Sitagliptin Viatris Pharmaceuticals 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Sitagliptin Viatris Pharmaceuticals 25 mg film-coated tablets EFG

Sitagliptin Viatris Pharmaceuticals 50 mg film-coated tablets EFG

Sitagliptin Viatris Pharmaceuticals 100 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 other people, even if they have the same symptoms as you, because it may 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 Sitagliptin Viatris Pharmaceuticals is and what it is used for
2. What you need to know before taking Sitagliptin Viatris Pharmaceuticals
3. How to take Sitagliptin Viatris Pharmaceuticals
4. Possible adverse effects
5. How to store Sitagliptin Viatris Pharmaceuticals
6. Contents of the pack and other information

1. What Sitagliptina Viatris Pharmaceuticals 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 insulin levels 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 (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 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 Viatris Pharmaceuticals

Do not take Sitagliptina Viatris Pharmaceuticals

• 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 your skin, this may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop taking this medicine.

Tell 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 currently or 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 or insulin medicine.

Children and adolescents

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

Other medicines and Sitagliptina Viatris Pharmaceuticals

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 digoxin blood levels may need to be monitored if you are taking this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 plan 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 drowsiness 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.

This medicine contains sodium

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

For 25 mg only:

Sitagliptina Viatris Pharmaceuticals 25 mg contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Sitagliptin Viatris Pharmaceuticals

Follow exactly the instructions for taking this medicine as 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
• 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 in combination with other medicines that also lower blood sugar.

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

If you take more sitagliptin than you should

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

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

If you forget to take this medicine

If you miss 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 a missed dose.

If you stop taking this medicine

Continue taking this medicine 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 the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may 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 extend to the back, with or without nausea and vomiting, as these may be signs of inflammation of the pancreas (pancreatitis) (frequency not known: cannot be estimated from available data).
• Severe allergic reaction, including rash, hives, skin blisters/skin peeling, and swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing. Your doctor will prescribe a medicine to treat the allergic reaction and will switch you to a different medicine for the treatment of diabetes (frequency not known: cannot be estimated from available data).

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
• various types of stomach discomfort when starting the combination of sitagliptin and metformin together

Uncommon: may affect up to 1 in 100 people

• stomach pain
• diarrhoea
• constipation
• drowsiness

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: may affect up to 1 in 10 people

• constipation

Some patients experienced the following adverse effects while taking sitagliptin and pioglitazone:

Common: may affect up to 1 in 10 people

• flatulence
• swelling of hands or legs

Some patients experienced the following adverse effects while taking sitagliptin in combination with pioglitazone and metformin:

Common: may affect up to 1 in 10 people

• swelling of hands or legs

Some patients experienced the following adverse effects while taking sitagliptin in combination with insulin (with or without metformin):

Common: may affect up to 1 in 10 people

• influenza-like illness

Uncommon: may affect up to 1 in 100 people

• dry mouth

Some patients experienced the following adverse effects while taking sitagliptin alone during clinical trials, or during use after approval alone and/or in combination with other diabetes medicines:

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

• dizziness
• constipation
• itching

Rare: may affect up to 1 in 1,000 people

• reduction in platelet count

Frequency not known: cannot be estimated from available data

• kidney problems (sometimes requiring dialysis)
• vomiting
• joint pain
• muscle pain
• back pain
• interstitial lung disease
• bullous pemphigoid (a type of blistering skin condition)

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible effect 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 Sitagliptina Viatris Pharmaceuticals

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

Do not use this medicine after the expiry date stated on the blister and carton following EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should 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 how to dispose of unused medicines and their packaging, ask your pharmacist. This helps protect the environment.

6. Contents of the pack and other information

Composition of Sitagliptina Viatris Pharmaceuticals

• The active substance is sitagliptin.

• Sitagliptina Viatris Pharmaceuticals 25 mg film-coated tablets: Each film-coated tablet contains sitagliptine hydrochloride monohydrate equivalent to 25 mg of sitagliptin.

• Sitagliptina Viatris Pharmaceuticals 50 mg film-coated tablets: Each film-coated tablet contains sitagliptine hydrochloride monohydrate equivalent to 50 mg of sitagliptin.

• Sitagliptina Viatris Pharmaceuticals 100 mg film-coated tablets: Each film-coated tablet contains sitagliptine hydrochloride monohydrate equivalent to 100 mg of sitagliptin.

• The other components are:

In the tablet core: calcium hydrogen phosphate, microcrystalline cellulose, sodium croscarmellose, stearic fumarate and sodium, magnesium stearate.

Film coating of Sitagliptina Viatris Pharmaceuticals 25 mg tablets contains: lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, iron oxide red (E172).

Film coating of Sitagliptina Viatris Pharmaceuticals 50 mg and Sitagliptina Viatris Pharmaceuticals 100 mg tablets contains: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172).

Appearance of the product and contents of the pack

Sitagliptina Viatris Pharmaceuticals 25 mg is a film-coated tablet, round, biconvex, with an approximate diameter of 6 mm, pink in colour, marked with "LC" on one side and unmarked on the other.

Sitagliptina Viatris Pharmaceuticals 50 mg is a film-coated tablet, round, biconvex, with an approximate diameter of 8 mm, orange in colour, marked with "C" on one side and unmarked on the other.

Sitagliptina Viatris Pharmaceuticals 100 mg is a film-coated tablet, round, biconvex, with an approximate diameter of 9.8 mm, beige in colour, marked with "L" on one side and unmarked on the other.

Opaque blisters (PVC/PVDC-Alu).

Pack sizes of 14, 28, 30, 56, and 98 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer

Laboratorios Liconsa S.A.

Avda. Miralcampo 7

Pol. Ind. Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

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

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

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