Label:information for the patient

Sitagliptin Sandoz 25 mg film-coated tablets

Sitagliptin Sandoz 50 mg film-coated tablets

Sitagliptin Sandoz 100 mg film-coated tablets

Read this label carefully before starting to take this medicine,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult yourdoctor orpharmacist.

-This medicine has been prescribedonlyto you, and you must not give it to other people even if they havethe same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,evenif they are not listed in this label. See section 4.

1.What Sitagliptin Sandoz is and for what it is used

2.What you need to knowbeforestarting totake Sitagliptin Sandoz

3.How to take Sitagliptin Sandoz

4.Possible adverse effects

5Storage of Sitagliptin Sandoz

6.Contents of the package and additional information

Sitagliptina Sandoz contains the active ingredient sitagliptin, which belongs to a class of medications known as DPP-4 inhibitors (inhibitors of dipeptidyl-peptidase 4) 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 you reduce your blood sugar, 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, and which 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 disease that consists of your body not producing enough insulin, and the insulin it does produce not functioning as well as it should. Your 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.

Do not take Sitagliptina Sandoz:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take sitagliptin.

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

If you notice 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 addiction, or very high levels of triglycerides in the blood. These medical conditions may increase your risk of developing pancreatitis (see section 4).
• type 1 diabetes.
• diabetic ketoacidosis (a complication of diabetes that causes 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 medication will cause low blood sugar because it does not work when blood sugar levels are low. However, when this medication is used in combination with a medication that contains a sulfonylurea or with insulin, low blood sugar (hypoglycemia) may occur. Your doctor may reduce the dose of your sulfonylurea or insulin medication.

Children and adolescents

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

Other medications and Sitagliptina Sandoz

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

Particularly, inform your doctor if you are taking digoxin (a medication used to treat irregular heartbeat and other heart problems). Your doctor may need to check your digoxin blood level if you are taking sitagliptin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.This medication should not be taken during pregnancy.

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

Driving and operating machinery

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

Additionally, taking this medication with medications called sulfonylureas or with insulin may cause low blood sugar (hypoglycemia), which may affect your ability to drive and operate machinery or work safely without support.

Sitagliptina Sandoz contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per 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 usual recommended dose is:

• one film-coated tablet of 100 mg
• 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 medication with or without food and drinks.

Your doctor may prescribe this medication alone or with other medications that also lower blood sugar. A 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 Sitagliptina Sandoz than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Sitagliptina Sandoz

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

If you interrupt treatment with Sitagliptina Sandoz

Continue taking this medication as long as your doctor prescribes it for you to continue helping control your blood sugar. You should not stop taking this medication without first 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 can cause side effects, although not everyone will experience them.

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

• Intense and persistent pain in the abdomen (stomach area) that can reach the back with or without nausea and vomiting, as these can be signs of pancreatitis (inflammation of the pancreas).

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 consult your doctor immediately. Your doctor will prescribe a medicine to treat the allergic reaction and change your medicine for diabetes treatment.

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

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

Uncommon (can affect up to 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness.

Some patients experienced different types of stomach discomfort when they started taking sitagliptin and metformin together (classified as common frequency).

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

Very common (can affect more than 1 in 10 people): low blood sugar.

Common: constipation.

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

Common: flatulence, swelling of hands or feet

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

Common: swelling of hands or feet.

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

Common: flu.

Uncommon: dry mouth.

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

Common: low blood sugar, headache, upper respiratory tract infection, congestion or nasal mucosity and sore throat, arthritis, pain in the arm or leg.

Uncommon: dizziness, constipation, itching.

Rare: reduction in platelet count.

Unknown frequency: kidney problems (which sometimes require dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blister on the skin).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for 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 and on the carton after CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Open the blister pack just before taking the tablets.

Do not usethis medicationif you observe visible signs of deterioration of the safety seal system.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines that you do not need in the SIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines that you do not need. By doing so, you will help protect the environment.

Composition of Sitagliptin Sandoz

• The active ingredient is sitagliptin.

Sitagliptin Sandoz 25 mg film-coated tablets

Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 25 mg of sitagliptin.

Sitagliptin Sandoz 50 mg film-coated tablets

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

Sitagliptin Sandoz 100 mg film-coated tablets

Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 100 mg of sitagliptin.

• The other excipients are: calcium hydrogen phosphate (E341), microcrystalline cellulose (E460), croscarmellose sodium (E468), magnesium stearate (E470b), sodium stearoyl fumarate, hypromellose (E464), hydroxypropyl cellulose (E463), macrogol (E1521), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172) (only applicable for the 100 mg dose), and talc (E553b).

Appearance of the product and contents of the package

Sitagliptin Sandoz 25 mg film-coated tablets

Film-coated, biconvex, round, pink, with the mark “ST 25” on one side. With a diameter of 5.7 – 6.6 mm.

Sitagliptin Sandoz 50 mg film-coated tablets

Film-coated, biconvex, round, light pink, with the mark “ST 50” on one side. With a diameter of 7.7 – 8.6 mm.

Sitagliptin Sandoz 100 mg film-coated tablets

Film-coated, biconvex, round, light brown, with the mark “ST 100” on one side. With a diameter of 9.7 – 10.6 mm.

Sitagliptin Sandoz is available in

Blister of OPA/Al/PVC//Al and in transparent blister of PVC/PE/PVDC//Al containing 28, 30, 50, 56, 60, 84, 90, 98, 100, 105, 108, 110, 112, 120, 168, 180, 196, 198 or 200 film-coated tablets.

Single-dose perforated blister containing 28x1, 30x1, 50x1, 56 x 1, 84 x 1, 90 x 1, 98 x 1 film-coated tablets.

HDPE bottle with a child-resistant polypropylene closure containing 30, 100 or 120 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Lek Pharmaceuticals d.d.

Trimlini 2D

9220 Lendava

Slovenia

or

Lek Pharmaceuticalsd.d.

Verovškova, 57

SLO-1526Ljubljana

Slovenia

or

Lek S.A

ul. Podlipie 16,

Strykow, 95-010

Poland

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Austria:Sitagliptin Sandoz 25 mg – Filmtabletten

Sitagliptin Sandoz 50 mg – Filmtabletten

Sitagliptin Sandoz 100 mg – Filmtabletten

Belgium:Sitagliptin Sandoz 25 mg filmomhulde tabletten

Sitagliptin Sandoz 50 mg filmomhulde tabletten

Sitagliptin Sandoz 100 mg filmomhulde tabletten

Denmark:Sitagliptin Sandoz

Finland:Sitagliptin Sandoz 25 mg kalvopäällysteiset tabletit

Sitagliptin Sandoz 50 mg kalvopäällysteiset tabletit

Sitagliptin Sandoz 100 mg kalvopäällysteiset tabletit

France:SITAGLIPTINE SANDOZ 50 mg, comprimé pelliculé

SITAGLIPTINE SANDOZ 100 mg, comprimé pelliculé

Hungary:Sitagliptin Sandoz 25 mg, 50 mg, 100 mg filmtabletta

Iceland:Sitagliptin Sandoz 25 mg filmuhúðaðar töflur

Sitagliptin Sandoz 50 mg filmuhúðaðar töflur

Sitagliptin Sandoz 100 mg filmuhúðaðar töflur

Italy:Sitagliptin Sandoz

Norway:Sitagliptin Sandoz 25 mg filmdrasjerte tabletter

Sitagliptin Sandoz 50 mg filmdrasjerte tabletter

Sitagliptin Sandoz 100 mg filmdrasjerte tabletter

Netherlands:Sitagliptine Sandoz 25 mg, filmomhulde tabletten

Sitagliptine Sandoz 50 mg, filmomhulde tabletten

Sitagliptine Sandoz 100 mg, filmomhulde tabletten

Portugal:Sitagliptina Sandoz

Northern Ireland:Sitagliptin Sandoz 25mg film-coated tablets

Sitagliptin Sandoz 50mg film-coated tablets

Sitagliptin Sandoz 100mg film-coated tablets

Sweden:Sitagliptin Sandoz 25 mg filmdragerade tabletter

Sitagliptin Sandoz 50 mg filmdragerade tabletter

Sitagliptin Sandoz 100 mg filmdragerade tabletter

Last revision date of thisleaflet:February 2021

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