Label:information for the patient

Xigduo 5mg/850mg film-coated tablets

Xigduo 5mg/1.000mg film-coated tablets

dapagliflozina/hidrocloruro de metformina

Read this label carefully before starting to takethismedicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor,pharmacistor nurse.
• This medicine has been prescribedonlyfor you,and you must not give it to others even if they have the same symptomsas you, as it may harm them.
• Ifyou experienceadverse effects, consult yourdoctororpharmacist, even if they do not appear in this label. See section4.

This medication contains two different active ingredients called dapagliflozina and metformina. Both belong to a group of medications known as “oral antidiabetics”. These are medications taken orally for diabetes.

Xigduo is used for a type of diabetes called “type 2” in adult patients (18 years of age or older) and typically appears when one gets 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 properly. This leads to a high level of sugar (glucose) in your blood.

• Dapagliflozina acts by removing excess sugar from your body through urine and reduces the amount of sugar in your blood. It may also help prevent heart diseases.
• Metformina acts mainly by inhibiting glucose production in the liver.

To treat diabetes:

• This medication is taken in combination with diet and exercise.
• This medication is used if your diabetes cannot be controlled with other medications used to treat diabetes.
• Your doctor may ask you to take this medication alone or with other medications to treat diabetes. This could be another oral medication and/or an injection medication, such as insulin or a GLP-1 receptor agonist (helps your body increase insulin production when your blood sugar is elevated).
• If you are already using dapagliflozina and metformina in individual tablets, your doctor may ask you to switch to this medication. To avoid overdose, do not continue taking the dapagliflozina and metformina tablets if you are taking Xigduo.

It is essential that you continue following the dietary and exercise recommendations provided by your doctor, pharmacist, or nurse.

Do not take Xigduo:

• if you are allergic to dapagliflozin, metformin, or any of the other ingredients in this medication (listed in section6).
• if you have 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” accumulate in the blood, which can lead to a pre-coma diabetic state. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or if your breath develops an unusual fruity odor.
• if you have severe kidney function reduction.
• if you have a severe infection.
• if you have lost a significant amount of body water (dehydration), for example, due to prolonged or severe diarrhea, 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 any serious blood circulation problem or difficulty breathing.
• if you have liver problems.
• if you consume large amounts of alcohol, every day or only occasionally (see section“Xigduo and alcohol”).

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

Warnings and precautions

Risk of lactic acidosis

Xigduo 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 excessive 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 diseases).

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

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

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

The symptoms of lactic acidosis include:

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

Consult your doctor, pharmacist, or nurse before starting to take Xigduo, and during treatment:

• if you have “type1” diabetes‑the type that typically appears when young and your body does not produce any insulin. Xigduo should not be used to treat this disease.
• if you experience rapid weight loss, nausea, vomiting, stomach pain, excessive thirst, rapid and deep breathing, confusion, drowsiness, and unusual fatigue, contact a doctor or the nearest hospital immediately. These symptoms may be a sign of “diabetic ketoacidosis” – a rare but serious condition, sometimeslife-threateningthat occurs with diabetes due to an increase in “ketone bodies” in your urine or blood, which is detected 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 greater need for insulin due to major surgery or a serious illness.
• if you have any kidney problems. Your doctor will check your kidney function.
• if you have very high blood sugar levels that may cause dehydration (losing too much body fluid). The possible signs of dehydration are listed in section4. Inform your doctor before starting to take this medication if you experience any of these signs.
• if you are taking medications to lower your blood pressure (antihypertensives) or have a history of low blood pressure (hypotension). More information is included later in “Xigduo and other medications”.
• if you frequently have urinary tract infections. This medication may cause urinary tract infections, and your doctor may want to monitor you more closely. Your doctor may consider changing your treatment temporarily if you develop a severe infection.

If you need to undergo major surgery, stop taking Xigduo while the procedure is being performed and for a time after it. Your doctor will decide when to interrupt treatment with Xigduo and when to resume it.

It is essential to regularly monitor your feet and follow any other foot care advice provided by your healthcare professional.

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

Consult your doctor immediately if you experience a combination of symptoms such as pain, tenderness, redness, or inflammation of the genitals or the area between the genitals and the anus, with fever or general discomfort. These symptoms may be a sign of a rare but potentially fatal condition called necrotizing fasciitis of the perineum or Fournier's gangrene, which destroys tissue under the skin. Fournier's gangrene should be treated immediately.

Kidney function

During treatment withXigduo, your doctor will check your kidney function at least once a year or more frequently if you are an older person and/or if your kidney function is deteriorating.

Blood sugar in urine

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

Children and adolescents

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

Xigduo and other medications

If you need to receive an intravenous injection of a contrast medium containing iodine, for example, in the context of an X-ray or examination, stop taking Xigduo before the injection or at the time of the injection.Your doctor will decide when to interrupt treatment withXigduoand when to resume it.

Inform your doctor if you are taking, have taken recently, or may need to take any other medication. You may need more frequent blood sugar and kidney function tests, or your doctor may need to adjust the dose of Xigduo. It is especially important to mention the following:

• if you are taking a medication used to eliminate body fluid (diuretic).
• if you are taking other medications that lower blood sugar, such as insulin or a “sulfonilurea” type medication. Your doctor may decide to reduce the dose of these medications to avoid low blood sugar (hypoglycemia).
• if you are taking lithium, as Xigduo may reduce lithium levels in the blood.
• if you are taking cimetidine, a medication 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 usingmedications used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib).
• if you are usingmedications used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).

Xigduo and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist 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 blood sugar levels during pregnancy.

Consult your doctor if you want to breastfeed or are breastfeeding before taking this medication. Do not usethis medicationwhile breastfeeding. Metformin passes into human milk in small amounts. It is unknown whether dapagliflozin passes into breast milk.

Driving and operating machines

This medication has no or negligible influence on your ability to drive or operate machines. Taking it with other medications that lower blood sugar, such as insulin or a “sulfonilurea” type medication, may cause very low blood sugar (hypoglycemia), which may cause symptoms such as weakness, dizziness, increased sweating, rapid heartbeat, visual disturbances, or difficulty concentrating, which may affect your ability to drive or operate machines. Do not drive or use tools or machines if you start to feel these symptoms.

Sodium content

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

Follow exactly the administration instructions of this medication as indicated by your doctor.This medication.In case of doubt, consult your doctor or pharmacist again.

How much to take

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

How to take this medication

• 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, once in the morning (breakfast) and once in the evening (dinner).

Your doctor may prescribe you this medication along with another medication(s) to reduce the amount of sugar in your blood. These may be oral medications or administered by injection, such as insulin or a GLP-1 receptor agonist. Remember to take these other medication(s) following your doctor's instructions. This will help you achieve the best results for your health.

Diet and exercise

To control your diabetes, you must continue with your diet and exercise, even when taking this medication. Therefore, it is essential to continue following the dietary and exercise recommendations from 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 Xigduo than you should

If you take more Xigduo tablets than you should, you may experience lactic acidosis. Symptoms of lactic acidosis include having many 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 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 forgot to take Xigduo

If you forgot 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 compensate for the missed doses.

If you interrupt treatment with Xigduo

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

If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.

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

Stop taking Xigduo and consult a doctor immediately if you notice any of these severe or potentially severe side effects:

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

Xigduo may cause a very rare but serious side effect called lactic acidosis (see section 2 “Warnings and precautions”), If this happens to you,you must stop taking Xigduo 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 side 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”):

• Increased levels of "ketone bodies" in your urine or blood
• rapid weight loss
• nausea or vomiting
• abdominal pain
• excessive thirst
• rapid and deep breathing
• confusion
• unusual drowsiness and fatigue
• sweet or metallic taste in your mouth, or a different odor in your urine or sweat.

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

• Necrotizing fasciitis of the perineum or 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 Xigduo and consult a doctor as soon as possible if you notice any of the following severe or potentially severe side 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
• burning sensation while urinating
• back or side pain.

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

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

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

The signs of decreased blood sugar levels 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 decreased blood sugar levels and what to do if you experience any of the above symptoms. If you have symptoms of decreased blood sugar levels, take glucose tablets, a high-sugar snack, or drink a fruit juice. Measure your blood sugar level, if possible, and rest.

Other side effects include:

Very common

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

Common

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

Rare(may affect up to 1 in 100 people)

• excessive loss of body fluids (dehydration, the signs may include dry or sticky mouth, infrequent or no urination, or rapid heartbeat)
• thirst
• constipation
• nocturnal awakenings due to the need to urinate
• dry mouth
• weight loss
• increase in creatinine (observed in blood tests) at the start of treatment
• increase in urea(observedin 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 side effects

If you experience any type of side effect, consulta doctor,pharmacistor nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational reporting system included in theAppendix V.

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

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

Do not use this medication after the expiration date that appears on the blister pack or container 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 through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Xigduo

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

Each film-coated tablet of Xigduo 5 mg/850 mg contains dapagliflozina propanodiol monohydrate equivalent to 5 mg of dapagliflozina and 850 mg of metformin hydrochloride.

Each film-coated tablet of Xigduo 5 mg/1,000 mg contains dapagliflozina propanodiol monohydrate equivalent to 5 mg of dapagliflozina and 1,000 mg of metformin hydrochloride.

• The other components 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 Xigduo 5 mg/850 mg).

Appearance of the product and contents of the pack

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

Xigduo 5 mg/850 mg film-coated tablets and Xigduo 5 mg/1,000 mg film-coated tablets are available in PVC/PCTFE/Alu blisters. The pack sizes are 14, 28, 56, and 60 film-coated tablets in uncut blisters, 60x1 film-coated tablets in pre-cut single-dose blisters, and multiple packs of 196 (2 packs of 98) film-coated tablets in uncut blisters.

Only some pack sizes may be marketed in your country.

Marketing Authorization Holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Responsible for manufacturing

AstraZeneca AB

Gärtunavägen

SE-152 57 Södertälje

Sweden

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of thissummary of product characteristics:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu