Package Leaflet: Information for the User

Xelevia 25Film-Coated Tablets

Xelevia 50Film-Coated Tablets

Xelevia 100Film-Coated Tablets

sitagliptina

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 pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. See section 4.

6. Contents of the pack and other information

Xelevia contains the active ingredient sitagliptin, which belongs to a class of medications called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that reduce blood sugar levels in adult patients with type 2 diabetes mellitus.

This medication helps to increase the levels of insulin 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 may be used alone or in combination with other medications (insulin, metformin, sulfonylureas, or thiazolidinediones) that reduce blood sugar, and which 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 Xelevia

• if you are allergic to sitagliptin or any of the other ingredients in this medication (listed in section 6).

Warnings and precautions

Cases of pancreatitis have been reported in patients treated with Xelevia (see section 4).

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 Xelevia.

Inform your doctor if you have or have had:

• pancreatitis (a disease of the pancreas)
• gallstones, alcohol addiction, or very high levels of triglycerides (a type of fat) in your blood. These medical conditions may increase your risk of developing pancreatitis (see section 4)
• type 1 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 Xelevia (see section 4)

It is unlikely that this medication will 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. The safety and efficacy of this medication in children under 10 years old are unknown.

Other medications and Xelevia

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 Xelevia.

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.

Xelevia contains sodium

This medication contains less than 23 mg of sodium (1 mmol) 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 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 medication with or without food and drinks.

Your doctor may prescribe this medication alone or with other medications that also lower 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 Xelevia.

If you take more Xelevia than you should

If you take more doses of this medication than prescribed, contact your doctor immediately.

If you forget to take Xelevia

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 Xelevia

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 Xelevia 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 can be signs of pancreatitis inflammation.

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 can 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 (can affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting

Rarely (can 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 (can 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

Rarely: dry mouth

Some patients experienced the following side effects while taking sitagliptin only during clinical trials, or during use after approval alone and/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

Rarely: dizziness, constipation, itching

Rare: reduced 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

If you 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 theAppendix V.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 Xelevia

• The active ingredient is sitagliptina:

• Cada comprimido recubierto con película de Xelevia 25mg (comprimido) contiene sitagliptina fosfato monohidrato equivalente a 25mg de sitagliptina.
• Cada comprimido recubierto con película de Xelevia 50mg (comprimido) contiene sitagliptina fosfato monohidrato equivalente a 50mg de sitagliptina.
• Cada comprimido recubierto con película de Xelevia 100mg (comprimido) contiene sitagliptina fosfato monohidrato equivalente a 100mg de sitagliptina.

• 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) y óxido de hierro amarillo (E172).

Appearance of the productand contents of the package

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

Blister packs (PVC/PE/PVDC and aluminium). Pack sizes: 14, 28, 30, 56, 84, 90 or 98film-coated tablets and 50x1 film-coated tablet in pre-cut single-dose blister packs.

Only some pack sizes may be marketed.

Marketing authorisation holder and manufacturer responsible

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 authorisation holder:

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

For detailed information on this medicinal product, please visit the website of the European Medicines Agency:http://www.ema.europa.eu.