5 mg/100 mg and 15 mg/100 mg film-coated tablets
ertugliflozin/sitagliptin
What Steglujan is and what it is used for
What Steglujan is
Steglujan contains two active substances, ertugliflozin, and sitagliptin.
- Ertugliflozin belongs to a group of medicines called sodium-glucose cotransporter 2 (SGLT2) inhibitors.
- Sitagliptin belongs to a group of medicines called DPP‑4 (dipeptidyl peptidase‑4) inhibitors.
What Steglujan is used for
- Steglujan lowers the blood sugar level in adult patients (18 years and older) with type 2 diabetes.
- Steglujan can be used instead of taking both ertugliflozin and sitagliptin as separate tablets.
- Steglujan 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 Steglujan.
How Steglujan works
- Ertugliflozin works by blocking the SGLT2 protein in the kidneys. This leads to blood sugar being removed via the urine.
- Sitagliptin helps to raise the level of insulin produced after a meal. It also lowers the amount of sugar produced in your body.
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. 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 Steglujan
Do not take the Steglujan
- if you are allergic to ertugliflozin or sitagliptin 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 Steglujan if you:
- have kidney problems.
- have or have had fungal infections in the vagina or penis.
- have or have had a disease of the pancreas (such as pancreatitis).
- have type 1 diabetes. Stegluja should not be used to treat this disease.
- taking other diabetes medicines: 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.
- have or have had gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in your blood. These medical conditions may increase your risk of developing pancreatitis (see section 4).
- experience 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 and 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.
You must check your feet regularly and follow any other advice about foot care and adequate hydration given to you by healthcare professionals.
Cases of inflammation of the pancreas ( pancreatitis ) have been reported in patients receiving sitagliptin (see section 4).
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 Steglujan 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 Steglujan
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 amount of sugar in the blood, such as insulin or medicines that increase the release of insulin from the pancreas.
- if you are taking digoxin (a medicine used to treat irregular heartbeats and other heart problems). The level of digoxin in the blood may need to be checked if you take it together with Steglujan.
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 Steglujan can harm your unborn baby. You should not take this medicine during pregnancy.
It is not known whether this medicine passes into breast milk. Talk to your doctor about the best way to feed your baby if you are taking Steglujan. You should not use this medicine if you are breastfeeding or plan to breastfeed.
Driving ability and use of machinery
This medicine has no or negligible effect on the ability to drive and use machines. However, dizziness and drowsiness have been reported when using sitagliptin, which may affect your ability to drive or use machines. Do not drive vehicles or use tools or machines if you feel dizzy while taking Steglujan.
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.
Stegluja 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 Steglujan
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 recommended dose of Steglujan is one tablet once a day.
- The dose of Steglujan you take depends on your condition and how much ertugliflozin and sitagliptin are needed to control your blood sugar.
- 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 your tablet with or without food.
- You must continue to follow your diet and exercise program while taking Steglujan.
If you have taken too much Steglujan
Talk to a doctor or pharmacist immediately if you have taken too much Steglujan.
If you have forgotten to take Steglujan
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 Steglujan
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.
Stop taking Steglujan and contact your doctor immediately if you notice any of the following serious side effects:
- Severe and persistent pain in the abdomen (stomach) that may radiate to the back, with or without nausea and vomiting, as this may be a sign of inflammation of the pancreas ( pancreatitis ).
- A serious allergic reaction (frequency not known), including rash, hives, skin blistering/scaly skin, and swelling of the face, lips, tongue, and throat which may cause difficulty in breathing or swallowing. The doctor may prescribe one medicine to treat your allergic reaction and another medicine for your diabetes.
If you notice any of the above serious side effects, stop taking this medicine and contact your doctor immediately.
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 your mouth, or a different smell to urine or sweat.
This can occur regardless of blood sugar levels. The doctor can decide to stop treatment with Steglujan 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 occurring side effects:
Very common
- vaginal yeast infection (cod)
- low blood sugar
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 )
- constipation
- gas formation
- swelling of the hands or legs
- influenza
- headache
- upper respiratory tract infection
- stuffy or runny nose and sore throat
- osteoarthritis
- pain in arms or legs
- nausea/vomiting
Uncommon (may affect up to 1 in 100 users)
- blood tests may show changes related to kidney function (such as “creatinine”)
- stomach ache
- diarrhea
- drowsiness
- dry mouth
- dizziness
- itching
Rare
- decreased number of platelets
Frequency not known (cannot be calculated from available data)
- kidney problems (which sometimes require dialysis )
- joint pain
- muscle pain
- back pain
- interstitial lung disease
- bullous pemphigoid (a type of skin blister)
How Steglujan 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 substances are ertugliflozin and sitagliptin.
- Each Steglujan 5 mg/100 mg film-coated tablet contains 5 mg ertugliflozin (as ertugliflozin-L‑pyroglutamic acid) and 100 mg sitagliptin (as sitagliptin phosphate monohydrate).
- Each Steglujan 15 mg/100 mg film-coated tablet contains 15 mg ertugliflozin (as ertugliflozin-L‑pyroglutamic acid) and 100 mg sitagliptin (as sitagliptin phosphate monohydrate).
- Other ingredients are:
- Tablet core: microcrystalline cellulose (E460), calcium hydrogen phosphate (anhydrous), croscarmellose sodium, sodium stearyl fumarate (E487), magnesium stearate (E470b).
- Tablet coating: hypromellose (E464), hydroxypropyl cellulose (E463), titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), carnauba wax (E903).
Appearance and package sizes of the medicine
- Steglujan 5 mg/100 mg film-coated tablets (tablets) are beige, 12.0 × 7.4 mm, almond-shaped, film-coated tablets debossed with “554” on one side and plain on the other side.
- Steglujan 15 mg/100 mg film-coated tablets (tablets) are brown, 12.0 × 7.4 mm, almond-shaped, film-coated tablets debossed with “555” on one side and plain on the other side.
The step hood is packed in blisters of Alu/PVC/PA/Alu. 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 Authorization Holder Merck Sharp & Dohme BV Waarderweg 39 2031 BN Haarlem The Netherlands | Manufacturer Schering-Plough Labo NV Industriepark 30 2220 Heist-op-den-BergBelgium |
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