Label: Information for the Patient

sitagliptin cinfamed 50mg 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 only for you, and you should not give it to others who may 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 sitagliptina 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 sitagliptina (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).

• type1 diabetes;
• diabetic ketoacidosis (a complication of diabetes that produces 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 act 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 sitagliptina 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 produce 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 visual 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.

Sitagliptina cinfamed 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 usual recommended 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 pain in the abdomen (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 (frequency not known) 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, pain in the arm or leg.

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 shown 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 your local pharmacy's Sigre point. 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 50 mg of sitagliptin.

• The other components are as follows:

Tablet core: Calcium 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 packaging contents

Film-coated tablets, round, biconvex, approximately 8 mm in diameter, orange in color, engraved with "C" on one side and smooth on the other.

The 50 mg film-coated tablets are packaged in:

• PVC OPACO/PVDC-aluminum composite blisters containing

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

• White high-density polyethylene (HDPE) bottle with a desiccant container with silica gel in the polypropylene screw cap, containing 100 film-coated tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer responsible:

Marketing authorization holder

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Manufacturer responsible

Laboratorios Liconsa S.A.

Avda. Miralcampo, Nº 7, Industrial Estate Miralcampo

19200 Azuqueca de Henares

Guadalajara – Spain

Laboratórios Basi - Indústria Farmacêutica, S.A.

Industrial Park Manuel Lourenço Ferreira, 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:

Last review date of this leaflet: july 2021

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/86324/P_86324.html

QR code to: https://cima.aemps.es/cima/dochtml/p/86324/P_86324.html