Patient Information Leaflet

Steglatro 5 mg Film-Coated Tablets

Steglatro 15 mg Film-Coated Tablets

ertugliflozina

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 are unsure about anything, 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 section 4.

1.What is Steglatro and what it is used for

2.What you need to know before you start taking Steglatro

3.How to take Steglatro

4.Possible side effects

5.Storage of Steglatro

6.Contents of the pack and additional information

What is Steglatro

Steglatro contains the active ingredient ertugliflozina.

Steglatro belongs to a group of medicines called sodium-glucose cotransporter 2 (SGLT2) inhibitors.

What is Steglatro used for

• Steglatro 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.
• Steglatro can be used alone or in combination with other medicines that lower blood sugar levels.
• You must follow your diet and exercise plan while taking Steglatro.

How does Steglatro work

Ertugliflozina acts by blocking the SGLT2 protein in your kidneys, causing sugar to be eliminated from your blood through your urine.

What is type 2 diabetes

Type 2 diabetes is a disease 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.

Do not take Steglatro

• if you are allergic to ertugliflozina or any of the other components of this medication (listed in section 6).

Warnings and precautions

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

• have kidney problems.Your doctor may perform blood tests to check the function of your kidneys.

• have or have had urinary tract infections.
• have or have had vaginal or penile fungal infections.
• have type 1 diabetes. Steglatro should not be used to treat this diseaseas 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 65 years old). Ask about ways to prevent dehydration.
• experience rapid weight loss, nausea, vomiting, stomach pain, excessive thirst, rapid and deep breathing, confusion, drowsiness or unusual fatigue, 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 may be a sign of “diabetic ketoacidosis”, a problem you may have with diabetes due to an increase, detected in tests, of “ketone bodies” in urine or blood. The risk of suffering from 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 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 experience 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 discomfort. 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 the release of insulin 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.

Blood glucose in urine

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

Children and adolescents

Children and adolescents under 18 years old should not take this medication. The safety and efficacy of this medication in children and adolescents under 18 years old are unknown.

Other medications and Steglatro

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

Especially, inform your doctor:

• if you are taking medications that increase urine production (diuretics).
• if you are taking other medications that reduce your blood sugar, such as insulin or medications that increase the release of insulin by the pancreas.

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

Pregnancy and breastfeeding

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

The safety of Steglatro for the fetus is unknown. If you are pregnant, consult your doctor about the best way to control your blood sugar during pregnancy. Do not use Steglatro if you are pregnant.

The safety of Steglatro for the baby is unknown. Consult your doctor about the best way to feed your baby if you take Steglatro. Do not use Steglatro 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 the release of insulin by the pancreas may cause excessive drops in 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 Steglatro.

Steglatro contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Steglatro contains sodium

This medication contains less than1mmolof sodium (23mg) per tablet; it is essentially “sodium-free”.

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

How much to take

• The initial dose of Steglatro is one 5 mg tablet per day. Your doctor will decide if you should increase the dose to 15 mg.
• Your doctor will prescribe the most suitable dose for your case. Do not modify the dose unless your doctor has instructed you to do so.

How to take this medication

• Swallow the tablet; if you have difficulty swallowing, the tablet can be broken or crushed.
• Take one tablet each morning. Try to take it at the same time; this will help you remember to take it.
• You can take the tablet with or without food.
• You must follow your diet and exercise plan while taking Steglatro.

If you take more Steglatro than you should

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

If you forget to take Steglatro

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 Steglatro 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 on the same day) to compensate for the missed doses.

If you interrupt treatment with Steglatro

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 the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may 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 severe side effects:

Diabetic ketoacidosis (rare, may affect up to 1 in 100,000 people)

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

• Increased levels of "ketone bodies" in your urine or blood
• Rapid weight loss
• Nausea or vomiting
• Abdominal pain
• Excessive thirst
• Deep and rapid breathing
• Confusion
• Unusual drowsiness or fatigue
• Sweet odor of breath, 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 Steglatro.

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 to consult your 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
• Pain in the pelvis or middle back (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 symptoms or signs listed below. Your doctor may reduce your insulin dose or the dose of your other diabetes medications.

The signs and symptoms of low blood sugar may include:

• Headache
• Drowsiness
• Irritability
• Hunger
• Dizziness
• Confusion
• Sweating
• Restlessness
• Weakness
• Fast heart rate

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

Other side effects of taking Steglatro:

Very common

• Vaginal yeast infection (candidiasis)

Common

• Fungal infections of the penis
• Urination changes, including the need to urinate more frequently, in larger amounts, or at night
• Thirst
• Vaginal itching
• 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 present in your blood)
• Blood tests may show changes in the amount of red blood cells in your blood (called hemoglobin)

Rare (may affect up to 1 in 100 people)

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

Unknown frequency

• Rash

Reporting 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 the national notification system included 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 outer packaging 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 packaging is damaged or shows signs of tampering.

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

Composition of Steglatro

• The active ingredient is ertugliflozina.

• Each film-coated tablet of Steglatro 5 mg contains L-pyroglutamic acid of ertugliflozina, equivalent to 5 mg of ertugliflozina.
• Each film-coated tablet of Steglatro 15 mg contains L-pyroglutamic acid of ertugliflozina, equivalent to 15 mg of ertugliflozina.

• The other components are:

• Tablet core: microcrystalline cellulose (E460), lactose monohydrate (see section 2), sodium carboxymethylcellulose (Type A), magnesium stearate (E470b).
• Film coating: hypromellose 2910/6 (E464), lactose monohydrate (see section 2), macrogol 3350 (E1521), triacetin (E1518), titanium dioxide (E171), iron oxide red (E172).

Appearance of the product and contents of the pack

• The film-coated tablets (tablets) of Steglatro 5 mg are pink, 6.4 x 6.6 mm, triangular in shape, with "701" engraved on one face and smooth on the other face.
• The film-coated tablets (tablets) of Steglatro 15 mg are red, 9.0 x 9.4 mm, triangular in shape, with "702" engraved on one face and smooth on the other face.

Steglatro is available in Alu/PVC/PA/Alu blisters. The pack sizes are 14, 28, 30, 84, 90 and 98 film-coated tablets in uncut blisters and 30 film-coated tablets in single-dose blisters.

Only some pack sizes may be marketed.

Marketing Authorisation Holder

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

Responsible for manufacturing

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

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 authorisation holder:

Last update of this leaflet:

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