Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - segluromet

Document Subject

Generated Narrative: MedicinalProductDefinition mpfde715eb4d71a80815177e9bcc18c25e

identifier: http://ema.europa.eu/identifier/EU/1/18/1265/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Segluromet 2.5 mg/850 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-fde715eb4d71a80815177e9bcc18c25e

identifier: http://ema.europa.eu/identifier/EU/1/18/1265/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - segluromet

Attesters

What is in this leaflet

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

What Segluromet is Segluromet contains two active substances, ertugliflozin and metformin. Each belongs to a group of medicines called oral anti-diabetics . These are medicines taken by mouth to treat diabetes.

• 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 Segluromet is used for
• Segluromet lowers blood sugar levels in adult patients (aged 18 years and older) with type 2 diabetes.
• It can also help prevent heart failure in patients with type 2 diabetes.
• Segluromet can be used instead of taking both ertugliflozin and metformin as separate tablets.
• Segluromet can be used alone or with some other medicines that lower blood sugar.
• You need to keep following your food and exercise plan while taking Segluromet. How Segluromet works
• Ertugliflozin works by blocking the SGLT2 protein in your kidneys. This causes blood sugar to be removed in your urine.
• Metformin works by decreasing sugar (glucose) production in the liver. What is type 2 diabetes? Type 2 diabetes is a condition in which your body does not make enough insulin or the insulin that your body produces does not work as well as it should. This leads to a high level of sugar in your blood. When this happens, this can lead to serious medical problems, like heart disease, kidney disease, blindness and poor circulation.

Do not take 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 severely reduced kidney function or need dialysis.

• if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, 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 pre-coma. Symptoms include stomach pain, fast and deep breathing, sleepiness, or your breath developing an unusual fruity smell.

• 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 breathing difficulties.

• if you have liver problems.

• if you drink large amounts of alcohol, either regularly or from time to time (please see section Segluromet with alcohol ). 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 precautions Risk of lactic acidosis Segluromet may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease). If any of the above apply to you, talk to your doctor for further instructions. 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, diarrhoea, fever, exposure to heat or if you drink less fluid than normal. Talk to your doctor for further instructions. Stop taking Segluromet and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma. Symptoms of lactic acidosis include:

• vomiting

• stomach ache (abdominal pain)

• muscle cramps

• a general feeling of not being well with severe tiredness

• difficulty in breathing

• reduced body temperature and heartbeat

• Lactic acidosis is a medical emergency and must be treated in a hospital. Talk to your doctor, pharmacist, or nurse before and while taking Segluromet, if you:

• have kidney problems. Your doctor may do blood tests to check how well your kidneys are working.

• have or have had urinary tract infections.

• have or have had yeast infections of the vagina or penis.

• have type 1 diabetes. Segluromet 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 with certain medicines.

• might be at risk of dehydration (for example, if you are taking medicines that increase urine production [diuretics] lower blood pressure or if you are over 65 years old). Ask about ways to prevent dehydration.

• experience rapid weight loss, feeling sick or being sick, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat, contact a doctor or the nearest hospital straight away. These symptoms could be a sign of diabetic ketoacidosis
  a problem you can get with diabetes because of increased levels of ketone bodies in your urine or blood, seen in tests. The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness. It is important to check your feet regularly and adhere to any other advice regarding foot care given by your healthcare professional. Talk to your doctor immediately if you develop a combination of symptoms of pain, tenderness, redness, or swelling of the genitals or the area between the genitals and the anus with fever or feeling generally unwell. These symptoms could be a sign of a rare but serious or even life-threatening infection, called necrotising fasciitis of the perineum or Fournier s gangrene which destroys the tissue under the skin. Fournier s gangrene has to be treated immediately. When this medicine is used in combination with insulin or medicines that increase insulin release from the pancreas, low blood sugar (hypoglycaemia) can occur. Your doctor may reduce the dose of your insulin or other medicine. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. If you need to have major surgery you must stop taking Segluromet during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Segluromet. During treatment with Segluromet, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function. Urine glucose Because of how Segluromet works, your urine will test positive for sugar (glucose) while you are on this medicine. Children and adolescents Children and adolescents below 18 years 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 more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of Segluromet. In particular, tell your doctor:

• if you are taking medicines which increase urine production (diuretics).

• if you are taking other medicines that lower the sugar in your blood, such as insulin or medicines that increase insulin release from the pancreas.

• if you are taking medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib).

• if you are taking certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).

• if you are taking corticosteroids (used to treat a variety of conditions, such as severe inflammation of the skin or in asthma).

• if you are taking beta-2 agonists such as salbutamol or terbutaline (used to treat asthma).

• if you are taking medicines that may change the amount of metformin in your blood, especially if you have reduced kidney function (verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib or olaparib). If any of the above apply to you (or you are not sure), tell your doctor. If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example, in the context of an X-ray or scan, you must stop taking Segluromet before or at the time of the injection. Your doctor will decide when you must stop and when to restart your treatment with Segluromet. Segluromet with alcohol Avoid excessive alcohol intake while taking Segluromet since this may increase the risk of lactic acidosis (see section Warnings and precautions ). Pregnancy and breast-feeding If you are pregnant or breast-feeding, 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 with 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 with your doctor about the best way to feed your baby if you take this medicine. You should not use Segluromet if you are breast-feeding. Driving and using machines This medicine has no or negligible influence on the ability to drive and use machines. However, taking this medicine in combination with insulin or medicines that increase insulin release from the pancreas can cause blood sugar levels to drop too low (hypoglycaemia), which may cause symptoms such as shaking, sweating and change in vision, and may affect your ability to drive and use machines. Do not drive or use any tools or machines if you feel dizzy while taking Segluromet. Segluromet contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium-free .

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. How much to take

• The recommended dose of Segluromet is one tablet twice a day.
• The dose of Segluromet that you take will depend 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 has told you to. Taking this medicine
• Swallow the tablet; if you have difficulties in swallowing the tablet can be broken or crushed.
• Take one tablet twice daily. Try to take it at the same time each day; this will help you remember to take it.
• It is best to take your tablet with a meal. This will lower your chance of having an upset stomach.
• You need to keep following your food and exercise plan while taking Segluromet. If you take more Segluromet than you should If you take too much Segluromet, talk to a doctor or pharmacist straight away. If you forget to take Segluromet What to do if you forget to take a tablet depends on how long it is until your next dose.
• If it is 12 hours or more until your next dose, take a dose of Segluromet as soon as you remember. Then take your next dose at the usual time.
• If it is 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 at the same time) to make up for a forgotten dose. If you stop taking Segluromet Do not stop taking this medicine without talking to your doctor. Your blood sugar levels may increase if you stop the medicine. If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Contact a doctor or the nearest hospital straight away if you have any of the following serious side effects: Lactic acidosis (very rare, may affect up to 1 in 10 000 people) Segluromet may cause a very rare, but very serious side effect called 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 may lead to coma. Diabetic ketoacidosis (rare, may affect up to 1 in 1 000 people) These are the signs of diabetic ketoacidosis (see also section Warnings and precautions ):

• increased levels of ketone bodies in your urine or blood
• rapid weight loss
• feeling sick or being sick
• stomach pain
• excessive thirst
• fast and deep breathing
• confusion
• unusual sleepiness or tiredness
• a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat This may occur regardless of blood glucose level. Your doctor may decide to temporarily or permanently stop your treatment with Segluromet. Necrotising fasciitis of the perineum or Fournier s gangrene (not known, cannot be estimated from the available data) A serious soft tissue infection 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 side effects above, contact a doctor or the nearest hospital straight away. Contact your doctor as soon as possible if you notice the following side effects: Urinary tract infection (very common, may affect more than 1 in 10 people) The signs of urinary tract infection are:

burning sensation when passing urine

urine that appears cloudy

pain in the pelvis or mid-back (when kidneys are infected) Although uncommon, if you have fever or see blood in your urine, tell your doctor immediately. Dehydration (losing too much water from your body; common, may affect up to 1 in 10 people) Symptoms of dehydration include:

• dry mouth

• feeling dizzy, light-headed, or weak, especially when you stand up

• fainting You may be more likely to get dehydrated if you:

• have kidney problems

• take medicines that increase your urine production (diuretics) or lower blood pressure

• are 65 years or older Low blood sugar (hypoglycaemia; common) Your doctor will tell you how to treat low blood sugar and what to do if you have any of the symptoms or signs below. The doctor may lower the dose of your insulin or other diabetes medicine. Signs and symptoms of low blood sugar may include:

• headache

• drowsiness

• irritability

• hunger

• dizziness

• confusion

• sweating

• feeling jittery

• weakness

• fast heartbeat If you notice any of the side effects above, contact your doctor as soon as possible. Other side effects include: Very common

• vaginal yeast infection (thrush)

• feeling sick (nausea)

• vomiting

• diarrhoea

• stomach ache

• loss of appetite Common

• yeast infections of the penis

• changes in urination, including urgent need to urinate more often, in larger amounts, or at night

• thirst

• vaginal itching

• change in taste

• blood tests may show changes in the amount of urea in your blood

• blood tests may show changes in the amount of total 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 haemoglobin)

• decreased or low vitamin B12 levels in the blood (symptoms may include extreme tiredness (fatigue), a sore and red tongue (glossitis), pins and needles (paraesthesia) or pale or yellow skin). Your doctor may arrange some tests to find out the cause of your symptoms because some of these may also be caused by diabetes or due to other unrelated health problems. Uncommon (may affect up to 1 in 100 people)

• blood tests may show changes related to kidney function (such as creatinine ) Very rare

• liver function test disorders

• hepatitis (a liver problem)

• hives

• redness of the skin

• itching 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.

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 the carton after EXP. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. Do not use this medicine if the packaging is damaged or shows signs of tampering. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Segluromet contains

• The active substances are ertugliflozin and metformin.* Each Segluromet 2.5 mg/850 mg film-coated tablet contains ertugliflozin L-pyroglutamic acid, equivalent to 2.5 mg of ertugliflozin, and 850 mg of metformin hydrochloride.* Each Segluromet 2.5 mg/1 000 mg film-coated tablet contains ertugliflozin L-pyroglutamic acid, equivalent to 2.5 mg of ertugliflozin, and 1 000 mg of metformin hydrochloride.* Each Segluromet 7.5 mg/850 mg film-coated tablet contains ertugliflozin L-pyroglutamic acid, equivalent to 7.5 mg of ertugliflozin, and 850 mg of metformin hydrochloride.* Each Segluromet 7.5 mg/1 000 mg film-coated tablet contains ertugliflozin L-pyroglutamic acid, equivalent to 7.5 mg of ertugliflozin, and 1 000 mg of metformin hydrochloride.
• The other ingredients are:* Tablet core: povidone (K29-32) (E1201), microcrystalline cellulose (E460), crospovidone (E1202), sodium lauryl sulphate (E487), magnesium stearate (E470b).* Film coating: Segluromet 2.5 mg/850 mg tablets and Segluromet 7.5 mg/850 mg tablets: hypromellose (E464), hydroxypropyl cellulose (E463), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172), carnauba wax (E903). Segluromet 2.5 mg/1 000 mg tablets and Segluromet 7.5 mg/1 000 mg tablets: hypromellose (E464), hydroxypropyl cellulose (E463), titanium dioxide (E171), iron oxide red (E172), carnauba wax (E903). What Segluromet looks like and contents of the pack
• Segluromet 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 plain on the other side.
• Segluromet 2.5 mg/1 000 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 plain on the other side.
• Segluromet 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 plain on the other side.
• Segluromet 7.5 mg/1 000 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 plain on the other side. Segluromet is available in Alu/PVC/PA/Alu blisters. The pack sizes are 14, 28, 56, 60, 168, 180, and 196 film-coated tablets in non-perforated blisters and 30x1 film-coated tablets in perforated unit dose blisters. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Merck Sharp & Dohme B.V. Waarderweg 2031 BN Haarlem The Netherlands For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien MSD Belgium T l/Tel: +32(0)27766dpoc_belux@merck.com Lietuva UAB Merck Sharp & Dohme Tel: + 370 5 2780msd_lietuva@merck.com

Te .: + 359 2 819 3info-msdbg@merck.com Luxembourg/Luxemburg MSD Belgium T l/Tel: +32(0)27766dpoc_belux@merck.com esk republika Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 dpoc_czechslovak@merck.com Magyarorsz g MSD Pharma Hungary Kft. Tel.: + 36 1 888-5hungary_msd@merck.com Danmark MSD Danmark ApS Tlf: +45 4482 4dkmail@merck.com Malta Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558) malta_info@merck.com Deutschland MSD Sharp & Dohme GmbH Tel: 0800 673 673 673 (+49 (0) 89 4561 0) e-mail@msd.de Nederland Merck Sharp & Dohme B.V. Tel: 0800 9999000 (+31 23 5153153) medicalinfo.nl@merck.com Eesti Merck Sharp & Dohme O Tel: + 372 6144 msdeesti@merck.com Norge MSD (Norge) AS Tlf: + 47 32 20 73 msdnorge@msd.no

MSD . . . . . : + 30 210 98 97 dpoc_greece@merck.com sterreich Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 dpoc_austria@merck.com Espa a Merck Sharp & Dohme de Espa a, S.A. Tel: +34 91 321 06 msd_info@merck.com Polska MSD Polska Sp. z o.o. Tel.: +48 22 549 51 msdpolska@merck.com France MSD France T l: + 33 (0) 1 80 46 40 Portugal Merck Sharp & Dohme, Lda Tel: + 351 21 4465inform_pt@merck.com Hrvatska Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 croatia_info@merck.com
Rom nia Merck Sharp & Dohme Romania S.R.L. Tel: +40 21 529 29 msdromania@merck.com Ireland Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998medinfo_ireland@merck.com Slovenija Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: + 386 1 5204msd_slovenia@merck.com sland Vistor hf. S mi: + 354 535 7Slovensk republika Merck Sharp & Dohme, s.r.o. Tel: + 421 (2) 58282dpoc_czechslovak@merck.com Italia MSD Italia S.r.l. Tel: 800 23 99 89 (+39 06 361911) medicalinformation.it@msd.com Suomi/Finland MSD Finland Oy Puh/Tel: + 358 (0)9 804info@msd.fi

Merck Sharp & Dohme Cyprus Limited : 800 00 +357 22866cyprus_info@merck.com Sverige Merck Sharp & Dohme (Sweden) AB Tfn: + 46 (0)77 570 04 medicinskinfo@merck.com Latvija SIA Merck Sharp & Dohme Latvija Tel: + 371 67 364msd_lv@merck.com United Kingdom (Northern Ireland) Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998medinfoNI@msd.com

This leaflet was last revised in Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.