Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - tesavel

Document Subject

Generated Narrative: MedicinalProductDefinition mp118afad7684b14db488523a58f186d8f

identifier: http://ema.europa.eu/identifier/EU/1/07/435/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Tesavel 25 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-118afad7684b14db488523a58f186d8f

identifier: http://ema.europa.eu/identifier/EU/1/07/435/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - tesavel

Attesters

What is in this leaflet

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

Tesavel contains the active substance sitagliptin which is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus. This medicine helps to increase the levels of insulin produced after a meal and decreases the amount of sugar made by the body. Your doctor has prescribed this medicine to help lower your blood sugar, which is too high because of your type 2 diabetes. This medicine can be used alone or in combination with certain other medicines (insulin, metformin, sulphonylureas, or glitazones) that lower blood sugar, which you may already be taking for your diabetes together with a food and exercise plan. What is type 2 diabetes? Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems like heart disease, kidney disease, blindness, and amputation.

Do not take Tesavel

• if you are allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving Tesavel (see section 4). If you encounter blistering of the skin it may be a sign for a condition called bullous pemphigoid. Your doctor may ask you to stop Tesavel. Tell your doctor if you have or have had:

• a disease of the pancreas (such as pancreatitis)

• gallstones, alcohol dependence or very high levels of triglycerides (a form of fat) in your blood. These medical conditions can increase your chance of getting pancreatitis (see section 4).

• type 1 diabetes

• diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea or vomiting)

• any past or present kidney problems

• an allergic reaction to Tesavel (see section 4) This medicine is unlikely to cause low blood sugar because it does not work when your blood sugar is low. However, when this medicine is used in combination with a sulphonylurea medicine or with insulin, low blood sugar (hypoglycaemia) can occur. Your doctor may reduce the dose of your sulphonylurea or insulin medicine. Children and adolescents Children and adolescents below 18 years should not use this medicine. It is not effective in children and adolescents between the ages of 10 and 17 years. It is not known if this medicine is safe and effective when used in children younger than 10 years. Other medicines and Tesavel 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 digoxin (a medicine used to treat irregular heartbeat and other heart problems). The level of digoxin in your blood may need to be checked if taking with Tesavel. 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. You should not take this medicine during pregnancy. It is not known if this medicine passes into breast milk. You should not take this medicine if you are breast-feeding or plan to breast-feed. Driving and using machines This medicine has no or negligible influence on the ability to drive and use machines. However, dizziness and drowsiness have been reported, which may affect your ability to drive or use machines. Taking this medicine in combination with medicines called sulphonylureas or with insulin can cause hypoglycaemia, which may affect your ability to drive and use machines or work without safe foothold. Tesavel 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 has told you. Check with your doctor or pharmacist if you are not sure. The usual recommended dose is:

one 100 mg film-coated tablet

once a day

by mouth If you have kidney problems, your doctor may prescribe lower doses (such as 25 mg or 50 mg). You can take this medicine with or without food and drink. Your doctor may prescribe this medicine alone or with certain other medicines that lower blood sugar. Diet and exercise can help your body use its blood sugar better. It is important to stay on the diet and exercise recommended by your doctor while taking Tesavel. If you take more Tesavel than you should If you take more than the prescribed dosage of this medicine, contact your doctor immediately. If you forget to take Tesavel If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take a double dose of this medicine. If you stop taking Tesavel Continue to take this medicine as long as your doctor prescribes it so you can continue to help control your blood sugar. You should not stop taking this medicine without talking to your doctor first. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. STOP taking Tesavel and contact a doctor immediately if you notice any of the following serious side effects:

• Severe and persistent pain in the abdomen (stomach area) which might reach through to your back with or without nausea and vomiting, as these could be signs of an inflamed pancreas (pancreatitis). If you have a serious allergic reaction (frequency not known), including rash, hives, blisters on the skin/peeling skin and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing, stop taking this medicine and call your doctor right away. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes. Some patients have experienced the following side effects after adding sitagliptin to metformin: Common (may affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting Uncommon (may affect up to 1 in 100 people): stomach ache, diarrhoea, constipation, drowsiness Some patients have experienced different types of stomach discomfort when starting the combination of sitagliptin and metformin together (frequency is common). Some patients have experienced the following side effects while taking sitagliptin in combination with a sulphonylurea and metformin: Very common (may affect more than 1 in 10 people): low blood sugar Common: constipation Some patients have experienced the following side effects while taking sitagliptin and pioglitazone: Common: flatulence, swelling of the hands or legs Some patients have experienced the following side effects while taking sitagliptin in combination with pioglitazone and metformin: Common: swelling of the hands or legs Some patients have experienced the following side effects while taking sitagliptin in combination with insulin (with or without metformin): Common: flu Uncommon: dry mouth Some patients have experienced the following side effects while taking sitagliptin alone in clinical studies, or during post-approval use alone and/or with other diabetes medicines: Common: low blood sugar, headache, upper respiratory infection, stuffy or runny nose and sore throat, osteoarthritis, arm or leg pain Uncommon: dizziness, constipation, itching Rare: reduced number of platelets Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister) 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. Store below 25 C. Do not throw away 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 Tesavel contains

• The active substance is sitagliptin:* Each Tesavel 25 mg film-coated tablet (tablet) contains sitagliptin phosphate monohydrate, equivalent to 25 mg sitagliptin.* Each Tesavel 50 mg film-coated tablet (tablet) contains sitagliptin phosphate monohydrate, equivalent to 50 mg sitagliptin.* Each Tesavel 100 mg film-coated tablet (tablet) contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.
• The other ingredients are:* Tablet core: microcrystalline cellulose (E460), calcium hydrogen phosphate, anhydrous (E341), croscarmellose sodium (E468), magnesium stearate (E470b), sodium stearyl fumarate and propyl gallate. * Film coating: poly(vinyl alcohol), macrogol 3350, talc (E553b), titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172). What Tesavel looks like and contents of the pack
• Tesavel 25 mg film-coated tablets are round, pink film-coated tablets with 221 on one side.
• Tesavel 50 mg film-coated tablets are round, light beige film-coated tablets with 112 on one side.
• Tesavel 100 mg film-coated tablets are round, beige film-coated tablets with 277 on one side. Opaque blisters (PVC/PE/PVDC and aluminium). Packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets and 50 x 1 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: Belgique/Belgi /Belgien MSD Belgium T l/Tel: +32 (0)27766dpoc_belux@merck.com Lietuva UAB Merck Sharp & Dohme Tel.: +370 5 278 02 msd_lietuva@merck.com

.: +359 2 819 3info-msdbg@merck.com Luxembourg/Luxemburg MSD Belgium T l: +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 53 hungary_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 E 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 Almirall, S.A. Tel: +34 93 291 30 info.spain@almirall.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 66 11 croatia_info@merck.com Rom nia Merck Sharp & Dohme Romania S.R.L. Tel: + 4021 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 5204 msd_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 talia 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) 9 804 info@msd.fi

Merck Sharp & Dohme Cyprus Limited : 80000 673 (+357 22866700) cyprus_info@merck.com Sverige Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700medicinskinfo@merck.com Latvija SIA Merck Sharp & Dohme Latvija Tel: +371 67364 msd_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 {MM/YYYY}. Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.