Sitagliptin Krka 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sitagliptina Krka 25mg film-coated tablets EFG

Sitagliptina Krka 50mg film-coated tablets EFG

Sitagliptina Krka 100mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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 give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What Sitagliptina Krka is and what it is used for
2. What you need to know before taking Sitagliptina Krka
3. How to take Sitagliptina Krka
4. Possible adverse effects
5. How to store Sitagliptina Krka
6. Contents of the pack and other information

1. What is Sitagliptin Krka and what is it used for?

Sitagliptin Krka contains the active substance sitagliptin, which belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that reduce blood sugar levels in adult patients with type 2 diabetes mellitus.

This medicine helps increase the levels of insulin produced after a meal and decreases 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 that is produced 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 Sitagliptin Krka

Do not take Sitagliptin Krka

• 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 Krka (see section 4).

If you notice blisters on your skin, this may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop taking Sitagliptin Krka.

Tell your doctor if you have or have had:

• a disease of the pancreas (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 Krka (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 sulfonylurea or insulin, low blood sugar (hypoglycemia) may occur. Your doctor may reduce the dose of your medicine containing sulfonylurea or insulin.

Children and adolescents

Children and adolescents under 18 years of age must 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 Sitagliptin Krka

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 Sitagliptin Krka.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You must not take this medicine during pregnancy.

It is not known whether this medicine passes into breast milk. You must not take this medicine if you are breast-feeding or plan to breast-feed.

Driving and using machines

The effect of this medicine on the ability to drive or use machines is negligible or none. However, dizziness and drowsiness have been reported, which may affect your ability to drive or use machines.

In addition, taking this medicine together with medicines called sulfonylureas or with insulin may cause hypoglycemia, which may affect your ability to drive and use machines or work without secure support.

Sitagliptin Krka contains sodium

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

3. How to take Sitagliptina Krka

Follow exactly the instructions for use of 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.

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

Your doctor may prescribe this medicine alone or together with other medicines that also lower blood sugar.

Diet and exercise can help your body use sugar better. It is important 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 of this medicine than prescribed, contact your doctor, pharmacist, or call the Poison Information Service immediately at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Sitagliptina Krka

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, then 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 Sitagliptina Krka

Keep taking this medicine for as long as your doctor continues to prescribe it, so it can keep helping 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 can cause adverse effects, although not everyone will experience them.

STOP taking Sitagliptin Krka and contact your doctor immediately if you notice any of the following serious adverse effects:

• Severe and persistent pain in the abdomen (stomach area) which may extend to the back, with or without nausea and vomiting, as these may be signs of inflammation of the pancreas (pancreatitis).

If you have a severe allergic reaction (frequency not known), including skin rash, hives, blistering or peeling of the skin, and swelling of the face, lips, tongue, or throat which may cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor immediately. Your doctor will prescribe a medicine to treat the allergic reaction and will switch you to a different medicine for the treatment of diabetes.

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

Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhoea, constipation, somnolence.

Some patients experienced various types of stomach discomfort when starting treatment with sitagliptin and metformin together (frequency classified as common).

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

Common: flatulence, swelling of hands or legs

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

Common: swelling of hands or legs

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

Common: influenza

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

Uncommon: dizziness, constipation, itching

Rare: reduction in platelet count

Frequency not known: kidney problems (which sometimes require dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin rash)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sitagliptin Krka

Keep this medicine out of sight and reach of children.

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

Do not store above 25°C.

Keep in the original container to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sitagliptin Krka

• The active substance is sitagliptin.

Sitagliptin Krka 25 mg film-coated tablets EFG

Each film-coated tablet contains 25 mg of sitagliptin.

Sitagliptin Krka 50 mg film-coated tablets EFG

Each film-coated tablet contains 50 mg of sitagliptin.

Sitagliptin Krka 100 mg film-coated tablets EFG

Each film-coated tablet contains 100 mg of sitagliptin.

• The other components are:

Tablet core:

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

Coating:

Opadry White 85F280010 II HP (containing polyvinyl alcohol, macrogol 3350, talc (E553b), titanium dioxide (E171)), red iron oxide (E172) and yellow iron oxide (E172).

See section 2 “Sitagliptin Krka contains sodium”.

Appearance of the product and pack contents

Sitagliptin Krka 25 mg film-coated tablets EFG: film-coated tablets, round, slightly biconvex, pink in colour, marked with the code “K25” on one side (approximate diameter 7 mm, thickness 2.0 – 3.2 mm).

Sitagliptin Krka 50 mg film-coated tablets EFG: film-coated tablets, round, biconvex, light orange in colour, with a score line on one side. The tablet is marked with the letter “K” on one side of the score and “50” on the other (approximate diameter 9 mm, thickness 2.8 – 3.8 mm). The tablet can be divided into equal doses.

Sitagliptin Krka 100 mg film-coated tablets EFG: film-coated tablets, round, biconvex, brownish-orange in colour, with a score line on one side. The tablet is marked with the letter “K” on one side of the score and “100” on the other (approximate diameter 11 mm, thickness 3.3 – 4.5 mm). The tablet can be divided into equal doses.

Sitagliptin Krka is available in packs of 14, 28, 30, 56, 60, 90 or 98 tablets in blisters.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 Authorisation Holder:

KRKA Farmacéutica, S.L., Calle de Anabel Segura 10, 28108 Alcobendas, Madrid, 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: July 2024

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