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.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section4.

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 during breastfeeding 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. 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:

• 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 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 essential 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 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:

• Intense and persistent abdominal pain (stomach area) that can reach the back with or without nausea and vomiting, as these may be signs of pancreatitis (inflammation of the pancreas).

If you have a severe allergic reaction (unknown frequency), including skin rash, urticaria, 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 throat pain, 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 leaflet.You can also report them directly through thenational notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information about 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

• The active ingredient is sitagliptin:

• Cada comprimido recubierto con película de Tesavel 25mg (comprimido) contains sitagliptina fosfato monohidrato equivalent to 25mg of sitagliptin.
• Cada comprimido recubierto con película de Tesavel 50mg (comprimido) contains sitagliptina fosfato monohidrato equivalent to 50mg of sitagliptin.
• Cada comprimido recubierto con película de Tesavel 100mg (comprimido) contains sitagliptina fosfato monohidrato equivalent to 100mg of sitagliptin.

• The other components are:

• Núcleo del comprimido: celulosa microcristalina (E460), hidrogenofosfato de calcio anhidro (E341), croscarmelosa sódica (E468), estearato de magnesio (E470b), fumarato de estearilo y sodio y galato de propilo.
• Recubrimiento con película: alcohol polivinílico, macrogol 3350, talco (E553b), dióxido de titanio (E171), óxido de hierro rojo (E172) and óxido de hierro amarillo (E172).

Appearance of the productand contents of the package

• The Tesavel 25mg film-coated tablets are round, pink, with “221” on one side.
• The Tesavel 50mg film-coated tablets are round, light beige, with “112” on one side.
• The Tesavel 100mg film-coated tablets are round, beige, with “277” on one side.

Blister packs (PVC/PE/PVDC and aluminum). Pack sizes: 14, 28, 30, 56, 84, 90 or 98 film-coated tablets and 50 x 1 film-coated tablet in pre-cut single-dose blister packs.

Only some pack 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 further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last date of revision of the summary of product characteristics:{MM/AAAA}.

Further information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.