercise even while taking this medicine. It is therefore important that you continue to follow the dietary and exercise advice provided by your doctor, pharmacist, or nurse. In particular, if you are following a diabetic weight-control diet, 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. Symptoms of lactic acidosis include severe nausea or vomiting, stomach pain, muscle cramps, extreme tiredness, or difficulty breathing. If this happens to you, you may need immediate hospital treatment, as lactic acidosis can lead to coma. Stop taking this medicine immediately and contact a doctor or go to the nearest hospital straight away (see section 2). Take the medicine packaging 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 dosing 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 consulting your doctor. Your blood sugar levels may increase without this medicine.

If you have any further questions about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Stop taking Ebymect and consult a doctor immediately if you notice any of the following 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, 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”):

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

This may occur despite blood glucose levels. Your doctor must decide whether to temporarily or permanently discontinue your treatment with Ebymect.

• Necrotizing fasciitis of the perineum or Fournier’s gangrene, a serious infection of the soft tissues of the genitals or the area between the genitals and the anus, very rarely reported.

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
• burning sensation when urinating (micturition)
• back or flank pain.

Although uncommon, if you notice blood in your urine, inform your doctor immediately.

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

• Decreased blood sugar levels (hypoglycaemia), very commonly observed (may affect more than 1 in 10 people) – when taking this medicine together with a sulphonylurea or other medicines that lower blood sugar levels, such as insulin.

Signs of low blood sugar include:

• chills, sweating, feeling of intense anxiety, rapid heartbeat
• feeling of hunger, headache, vision disturbances
• mood changes or feeling confused.

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

Other adverse effects include:

Very common

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

Common

• genital infections (candidiasis) of the penis or vagina (signs may include irritation, itching, and abnormal discharge or odor)
• back pain
• discomfort when urinating, increased urine output, or need to urinate more frequently
• changes in blood cholesterol or lipid levels (observed in blood tests)
• increase in red blood cell count (observed in blood tests)
• decrease in renal creatinine clearance (observed in blood tests) at the start of treatment
• changes in taste
• dizziness
• rash
• low or decreased vitamin B12 levels in blood (symptoms may include extreme tiredness (fatigue), red and sore tongue (glossitis), tingling (paraesthesia), or pale or yellowish skin). Your doctor may request some tests to determine the cause of your symptoms, as some of them may also be caused by diabetes or other unrelated health problems.

Uncommon (may affect up to 1 in 100 people)

• excessive fluid loss from the body (dehydration, signs may include very dry or sticky mouth, little or no urination, or rapid heartbeat)
• fungal infection
• thirst
• constipation
• waking up at night 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 results in liver function tests, inflammation of the liver (hepatitis)
• skin redness (erythema), itching or pruritus (hives)
• inflammation of the kidneys (tubulointerstitial nephritis)

Reporting of adverse effects

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

By reporting adverse effects, you can help provide 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 expiry date stated on the blister or packaging following EXP/CAD. The expiry date refers to 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 unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ebymect

• The active substances 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.

• The other components are:

• tablet core: hypromellose (E463), microcrystalline cellulose (E460(i)), magnesium stearate (E470b), sodium carboxymethyl starch (type A).

• film coating: polyvinyl alcohol (E1203), macrogol (3350) (E1521), talc (E553b), titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172) (only in Ebymect 5 mg/850 mg).

Nature and contents of the container

• Ebymect 5 mg/850 mg film-coated tablets are brown, oval-shaped, 9.5 x 20 mm. They are marked with "5/850" on one side and "1067" on the other.
• Ebymect 5 mg/1,000 mg film-coated tablets are yellow, oval-shaped, 10.5 x 21.5 mm. They are marked 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. Pack sizes are 14, 28, 56 and 196 (2 packs of 98) film-coated tablets in non-perforated calendar blisters containing 14 tablets, 60 film-coated tablets in non-perforated blisters of 10 tablets, and 60x1 film-coated tablets in single-dose perforated blisters.

Only certain pack 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

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.euopa.eu