Label: Information for the Patient

sitagliptin cinfamed 100mg film-coated tablets

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed for you only, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section4.

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

This medication helps to increase the level of insulin generated after a meal and reduces 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 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 sitagliptin cinfamed

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

Cases of pancreatitis have been reported in patients treated with sitagliptin (see section4).

The appearance of blisters on the skin may be a sign of a disease called bullous pemphigoid. Your doctor may ask you to stop taking this medication.

Inform your doctor if you have or have had:

• pancreatitis disease (such as pancreatitis);
• gallstones, alcohol addiction, or very high levels of triglycerides in the blood (a type of fat).

These medical conditions may increase your risk of developing pancreatitis (see section4).

• type 1 diabetes;
• diabetic ketoacidosis (a complication of diabetes that causes high blood sugar levels, rapid weight loss, nausea, or vomiting);
• any kidney problem you currently have or have had in the past;
• any allergic reaction to this medication (see section4).

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 containing 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.This medication is not effective when used in children and adolescents between 10 and 17years old.The safety and effectiveness of this medication in children and adolescents under 10years old are unknown.

Other medications and sitagliptin cinfamed

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 level if you are taking this medication.

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 medications called sulfonylureas or with insulin may cause hypoglycemia, which may affect your ability to drive and operate machinery or work safely without a secure support point.

Your concentration and reaction abilities may be affected due to symptoms caused by hypoglycemia or hyperglycemia, such as vision difficulties. This may be hazardous in situations where these skills are essential (e.g., driving or operating machinery). Therefore, consult your doctor if it is recommended to drive or operate machinery.

Sitagliptin cinfa 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. In case of doubt, consult your doctor or pharmacist again.

The recommended usual dose is

• one tablet of100mg film-coated
• once a day
• by mouth.

If you have kidney problems, your doctor may prescribe lower doses (such as 25mg or 50mg).

You can take this medication with food and drinks or without them.

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 this medication.

If you take more sitagliptin cinfamed than you should

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

If you forgot to take sitagliptin cinfamed

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 to make up for the missed dose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you interrupt treatment with sitagliptin cinfamed

Continue taking this medication as long as your doctor prescribes it to control blood sugar. Do not stop taking this medication without consulting your doctor first.

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 this medicine 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 of the pancreas).

If you have a severe allergic reaction (unknown frequency) that includes skin rash, urticaria, blisters on the skin or 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 may prescribe a medicine to treat the allergic reaction and a different medicine for diabetes.

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, and vomiting. Less frequent (can affect up to 1 in 100 people): stomach pain, diarrhea, constipation, and drowsiness.

Some patients experienced different types of stomach discomfort when they started combining sitagliptin with metformin (frequency 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 metformin or without it):

Frequent: flu

Less frequent: dry mouth

Some patients experienced the following side effects while taking only sitagliptin during clinical trials or during use after approval alone or with other medicines for diabetes:

Frequent: low blood sugar, headache, upper respiratory tract infection, congestion or nasal mucosity, and throat pain, arthritis, arm or leg pain.

Less frequent: dizziness, constipation, itching

Less frequent: 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 skin blister)

Reporting of side effects

If you experience side effects, consult your doctor, pharmacist, or nurse. This includes side effects not listed in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.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 or bottle and on the packaging after "CAD". The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the Sigre point of your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

• The active ingredient is sitagliptin.

Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 100mg of sitagliptin.

• The other components are as follows:

Tablet core:Calcium hydrogen phosphate anhydrous, microcrystalline cellulose, sodium croscarmellose, sodium stearate fumarate, and magnesium stearate.

Coating:Polivinyl alcohol, titanium dioxide, macrogol, talc, yellow iron oxide, and red iron oxide.

Appearance of sitagliptina cinfamed and contents of the package

Film-coated tablets, round, biconvex, approximately 9.8mm in diameter, beige in color, with "L" engraved on one side and smooth on the other.

The 100mg film-coated tablets are packaged in:

• blister packs composed of PVC OPACO/PVDC-aluminum that contain

10, 14, 28, 30, 56, 98, 100, 105, and 120film-coated tablets.

• White high-density polyethylene (HDPE) bottle with a desiccant container with silica gel in the polypropylene screw cap, containing100film-coated tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer:

Marketing authorization holder

Cinfa Laboratories, S.A

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Responsible manufacturer

Liconsa Laboratories S.A.

Miralcampo Avenue, No. 7, Miralcampo Industrial Estate

19200 Azuqueca de Henares

Guadalajara – Spain

Basi Laboratories - Pharmaceutical Industry, S.A.

Manuel Lourenço Ferreira Industrial Park, Lots 8, 15, and 16

3450-232 Mortágua, Portugal

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Date of the last review of this prospectus: July 2021

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es

Youcan access detailed and updated information about this medicine by scanning with your smartphone the QR code included in the prospectus and packaging. You can also access this information on the following internet address:https://cima.aemps.es/cima/dochtml/p/86323/P_86323.html

QR code to:https://cima.aemps.es/cima/dochtml/p/86323/P_86323.html