SITAGLIPTIN KERN PHARMA 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Sitagliptina Kern Pharma 25 mg film-coated tablets EFG

Sitagliptina Kern Pharma 50 mg film-coated tablets EFG

Sitagliptina Kern Pharma 100 mg 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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Sitagliptina Kern Pharma and what is it used for
2. What you need to know before you take Sitagliptina Kern Pharma
3. How to take Sitagliptina Kern Pharma
4. Possible side effects
5. Storage of Sitagliptina Kern Pharma
6. Contents of the pack and other information

1. What is Sitagliptina Kern Pharma and what is it used for

This medicine 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 to increase the levels of insulin produced after a meal and decrease the amount of sugar produced by the body.

Your doctor has prescribed this medicine to help you reduce your blood sugar level, which is too high due to your type 2 diabetes. This medicine can be used alone or in combination with other medicines (insulin, metformin, sulfonylureas, or glitazones) that reduce blood sugar levels, which you may already be taking for your diabetes, along with your diet and exercise program.

What is type 2 diabetes?

Type 2 diabetes is a disease in which your body does not produce enough insulin, and the insulin it produces 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 cause serious medical problems, such as heart disease, kidney disease, blindness, and amputation.

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

Do not take Sitagliptina Kern Pharma

• if you are allergic to sitagliptin or any of the other ingredients of this medicine (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 medicine.

Tell your doctor if you have or have had:

• a pancreatic disease (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 complication of diabetes that causes high blood sugar levels, rapid weight loss, nausea, or vomiting)
• any kidney problem you have now or have had in the past
• an allergic reaction to sitagliptin (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 medicine that contains a sulfonylurea or with 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 between 10 and 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 Sitagliptina Kern Pharma

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 this medicine.

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 or minimal. However, dizziness and somnolence have been reported, which may affect your ability to drive or use machines.

Also, taking this medicine with sulfonylurea or insulin medicines may cause low blood sugar (hypoglycemia), which may affect your ability to drive or use machines or work without a safe support point.

This medicine contains sodium

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

3. How to take Sitagliptina Kern Pharma

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 and drink.

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 this medicine.

If you take more Sitagliptina Kern Pharma than you should

If you take more of this medicine than you should, 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 medicine and the amount taken.

If you forget to take Sitagliptina Kern Pharma

If you forget a dose, take it as soon as you remember. If you do not remember until the time of your 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 Sitagliptina Kern Pharma

Continue taking this medicine as long as your doctor tells you to, so it can continue 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 medicine, 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 this medicine 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/exfoliative skin, 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 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(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 and 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 medicines:

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 the 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 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 to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sitagliptina Kern Pharma

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 carton after EXP.

The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other 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 ingredients 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 packaging

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 packs of 28 film-coated tablets.

Sitagliptina 100 mg is available in packs 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 last revision of this leaflet:December 2023

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