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Patient Information Leaflet

Sitagliptina Viatris 25mg Film-Coated Tablets

Sitagliptina Viatris 50mg Film-Coated Tablets

Sitagliptina Viatris 100mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine. 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. Do not give it to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Sitagliptina Viatris is and what it is used for

2.What you need to know before you start taking Sitagliptina Viatris

3.How to take Sitagliptina Viatris

4.Possible side effects

5.Storage of Sitagliptina Viatris

6.Contents of the pack and additional information

Sitagliptina 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 to increase the levels of insulin 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 may be used alone or in combination with other medications (insulin, metformin, sulfonylureas, or thiazolidinediones) that reduce blood sugar levels, and 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 occurs, sugar (glucose) accumulates in the blood. This can cause serious medical problems, such as heart disease, kidney disease, blindness, and amputation.

Do not take Sitagliptina Viatris:

• If you are allergic to sitagliptin or any of the other components of this medication (listed in section6).

Warnings and precautions

Cases of pancreatitis have been reported in patients taking sitagliptin (see section 4).

If you develop blisters on your skin, it 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 dependence, or very high levels of triglycerides (a type of fat) in your blood.

These conditions may increase your risk 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, hypoglycemia may occur. Your doctor may reduce the dose of your sulfonylurea or insulin.

Children and adolescents

Children and adolescents under 18 years old should not take this medication. It is not effective in children and adolescents between 10 and 17 years old. The safety and efficacy of this medication in children under 10 years old are unknown.

Other medications and Sitagliptina Viatris

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

Inform your doctor especially if you are taking digoxin (a medication used to treat irregular heartbeat and other heart problems). Your doctor may need to monitor your digoxin levels if you take it with sitagliptin.

Pregnancy and breastfeeding

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

You should not take this medication during pregnancy.

The safety of this medication in breastfeeding women is unknown. You should not take this medication if you are breastfeeding or plan to breastfeed.

Driving and operating machinery

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

The use of this medication in combination with sulfonylureas or insulin may cause hypoglycemia, which may affect your ability to drive and operate machinery or work safely without support.

Sitagliptina Viatris contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

• one film-coated tablet of 100 mg

• once a day

• by oral route

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.

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 Viatris than you should

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

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 return to your regular schedule. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Sitagliptin Viatris

Continue taking this medication as long as your doctor prescribes it so that you can continue to help control your blood sugar level. Do not stop taking this medication before consulting your doctor.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

Severe and persistent abdominal pain (stomach area) that could reach the back with or without nausea and vomiting, as they could be signs of pancreatitis inflammation.

If you have a severe allergic reaction (unknown frequency), including skin rash, urticaria, blisters on the skin/skin peeling and swelling of the face, lips, tongue, and throat that can 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:

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

Infrequent (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 (frequency classified as frequent).

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

Very frequent (may affect more than 1 in 10 people): low blood sugar

Frequent: constipation

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

Frequent: flatulence, swelling of hands or feet

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

Frequent: swelling of hands or feet

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

Frequent: flu

Infrequent: 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 medications:

Frequent: low blood sugar, headache, upper respiratory tract infection, congestion or nasal secretion, and throat pain, osteoarthritis, arm or leg pain

Infrequent: dizziness, constipation, itching

Rare: reduction in platelet count

Unknown frequency: 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 experience side effects, consult your doctor, pharmacist, or nurse,even if they are side effects that do not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack, on the bottle label, and on the carton after CAD or 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 drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Sitagliptin Viatris

• The active ingredient is sitagliptin. Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 25 mg of sitagliptin
• The active ingredient is sitagliptin. Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin
• The active ingredient 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, sodium croscarmellose, anhydrous colloidal silica, calcium hydrogen phosphate and magnesium stearate. The film coating contains polyvinyl alcohol, macrogol, talc (E553b), titanium dioxide (E171), iron oxide red (E172) and iron oxide yellow (E172).

Appearance of the product and contents of the pack

The film-coated tablets of Sitagliptin Viatris 25 mg are round, biconvex and pink, marked with “M” on one face and “SL1” on the other.

The film-coated tablets of Sitagliptin Viatris 50 mg are round, biconvex and light brown, marked with “M” on one face and “SL2” on the other.

The film-coated tablets of Sitagliptin Viatris 100 mg are round, biconvex and brown, marked with “M” on one face and “SL3” on the other.

The film-coated tablets of Sitagliptin Viatris 25 mg are available in blisters (OPA/Alu/PVC//Alu) containing 14, 28, 30, 56 or 98 film-coated tablets, in perforated unit 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 white screw-top caps containing 98, 100 or 250 film-coated tablets.

The film-coated tablets of Sitagliptin Viatris 50 mg are available in blisters (OPA/Alu/PVC//Alu) containing 14, 28, 30, 56 or 98 film-coated tablets, in perforated unit 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 white screw-top caps containing 98, 100 or 250 film-coated tablets.

The film-coated tablets of Sitagliptin Viatris 100 mg are available in blisters (OPA/Alu/PVC//Alu) containing 14, 28, 30, 56 or 98 film-coated tablets, in perforated unit 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 white screw-top caps containing 98, 100 or 250 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorisation Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible Person

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

Unit 35/36 Baldoyle Industrial Estate

Grange Road, Dublin 13

Ireland

O

Medis International a.s.

Vyrobni zavod Bolatice, Prumyslova 961/16

Bolatice, 747 23

Czech Republic

O

Mylan Hungary Kft./Mylan Hungary Ltd.

Mylan utca 1., Komarom, 2900

Hungary

O

Mylan Germany GmbH

Benzstraße 1

61352 Bad Homburg v.d. Höhe

Germany

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorisation holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

DenmarkSitagliptin Mylan

AustriaSitagliptin Mylan 25 mg/50 mg/100 mg Filmtabletten

CyprusSitagliptin/Mylan 25 mg, 50 mg and 100 mg Film Coated tablets

Czech RepublicSitagliptin Mylan

GreeceSitagliptin/Mylan 25 mg, 50 mg and 100 mg Film Coated tablets

SpainSitagliptina Viatris 25 mg, 50 mg and 100 mg film-coated tablets

FinlandSitagliptin Mylan 25 mg, 50 mg, 100 mg kalvopäällysteinen tabletti

FranceSitagliptine Mylan 25 mg film-coated tablet

Sitagliptine Mylan 50 mg film-coated tablet

Sitagliptine Mylan 100 mg film-coated tablet

GermanySitagliptin Mylan 25 mg Filmtabletten

Sitagliptin Mylan 50 mg Filmtabletten

Sitagliptin Mylan 100 mg Filmtabletten

IrelandSitagliptin Mylan 25 mg, 50 mg & 100 mg film-coated tablets

IcelandSitagliptin Mylan 25 mg, 50 mg, 100 mg film-coated tablets

ItalySitagliptin Mylan

NetherlandsSitagliptine Mylan 25 mg, 50 mg, 100 mg, film-coated tablets

NorwaySitagliptin Mylan 25 mg, 50 mg, 100 mg film-coated tablets

PortugalSitagliptina Mylan

Slovak RepublicSitagliptin Mylan 50 mg

Sitagliptin Mylan 100 mg

SwedenSitagliptin Mylan 25 mg, 50 mg, 100 mg film-coated tablets

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

Last update of this leaflet: 03/2021

Further detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/