Package Leaflet: Information for the User

Sitagliptin Krka 25mg Film-Coated Tablets

Sitagliptin Krka 50mg Film-Coated Tablets

Sitagliptin Krka 100mg Film-Coated Tablets

Read this 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Sitagliptina Krka 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.

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 can be used alone or in combination with other medications (insulin, metformin, sulfonylureas, or thiazolidinediones) that reduce blood sugar, and 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 disease that consists of your body not producing enough insulin, and the insulin it produces not working 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 Krka

-if you are allergic to sitagliptin or any of the other ingredients of this medication (listed in section6).

Warnings and precautions

Cases of pancreatitis have been reported in patients treated with Sitagliptina Krka (see section4).

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 Sitagliptina Krka.

Inform your doctor if you have or have had:

-pancreatitis (such as pancreatitis)

-gallstones, alcohol addiction, or very high levels of triglycerides in your blood. These medical conditions may increase your risk of developing pancreatitis (see section4)

-type1 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 Sitagliptina Krka (see section4).

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 sulfonylurea or 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 Krka

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 Sitagliptina Krka.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or 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 your 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 sulfonylureas or insulin may cause hypoglycemia, which may affect your ability to drive and operate machinery or work safely without support.

Sitagliptina Krka contains sodium

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

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

The usual 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 medication with or without food.

Sitagliptina Krka 50 mg and 100 mg can be divided into equal doses.

Your doctor may prescribe this medication alone or with other medications that also lower blood sugar.

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

If you take more Sitagliptina Krka than you should

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

If you forget to take Sitagliptina Krka

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 Krka

Continue taking this medication as long as your doctor prescribes it so that it can continue to help 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 may cause side effects, although not everyone will experience them.

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

• Intense and persistent abdominal pain (stomach area) that can reach the back with or without nausea and vomiting, as these may 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 may 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 the medicine for diabetes treatment..

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

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

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

Some patients experienced different types of stomach discomfort when initiating the combination of sitagliptin and metformin together (classified as frequent).

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

Frequent: flatulence, swelling of hands or feet

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

Frequent: swelling of hands or feet

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

Frequent: flu

Rare: dry mouth

Some patients experienced the following side effects while taking sitagliptin only during clinical trials, orafter approval onlyand/or with other diabetes medications:

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

Rare: dizziness, constipation, itching

Rare: reduced 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 skin blister)

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 the Spanish System for the Pharmacovigilance of Medicines for Human Use: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 box after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Sitagliptin Krka

• The active ingredient is sitagliptin.

Sitagliptin Krka 25mg film-coated tablets

Cada film-coated tablet contains 25 mg of sitagliptin.

Sitagliptin Krka 50mg film-coated tablets

Cada film-coated tablet contains 50 mg of sitagliptin.

Sitagliptin Krka 100mg film-coated tablets

Cada film-coated tablet contains 100 mg of sitagliptin.

• The other components are:

Tablet core:

microcrystalline cellulose (E460),calcium hydrogen phosphate anhydrous (E341),sodium croscarmellose (E468),magnesium stearate (E470b) andstearoyl fumarate and sodium.

Coating:

Opadry white 85F280010 II HP (containingpolyvinyl alcohol,macrogol 3350, talc (E553b),di titanium dioxide (E171)),iron oxide red (E172) andiron oxide yellow (E172).

See section 2 “Sitagliptin Krka contains sodium”.

Appearance of the productand contents of the package

Sitagliptin Krka 25mg film-coated tablets: film-coated tablets, round, slightly biconvex, pink in color andhave the mark “K25” engraved on one of the faces (diameter approx. 7 mm, thickness2.0 – 3.2 mm).

Sitagliptin Krka 50mg film-coated tablets: film-coated tablets, round, biconvex, light orange in color with a groove on one of the faces. The tablethas the mark K engraved on one side of the groove and 50 on the other (diameter approx. 9 mm, thickness2.8 – 3.8 mm). The tablet can be divided into equal doses.

Sitagliptin Krka 100mg film-coated tablets: film-coated tablets, round, biconvex, orange-brown in color with a groove on one of the faces. The tablethas the mark K engraved on one side of the groove and 100 on the other (diameter approx. 11 mm, thickness3.3 – 4.5 mm). The tablet can be divided into equal doses.

Sitagliptin Krka is available in packages of 14, 28, 30, 56, 60, 90 or 98 film-coated tablets in blisters.

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann - Straße 5, 27472 Cuxhaven, Germany

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., Calle de Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

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

Last revision date of this leaflet:July 2024

For detailed information about this medicinal product, please visit the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).