Segluromet 7.5 mg/1000 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

ertugliflozin/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 others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Segluromet is and what it is used for
2. What you need to know before taking Segluromet
3. How to take Segluromet
4. Possible side effects
5. How to store Segluromet
6. Contents of the pack and other information

1. What Segluromet is and what it is used for

What Segluromet is

Segluromet contains two active substances, ertugliflozin and metformin. Each belongs to a group of medicines called "oral antidiabetics." These are medicines taken by mouth to treat diabetes.

• Ertugliflozin belongs to a group of medicines known as sodium-glucose cotransporter 2 (SGLT2) inhibitors.
• Metformin belongs to a group of medicines known as biguanides.

What Segluromet is used for

• Segluromet lowers blood sugar levels in adult patients (aged 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 ertugliflozin and metformin tablets.
• Segluromet can be used alone or together with other medicines that lower blood sugar.
• You must continue to follow your diet and exercise plan while taking Segluromet.

How Segluromet works

• Ertugliflozin works by blocking the SGLT2 protein in your kidneys. This causes blood sugar to be removed from your body through your urine.
• Metformin works by reducing the production of sugar (glucose) in the liver.

What is type 2 diabetes?

Type 2 diabetes is a condition in which your body does not produce enough insulin or the insulin your body produces does not work 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.

2. What you need to know before starting 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 kidney function is severely impaired or you require dialysis.
• if you have uncontrolled diabetes, accompanied for example by 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” accumulate in the blood and may lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or unusual fruity-smelling breath.
• if you have a serious infection or are dehydrated.
• if you have recently had a heart attack or have serious 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 any of the above apply to you. If you are unsure, consult your doctor before taking Segluromet.

Warnings and precautions

Risk of lactic acidosis

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

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

Contact your doctor immediately for guidance if:

• You are known to have a genetic mitochondrial disease (diseases affecting the energy-producing components inside cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• You develop any of the following symptoms after starting treatment with metformin: seizures, cognitive decline, difficulty with body movements, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Stop taking Segluromet temporarily if you develop a condition that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you are drinking less fluid than usual. Consult your doctor for further advice.

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

Symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general feeling of being unwell with severe fatigue
• difficulty breathing
• decreased body temperature and heart rate

Lactic acidosis is a medical emergency and must 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.
• are taking other diabetes medications; you may be more likely to experience low blood sugar with certain medications.
• may be at risk of dehydration (for example, if you are taking medications that increase urine production [diuretics], 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 tiredness, sweet-smelling 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 signs of “diabetic ketoacidosis,” a condition that may occur in diabetes due to an increase, detected in tests, of “ketone bodies” in urine or blood. The risk of diabetic ketoacidosis may increase during prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or increased insulin requirements due to major surgery or serious illness.

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

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

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

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

If you need to undergo major surgery, you must stop taking Segluromet during the procedure and for a certain time afterward. 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 elderly or if your kidney function is worsening.

Glucose in urine

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

Children and adolescents

Children and adolescents under 18 years of age must not take this medicine. It is unknown whether this medicine is safe and effective in children and adolescents under 18 years of age.

Other medicines and Segluromet

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

You may need more frequent blood glucose and kidney function tests, 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 blood sugar, such as insulin or medications that increase insulin release from 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 conditions, 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 kidney function (verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, or olaparib).

If any of the above apply to you (or if you are unsure), inform your doctor.

If you need to receive an intravenous contrast agent containing iodine, for example during an X-ray or CT scan, you must stop taking Segluromet before or at the time of the injection. Your doctor will decide when to interrupt and resume your treatment with Segluromet.

Taking Segluromet with alcohol

Avoid excessive alcohol consumption while taking Segluromet, as this could 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 using this medicine.

It is unknown whether Segluromet is harmful to the fetus. If you are pregnant, consult your doctor about the best way to manage your blood sugar during pregnancy. You must not use Segluromet if you are pregnant.

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

Driving and using machines

The effect of this medicine on the ability to drive and use machines is negligible or none. However, taking this medicine in combination with insulin or medications that increase insulin release from the pancreas may cause excessively low blood sugar levels (hypoglycemia), which may lead to symptoms such as trembling, sweating, or vision disturbances and may affect your ability to drive and use machines. Do not drive or operate tools or machinery if you feel dizzy while taking Segluromet.

Segluromet contains sodium

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

3. How to take Segluromet

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, check with your doctor or pharmacist again.

How much to take

• The recommended dose of Segluromet is one tablet twice daily.
• The dose of Segluromet you should take will depend on your condition and the amounts of ertugliflozin and metformin needed to control your blood sugar levels.
• Your doctor will prescribe the most appropriate dose for you. Do not change the dose unless your doctor has instructed you to do so.

How to take this medicine

• Swallow the tablet whole; if you have difficulty swallowing, the tablet may be split or crushed.
• Take one tablet twice daily. Try to take it at the same time each 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 continue to follow your diet and exercise plan while taking Segluromet.

If you take more Segluromet than you should

If you take too much Segluromet, contact a doctor or pharmacist immediately.

If you forget to take Segluromet

What you should do if you forget to take a dose depends on how long it is until your next dose.

• If there are 12 hours or more until your next dose, take the missed dose as soon as you remember. Then take your next dose at the usual time.
• If there are less than 12 hours 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 make up for a missed dose.

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 further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this occurs, 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 signs of diabetic ketoacidosis (also see section “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
• drowsiness or unusual tiredness
• sweet smell on the breath, sweet or metallic taste in the mouth, or a different smell in 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 serious infection of the soft tissues of the genitals or the area between the genitals and the anus (see section “Warnings and precautions” for symptoms).

If you notice any of the above-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)

Signs of urinary tract infection include:

• burning sensation when urinating
• cloudy-looking urine
• pain in the pelvis or middle back (when the kidneys are infected)

Although uncommon, 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)

Symptoms of dehydration include:

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

You are more likely to become dehydrated if you:

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

Low blood sugar (hypoglycaemia; common)

Your doctor will advise you on how to treat low blood sugar and what to do if you experience any of the symptoms listed below. Your doctor may reduce your dose of insulin or other diabetes medicines.

Signs and symptoms of low blood sugar may include:

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

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

Other side effects include:

Very common

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

Common

• fungal infections of the penis
• urinary problems, including a sudden need to urinate more frequently, in larger amounts, or at night
• thirst
• vaginal itching
• altered 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) cholesterol, a type of fat in your blood)
• blood tests may show changes in the amount of red blood cells in your blood (called haemoglobin)
• decreased or low levels of vitamin B12 in the blood (symptoms may include extreme tiredness (fatigue), pain and redness of the tongue (glossitis), tingling (paraesthesia), or pale or yellowish skin). Your doctor may order 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)

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

Very rare

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

Frequency not known

• rash

Reporting of side effects

If you experience any side effect, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Segluromet

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister pack and outer packaging following EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Pack contents and other information

Composition of Segluromet

• The active substances are ertugliflozin and metformin.

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

• Other components 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 tablets and Segluromet 7.5 mg/850 mg tablets: hypromellose (E464), hydroxypropylcellulose (E463), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172), carnauba wax (E903).

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

Appearance of the product and pack 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. 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.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

The Netherlands

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:

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