E
5 mg and 15 mg film-coated tablets
ertugliflozin
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 the blood sugar level in adult patients (18 years and older) with type 2 diabetes. It can also help prevent heart failure.
- Steglatro can be used alone or together with certain other medicines that lower blood sugar.
- You must continue to follow your diet and exercise program while taking Steglatro.
How Steglatro works
Ertugliflozin works by blocking the SGLT2 protein in the kidneys. This leads to blood sugar being removed via the urine.
What is type 2 diabetes?
Type 2 diabetes is a disease that means your body doesn’t produce enough insulin or that the insulin your body produces doesn’t work as well as it should. Your body can also produce too much sugar. When this happens, sugar ( glucose ) accumulates in the blood. It can lead to serious medical problems such as heart disease, kidney disease, blindness, and poor circulation.
What you need to know before taking 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 and while taking Steglatro if you:
- have kidney problems.
- have or have had fungal infections in the vagina or penis.
- have type 1 diabetes. Steglatro should not be used to treat this disease.
- taking other diabetes medications; you are more likely to get low blood sugar with certain medicines.
- maybe at risk of dehydration (e.g. if you take medicines that increase urine production [diuretics] or lower blood pressure etc or if you are over 65 years old). Ask about ways to prevent dehydration.
- experiencing rapid weight loss, nausea or vomiting, stomach pain, severe thirst, rapid and deep breathing, confusion, unusual sleepiness or tiredness, a sweet breath, a sweet or metallic taste in the mouth, or a different smell of urine or sweat. Contact a doctor or the nearest hospital immediately. These symptoms may be signs of ‘diabetic ketoacidosis’ – a condition you can get with diabetes due to increased levels of ‘ketone bodies in your urine or blood and which can be detected by tests. The risk of developing diabetic ketoacidosis may increase with prolonged fasting, high alcohol consumption, dehydration, sudden reduction in insulin dose, or increased need for insulin due to major surgery or serious illness.
It is important that you check your feet regularly and that you follow any other foot care advice given to you by healthcare professionals.
Talk to your doctor straight away if you experience a combination of symptoms such as pain, tenderness, redness, or swelling of the genitals or the area between the genitals and the rectum along with a fever or feeling generally unwell. These symptoms may be a sign of a rare but serious and, in the worst case, a life-threatening infection called necrotizing fasciitis of the perineum or Fournier’s gangrene which destroys the tissue under the skin. Fournier’s gangrene must be treated immediately.
When this medicine is used in combination with insulin or medicines that increase the release of insulin from the pancreas, low blood sugar (hypoglycemia) may occur. The doctor can then reduce the dose of one of your insulin or other medicines.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Urine glucose
Depending on how this medicine works, your urine will test positive for sugar ( glucose ) while you are taking this medicine.
Children and young people
Children and adolescents under the age of 18 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 the doctor:
- if you take medicines that increase urine production ( diuretics ).
- if you are taking other medicines that reduce the sugar in your blood, such as insulin or medicines that increase the release of insulin from the pancreas.
If any of the above apply to you (or if you are not sure), talk to 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 whether Steglatro can harm your unborn baby. If you are pregnant, talk to your doctor about the best way to control your blood sugar while you are pregnant. Do not use Steglatro if you are pregnant.
It is not known whether Steglatro passes into breast milk. Talk to your doctor about the best way to feed your baby if you are taking Steglatro. Do not use Steglatro if you are breastfeeding.
Driving ability and use of machinery
This medicine has no or negligible effect on the ability to drive and use machines. If this medicine is taken in combination with insulin or medicines that increase the release of insulin from the pancreas, the blood sugar level may drop too much (hypoglycemia), which may cause symptoms such as tremors, sweating, and changes in vision which may affect your ability to drive and use machines. Do not drive or use tools or machines if you feel dizzy while taking Steglatro.
Steglatro contains lactose and sodium
Steglatro contains lactose
Steglatro contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine.
Steglatro contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost ‘sodium-free’.
How to take Steglatro
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
How much to take
- The starting dose of Steglatro is one 5 mg tablet every day. The doctor decides whether the dose should be increased to 15 mg.
- The doctor will prescribe the right dose for you. Do not change your dose unless your doctor tells you to.
How to take this medicine
- Swallow the tablet; if you have difficulty swallowing, the tablet may be split or crushed.
- Take one tablet every morning. Try to take the tablet at the same time each day. Then it will be easier to remember to take it.
- You can take the tablet with or without food.
- You must continue to follow your diet and exercise program while taking Steglatro.
If you have taken too much Steglatro
Talk to your doctor or pharmacist immediately if you have taken too much Steglatro.
If you forget to take Steglatro
If you have forgotten to take a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue according to your regular schedule.
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 first talking to your doctor. Your blood sugar levels may rise if you stop taking the medicine.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor or the nearest hospital immediately if you experience any of the following serious side effects:
Diabetic ketoacidosis (rare, may affect up to 1 in 1,000 people)
These are signs of diabetic ketoacidosis (see also section “Warnings and precautions”):
- increased levels of “ketone bodies” in the urine or blood
- rapid weight loss
- nausea or vomiting
- stomach pain
- severe thirst
- rapid and deep breathing
- confusion
- unusual sleepiness or tiredness
- a sweet breath, a sweet or metallic taste in the mouth, or a different smell to urine or sweat.
This can occur regardless of blood sugar levels. The doctor may decide to stop treatment with Steglatro temporarily or permanently.
Necrotizing fasciitis of the perineum or Fournier’s gangrene (frequency not known, cannot be estimated from available data)
A serious soft tissue infection of the genitals or the area between the genitals and the rectum (see section “Warnings and precautions” for symptoms).
If you notice any of the above side effects, you should immediately contact a doctor or the nearest hospital.
Contact a doctor as soon as possible if you notice any of the following side effects:
Urinary tract infection (very common, may affect more than 1 in 10 people)
Symptoms of urinary tract infection are:
- burning when urinating
- cloudy urine
- pain in the pelvis or middle of the back (if the kidneys are affected).
You should talk to your doctor immediately if you develop a fever or see blood in your urine, although this is less common.
Dehydration (loss of too much water from the body; common, may affect up to 1 in 10 people)
Symptoms of dehydration are:
- dry mouth
- dizziness, lightheadedness, or feeling weak, especially when you stand up
- fainting.
The risk of becoming dehydrated increases if you:
- have kidney problems
- taking medicines that increase your urine production ( diuretics ) or lower blood pressure etc
- are 65 years of age or older.
Low blood sugar (hypoglycemia; common)
The doctor will inform you about how to treat low blood sugar and what to do if you get any of the symptoms or signs below. The doctor may reduce your dose of insulin or other diabetes medicines.
Signs and symptoms of low blood sugar may include:
- headache
- drowsiness
- frivolity
- hunger
- dizziness
- confusion
- sweating
- tremors
- feeling of weakness
- rapid pulse.
If you notice any of the above side effects, you should contact a doctor as soon as possible.
Other side effects when taking Steglatro:
Very common
- vaginal yeast infection (cod).
Usual
- fungal infection of the penis
- changes in urination, including an urgent need to urinate more often, with a larger volume of urine, or during the night
- thirst
- vaginal itching
- blood tests can show changes in the amount of urea in the blood
- blood tests can show changes in the amount of total and dangerous cholesterol (called LDL, a type of fat in the blood)
- blood tests may show changes in the number of red blood cells in your blood (called hemoglobin ).
Uncommon (may affect up to 1 in 100 users)
- blood tests may show changes related to kidney function (such as “creatinine”).
How Steglatro should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the blister and carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is ertugliflozin.
- Each Steglatro 5 mg film-coated tablet contains 5 mg ertugliflozin (as ertugliflozin-L‑pyroglutamic acid).
- Each Steglatro 15 mg film-coated tablet contains 15 mg of ertugliflozin (as ertugliflozin-L‑pyroglutamic acid).
- Other ingredients are:
- Tablet core: microcrystalline cellulose (E460), lactose monohydrate (see section 2), sodium starch glycolate (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).
Appearance and package sizes of the medicine
- Steglatro 5 mg film-coated tablets (tablets) are pink, 6.4 x 6.6 mm, triangular-shaped tablets with “701” on one side and plain on the other side.
- Steglatro 15 mg film-coated tablets (tablets) are red, 9.0 x 9.4 mm, triangular-shaped tablets with “702” on one side and plain on the other side.
Steglatro is packaged in Alu/PVC/PA/Alu blisters. Pack sizes are 14, 28, 30, 84, 90, and 98 film-coated tablets in non-perforated blisters and 30×1 film-coated tablets in perforated single-dose blisters.
Not all pack sizes may be marketed.
| Marketing Authorisation HolderMerck Sharp & Dohme BVWaarderweg 392031 BN HaarlemNetherlands | ManufacturerSchering-Plough Labo NVIndustriepark 302220 Heist-op-den-BergBelgium |
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