SITAGLIPTINA 50 mg Film-Coated Tablets

2. What you need to know before you take Sitagliptin Viatris

Do not take Sitagliptin Viatris:

• If you are allergic to sitagliptin or any of the other ingredients of this medicine (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 disease of the pancreas (such as pancreatitis)
• gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in your blood.

These diseases may increase your chance of getting 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 medicine will cause low blood sugar, as it does not work when your blood sugar level is low. However, when this medicine 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 medicine. It is not effective in children and adolescents between 10 and 17 years of age. It is not known if this medicine is safe and effective when used in children under 10 years of age.

Other medicines and Sitagliptin Viatris

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

Tell your doctor especially if you are taking digoxin (a medicine used to treat irregular heartbeat and other heart problems). Your doctor may need to check the level of digoxin in your blood if you take it with sitagliptin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take this medicine during pregnancy.

It is not known if this medicine passes into breast milk. Do not take this medicine if you are breastfeeding or plan to breastfeed.

Driving and using machines

The effect of this medicine on your ability to drive or use machines is negligible. However, dizziness and drowsiness have been reported, which may affect your ability to drive or use machines.

Taking this medicine in combination with medicines called sulfonylureas or insulin may cause low blood sugar, which may affect your ability to drive or use machines or work without a safe support.

Sitagliptin Viatris contains sodium

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

3. How to take Sitagliptin Viatris

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose is:

• one 100 mg film-coated tablet

• once a day

• by mouth

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

You can take this medicine with or without food or drink.

Your doctor may prescribe this medicine alone or with other medicines that reduce blood sugar levels.

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

If you take more Sitagliptin Viatris than you should

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

If you forget to take Sitagliptin Viatris

If you forget 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 go back to your regular schedule. Do not take a double dose to make up for missed doses.

If you stop taking Sitagliptin Viatris

Keep taking this medicine while your doctor tells you to, so it can continue to help you control your blood sugar level. Do not stop taking this medicine without talking to your doctor first.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP taking sitagliptin and contact a doctor immediatelyif 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/peeling of the skin, and swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing, stop taking this medicine and call your doctor immediately. Your doctor may prescribe a medicine 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, drowsiness

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 studies, or during its use after approval alone and/or with other diabetes medicines:

Common: low blood sugar, headache, upper respiratory tract infection, nasal congestion or discharge, and sore throat

Uncommon: dizziness, constipation, itching

Rare: reduced 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 of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sitagliptin Viatris

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

Do not use this medicine after the expiry date which is stated on the blister, label, or carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Sitagliptin Viatris

• The active substance is sitagliptin. Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 25 mg of sitagliptin
• The active substance is sitagliptin. Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin
• The active substance is sitagliptin. Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 100 mg of sitagliptin

The other ingredients are: In the core of the tablet: microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, calcium hydrogen phosphate, and magnesium stearate. The tablet coating contains polyvinyl alcohol, macrogol, talc (E553b), titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172).

Appearance and packaging

Sitagliptin Viatris 25 mg film-coated tablets are round, biconvex, and pink, marked with "M" on one side and "SL1" on the other.

Sitagliptin Viatris 50 mg film-coated tablets are round, biconvex, and light brown, marked with "M" on one side and "SL2" on the other.

Sitagliptin Viatris 100 mg film-coated tablets are round, biconvex, and brown, marked with "M" on one side and "SL3" on the other.

Sitagliptin Viatris 25 mg film-coated tablets are available in blisters (OPA/Alu/PVC//Alu) containing 14, 28, 30, 56, or 98 film-coated tablets, in single-dose blisters OPA/Alu/PVC//Alu containing 14 x 1, 28 x 1, or 30 x 1 film-coated tablets, or in calendar blisters containing 28 film-coated tablets, and in white plastic bottles with a white screw cap containing 98, 100, or 250 film-coated tablets.

Sitagliptin Viatris 50 mg film-coated tablets are available in blisters (OPA/Alu/PVC//Alu) containing 14, 28, 30, 56, or 98 film-coated tablets, in single-dose blisters OPA/Alu/PVC//Alu containing 14 x 1, 28 x 1, or 56 x 1 film-coated tablets, or in calendar blisters containing 28 film-coated tablets, and in white plastic bottles with a white screw cap containing 98, 100, or 250 film-coated tablets.

Sitagliptin Viatris 100 mg film-coated tablets are available in blisters (OPA/Alu/PVC//Alu) containing 14, 28, 30, 56, or 98 film-coated tablets, in single-dose blisters OPA/Alu/PVC//Alu containing 14 x 1, 28 x 1, or 56 x 1 film-coated tablets, or in calendar blisters containing 28 or 56 film-coated tablets, and in white plastic bottles with a white screw cap containing 98, 100, or 250 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

McDermott Laboratories Limited T/A Gerard Laboratories T/A Mylan

Unit 35/36 Baldoyle Industrial Estate

Grange Road, Dublin 13

Ireland

Or

Medis International a.s.

Vyrobni zavod Bolatice, Prumyslova 961/16

Bolatice, 747 23

Czech Republic

Or

Mylan Hungary Kft./Mylan Hungary Ltd.

Mylan utca 1., Komarom, 2900

Hungary

Or

Mylan Germany GmbH

Benzstraße 1

61352 Bad Homburg v.d. Höhe

Germany

You can ask for more information about this medicine from the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

Denmark Sitagliptin Mylan

Austria Sitagliptin Mylan 25 mg/50 mg/100 mg Filmtabletten

Cyprus Sitagliptin/Mylan 25 mg, 50 mg and 100 mg Film Coated tablets

Czech Republic Sitagliptin Mylan

Greece Sitagliptin/Mylan 25 mg, 50 mg and 100 mg Film Coated tablets

Spain Sitagliptina Viatris 25 mg, 50 mg and 100 mg film-coated tablets EFG

Finland Sitagliptin Mylan 25 mg, 50 mg, 100 mg kalvopäällysteinen tabletti

France Sitagliptine Mylan 25 mg comprimé pelliculé

Sitagliptine Mylan, 50 mg comprimé pelliculé

Sitagliptine Mylan 100 mg comprimé pelliculé

Germany Sitagliptin Mylan 25 mg Filmtabletten

Sitagliptin Mylan 50 mg Filmtabletten

Sitagliptin Mylan 100 mg Filmtabletten

Ireland Sitagliptin Mylan 25 mg, 50 mg & 100 mg film-coated tablets

Iceland Sitagliptin Mylan 25 mg, 50 mg, 100 mg filmuhúðaðar töflur

Italy Sitagliptin Mylan

Netherlands Sitagliptine Mylan 25 mg, 50 mg, 100 mg filmomhulde tabletten

Norway Sitagliptin Mylan 25 mg, 50 mg, 100 mg filmdrasjerte tabletter

Portugal Sitagliptina Mylan

Slovakia Sitagliptin Mylan 50 mg

Sitagliptin Mylan 100 mg

Sweden Sitagliptin Mylan 25 mg, 50 mg, 100 mg filmdragerade tabletter

United Kingdom Sitagliptin Mylan 25 mg, 50 mg and 100 mg film-coated tablets

Date of last revision of this leaflet: 03/2021

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