SITAGLIPTIN KRKA 100 mg FILM-COATED TABLETS

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

Do not take Sitagliptin Krka

Warnings and precautions

There have been reports of pancreatitis (inflammation of the pancreas) in patients treated with Sitagliptin Krka (see section 4).

If you notice blisters on your skin, it may be a sign of a disease 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 dependence, or very high levels of triglycerides (a type of fat) 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 current or past kidney problems
• an allergic reaction to Sitagliptin Krka (see section 4).

It is unlikely that this medicine will cause low blood sugar because it does not work 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 sulfonylurea or insulin medicine.

Children and adolescents

Children and adolescents under 18 years of age should not use this medicine. It is not effective in children and adolescents aged 10 to 17 years. It is not known if 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 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 doctor may need to check your digoxin blood levels if you are taking Sitagliptin Krka.

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.

This medicine should not be taken during pregnancy.

It is not known if this medicine passes into breast milk. You should not take this medicine if you are breastfeeding or planning to breastfeed.

Driving and using machines

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

Also, taking this medicine with sulfonylureas or insulin may cause hypoglycemia, which may affect your ability to drive or use machines or work without a 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 Sitagliptin Krka

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 a lower dose (such as 25 mg or 50 mg).

You can take this medicine with or without food.

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

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

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

If you take more Sitagliptin Krka than you should

If you take more of this medicine than you should, contact your doctor, pharmacist, or call the Poison Information Service immediately, stating the medicine and the amount taken.

If you forget to take Sitagliptin Krka

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

If you stop taking Sitagliptin Krka

Keep taking this medicine while your doctor recommends it to help control your blood sugar levels. You should not stop taking this medicine without first talking to your doctor.

If you have any further questions on the use of this product, 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 Krka 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 contact your doctor immediately. Your doctor will prescribe a medicine to treat the allergic reaction and change your diabetes medicine.

Some patients experienced the following side effects after adding sitagliptin to their 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, diarrhea, constipation, somnolence.

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

Some patients experienced the following side 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 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 alone during clinical trials or after marketing authorization, alone and/or in combination with other diabetes medicines:

Common: low blood sugar, headache, upper respiratory tract infection, nasal congestion or runny nose, and sore throat, arthrosis, pain in the arm or leg

Uncommon: dizziness, constipation, itching

Rare: reduced platelet count

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

Reporting of side effects

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

5. Storage of Sitagliptin Krka

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 and carton after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.

Store in the original package to protect from moisture.

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 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 ingredients are:

Tablet core:

microcrystalline cellulose (E460), anhydrous calcium hydrogen phosphate (E341), sodium carboxymethyl cellulose (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, and engraved with "K25" on one side (diameter approx. 7 mm, thickness 2.0 - 3.2 mm).

Sitagliptin Krka 50 mg film-coated tablets EFG: film-coated tablets, round, biconvex, light orange, with a score line on one side. The tablet is engraved with "K" on one side of the score line and "50" on the other (diameter approx. 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, orange-brown, with a score line on one side. The tablet is engraved with "K" on one side of the score line and "100" on the other (diameter approx. 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 film-coated tablets in blisters.

Not all 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

You can obtain further information on this medicine from the representative of the marketing authorisation holder:

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

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

Date of last revision of this leaflet:July 2024

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