Patient Information Leaflet

Segluromet 2.5mg/850mg Film-Coated Tablets

Segluromet 2.5mg/1000mg Film-Coated Tablets

Segluromet 7.5mg/850mg Film-Coated Tablets

Segluromet 7.5mg/1000mg Film-Coated Tablets

ertugliflozina/metformina hidrocloruro

Read this 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. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section4.

1.What is Segluromet and what it is used for

2.What you need to know before starting Segluromet

3.How to take Segluromet

4.Possible side effects

5.Storage of Segluromet

6.Contents of the pack and additional information

What is Segluromet

Segluromet contains two active ingredients, ertugliflozina and metformina. Each one belongs to a group of medications called "oral antidiabetic medications". These are medications taken by mouth to treat diabetes.

• Ertugliflozina belongs to a group of medications called sodium-glucose cotransporter 2 (SGLT2) inhibitors.
• Metformina belongs to a group of medications called biguanides.

What is Segluromet used for

• Segluromet reduces blood sugar levels in adult patients (18 years and older) with type 2 diabetes.
• It may also help prevent heart failure in patients with type 2 diabetes.
• Segluromet can be used instead of taking separate tablets of ertugliflozina and metformina.
• Segluromet can be used alone or in combination with other medications that reduce blood sugar levels.
• You must follow your diet and exercise plan while taking Segluromet.

How Segluromet works

• Ertugliflozina acts by blocking the SGLT2 protein in the kidneys. This causes the sugar in the blood to be eliminated through urine.
• Metformina acts by reducing the production of sugar (glucose) in the liver.

What is type 2 diabetes?

Type 2 diabetes is a disease in which the body does not produce enough insulin or the insulin produced by the body does not function as well as it should. This leads to high blood sugar levels. When this occurs, it can cause serious medical problems, such as heart disease, kidney disease, blindness, and poor circulation.

Do not take Segluromet

• if you are allergic to ertugliflozin or metformin or any of the other ingredients of this medication (listed in section6).
• if your kidney function is severely impaired or you need dialysis.
• if you have uncontrolled diabetes, accompanied by for example, severe hyperglycemia (elevated blood glucose), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis. Ketoacidosis is a disorder in which ketone bodies accumulate in the blood and can end in diabetic precoma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness or unusual sweet-smelling breath.
• if you have a severe infection or are dehydrated.
• if you have recently had a heart attack or have severe circulatory problems, such as "shock" or difficulty breathing.
• if you have liver problems.
• if you drink large amounts of alcohol, either regularly or occasionally (see section "Segluromet with alcohol").

Do not take Segluromet if you are affected by any of the above situations. If you are unsure, consult your doctor before taking Segluromet.

Warnings and precautions

Risk of lactic acidosis

Segluromet may cause a rare but serious side effect called lactic acidosis, especially if your kidneys do not function properly. The risk of lactic acidosis also increases in cases of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see additional information below), liver problems, and any disease in which a part of the body receives insufficient oxygen (such as acute and severe heart disease).

If you are affected by any of the above situations, consult your doctor for further instructions.

Stop taking Seglurometfor 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 fluid than normal. Consult your doctor for additional instructions.

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

The symptoms of lactic acidosis include:

• vomiting
• abdominal pain (abdominal pain)
• muscle cramps
• general feeling of being unwell with intense fatigue
• difficulty breathing
• decreased body temperature and heart rate
• Lactic acidosis is a medical emergency and should be treated in a hospital.

Consult your doctor, pharmacist, or nurse before starting to take and during treatment with Segluromet if you:

• have kidney problems.Your doctor may perform blood tests to check your kidney function.
• have or have had urinary tract infections.
• have or have had fungal infections of the vagina or penis.
• have type1 diabetes. Segluromet should not be used to treat this disease as it may increase the risk of diabetic ketoacidosis in these patients.
• are taking other diabetes medications; it is more likely that you will have low blood sugar with certain medications.
• may be at risk of dehydration (for example, if you take medications that increase urine production [diuretics] or have low blood pressure or if you are over 65years old). Ask about ways to prevent dehydration.
• experience rapid weight loss, nausea or vomiting, abdominal pain, excessive thirst, rapid and deep breathing, confusion, drowsiness or unusual fatigue, sweet-smelling breath, sweet or metallic taste in the mouth or unusual odor of urine or sweat, contact a doctor or go to the nearest hospital immediately. These symptoms may be a sign of “diabetic ketoacidosis”, a complication that you may have with diabetes due to an increase, detected in tests, of “ketone bodies” in urine or blood. The risk of developing diabetic ketoacidosis may increase in cases of prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose or increased need for insulin due to major surgery or severe illness.

It is essential that you regularly inspect your feet and follow the advice given by your healthcare professional on foot care.

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

When this medication is used in combination with insulin or medications that increase insulin release by the pancreas, hypoglycemia (low blood sugar) may occur. Your doctor may reduce the dose of your insulin or other medications.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

If you need to undergo major surgery, you should stop taking Segluromet during the procedure and for a certain period of time afterwards. Your doctor will decide when to interrupt and resume your treatment with Segluromet.

During treatment with Segluromet, your doctor will check your kidney function at least once a year or more frequently if you are an elderly person or if your kidney function is worsening.

Blood glucose in urine

Due to the way Segluromet works, your urine will test positive for sugar (glucose) while you are taking this medication.

Children and adolescents

Children and adolescents under 18years should not take this medication. The safety and efficacy of this medication in children and adolescents under 18years have not been established.

Other medications and Segluromet

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

You may need to have blood tests more frequently to check your blood glucose levels and kidney function or your doctor may need to adjust the dose of Segluromet. In particular, inform your doctor:

• if you are taking medications that increase urine production (diuretics).
• if you are taking other medications that lower your blood sugar, such as insulin or medications that increase insulin release by the pancreas.
• if you are taking medications for pain and inflammation (NSAIDs and COX‑2 inhibitors, such as ibuprofen and celecoxib).

• if you are taking certain medications for high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).
• if you are taking corticosteroids (used to treat various diseases, such as severe skin inflammation or asthma).
• if you are taking beta‑2 agonists such as salbutamol or terbutaline (used to treat asthma).
• if you are taking medications that may alter the amount of metformin in your blood, especially if you have reduced renal function (verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib or olaparib).

If you are affected by any of the above situations (or are unsure), inform your doctor.

If you need to receive an injection of a contrast medium containing iodine, for example, in the context of aradiography or scan, you should stop taking Segluromet before or at the time of the injection. Your doctor will decide when to interrupt and resume your treatment with Segluromet.

Segluromet and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

The safety of Segluromet in pregnancy has not been established. If you are pregnant, consult your doctor about the best way to control your blood sugar during pregnancy. Do not use Segluromet if you are pregnant.

The safety of Segluromet in breastfeeding has not been established. Consult your doctor about the best way to feed your baby if you are taking this medication. Do not use Segluromet if you are breastfeeding.

Driving and operating machinery

The influence of this medication on the ability to drive and operate machinery is negligible or insignificant. However, taking this medication in combination with insulin or medications that increase insulin release by the pancreas may cause excessive lowering of blood sugar (hypoglycemia), which may cause symptoms such as tremors, sweating or visual disturbances and may affect your ability to drive and operate machinery. Do not drive or operate tools or machinery if you feel dizzy while taking Segluromet.

Segluromet contains sodium

This medication contains less than 1mmol of sodium (23mg) per tablet; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How much to take

• The recommended dose of Segluromet is one tablet twice a day.
• The dose of Segluromet you should take will depend on your situation and the amounts of ertugliflozina and metformin needed to control your blood sugar levels.
• Your doctor will prescribe the most suitable dose for your case. Do not modify the dose unless instructed by your doctor.

How to take this medication

• Swallow the tablet; if you have difficulty swallowing, the tablet can be broken or crushed.
• Take one tablet twice a day. Try to take it at the same time every day; this will help you remember to take it.
• It is best to take the tablet with a meal. This will reduce the likelihood of stomach discomfort.
• You must follow your diet and exercise plan while taking Segluromet.

If you take more Segluromet than you should

If you take an excessive amount of Segluromet, consult a doctor or pharmacist immediately.

If you forget to take Segluromet

What to do if you forget to take a tablet depends on the time remaining until your next dose.

• If 12 hours or more remain until your next dose, take a dose of Segluromet as soon as you remember. Then take your next dose at the usual time.
• If less than 12 hours remain until your next dose, skip the missed dose. Then take your next dose at the usual time.

Do not take a double dose (two doses at the same time) to compensate for missed doses.

If you interrupt treatment with Segluromet

Do not stop taking this medication without consulting your doctor. If you stop taking the medication, your blood sugar levels may increase.

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.

Contact a doctor or go to the nearest hospital immediately if you experience any of the following serious side effects:

Lactic acidosis (very rare, may affect up to 1 in 10,000 people)

Segluromet may cause a very rare but serious side effect called lactic acidosis (see the "Warnings and precautions" section). If this happens, stop taking Segluromet and contact a doctor or go to the nearest hospital immediately, as lactic acidosis can lead to coma.

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

The following are the signs of diabetic ketoacidosis (also see the "Warnings and precautions" section):

• 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 or fatigue
• sweet or metallic taste in the mouth, or a different odor of urine or sweat

This can occur regardless of your blood glucose levels. Your doctor may decide to temporarily or permanently discontinue your treatment with Segluromet.

Fournier's gangrene or necrotizing fasciitis of the perineum (unknown frequency, cannot be estimated from available data)

A severe infection of the soft tissues of the genitals or the area between the genitals and the anus (see the "Warnings and precautions" section for symptoms).

If you notice any of the previously mentioned side effects, contact a doctor or go to the nearest hospital immediately.

Contact your doctor as soon as possible if you notice the following side effects:

Urinary tract infection (very common, may affect more than 1 in 10 people)

The signs of urinary tract infection are:

• burning sensation while urinating
• cloudy urine
• pelvic or mid-back pain (when kidney infection is present)

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

Dehydration (excessive loss of water from the body; common, may affect up to 1 in 10 people)

The symptoms of dehydration include:

• dry mouth
• sensation of dizziness, fainting, or weakness, especially when standing up
• fainting

You are more likely to become dehydrated if you:

• have kidney problems
• take medications that increase your urine production (diuretics) or have low blood pressure
• are over 65 years old

Low blood sugar (hypoglycemia; common)

Your doctor will instruct you on how to treat low blood sugar and what to do if you experience any of the following symptoms or signs. Your doctor may reduce your insulin dose or the dose of other diabetes medications.

The symptoms and signs of low blood sugar may include:

• headache
• drowsiness
• irritability
• hunger
• dizziness
• confusion
• sweating
• restlessness
• weakness
• rapid heartbeat

If you notice any of the previously mentioned side effects, contact your doctor as soon as possible.

Other side effects include:

Very common

• vaginal yeast infection (candidiasis)
• nausea
• vomiting
• diarrhea
• stomach pain
• loss of appetite

Common

• viral penile infections
• urination changes, including the need to urinate more frequently, in larger amounts, or at night
• thirst
• vaginal itching
• alteration of taste
• blood tests may show changes in the amount of urea in your blood
• blood tests may show changes in the amount of total cholesterol and "bad" cholesterol (called low-density lipoprotein (LDL), a type of fat present in your blood)
• blood tests may show changes in the amount of red blood cells in your blood (called hemoglobin)
• decrease or low levels of vitamin B12 in the blood (symptoms may include extreme fatigue, pain, and inflammation of the tongue (glossitis), tingling (paresthesia), or pale or yellowish skin). Your doctor may request tests to determine the cause of your symptoms because some of them may also be caused by diabetes or other unrelated health problems.

Rare (may affect up to 1 in 100 people)

• blood tests may show changes related to kidney function (such as "creatinine")

Very rare

• liver function test abnormalities
• hepatitis (a liver problem)
• urticaria
• skin redness
• itching

Unknown frequency

• eruption

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through thenational notification systemincluded in theAppendixV. 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 and on the container after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Do not use this medication if you observe that the container is damaged or shows signs of manipulation.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Segluromet

• The active ingredients are ertugliflozina and metformina.
• • Each film-coated tablet of Segluromet 2.5 mg/850 mg contains L-pyroglutamic acid of ertugliflozina, equivalent to 2.5 mg of ertugliflozina and 850 mg of metformin hydrochloride.
  • Each film-coated tablet of Segluromet 2.5 mg/1,000 mg contains L-pyroglutamic acid of ertugliflozina, equivalent to 2.5 mg of ertugliflozina and 1,000 mg of metformin hydrochloride.
  • Each film-coated tablet of Segluromet 7.5 mg/850 mg contains L-pyroglutamic acid of ertugliflozina, equivalent to 7.5 mg of ertugliflozina and 850 mg of metformin hydrochloride.
  • Each film-coated tablet of Segluromet 7.5 mg/1,000 mg contains L-pyroglutamic acid of ertugliflozina, equivalent to 7.5 mg of ertugliflozina and 1,000 mg of metformin hydrochloride.

• The other components are:
• • Core tablet: povidone (K29-32) (E1201), microcrystalline cellulose (E460), crospovidone (E1202), sodium lauryl sulfate (E487), magnesium stearate (E470b)

• Coating with film:Film-coated tablets of Segluromet 2.5 mg/850 mg and film-coated tablets of Segluromet 7.5 mg/850 mg: hypromellose (E464), hydroxypropylcellulose (E463), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172), carnauba wax (E903).

Film-coated tablets of Segluromet 2.5 mg/1,000 mg and film-coated tablets of Segluromet 7.5 mg/1,000 mg: hypromellose (E464), hydroxypropylcellulose (E463), titanium dioxide (E171), iron oxide red (E172), carnauba wax (E903).

Appearance of the product and contents of the package

• Film-coated tablets (tablets) of Segluromet 2.5 mg/850 mg are beige, 18 x 10 mm, oval-shaped, with "2.5/850" engraved on one side and smooth on the other side.
• Film-coated tablets (tablets) of Segluromet 2.5 mg/1,000 mg are pink, 19.1 x 10.6 mm, oval-shaped, with "2.5/1000" engraved on one side and smooth on the other side.
• Film-coated tablets (tablets) of Segluromet 7.5 mg/850 mg are dark brown, 18 x 10 mm, oval-shaped, with "7.5/850" engraved on one side and smooth on the other side.
• Film-coated tablets (tablets) of Segluromet 7.5 mg/1,000 mg are red, 19.1 x 10.6 mm, oval-shaped, with "7.5/1000" engraved on one side and smooth on the other side.

Segluromet is available in Alu/PVC/PA/Alu blister packs. The package sizes are 14, 28, 56, 60, 168, 180, and 196 film-coated tablets in uncut blister packs and 30 film-coated tablets in pre-cut blister packs for single-dose use.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
Netherlands

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last revision date of this leaflet:

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