SEGLUROMET 7.5 mg/1000 mg FILM-COATED TABLETS

2. What you need to know before you take Segluromet

Do not take Segluromet

• if you are allergic to ertugliflozin or metformin or any of the other ingredients of this medicine (listed in section 6).
• if your kidneys are severely impaired or you need dialysis.
• if you have uncontrolled diabetes, accompanied by, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or diabetic ketoacidosis. Diabetic ketoacidosis is a condition where substances called "ketone bodies" build up in the blood and can lead to diabetic precoma. The symptoms include stomach pain, rapid and deep breathing, drowsiness, or unusual fruity odor of the 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 from time to time (see section "Segluromet with alcohol").

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

Warnings and precautions

Risk of lactic acidosis

Segluromet may cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys are not working properly. The risk of lactic acidosis also increases in case of uncontrolled diabetes, severe infections, prolonged fasting, or alcohol consumption, dehydration (see additional information below), liver problems, and any condition in which a part of your body is not getting enough oxygen (such as acute and severe heart disease).

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

Consult your doctor immediately for guidance on what to do if:

• You know you have a genetic disorder that affects the mitochondria (the energy-producing parts within cells), such as MELAS syndrome (mitochondrial encephalomyopathy, 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, deterioration of cognitive abilities, difficulty with body movements, symptoms indicating nerve damage (e.g., pain or numbness), migraine, and hearing loss.

Stop taking Segluromet for a short period of time 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 guidance.

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 lead to coma.

The symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general feeling of not being well 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 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 type 1 diabetes. Segluromet should not be used to treat this condition as it may increase the risk of diabetic ketoacidosis in these patients.
• take other medicines for diabetes; it is more likely that you will have low blood sugar with certain medicines.
• may be at risk of dehydration (for example, if you take medicines that increase urine production [diuretics] or have low blood pressure or are over 65 years of age). Ask about ways to prevent dehydration.
• experience rapid weight loss, nausea, or vomiting, stomach pain, excessive thirst, rapid and deep breathing, confusion, drowsiness, or unusual fatigue, sweet odor of the breath, sweet or metallic taste in the mouth, or a different odor of urine or sweat, contact a doctor or go to the nearest hospital immediately. These symptoms could be a sign of "diabetic ketoacidosis", a problem you may have with diabetes due to an increase in "ketone bodies" in urine or blood. The risk of diabetic ketoacidosis may increase in case of prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or increased need for insulin due to major surgery or serious illness.

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

Consult your doctor immediately if you experience a combination of symptoms of pain, tenderness, redness, or swelling of the genitals or the area between the genitals and the anus, with fever or general feeling of being unwell. These symptoms could be a sign of a rare but serious infection, including potentially life-threatening, 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 medicine is used in combination with insulin or medicines that increase insulin release from the pancreas, it may cause a drop in blood sugar levels (hypoglycemia). Your doctor may reduce the dose of your insulin or other medicines.

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

If you need to undergo major surgery, you should stop taking Segluromet during and for some time after surgery. Your doctor will decide when you should stop and restart 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.

Glucose in urine

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

Children and adolescents

Children and adolescents under 18 years of age should not take this medicine. It is not known if this medicine is safe and effective when used in children and adolescents under 18 years of age.

Other medicines and Segluromet

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

• if you are taking medicines that increase urine production (diuretics).
• if you are taking other medicines that reduce blood sugar levels, such as insulin or medicines that increase insulin release from the pancreas.
• if you are taking medicines for pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib).

• if you are taking certain medicines 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 medicines that may affect the amount of metformin in your blood, especially if you have reduced kidney 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), tell your doctor.

If you need to receive an injection into your bloodstream of a contrast medium that contains iodine, for example, for an X-ray or scan, you should stop taking Segluromet before or at the time of the injection. Your doctor will decide when you should stop and restart your treatment with Segluromet.

Taking Segluromet with 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, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is not known if Segluromet is harmful to the unborn baby. If you are pregnant, consult your doctor about the best way to control your blood sugar levels during pregnancy. You should not use Segluromet if you are pregnant.

It is not known if Segluromet passes into breast milk. Consult your doctor about the best way to feed your baby if you are taking this medicine. You should not use Segluromet if you are breastfeeding.

Driving and using machines

The effect of this medicine on your ability to drive or use machines is negligible or non-existent. However, taking this medicine in combination with insulin or medicines that increase insulin release from the pancreas may cause a drop in blood sugar levels (hypoglycemia), which can cause symptoms such as trembling, sweating, or changes in vision and may affect your ability to drive or use machines. Do not drive or operate tools or machines if you feel dizzy while taking Segluromet.

Segluromet contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Segluromet

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.

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 ertugliflozin and metformin needed to control your blood sugar levels.
• Your doctor will prescribe the most suitable dose for you. Do not change the dose unless your doctor tells you to.

How to take this medicine

• Swallow the tablet; if you have difficulty swallowing, the tablet can be split 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 upset.
• You should continue to follow your diet and exercise plan while taking Segluromet.

If you take more Segluromet than you should

If you take more Segluromet than you should, consult a doctor or pharmacist immediately.

If you forget to take Segluromet

What you should do if you miss a dose depends on how much time is left before your next dose.

• If it is 12 hours or more before your next dose, take a dose of Segluromet as soon as you remember. Then take your next dose at the usual time.
• If it is less than 12 hours before 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 make up for missed doses.

If you stop taking Segluromet

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

If you have any other questions about the use of this medicine, 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.

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

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

Segluromet may cause a very rare but very serious adverse effect called lactic acidosis (see section “Warnings and Precautions”). 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 signs of diabetic ketoacidosis are listed below (also see the section “Warnings and Precautions”):

• increase in “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 breath odor, sweet taste or metallic taste in the mouth, or a different odor of urine or sweat

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

Necrotizing Fasciitis of the Perineum or Fournier's Gangrene (frequency not known, 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 section “Warnings and Precautions” for symptoms).

If you notice any of the aforementioned adverse effects, contact a doctor or go to the nearest hospital immediately.

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

Urinary Tract Infection (very common, may affect more than 1 in 10 people)

The signs of urinary tract infection are:

• burning sensation when urinating
• cloudy urine
• pelvic or middle back pain (when kidneys are infected)

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

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

The symptoms of dehydration include:

• dry mouth
• 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 urine production (diuretics) or have low blood pressure
• are over 65 years old

Low Blood Sugar (Hypoglycemia; common)

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

The signs and symptoms of low blood sugar may include:

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

If you notice any of the aforementioned adverse effects, contact your doctor as soon as possible.

Other Adverse Effects Include:

Very Common

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

Common

• penile fungal infections
• urination disorders, including urgent need to urinate more frequently, in larger amounts, or at night
• thirst
• vaginal itching
• taste disturbance
• 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 (low-density lipoprotein (LDL) cholesterol, a type of fat in your blood)
• blood tests may show changes in the amount of red blood cells in your blood (hemoglobin)
• decrease or low levels of vitamin B12 in blood (symptoms may include extreme fatigue, pain, and redness 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.

Uncommon (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

Frequency Not Known

• rash

Reporting Adverse Effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects 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 help provide more information on the safety of this medicine.

5. Storage of Segluromet

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

Do not use this medicine after the expiration date stated on the blister pack and carton after EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Segluromet

• The active ingredients are ertugliflozin and metformin.

• Each film-coated tablet of Segluromet 2.5 mg/850 mg contains L-pyroglutamic acid ertugliflozin, equivalent to 2.5 mg of ertugliflozin and 850 mg of metformin hydrochloride.
• Each film-coated tablet of Segluromet 2.5 mg/1,000 mg contains L-pyroglutamic acid ertugliflozin, equivalent to 2.5 mg of ertugliflozin and 1,000 mg of metformin hydrochloride.
• Each film-coated tablet of Segluromet 7.5 mg/850 mg contains L-pyroglutamic acid ertugliflozin, equivalent to 7.5 mg of ertugliflozin and 850 mg of metformin hydrochloride.
• Each film-coated tablet of Segluromet 7.5 mg/1,000 mg contains L-pyroglutamic acid ertugliflozin, equivalent to 7.5 mg of ertugliflozin and 1,000 mg of metformin hydrochloride.

• Other ingredients are:

• Tablet core: povidone (K29-32) (E1201), microcrystalline cellulose (E460), crospovidone (E1202), sodium lauryl sulfate (E487), magnesium stearate (E470b)
• Film coating: Segluromet 2.5 mg/850 mg and Segluromet 7.5 mg/850 mg tablets: hypromellose (E464), hydroxypropylcellulose (E463), titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), carnauba wax (E903).
• Segluromet 2.5 mg/1,000 mg and Segluromet 7.5 mg/1,000 mg tablets: hypromellose (E464), hydroxypropylcellulose (E463), titanium dioxide (E171), red iron oxide (E172), carnauba wax (E903).

Appearance of the Product and Package Contents

• The 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.
• The 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.
• The 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.
• The 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 blisters. The pack sizes are 14, 28, 56, 60, 168, 180, and 196 film-coated tablets in non-perforated blisters and 30 film-coated tablets in perforated unit-dose blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

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