5 mg / 850 mg, 5 mg / 1000 mg film-coated tablets 
dapagliflozin / metformin hydrochloride

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this 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 packaging 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 called oral diabetes medicines. These are medicines that are taken orally for diabetes.

Ebymect is used for a type of diabetes called “type 2 diabetes” in adult patients (18 years and older). If you have type 2 diabetes, your pancreas does not produce enough insulin or your body cannot use the insulin that is produced properly. This leads to a high level of sugar ( glucose ) in the blood.

  • Dapagliflozin works by removing excess sugar from the body through the urine and lowering the amount of sugar in the blood. It can also help prevent heart disease.
  • Metformin works primarily by inhibiting glucose production in the liver.

For the treatment of type 2 diabetes:

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

It is important to continue to follow the advice on diet and exercise that you have received from 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 ingredients of this medicine (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 condition in which substances called ketone bodies to accumulate in the blood, which can lead to diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or that your breath gets a different, fruity odor.
  • if you have severe renal impairment.
  • if you have a condition that can cause your kidney function to deteriorate, such as
    • loss of much water from the body (dehydration), e.g. due to prolonged or severe diarrhea or if you have vomited several times in a row.
    • a severe infection
    • severe problems with blood circulation ( shock ).
  • if you have a disease that causes problems with blood supply to your organs, e.g. if you have
    • heart failure
    • difficult to breathe due to acute heart or lung disease
    • recently had a heart attack
    • severe problems with blood circulation ( shock ).
  • if you have liver problems.
  • if you drink large amounts of alcohol (either daily or only occasionally) (see section “Ebymect with alcohol”).

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

Warnings and cautions

Risk of lactic acidosis

Ebymect can cause the very rare, but very serious side effect of lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased in uncontrolled diabetes, severe infections, long-term fasting or alcohol intake, dehydration (see more information below), liver problems, and conditions where part of the body has reduced oxygen supply (including acute severe heart disease).

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

Stop taking Ebymect for a short time if you have a condition that may be associated with dehydration, such as severe vomiting, diarrhea, fever, exposure to heat, or if you drink less fluid than normal. Talk to a doctor for further instructions.

Stop taking Ebymect and contact your doctor or nearest hospital immediately if you get any of the symptoms of lactic acidosis as the condition may lead to coma.

Symptoms of lactic acidosis include:

  • vomiting
  • abdominal pain (stomach pain)
  • muscle cramps
  • a general feeling of not feeling well and pronounced fatigue
  • hard to breathe
  • lowered body temperature and heart rate.

Lactic acidosis is an acute medical condition that must be treated in a hospital.

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

  • If you experience rapid weight loss, nausea or vomiting, abdominal pain, severe thirst, rapid and deep breathing, confusion, unusual sleepiness or fatigue, a sweet breath, a sweet taste or metallic taste in your mouth, or a different smell of urine or sweat, contact your doctor. or the nearest hospital immediately. These symptoms can be signs of “diabetic ketoacidosis” – a rare but serious, sometimes life-threatening problem that you can get in diabetes due to increased levels of “ketone bodies” in the urine or blood. This is shown in tests. The risk of developing diabetic ketoacidosis may increase with prolonged fasting, high alcohol consumption, dehydration, a sudden decrease in insulin dose, or a greater need for insulin due to major surgery or a 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 levels of glucose in your blood that can make you dehydrated (loses too much body fluid). Possible symptoms of dehydration are listed at the beginning of section 4. Tell your doctor before taking this medicine if you have any of these signs.
  • if you are taking medicines that lower blood pressure (antihypertensive drugs) and have had low blood pressure ( hypotension ). More information is given below under “Other medicines and Ebymect”.
  • if you often get urinary tract infections. This medicine may cause urinary tract infections and your doctor may need to monitor you more closely. Your doctor may consider changing your treatment temporarily if you get a serious infection.

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

Talk to your doctor immediately if you experience a combination of symptoms such as pain, tenderness, redness, or swelling of the genitals or the area between the genitals and the rectum along with fever or general malaise. These symptoms can be a sign of a rare but serious and in the worst-case life-threatening infection called necrotizing fasciitis of the perineum or Fournier’s gangrene which destroys the tissue under the skin. Fournier’s gangrene must be treated immediately.

Operation

If you are going to have a major operation, you must stop taking Ebymect during the operation and for some time after it. Your doctor will decide when you need to stop taking Ebymect and when you should start taking it again.

Renal function

Your kidneys should be checked before you start taking Ebymect. During treatment with this medicine, your doctor will check your kidney function at least once a year or more often if you are older and/or if your kidney function is deteriorating.

Chiropody

It is important to check your feet regularly and to follow the advice on foot care provided by healthcare professionals.

Sugar in the urine

Because of the effect of this medicine, your urine will show positive test results for sugar when you take this medicine.

Elderly (65 years and older)

If you are older, there may be a higher risk that your kidneys are not working well and that you are being treated with other medicines (see also “Kidney function” above and “Other medicines and Ebymect” below).

Children and young people

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 get an injection into the bloodstream with contrast agents that contain iodine, for example in connection with X-rays or computed tomography, you must stop taking Ebymect before or at the time of injection. Your doctor will decide when you need to stop taking Ebymect and when you should start taking it again.

Tell your doctor if you are taking, have recently taken, or might take any other medicines. You may need to do more blood sugar and kidney function tests, or your doctor may need to adjust the dose of one of Ebymect. You must mention the following:

  • if you are taking medicines that increase urine production ( diuretics ). Your doctor may ask you to stop taking this medicine. Possible symptoms of loss of excess fluid from the body are listed at the beginning of section 4.
  • if you are taking other medicines that lower your blood sugar, such as insulin or a sulphonylurea. Your doctor may want to lower the dose of one of the other medicines to prevent you from getting too low blood sugar levels (hypoglycemia).
  • if you are taking cimetidine, a medicine used to treat stomach problems.
  • if you are using tracheal dilators (beta ‑ 2‑ agonists ) which are used to treat asthma.
  • if you are using corticosteroids (used to treat inflammation in diseases such as asthma and arthritis ) given orally, as an injection or inhalation.
  • if you are taking medicines used to treat pain and inflammation ( NSAIDs and COX 2 inhibitors, such as ibuprofen and celecoxib).
  • if you are taking certain medicines to treat high blood pressure ( ACE inhibitors and angiotensin II receptor antagonists).

Ebymect with alcohol

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

Pregnancy and breastfeeding

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, as it is not recommended during the second and third trimesters of pregnancy (last six months of pregnancy). Talk to your doctor about the best way to control your blood sugar when you are pregnant.

Talk to your doctor if you want to breast-feed or breast-feeding before taking this medicine. Do not use this medicine if you are breast-feeding. Metformin passes into 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 effect 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 sulphonylurea, can cause too low blood sugar levels (hypoglycemia), which can cause symptoms such as weakness, dizziness, increased sweating, rapid heartbeat, change in vision or difficulty concentrating and affect your ability to drive and use machines. Do not drive or use any tools or machines if you start to feel these symptoms.

Ebymect contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’.

3. How to take Ebymect

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

How much medicine to take

  • The amount of this medicine you will 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 what dose of this medicine to take.
  • The recommended dose is one tablet twice a day.

How to take the medicine

  • Swallow the tablet whole with half a glass of water.
  • Take the tablet with meals. It reduces the risk of side effects in the stomach.
  • Take the tablet twice daily, once in the morning (breakfast) and one in the evening (dinner).

Your doctor may prescribe this medicine together with one or more other medicines to lower your blood sugar levels. These can be medicines taken by mouth or given by injection, e.g. insulin or a GLP ‑ 1‑ receptor agonist. Remember to take these other medicines according to your doctor’s instructions. It gives the best result for your health.

Diet and exercise

To control your diabetes, you need to eat the right diet and exercise, even while taking this medicine. Therefore, it is important to continue to follow the advice on diet and exercise that you have received from a doctor, pharmacist, or nurse. Especially if you are following a diabetic weight control diet, you should continue to follow it while taking this medicine.

If you take more Ebymect than you should

If you have taken too many Ebymect tablets, you may get lactic acidosis. The symptoms of lactic acidosis are severe nausea, vomiting, stomach pain, muscle cramps, severe fatigue, or difficulty breathing. If this happens to you, you may need immediate hospitalization, as lactic acidosis can lead to coma. Stop taking this medicine immediately and contact your doctor or nearest hospital immediately (see section 2). Take the medicine pack with you.

If you forget to take Ebymect

If you forget to take 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 go back to your regular schedule. 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 rise if you do not take this medicine.

If you have any further questions on the use of this product, 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 immediately if you notice any of the following serious or potentially serious side effects:

  • Lactic acidosis, which is very rare (may affect up to 1 in 10,000 people)Ebymect can cause a very rare but very serious side effect a lactic acidosis (see section “Warnings and Precautions”). If this happens to you, you must stop taking Ebymect and contact a doctor or nearest hospital immediately as lactic acidosis may lead to coma.

Contact your doctor or nearest hospital immediately if you get any of the following side effects:

  • Diabetic ketoacidosis, rare (may affect up to 1 in 1 000)

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

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

This can occur regardless of the blood glucose level. Your doctor may decide to temporarily or permanently discontinue treatment with Ebymect.
 

  • Necrotizing fasciitis of the perineum or Fournier’s gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the rectum, is very rare.

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

  • Dehydration: loss of too much fluid from the body is less common (may affect up to 1 in 100 people).

These are signs of dehydration:

  • very dry or sticky mouth, strong thirst
  • very sleepy or tired
  • little or no urine
  • fast heartbeat.
  • Urinary tract infection is common (may affect up to 1 in 10 people).

These are signs of a severe urinary tract infection:

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

Although less common, tell your doctor immediately if you notice any blood in your urine.

Contact a doctor as soon as possible if you notice any of the following side effects:

  • Low blood sugar (hypoglycemia) is very common (may affect more than 1 in 10 people) – when you take this medicine with a sulphonylurea or other medicines that lower the amount of sugar in your blood, such as insulin.

These are signs of low blood sugar:

  • tremors, sweating, strong anxiety, rapid heartbeat
  • feeling hungry, headache, vision changes
  • mood swings or confusion.

Your doctor can tell you how to treat low blood sugar levels and what to do if you get any of the above symptoms. If you have symptoms of low blood sugar, eat glucose tablets, a high sugar snack, or drink fruit juice. Measure your blood sugar if possible and rest.

Other side effects are:

Very common

  • nausea, vomiting
  • diarrhea or stomach pain
  • lost appetite

Usual

  • genital infection (cod) on the penis or vagina (may cause irritation, itching, abnormal discharge, or odor)
  • back pain
  • discomfort when urinating, the greater amount of urine than usual, or need to urinate more often
  • changes in blood cholesterol or blood fat levels (shown by tests)
  • increases in the number of red blood cells in the blood (shown by tests)
  • decreased renal excretion of creatinine (shown by tests) at the beginning of treatment
  • taste changes
  • dizziness
  • rash

Less common

  • fungal infection
  • thirst
  • constipation
  • waking up at night to have to pee
  • dry mouth
  • weight loss
  • increase in creatinine (shown by laboratory blood tests) at the beginning of treatment
  • increases in urea (shown by laboratory blood tests)

Very rare

  • decreased levels of vitamin B12 in the blood
  • abnormal liver function tests, liver inflammation ( hepatitis )
  • redness ( erythema ), itching, or an itchy rash (hives).

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 expiration date is the last day of the specified month.

This medicine does not require any special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substances are dapagliflozin and metformin hydrochloride ( metforminHCl ).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.
  • Other ingredients are:
    • tablet core: hydroxypropylcellulose (E463), microcrystalline cellulose (E460 (i)), magnesium stearate (E470b), sodium starch glycolate (type A).
    • film coating: poly (vinyl alcohol) (E1203), macrogol (3350) (E1521), talc (E553b), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) (Ebymect 5 mg / 850 mg only).

What the medicine looks like and the contents of the pack

  • Ebymect 5 mg / 850 mg are 9.5 x 20 mm oval, brown, film-coated tablets. It says “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. It says “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 / Alum blisters. The pack sizes are 14, 28, 56 and 196 (2 packs 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 60 x 1 film-coated tablets in perforated single-dose blisters.

Not all pack sizes may be marketed in your country.

Manufacturer

AstraZeneca GmbH

Tinsdaler Weg 183

22880 Wedel

Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienAstraZeneca SA / NVTel: +32 2 370 48 11 LithuaniaUAB AstraZeneca LietuvaTel: +370 5 2660550
BulgariaAstrology Bulgaria BODYTel: +359 (2) 44 55 000 Luxembourg / LuxemburgAstraZeneca SA / NVTel: +32 2 370 48 11
Czech RepublicAstraZeneca Czech Republic sroTel: +420 222 807 111 HungaryAstraZeneca Kft.Tel .: +36 1 883 6500
DenmarkAstraZeneca A / STel: +45 43 66 64 62 MaltaAssociated Drug Co. Ltd.Tel: +356 2277 8000
GermanyAstraZeneca GmbHTel: +49 41 03 7080 The NetherlandsAstraZeneca BVTel: +31 79 363 2222
EestiAstraZenecaTel: +372 6549 600 NorwayAstraZeneca ASTel: +47 21 00 64 00
GreeceAstraZeneca AE:Ηλ: +30 2 106871500 AustriaAstraZeneca Österreich GmbHTel: +43 1 711 31 0
SpainEsteve Pharmaceuticals, SATel: +34 93 446 60 00
Laboratory Tau, SATel: +34 91 301 91 00
PolandAstraZeneca Pharma Poland Sp. z ooTel .: +48 22 874 35 00
FranceAstraZenecaTel: +33 1 41 29 40 00 PortugalBIAL-Portela & Cª., SATel .: +351 22 986 61 00
CroatiaAstraZeneca dooTel: +385 1 4628 000 RomaniaAstraZeneca Pharma SRLTel: +40 21 317 60 41
IrelandAstraZeneca Pharmaceuticals (Ireland) DACTel: +353 1609 7100 SloveniaAstraZeneca UK LimitedTel: +386 1 51 35 600
IcelandVistor hf.Phone: +354 535 7000 Slovak RepublicAstraZeneca AB, ozTel: +421 2 5737 7777
ItalyAstraZeneca SpATel: +39 02 9801 1 Finland / FinlandAstraZeneca OyPuh / Tel: +358 10 23 010
LatviaSIA AstraZeneca LatvijaTel: +371 67377100 United KingdomAstraZeneca UK LtdTel: +44 1582 836 836

Muhammad Nadeem

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