STEGLATRO 15 mg FILM-COATED TABLETS

2. What you need to know before you take Steglatro

Do not take Steglatro

• if you are allergic to ertugliflozin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting and while taking Steglatro if you:

• have kidney problems. Your doctor may do 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. Steglatro should not be used to treat this condition as it may increase the risk of diabetic ketoacidosis in these patients.
• take other diabetes medicines; you are more likely to get low blood sugar levels 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 if you 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 smell of breath, sweet or metallic taste in the mouth or a different smell 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 your diabetes due to an increase in "ketone bodies" in your 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 severe illness.

It is essential that you regularly check your feet and follow the advice your healthcare professional gives you about foot care.

Talk to your doctor immediately if you have a combination of symptoms of pain, tenderness, redness, or swelling of the genitals or the area between the genitals and 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 requires immediate treatment.

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

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

Glucose in urine

Due to the way this medicine 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 Steglatro

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

In particular, tell your doctor:

• if you are taking medicines that increase urine production (diuretics).
• if you are taking other medicines that lower blood sugar levels, such as insulin or medicines that increase insulin release from the pancreas.

If you are affected by any of the above (or if you are not sure), tell your doctor.

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 Steglatro is harmful to the unborn baby. If you are pregnant, talk to your doctor about the best way to control your blood sugar levels during pregnancy. Do not take Steglatro if you are pregnant.

It is not known if Steglatro passes into breast milk. Talk to your doctor about the best way to feed your baby if you take Steglatro. Do not take Steglatro if you are breastfeeding.

Driving and using machines

The effect of this medicine on your ability to drive or use machines is negligible. However, taking this medicine in combination with insulin or medicines that increase insulin release from the pancreas may cause low blood sugar levels (hypoglycemia), which can cause symptoms such as shaking, 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 Steglatro.

Steglatro contains lactose

If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

Steglatro contains sodium

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

3. How to take Steglatro

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to 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 need to increase the dose to 15 mg.
• 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 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 should continue to follow your diet and exercise plan while taking Steglatro.

If you take more Steglatro than you should

If you take too much Steglatro, talk to a doctor or pharmacist immediately.

If you forget to take Steglatro

What to 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 Steglatro 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 on the same day) to make up for missed doses.

If you stop taking Steglatro

Do not stop taking this medicine without talking to 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

The following are signs of diabetic ketoacidosis (see also 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
• drowsiness or unusual fatigue
• sweet smell of breath, sweet or metallic taste in the mouth or a different smell of urine or sweat

This can happen even if your blood sugar levels are normal. Your doctor may decide to stop your treatment with Steglatro temporarily or permanently.

Necrotizing fasciitis of the perineum or Fournier's gangrene (frequency not known, cannot be estimated from the available data)

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

If you notice any of the above side effects, talk to a doctor or go to the nearest hospital immediately.

Talk to your doctor as soon as possible if you get any of the following side effects:

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

Signs of urinary tract infection are:

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

Although rare, if you have fever or see blood in your urine, talk to your doctor immediately.

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

Dehydration symptoms include:

• dry mouth
• feeling dizzy, fainting, or weakness, especially when standing up
• fainting

You are more likely to get dehydrated if you:

• have kidney problems
• take medicines 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 get any of the following symptoms or signs.

Signs and symptoms of low blood sugar can include:

• headache
• drowsiness
• irritability
• hunger
• dizziness
• confusion
• sweating
• feeling restless
• weakness
• fast heartbeat

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

Other side effects when taking Steglatro:

Very common

• vaginal yeast infection (candidiasis)

Common

• penile yeast infections
• urination problems, including urgent need to urinate, more frequent urination, or increased urination 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 in your blood)
• blood tests may show changes in the amount of red blood cells in your blood (called hemoglobin)

Uncommon (may affect up to 1 in 100 people)

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

Frequency not known

• rash

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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. Storing Steglatro

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

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

No special storage conditions are required.

Do not use this medicine if you notice 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 medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Steglatro Composition

• The active ingredient is ertugliflozin.

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

• The other ingredients are:

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

Product Appearance and Package Contents

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

Steglatro is available in Alu/PVC/PA/Alu blisters. The pack sizes are 14, 28, 30, 84, 90, and 98 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 Authorisation Holder

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

Manufacturer

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 medicinal product by contacting the local representative of the marketing authorisation holder:

Date of Last Revision of this Leaflet:

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