Steglatro 5 mg film-coated tablets

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Steglatro 5 mg film-coated tablets

Steglatro 15 mg film-coated tablets

ertugliflozin

Read the entire leaflet carefully before you start taking this medicine, as 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Steglatro is and what it is used for

What Steglatro is

Steglatro contains the active substance ertugliflozin.

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

What Steglatro is used for

• Steglatro lowers 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 together with other medicines that lower blood sugar.

• You must continue to follow your diet and exercise plan while taking Steglatro.

How Steglatro works

Ertugliflozin works by blocking the SGLT2 protein in your kidneys. This causes blood sugar to be removed from the body through your urine.

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 Steglatro

Do not take Steglatro

• if you are allergic to ertugliflozin or to 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 during treatment with Steglatro if you:

• have kidney problems. Your doctor may carry out blood tests to check how well your kidneys are working.
• 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.
• are taking other medicines for diabetes; you may be more likely to experience low blood sugar levels when taking certain medications.
• may be at risk of dehydration (for example, if you are taking medicines 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, deep and rapid breathing, confusion, drowsiness or unusual tiredness, sweet breath odour, sweet or metallic taste in the mouth, or a different odour in 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 people with diabetes due to increased levels of “ketone bodies” detected in blood or urine tests. The risk of developing 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 that you regularly check your feet and follow the advice provided by your healthcare professional regarding foot care.

Contact your doctor immediately if you experience a combination of symptoms such as pain, tenderness, redness, or swelling in the genital area or the area between the genitals and the anus, accompanied by fever or general malaise. These symptoms could be signs of a rare but serious, potentially life-threatening infection 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 (hypoglycaemia) may occur. Your doctor may reduce your insulin dose or the dose of your other medicines.

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

Glucose in urine

Due to the way this medicine 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 Steglatro

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

In particular, inform your doctor:

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

It is unknown whether Steglatro is harmful to the fetus. 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.

It is unknown whether Steglatro passes into breast milk. Consult your doctor about the best way to feed your baby if you are taking Steglatro. Do not use Steglatro if you are breastfeeding.

Driving and using machines

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

Steglatro contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him or her before taking this medicine.

Steglatro contains sodium

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

3. How to take Steglatro

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

How much to take

• The starting dose of Steglatro is one 5 mg tablet per day. Your doctor will decide whether your dose should be increased to 15 mg.
• Your doctor will prescribe the dose most suitable 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 each morning. Try to take it at the same time every day; this will help you remember to take it.
• You may take the tablet with or without food.
• It is important that you 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, contact a doctor or pharmacist immediately.

If you forget to take Steglatro

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

• If there are 12 hours or more until your next dose, take a dose of Steglatro 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 on the same day) to make up for a missed dose.

If you stop taking Steglatro

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 adverse effects

Like all medicines, this medicine can cause adverse 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 adverse 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”):

• 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-smelling breath, sweet or metallic taste in the mouth, or a different odor in urine or sweat

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

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 previously mentioned 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)

Signs of urinary tract infection are:

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

Although uncommon, if you have fever or notice 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 uneasy
• weakness
• rapid heartbeat

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

Other adverse effects with Steglatro:

Very common

• vaginal fungal infection (candidiasis)

Common

• fungal infections of the penis
• urinary changes, including a sudden need to urinate more frequently, in larger amounts, or at night
• thirst
• vaginal itching
• blood tests may show changes in the level of urea in your blood
• blood tests may show changes in the level 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 number of red blood cells in your blood (called haemoglobin)

Uncommon (may affect up to 1 in 100 people)

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

Frequency not known

• rash

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect 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 Steglatro

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

Do not use this medicine after the expiry date stated on the blister and on the outer packaging following EXP. The expiry 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 medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Steglatro

• The active substance is ertugliflozin.

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

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

• The other components 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), iron oxide red (E172).

Appearance of the product and contents of the pack

• 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.
• 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.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

The Netherlands

Manufacturer

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

The Netherlands

For further information on 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 European Medicines Agency website: https://www.ema.europa.eu.