SITAGLIPTIN KERN PHARMA 25 mg FILM-COATED TABLETS

2. What you need to know before taking Sitagliptina Kern Pharma

Do not take Sitagliptina Kern Pharma

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

Warnings and precautions

There have been reports of pancreatitis (inflammation of the pancreas) in patients treated with sitagliptin (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 this medication.

Tell your doctor if you have or have had:

• a pancreatic disease (such as pancreatitis)
• gallstones, alcohol addiction, or very high blood triglyceride levels (a type of fat). 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 (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 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 of age should not use this medication. It is not effective in children and adolescents between 10 and 17 years of age. It is not known if this medication is safe and effective when used in children under 10 years of age.

Other medications and Sitagliptina Kern Pharma

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

In particular, tell 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 levels if you are taking this medication.

Pregnancy and breastfeeding

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

This medication should not be taken during pregnancy.

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

Driving and using machines

The effect of this medication on the 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.

Additionally, taking this medication with sulfonylureas or insulin may cause hypoglycemia, which can affect your ability to drive and use machines or work without a secure support.

This medication contains sodium

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

3. How to take Sitagliptina Kern Pharma

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

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 medication with or without food and drinks.

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

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

If you take more sitagliptin than you should

If you take more 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take sitagliptin

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 missed doses.

If you stop taking sitagliptin

Continue taking this medication as long as your doctor prescribes it to help control your blood sugar levels. You should not stop taking this medication without consulting your doctor first.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

STOP taking this medication and consult your doctor immediately if 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/exfoliative skin, and swelling of the face, lips, tongue, and throat that can cause difficulty breathing or swallowing, stop taking this medication and consult your doctor immediately. Your doctor will prescribe a medication to treat the allergic reaction and change your diabetes medication.

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(may affect up to 1 in 10 people): constipation

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

Common(may affect up to 1 in 10 people): flatulence, swelling of hands or feet

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

Common(may affect up to 1 in 10 people): swelling of hands or feet

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

Common(may affect up to 1 in 10 people): flu

Uncommon(may affect up to 1 in 100 people): dry mouth

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

Common(may affect up to 1 in 10 people): low blood sugar, headache, upper respiratory tract infection, nasal congestion or runny nose, and sore throat, arthrosis, pain in the arm or leg

Uncommon(may affect up to 1 in 100 people): dizziness, constipation, itching

Rare(may affect up to 1 in 1,000 people): reduced platelet count

Frequency not known(cannot be estimated from available data): kidney problems (which may require dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister)

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Sitagliptina Kern Pharma

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the package after

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 wastewater or household waste. Dispose of the packaging and any unused medication in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Sitagliptina Kern Pharma

• The active substance is sitagliptin.

Sitagliptina Kern Pharma 25 mg film-coated tablets EFG

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

Sitagliptina Kern Pharma 50 mg film-coated tablets EFG

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

Sitagliptina Kern Pharma 100 mg film-coated tablets EFG

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

• The other components are:

In the tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, povidone, sodium croscarmellose, and magnesium stearate. The tablet coating contains: macrogol, talc, titanium dioxide (E171), glycerol monocaprylate, partially hydrolyzed polyvinyl alcohol, red iron oxide (E172), and yellow iron oxide (E172).

Appearance and package contents

Sitagliptina Kern Pharma 25 mg film-coated tablets EFG

Film-coated tablet, round, pale pink, with "25" on one side.

Sitagliptina Kern Pharma 50 mg film-coated tablets EFG

Film-coated tablet, round, pale pink, with "50" on one side and a score line on the other side. The tablet can be divided into two equal doses.

Sitagliptina Kern Pharma 100 mg film-coated tablets EFG

Film-coated tablet, round, orange-pink, with "100" on one side and a score line on the other side. The tablet can be divided into two equal doses.

The tablets are packaged in white PVC/PE/PVdC 250/25/90 // aluminum blisters.

Sitagliptina 25 mg and 50 mg are available in packages of 28 film-coated tablets.

Sitagliptina 100 mg is available in packages of 28 or 56 film-coated tablets.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the last revision of this package leaflet:December 2023

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