2.5 mg / 850 mg, 2.5 mg / 1000 mg, 7.5 mg / 850 mg, 7.5 mg / 1000 mg film-coated tablets
ertugliflozin / metformin hydrochloride
What Segluromet is and what it is used for
What the Seglurome is
Seglurome contains two active substances, ertugliflozin, and metformin.
- Ertugliflozin belongs to a group of medicines called sodium-glucose co-transporter 2 (SGLT2) inhibitors.
- Metformin belongs to a group of medicines called biguanides.
What the Seglurome used for
- Segluroma lowers blood sugar levels in adult patients (18 years and older) with type 2 diabetes. It can also help prevent heart failure.
- Seglurom can be used instead of taking both ertugliflozin and metformin as separate tablets.
- Segluromet can be used alone or in combination with certain other medicines that lower blood sugar.
- You must continue to follow your diet and exercise program while taking Segluromet.
How Segluromet works
- Ertugliflozin works by blocking the SGLT2 protein in the kidneys. This causes blood sugar to be removed through the urine.
- Metformin works by inhibiting the production of sugar ( glucose ) in the liver.
What is type 2 diabetes?
Type 2 diabetes is a disease that means that your body does not produce enough insulin, or that the insulin that 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 Segluromet
Do not take the Segluromet
- if you are allergic to ertugliflozin or metformin or any of the other ingredients of this medicine (listed in section 6).
- if you have severe renal impairment or need dialysis treatment.
- if you have uncontrolled diabetes with, for example, severe hyperglycemia (high blood glucose), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below), or ketoacidosis. Ketoacidosis is a condition in which substances called “ketone bodies” accumulate in the blood and which can lead to diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or that your breath gets an unusual fruity odor.
- if you have a severe infection or are dehydrated.
- if you have recently had a heart attack or have severe circulatory problems, such as “shock” or difficulty breathing.
- if you have liver problems.
- if you drink too much alcohol (either regularly or occasionally).
Do not take Segluromet if any of the above apply to you. If you are not sure, talk to your doctor before taking Segluromet.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before and while taking Segluromet if you:
- have kidney problems.
- have or have had fungal infections in the vagina or penis.
- have type 1 diabetes. The segluromet should not be used to treat this disease.
- taking other diabetes medicines; You are more likely to get low blood sugar with certain medications.
- maybe at risk of dehydration (eg if you are taking medicines that increase the production of urine [diuretics] or lower your blood pressure or if you are over 65 years old). Ask about ways to counteract dehydration.
- experiences rapid weight loss, nausea or vomiting, abdominal pain, severe thirst, rapid and deep breathing, confusion, unusual sleepiness or fatigue, a sweet breath, a sweet or metallic taste in the mouth, or a different odor of urine and sweat. Contact a doctor or the nearest hospital immediately. These symptoms may be signs of “diabetic ketoacidosis” – a condition that you can get in diabetes due to increased levels of “ketone bodies” in the 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 decrease in insulin dose, or increased need for insulin due to major surgery or a serious illness.
It is important that you check your feet regularly and that you adhere to any other advice on foot care that you receive from health care professionals.
Talk to your doctor immediately 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 fever or general malaise. These symptoms can be a sign of a rare but serious and in the worst-case 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. Your doctor may then reduce the dose of one of your insulin or other medicines.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Risk of lactic acidosis
The glomerulus can cause the very rare, but very serious, side effect of lactic acidosis, especially if your kidneys are not working properly. The risk of developing lactic acidosis is also increased in uncontrolled diabetes, severe infections, long-term fasting or alcohol intake, dehydration (see more information below), liver problems, and medical conditions where any part of the body has reduced oxygen supply (such as acute severe heart disease).
If any of the above apply to you, talk to your doctor for more information.
Stop taking Segluromet for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhea, fever, exposure to heat, or if you drink less fluid than normal. Talk to a doctor for further instructions.
Stop taking Segluromet and contact your doctor or nearest hospital immediately if you experience any of the symptoms of lactic acidosis as the condition may lead to coma.
Symptoms of lactic acidosis include:
- vomiting
- stomach pain (abdominal pain)
- muscle cramps
- a general feeling of not feeling well with severe fatigue
- hard to breathe
- lowered body temperature and heart rate.
Lactic acidosis is an acute medical condition that must be treated in a hospital.
If you are going to undergo a major operation, you must stop taking Segluromet during the operation and for a certain time after it. Your doctor will decide when you need to stop taking Segluromet and when you should start taking it again.
During treatment with Segluromet, your doctor will check your kidney function at least once a year or more often if you are older and/or if your kidney function is deteriorating.
Urine glucose
Depending on how Segluromet works, your urine will test positive for sugar ( glucose ) while you are taking this medicine.
Children and young people
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 Segluromet
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You may need to do more frequent blood sugar and kidney function tests or your doctor may need to adjust the dose of Segluromet. Tell your doctor in particular:
- if you are taking 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 you are taking medicines used to treat pain and inflammation ( NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib).
- if you are taking certain medicines to treat high blood pressure ( ACE inhibitors and angiotensin II receptor antagonists).
If any of the above apply to you (or you are not sure), talk to a doctor.
If you need to get an injection of a contrast agent containing iodine into your blood, for example in connection with an X-ray examination or imaging examination, you must stop taking Segluromet before or at the time of injection. Your doctor will decide when you need to stop taking Segluromet and when you should start your treatment again.
Segluromet with alcohol
Avoid high alcohol intake while taking Segluromet as this may increase the risk of lactic acidosis (see section “Warnings and Precautions”).
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 Segluromet 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. You should not use Segluromet if you are pregnant.
It is not known if Segluromet passes into breast milk. Talk to your doctor about the best way to give your child food if you are taking this medicine. Do not use Segluromet if you are breastfeeding.
Driving and using machines
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, your blood sugar level may drop too much (hypoglycemia), which may cause symptoms such as shaking, sweating, and vision changes that may affect your ability to drive and use machines. Do not drive or use tools or machines if you feel dizzy while taking Segluromet.
The sailor contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
How to take Segluromet
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
How much to take
- The recommended dose of Segluromet is one tablet twice daily.
- The dose of Segluromet you take depends on your condition and the amount of ertugliflozin and metformin needed to control your blood sugar.
- Your 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 split or crush.
- Take one tablet twice daily. Try to take it at the same time each day. Then it will be easier to remember to take it.
- It is best to take the tablet with a meal. This reduces the risk of stomach upset.
- You must continue to follow your diet and exercise program while taking Segluromet.
If you take more Segluromet than you should
Talk to your doctor or pharmacist immediately if you have taken too much Segluromet.
If you forget to take Segluromet
If you forget to take a dose, take it as soon as you remember. If it is soon time for your next dose, skip the missed dose and continue as usual.
Do not take a double dose (two doses at the same time) to compensate for a missed dose.
If you stop taking Segluromet
Do not stop taking this medicine without first talking to a doctor. Your blood sugar levels may rise if you stop taking the medicine.
If you have any further questions on the use of this product, 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 get any of the following serious side effects:
Lactic acidosis (very rare, may affect up to 1 in 10,000 people)
The glomerulus can cause the very rare, but very serious, a side effect of lactic acidosis (see section “Warnings and Precautions”). If this happens, you must stop taking Segluromet and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.
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
- abdominal pain
- strong thirst
- rapid and deep breathing
- confusion
- unusual drowsiness or fatigue
- a sweet breath, a sweet or metallic taste in the mouth, or a different smell of urine or sweat.
This can occur regardless of blood sugar level. Your doctor may decide to stop your Segluromet treatment temporarily or permanently.
Necrotizing fasciitis of the perineum or Fournier’s gangrene (no known frequency, can not be calculated from the available data)
A severe 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, talk to your doctor or nearest hospital immediately.
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 user in 10)
Symptoms of urinary tract infection are:
- burning when urinating
- cloudy urine
- pain in the pelvis or the middle of the back (if the kidneys are affected).
You should talk to a doctor immediately if you get 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 weakness, especially when standing up
- fainting.
The risk of becoming dehydrated increases if you:
- have kidney problems
- Take drugs that increase your urine production ( diuretics ) or lower your blood pressure
- is 65 years or older.
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. Your doctor may reduce your dose of insulin or other antidiabetic medicines.
Signs and symptoms of low blood sugar can be:
- headache
- drowsiness
- irritability
- hunger
- dizziness
- confusion
- sweating
- tremors
- feeling weak
- fast pulse
If you notice any of the above side effects, contact your doctor as soon as possible.
Other side effects:
Very common
- vaginal fungal infection (cod)
- nausea
- vomiting
- diarrhea
- abdominal pain
- loss of appetite
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
- taste change
- 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 can show changes in the number 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 kidney function (such as “creatinine”)
Very rare
- decreased vitamin B 12 levels. This can cause anemia (low levels of red blood cells ).
- deviations in liver values
- hepatitis (a liver disease)
- hives
- reddening of the skin
- itching
How to store the Seglurome
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 expiration date is the last day of the specified month.
No special storage instructions.
Do not use this medicine if the package is damaged or shows signs of injury.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the packaging and other information
Content declaration
- The active substances are ertugliflozin and metformin.
- Each Segluromet 2.5 mg / 850 mg film-coated tablet contains 2.5 mg ertugliflozin (as ertugliflozin-L ‑ pyroglutamic acid) and 850 mg metformin hydrochloride.
- Each Seglurome 2.5 mg / 1000 mg film-coated tablet contains 2.5 mg ertugliflozin (as ertugliflozin-L ‑ pyroglutamic acid) and 1000 mg metformin hydrochloride.
- Each Segluromet 7.5 mg / 850 mg film-coated tablet contains 7.5 mg ertugliflozin (as ertugliflozin-L ‑ pyroglutamic acid) and 850 mg metformin hydrochloride.
- Each Segluromet 7.5 mg / 1000 mg film-coated tablet contains 7.5 mg ertugliflozin (as ertugliflozin-L ‑ pyroglutamic acid) and 1000 mg metformin hydrochloride.
- Other ingredients are:
- Tablet core: povidone (K29-32) (E1201), microcrystalline cellulose (E460), crospovidone (E1202), sodium lauryl sulphate (E487), magnesium stearate (E470b).
- Film coating:
- Seglurome 2.5 mg / 850 mg tablets and Segluromet 7.5 mg / 850 mg tablets: hypromellose (E464), hydroxypropylcellulose (E463), titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide ( E172), carnauba wax (E903).
- Seglurome 2.5 mg / 1000 mg tablets and Segluromet 7.5 mg / 1000 mg tablets: hypromellose (E464), hydroxypropylcellulose (E463), titanium dioxide (E171), red iron oxide (E172), carnauba wax (E903).
What the medicine looks like and the contents of the pack
- The Seglurome 2.5 mg / 850 mg film-coated tablets (tablets) are beige, 18 x 10 mm, oval, film-coated tablets debossed with “2.5 / 850” on one side and smooth on the other.
- The Seglurome 2.5 mg / 1000 mg film-coated tablets (tablets) are pink, 19.1 x 10.6 mm, oval, film-coated tablets debossed with “2.5 / 1000” on one side and smooth on the other.
- Seglurom 7.5 mg / 850 mg film-coated tablets (tablets) are dark brown, 18 x 10 mm, oval, film-coated tablets debossed with “7.5 / 850” on one side and smooth on the other side.
- Seglurom 7.5 mg / 1000 mg film-coated tablets (tablets) are red, 19.1 x 10.6 mm, oval, film-coated tablets debossed with “7.5 / 1000” on one side and smooth on the other side.
The sail aroma is available in blisters of Alu / PVC / PE / Alu. The pack sizes are 14, 28, 56, 60, 168, and 180 film-coated tablets in non-perforated blisters, multipacks containing 196 (4 packs of 49) 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 and Manufacturer
Merck Sharp & Dohme BV
Waarderweg 39
2031 BN Haarlem
Netherlands
Contact the representative of the marketing authorization holder to find out more about this medicine:
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