Leaflet: information for the user
Tesavel 25mg film-coated tablets
Tesavel 50mg film-coated tablets
Tesavel 100mg film-coated tablets
sitagliptin
Read this leaflet carefully before you start taking this medicine, because it contains important information for you.
1.What is Tesavel and what it is used for
2.What you need to know before starting to take Tesavel
3.How to take Tesavel
4.Possible side effects
5.Storage of Tesavel
6.Contents of the pack and additional information
Tesavel contains the active ingredient sitagliptin, which belongs to a class of medications known as DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that reduce blood sugar levels in adult patients with type 2 diabetes.
This medication helps to increase insulin levels produced after a meal and decreases the amount of sugar produced by the body.
Your doctor has prescribed this medication to help you reduce your blood sugar, which is too high due to your type 2 diabetes. This medication can be used alone or in combination with other medications (insulin, metformin, sulfonylureas, or thiazolidinediones) that reduce blood sugar, and that you may already be taking for your diabetes along with a diet and exercise program.
What is type 2 diabetes?
Type 2 diabetes is a disease that consists of your body not producing enough insulin, and the insulin it produces not working as well as it should. Your body may also produce too much sugar. When this happens, sugar (glucose) accumulates in the blood. This can cause serious medical problems, such as heart disease, kidney disease, blindness, and amputation.
Do not take Tesavel
-if you are allergic to sitagliptin or any of the other components of this medication (listed in section6).
Warnings and precautions
Cases of pancreatitis have been reported in patients treated with Tesavel (see section4).
If you notice blisters on your skin, it may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop taking Tesavel.
Inform your doctor if you have or have had:
-pancreatitis (such as pancreatitis)
-gallstones, alcohol addiction, or very high levels of triglycerides in your blood. These medical conditions may increase your risk of developing pancreatitis (see section4)
-type1 diabetes
-diabetic ketoacidosis (a complication of diabetes that causes high blood sugar levels, rapid weight loss, nausea, or vomiting)
-any kidney problems you currently have or have had in the past
-an allergic reaction to Tesavel (see section4)
This medication is unlikely to cause low blood sugar because it does not work when blood sugar levels are low. However, when this medication is used in combination with a medication that contains a sulfonylurea or with insulin, low blood sugar (hypoglycemia) may occur. Your doctor may reduce the dose of your sulfonylurea or insulin medication.
Children and adolescents
Children and adolescents under 18 years old should not use this medication. It is not effective in children and adolescents aged 10 to 17 years old. The safety and efficacy of this medication in children under 10 years old are unknown.
Other medications and Tesavel
Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.
Particularly, inform your doctor if you are taking digoxin (a medication used to treat irregular heartbeat and other heart problems). Your doctor may need to check your digoxin blood levels if you are taking Tesavel.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.
This medication should not be taken during pregnancy.
The safety of this medication in breastfeeding women is unknown. Do not take this medication if you are breastfeeding or plan to breastfeed.
Driving and operating machinery
The influence of this medication on your ability to drive or operate machinery is negligible or insignificant. However, dizziness and somnolence have been reported, which may affect your ability to drive or operate machinery.
Additionally, taking this medication with sulfonylureas or insulin may cause hypoglycemia, which may affect your ability to drive and operate machinery or work safely without support.
Tesavel contains sodium
This medication contains less than 23mg of sodium (1mmol) per tablet; it is essentially “sodium-free”.
Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.
The recommended usual dose is:
If you have kidney problems, your doctor may prescribe lower doses (such as 25 mg or 50 mg).
You can take this medication with or without food and drinks.
Your doctor may prescribe this medication alone or with other medications that also reduce blood sugar.
Diet and exercise can help your body use sugar better. It is important that you follow the diet and exercise recommended by your doctor while taking Tesavel.
If you take more Tesavel than you should
If you take more doses of this medication than prescribed, contact your doctor immediately.
If you forget to take Tesavel
If you forget a dose, take it as soon as you remember. If you do not remember until the time of the next dose, then skip the missed dose and continue with your regular schedule. Do not take a double dose of this medication.
If you interrupt treatment with Tesavel
Continue taking this medication as long as your doctor prescribes it for you to continue helping to control your blood sugar. You should not stop taking this medication without first consulting your doctor.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
STOP taking Tesavel and see your doctor immediately if you notice any of the following serious side effects:
If you have a severe allergic reaction (unknown frequency), including skin rash, hives, blisters on the skin/skin peeling and swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing, stop taking this medicine and consult your doctor immediately.Your doctor will prescribe a medicine to treat the allergic reaction and change the medicine for diabetes treatment..
Some patients experienced the following side effects after adding sitagliptin to treatment with metformin:
Frequent (may affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting
Infrequent (may affect up to 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness.
Some patients experienced different types of stomach discomfort when they started taking sitagliptin and metformin together (classified as frequent).
Some patients experienced the following side effects while taking sitagliptin in combination with a sulfonylurea and metformin:
Very frequent (may affect more than 1 in 10 people): low blood sugar
Frequent: constipation
Some patients experienced the following side effects while taking sitagliptin and pioglitazone:
Frequent: flatulence, swelling of hands or feet
Some patients experienced the following side effects while taking sitagliptin in combination with pioglitazone and metformin:
Frequent: swelling of hands or feet
Some patients experienced the following side effects while taking sitagliptin in combination with insulin (with or without metformin):
Frequent: flu
Infrequent: dry mouth
Some patients experienced the following side effects while taking sitagliptin only during clinical trials, orafter approval onlyand/or with other diabetes medications:
Frequent: low blood sugar, headache, upper respiratory tract infection, congestion or nasal mucosity and sore throat, arthritis, arm or leg pain
Infrequent: dizziness, constipation, itching
Rare: reduction in platelet count
Unknown frequency: kidney problems (which sometimes require dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blister on the skin)
Reporting of side effects
Ifyou experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through thenational notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the blister pack and on the container after CAD. The expiration date is the last day of the month indicated.
Store below 25°C.
Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.
Composition of Tesavel
Appearance of the productand contents of the package
Blister packs (PVC/PE/PVDC and aluminum). Packages of 14, 28, 30, 56, 84, 90 or 98film-coated tablets and 50x1 film-coated tablet in pre-cut single-dose blister packs.
Only some package sizes may be marketed.
Holder of the marketing authorization and responsible for manufacturing
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
Netherlands
For more information about this medicinal product, please contact the local representative of the marketing authorization holder:
Belgium/België/Belgien MSD Belgium Tel: +32 (0)27766211 | Lithuania UAB Merck Sharp & Dohme Tel: +37052780247 |
Bulgaria MSD Bulgaria EOOD Tel: +359 2 819 3737 | Luxembourg/Luxemburg MSD Belgium Tel: +32 (0)27766211 dpoc_belux@merck.com |
Czech Republic Merck Sharp & Dohme s.r.o. Tel: +420233010111 | Hungary MSD Pharma Hungary Kft. Tel: +3618885300 |
Denmark MSD Danmark ApS Tel: +45 4482 4000 | Malta Merck Sharp & Dohme CyprusLimited Tel: +35699917558 |
Germany MSD Sharp & Dohme GmbH Tel: 0800 673 673 673 (+49 (0) 89 4561 0) | Netherlands Merck Sharp & Dohme B.V. Tel: +31 23 5153153 |
Estonia Merck Sharp & Dohme OÜ Tel: +3726144 200 | Norway MSD (Norge) AS Tel: +47 32 20 73 00 |
Greece MSD Α.Φ.Β.Ε.Ε. Tel: + 30 210 98 97 300 | Austria Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 044 dpoc_austria@merck.com |
Spain Almirall, S.A. Tel: +3493 291 30 00 info.spai[email protected] | Poland MSD Polska Sp. z o.o. Tel: +48225495100 |
France MSD France Tel: + 33 (0) 1 80 46 40 40 | Portugal Merck Sharp & Dohme, Lda Tel: +351 214465700 |
Croatia Merck Sharp & Dohme d.o.o. Tel: + 385 1 66 11 333 | Romania Merck Sharp & Dohme Romania S.R.L. Tel: + 4021 529 29 00 |
Ireland Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998700 | Slovenia Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: +38615204201 |
Iceland Vistor hf. Tel: +354 535 7000 | Slovakia Merck Sharp & Dohme, s. r. o. Tel: +421258282010 |
Italy MSD Italia S.r.l. Tel: +39 06 361911 | Finland MSD Finland Oy Tel: +358 (0) 9 804650 |
Cyprus Merck Sharp & Dohme Cyprus Limited Tel: +35722866700 | Sweden Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488 |
Lithuania SIA Merck Sharp & Dohme Latvija Tel: +37167364224 | United Kingdom (Northern Ireland) Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998700 medinfoNI@msd.com |
Last date of revision of the summary of product characteristics:{MM/AAAA}.
For detailed information about this medicinal product, please visit the website of the European Medicines Agency:http://www.ema.europa.eu.
The average price of Tesavel 100 mg comprimidos recubiertos con pelicula in July, 2025 is around 26.52 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.