Sitagliptin Cinfamed 50 mg film-coated tablet EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

sitagliptina cinfamed 50 mg film-coated tablets EFG

Read the entire 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

1. What sitagliptina cinfamed is and what it is used for
2. What you need to know before taking sitagliptina cinfamed
3. How to take sitagliptina cinfamed
4. Possible side effects
5. How to store sitagliptina cinfamed
6. Contents of the pack and other information

1. What sitagliptina cinfamed is and what it is used for

This medicine contains the active substance sitagliptin, which belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), which lower blood sugar levels in adult patients with type 2 diabetes mellitus.

This medicine helps increase the amount of insulin produced after a meal and reduces the amount of sugar produced by the body.

Your doctor has prescribed this medicine to help you lower your blood sugar, which is too high due to your type 2 diabetes. This medicine may be used alone or in combination with other blood sugar-lowering medicines (such as insulin, metformin, sulfonylureas or glitazones) 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 condition in which your body does not produce enough insulin, and the insulin your body does produce does not work as well as it should. Your body may also produce too much sugar.

When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems, such as heart disease, kidney disease, blindness, and amputation.

2. What you need to know before taking sitagliptina cinfamed

Do not take sitagliptina cinfamed

• If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine.

Cases of inflammation of the pancreas (pancreatitis) have been reported in patients treated with sitagliptin (see section 4).

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 medicine.

Tell your doctor if you have or have had:

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

These medical conditions may increase your risk of developing pancreatitis (see section 4).

• type 1 diabetes;
• diabetic ketoacidosis (a complication of diabetes causing high blood sugar levels, rapid weight loss, nausea or vomiting);
• any kidney problems currently or in the past;
• an allergic reaction to this medicine (see section 4).

It is unlikely that this medicine will cause low blood sugar because it does not act when blood sugar levels are low. However, when this medicine is used in combination with a medicine containing a sulfonylurea or with insulin, low blood sugar (hypoglycemia) may occur. Your doctor may reduce the dose of your sulfonylurea-containing medicine or insulin.

Children and adolescents

Children and adolescents under 18 years of age should not use this medicine. It is not effective when used in children and adolescents aged between 10 and 17 years. It is unknown whether this medicine is safe and effective when used in children and adolescents under 10 years of age.

Other medicines and sitagliptina cinfamed

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, tell your doctor if you are taking digoxin (a medicine used to treat irregular heartbeat and other heart problems). Your blood digoxin levels may need to be monitored if you are taking this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

You should not take this medicine during pregnancy.

It is unknown whether this medicine passes into breast milk. You should not take this medicine if you are breastfeeding or planning to breastfeed.

Driving and using machines

The effect of this medicine on the ability to drive or operate machinery is negligible or none. However, dizziness and somnolence have been reported, which may affect your ability to drive or operate machinery.

In addition, taking this medicine together with medicines called sulfonylureas or with insulin may cause hypoglycemia, which may affect your ability to drive and operate machinery or work without secure support.

Your ability to concentrate and react may be impaired due to symptoms caused by hypoglycemia or hyperglycemia, such as vision disturbances. This may be dangerous in situations where these skills are important (e.g., driving or operating machinery). Therefore, consult your doctor to determine whether it is advisable to drive or operate machinery.

Sitagliptina cinfamed contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially sodium-free.

3. How to take sitagliptin cinfamed

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

The usual recommended dose is

• one 100 mg film-coated tablet
• once daily
• taken orally.

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

You may take this medicine with or without food and drinks.

Your doctor may prescribe this medicine alone or together with other medicines that also lower blood sugar.

Diet and exercise can help the body use sugar more effectively. It is important that you follow the diet and exercise regimen recommended by your doctor while taking this medicine.

If you take more sitagliptin cinfamed than you should

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

If you forget to take sitagliptin cinfamed

If you forget a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and continue with your regular dosing 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 Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you stop taking sitagliptin cinfamed

Continue taking this medicine for as long as your doctor prescribes it in order to control your blood sugar. You should not stop taking this medicine without first consulting your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

STOP taking this medicine and contact your doctor immediately if you notice any of the following serious adverse effects:

• Severe and persistent pain in the abdomen (stomach area) that may radiate to the back, with or without nausea and vomiting, as these may be signs of inflammation of the pancreas (pancreatitis).

If you have a severe allergic reaction (frequency not known) including rash, hives, skin blisters or skin peeling, and swelling of the face, lips, tongue, and throat which may 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 your diabetes.

Some patients experienced the following adverse effects after adding sitagliptin to metformin treatment:
Common (may affect up to 1 in 10 people): low blood sugar, nausea, flatulence, and vomiting.
Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhoea, constipation, and drowsiness.

Some patients experienced various types of stomach discomfort when starting combination treatment with sitagliptin and metformin (frequency classified as common).

Some patients experienced the following adverse effects while taking sitagliptin in combination with a sulfonylurea and metformin:
Very common (may affect more than 1 in 10 people): low blood sugar
Common: constipation

Some patients experienced the following adverse effects while taking sitagliptin and pioglitazone:
Common: flatulence, swelling of hands or legs

Some patients experienced the following adverse effects while taking sitagliptin in combination with pioglitazone and metformin:
Common: swelling of hands or legs

Some patients experienced the following adverse effects while taking sitagliptin in combination with insulin (with or without metformin):
Common: influenza-like illness
Uncommon: dry mouth

Some patients experienced the following adverse effects while taking sitagliptin alone during clinical trials or after approval, either alone or in combination with other antidiabetic medicines:
Common: low blood sugar, headache, upper respiratory tract infection, nasal congestion or runny nose, sore throat, osteoarthritis, arm or leg pain.
Uncommon: dizziness, constipation, itching
Uncommon: reduced platelet count
Frequency not known: kidney problems (which sometimes require dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blistering)

Reporting of adverse reactions

If you experience adverse reactions, consult your doctor, pharmacist, or nurse. This includes adverse reactions not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of sitagliptin cinfamed

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister or container and on the outer packaging following «EXP». The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the Sigre collection point at your usual pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

• The active substance is sitagliptin.

Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin.

• The other components are the following:

Tablet core: Anhydrous calcium hydrogen phosphate, microcrystalline cellulose, sodium croscarmellose, sodium stearyl fumarate, and magnesium stearate.

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

Appearance of sitagliptin cinfamed and contents of the container

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

The 50 mg film-coated tablets are packaged in:

• Opaque PVC/PVDC-aluminum blisters containing

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Laboratorios Liconsa S.A.

Avda. Miralcampo, Nº 7, Pol. Ind. Miralcampo

19200 Azuqueca de Henares

Guadalajara – Spain

Laboratórios Basi - Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 e 16

3450-232 Mortágua, Portugal

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

Date of the most recent review of this leaflet: July 2021

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Medical Devices (AEMPS) http://www.aemps.gob.es

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/86324/P_86324.html

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