SITAGLIPTIN VISO FARMACEUTICA 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Sitagliptin Viso Pharmaceutical 50 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Sitagliptin Viso Pharmaceutical is and what it is used for
2. What you need to know before taking Sitagliptin Viso Pharmaceutical
3. How to take Sitagliptin Viso Pharmaceutical
4. Possible side effects
5. Storage of Sitagliptin Viso Pharmaceutical
6. Package contents and additional information

1. What Sitagliptin Viso Pharmaceutical is and what it is used for

Sitagliptin 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 increase insulin levels produced after a meal and decreases the amount of sugar produced by the body.

Your doctor has prescribed this medication to help reduce your blood sugar level, 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 glitazones) that reduce blood sugar levels, which you may already be taking for your diabetes, along with a diet and exercise plan.

What is type 2 diabetes?

Type 2 diabetes is a disease in which the body does not produce enough insulin, and the insulin it produces does not work as well as it should. The 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.

2. What you need to know before taking Sitagliptin Viso Pharmaceutical

Do not take Sitagliptin Viso Pharmaceutical:

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

Warnings and precautions

There have been reports of pancreatitis (inflammation of the pancreas) in patients taking sitagliptin (see section 4).

If you develop blisters on your skin, it may be a sign of a disease called bullous pemphigoid. Your doctor may ask you to stop taking sitagliptin.

Tell your doctor if you have or have had:

• a pancreatic disease (such as pancreatitis)
• bile stones, alcohol dependence, or very high levels of triglycerides (a type of fat) in your blood.

These diseases may increase your likelihood of developing pancreatitis (see section 4).

• type 1 diabetes mellitus
• diabetic ketoacidosis (a complication of diabetes with high blood sugar levels, rapid weight loss, nausea, or vomiting)
• any past or present kidney problems.
• an allergic reaction to sitagliptin (see section 4).

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

Children and adolescents

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

Other medications and Sitagliptin Viso Pharmaceutical

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Tell your doctor especially if you are taking digoxin (a medication used to treat irregular heartbeat and other heart problems). It may be necessary to monitor your digoxin blood levels if you take it with sitagliptin.

Pregnancy and breastfeeding

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

You should not take this medication during pregnancy.

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

Driving and using machines

The influence of this medication on the ability to drive and use machines is negligible or nonexistent. However, dizziness and somnolence have been reported, which may affect your ability to drive or use machines.

Taking this medication in combination with medications called sulfonylureas or with insulin may cause hypoglycemia, which may affect your ability to drive or use machines or work without a secure support point.

Sitagliptin Viso Pharmaceutical contains sodium

Sodium:

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

3. How to take Sitagliptin Viso Pharmaceutical

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is:

• one 100 mg film-coated tablet
• once a day
• orally

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 or drink.

Your doctor may prescribe this medication alone or with other medications that reduce blood sugar levels.

Diet and exercise can help your body use blood sugar better. It is essential that you follow the diet and exercise recommended by your doctor while taking sitagliptin.

If you take more Sitagliptin Viso Pharmaceutical than you should

If you take more than the prescribed dose of this medication, contact your doctor immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Sitagliptin Viso Pharmaceutical

If you have forgotten to take a dose, take it as soon as you remember. If you do not remember until the time of the next dose, skip the missed dose and return to your regular schedule. Do not take a double dose to make up for missed doses.

If you stop taking Sitagliptin Viso Pharmaceutical

Continue taking this medication while your doctor prescribes it to you, so it can continue to help you control your blood sugar levels. Do not stop taking this medication without consulting your doctor first.

If you have any other questions about using this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

STOP taking sitagliptin and contact a doctor immediately if you notice any of the following serious side effects:

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

If you have a severe allergic reaction (frequency not known), including skin rash, hives, blisters on the skin/exfoliative skin, and swelling of the face, lips, tongue, and throat that can cause difficulty breathing or swallowing, stop taking this medication and call your doctor immediately. Your doctor may prescribe a medication to treat the allergic reaction and another for diabetes.

Some patients have experienced the following side effects after adding sitagliptin to 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, diarrhea, constipation, somnolence.

Some patients have experienced different types of stomach discomfort when starting the combination of sitagliptin and metformin (the frequency is classified as common).

Some patients have experienced the following side effects when 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 have experienced the following side effects when taking sitagliptin and pioglitazone:

Common: flatulence, swelling of hands or feet.

Some patients have experienced the following side effects when taking sitagliptin in combination with pioglitazone and metformin:

Common: swelling of hands or feet.

Some patients have experienced the following side effects when taking sitagliptin in combination with insulin (with or without metformin):

Common: flu.

Uncommon: dry mouth.

Some patients have experienced the following side effects when taking sitagliptin alone in clinical trials or during its use after approval, alone and/or with other diabetes medications:

Common: low blood sugar, headache, upper respiratory tract infection, nasal congestion or discharge, and sore throat, osteoarthritis, pain in arms or legs.

Uncommon: dizziness, constipation, itching.

Rare: decreased 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 skin blister).

Reporting side effects

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Sitagliptin Viso Pharmaceutical

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, label, and carton after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at the pharmacy. If you have any questions, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Sitagliptin Viso Pharmaceutical

• The active ingredient is sitagliptin.

Sitagliptin 50 mg:

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

• The other components are:

Core of the tablet:Calcium hydrogen phosphate, microcrystalline cellulose, sodium croscarmellose, sodium stearyl fumarate, magnesium stearate

Coating of the tablet (50 mg):Polyvinyl alcohol, titanium dioxide, macrogol/polyethylene glycol, talc, yellow iron oxide, red iron oxide.

Appearance of the product and package contents

Sitagliptin Viso Pharmaceutical 50 mg film-coated tablets EFG: Film-coated tablets of orange color, round, biconvex, approximately 8 mm in diameter, and marked with "C" on one face and smooth on the other face.

The tablets of Sitagliptin Viso Pharmaceutical 50 mg film-coated tablets EFG are packaged in:

• PVC/PVDC-aluminum blister packs: 10, 14, 28, 30, 56, 98, and 100 tablets.
• White high-density polyethylene (HDPE) bottles with a desiccant silica gel in the polypropylene (PP) cap and with a tamper-evident ring: 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Laboratorios Liconsa, S.A.

Avda. Miralcampo, nº 7, Pol. Ind.

Azuqueca de Henares

19200 Guadalajara

Spain

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7ª planta

28045 Madrid

Spain

This medication is authorized in the member states of the European Economic Area under the following names:

Date of the last revision of this package leaflet: August 2021

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