Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - steglatro

Document Subject

Generated Narrative: MedicinalProductDefinition mp3e75a55b0a0d0f0feaac242115a6585e

identifier: http://ema.europa.eu/identifier/EU/1/18/1267/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Steglatro 5 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

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-3e75a55b0a0d0f0feaac242115a6585e

identifier: http://ema.europa.eu/identifier/EU/1/18/1267/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - steglatro

Attesters

What is in this leaflet

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

What Steglatro is Steglatro contains the active substance ertugliflozin. Steglatro is a member of a group of medicines called sodium glucose co-transporter-2 (SGLT2) inhibitors. What Steglatro is used for

Steglatro 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.

Steglatro 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 Steglatro. How Steglatro works Ertugliflozin works by blocking the SGLT2 protein in your kidneys. This causes blood sugar to be removed in your urine. 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 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. 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. Steglatro 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] or 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. Urine glucose Because of how this medicine 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 Steglatro Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 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 any of the above apply to you (or you are not sure), tell your doctor. 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 Steglatro 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. Do not use Steglatro if you are pregnant. It is not known if Steglatro passes into breast milk. Talk with your doctor about the best way to feed your baby if you take Steglatro. Do not use Steglatro 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 Steglatro. Steglatro contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Steglatro 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 starting dose of Steglatro is one 5 mg tablet each day. Your doctor will decide whether to increase your dose to 15 mg.

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 with swallowing, the tablet can be broken or crushed.

Take one tablet every morning. Try to take it at the same time; this will help you remember to take it.

You can take your tablet with or without food.

You need to keep following your food and exercise plan while taking Steglatro. If you take more Steglatro than you should If you take too much Steglatro, talk to a doctor or pharmacist straight away. If you forget to take Steglatro 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 Steglatro 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 on the same day) to make up for a forgotten dose. If you stop taking Steglatro 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: 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 Steglatro. 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 when taking Steglatro: Very common

vaginal yeast infection (thrush) 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

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) Uncommon (may affect up to 1 in 100 people)

blood tests may show changes related to kidney function (such as creatinine ) Reporting of side effects If you get any side effects, talk to your doctor or, 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 Steglatro contains

The active substance is ertugliflozin. * Each Steglatro 5 mg film-coated tablet contains ertugliflozin L-pyroglutamic acid, equivalent to 5 mg ertugliflozin.* Each Steglatro 15 mg film-coated tablet contains ertugliflozin L-pyroglutamic acid, equivalent to 15 mg ertugliflozin.

The 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), iron oxide red (E172). What Steglatro looks like and contents of the pack

Steglatro 5 mg film-coated tablets (tablets) are pink, 6.4 x 6.6 mm, triangular-shaped, 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, with 702 on one side and plain on the other side. Steglatro is available in Alu/PVC/PA/Alu blisters. The pack sizes are 14, 28, 30, 84, 90 and 98 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 Merck Sharp & Dohme B.V. Waarderweg 2031 BN Haarlem The Netherlands Manufacturer Organon Heist bv Industriepark 2220 Heist-op-den-Berg Belgium Merck Sharp & Dohme B.V. Waarderweg 2031 BN Haarlem 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 and 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.