Sitagliptin Tecnimede 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Sitagliptin Tecnimede 100 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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 may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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

1. What Sitagliptina Tecnmede 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) that reduce blood sugar levels in adult patients with type 2 diabetes mellitus.

This medicine helps increase insulin levels produced after a meal and decreases 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 (insulin, metformin, sulfonylureas, or glitazones) 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 condition in which your body does not produce enough insulin, and the insulin it 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 starting Sitagliptin Tecnimede

Do not take Sitagliptin Tecnimede

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

Warnings and precautions

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

If you develop blisters on the skin, this may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop taking sitagliptin.

Inform your doctor if you have or have had:

• a 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 diabetes complication causing 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 sitagliptin (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 medication. It is not effective in children and adolescents between the ages of 10 and 17. It is unknown whether this medication is safe and effective when used in children under 10 years of age.

Other medicines and Sitagliptina Tecnimede

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

In particular, inform your doctor if you are taking digoxin (a medicine used to treat irregular heartbeat and other heart problems). It may be necessary to monitor the level of digoxine in your blood if you are taking sitagliptina.

Taking Sitagliptina Tecnimede with food and drinks
You can take this medicine with or without food and drinks.

Pregnancy, lactation and fertility

If you are pregnant or breastfeeding, think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine. This medicine should not be taken 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 Use of Machines

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

Likewise, taking this medicine together with medications called sulfonylureas or with insulin may cause hypoglycemia, which could impair your ability to drive, operate machinery, or work without a secure support point.

SitagliptinTecnimede contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; hence, it is essentially "sodium-free".

3. How to take Sitagliptina Tecnimede

Follow exactly the instructions for use of this medicine provided 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 beverages.

Your doctor may prescribe this medicine alone or together with other medicines that also lower blood sugar. Diet and exercise may help the body use sugar more effectively. It is important to follow the diet and exercise regimen recommended by your doctor while taking sitagliptin.

OverdoseSitagliptinTecnimedeWhatyoumustdo

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Sitagliptin Tecnimede

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 of this medicine.

If you stop treatment with Sitagliptin Tecnimede

Keep taking this medication for as long as your doctor prescribes it, so it can continue helping you control your blood sugar. You should not stop taking this medicine without first consulting your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

STOP taking Sitagliptin Tecnimede 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 extend 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 skin rash, hives, blistering or peeling of the skin, and swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing, stop taking this medicine and consult your doctor immediately. Your doctor will prescribe treatment for the allergic reaction and switch you to another medicine for the treatment of diabetes.

Some patients experienced the following adverse effects after adding sitagliptin to treatment with metformin:

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

Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhoea, constipation, drowsiness

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

Some patients experienced the following adverse effects while taking sitagliptin in combination with a sulphonylurea 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 during post-marketing use alone and/or in combination with other antidiabetic medicines:

Common: low blood sugar, headache, upper respiratory tract infection, nasal congestion or runny nose, sore throat, osteoarthritis, pain in the arm or leg

Uncommon: dizziness, constipation, itching

Rare: reduction in platelet count

Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin rash)

Reporting suspected adverse reactions

It is important to report suspected adverse reactions to the medicine after authorization. This enables continued monitoring of the benefit-risk balance of the medicine. Healthcare professionals are encouraged to report suspected adverse reactions via the

Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

5. Storage of Sitagliptin Tecnimede

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister pack and on the outer packaging after CAD/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 Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Sitagliptina Tecnimede

The active substance is sitagliptin. Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 100 mg of sitagliptin.

The other components are:

In the tablet core: microcrystalline cellulose (E 460), calcium hydrogen phosphate, sodium croscarmellose (E 468), colloidal anhydrous silica, sodium stearyl fumarate, magnesium stearate (E470b).

The tablet coating contains: poly (vinyl alcohol) (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E172), red iron oxide (E172).

Appearance of the product and contents of the package

Beige, round, film-coated tablets.

Sitagliptina Tecnimede is available in: opaque blisters (PVC/PE/PVDC and aluminum)

Pack sizes: 14, 28, and 56 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica S.A.

Avenida de Bruselas, 13, 3rd Floor, D

28108 Alcobendas (Madrid)

Spain

Marketing Authorization Holder

SAG MANUFACTURING, S.L.U.

Ctra. N-I, Km 36. 28750 San Agustin de Guadalix, Madrid (Spain)

GALENICUM HEALTH, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat, 08950

Barcelona, Spain

Date of the most recent review of this leaflet: November 2023

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