Sitagliptin Kern Pharma 50 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the patient

Sitagliptin Kern Pharma 25 mg film-coated tablets EFG

Sitagliptin Kern Pharma 50 mg film-coated tablets EFG

Sitagliptin Kern Pharma 100 mg film-coated tablets EFG

Read the entire 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, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Sitagliptin Kern Pharma is and what it is used for
2. What you need to know before taking Sitagliptin Kern Pharma
3. How to take Sitagliptin Kern Pharma
4. Possible side effects
5. How to store Sitagliptin 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 known as DPP‑4 inhibitors (dipeptidyl peptidase‑4 inhibitors) that reduce blood sugar levels in adult patients with type 2 diabetes mellitus.

This medicine helps increase insulin levels produced after a meal and reduces 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 your body does produce 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 Sitagliptina Kern Pharma

Do not take Sitagliptina Kern Pharma

• 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 (see section 4).

If you develop blisters on your skin, this may be a sign of a condition 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 diabetes complication causing 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 sitagliptin (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 medicine containing a sulfonylurea or with insulin, low blood sugar (hypoglycemia) may occur. Your doctor may reduce the dose of your sulfonylurea-containing medicine or insulin.

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 unknown whether 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 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 this medicine.

Pregnancy and breastfeeding

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

This medicine should not be taken during pregnancy.

It is unknown whether 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 influence of this medicine on the ability to drive or use machines is negligible or minor. 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.

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 Sitagliptin Kern Pharma

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended usual 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 and drinks.

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

Diet and exercise can help the body use sugar more effectively. It is important that you follow the diet and exercise plan recommended by your doctor while taking this medicine.

If you take more sitagliptin than you should

If you take more of this medicine 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 at telephone number 91 562 04 20, indicating the medicine 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 it is time for the next dose, then skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for missed doses.

If you stop taking sitagliptin

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 experiences them.

STOP taking this medicine 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 radiate to the back, with or without nausea and vomiting, as these may be signs of inflammation of the pancreas (pancreatitis).

If you experience a severe allergic reaction (frequency not known), including rash, hives, skin blisters/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 switch you to a different medicine for the treatment of diabetes.

Some patients experienced the following adverse effects when sitagliptin was added 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 combination treatment with sitagliptin and metformin together (frequency classified as common).

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

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

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

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

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

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

Uncommon (may affect up to 1 in 100 people): 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 (may affect up to 1 in 10 people): low blood sugar, headache, upper respiratory tract infection, nasal congestion or runny nose, sore throat, osteoarthritis, pain in 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): reduction in platelet count

Frequency not known (cannot be estimated from available data): 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 type of adverse effect, consult 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sitagliptin Kern Pharma

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after
EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the container and additional information

Composition of Sitagliptin Kern Pharma

• The active substance is sitagliptin.

Sitagliptin Kern Pharma 25 mg film-coated tablets EFG

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

Sitagliptin Kern Pharma 50 mg film-coated tablets EFG

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

Sitagliptin Kern Pharma 100 mg film-coated tablets EFG

Each tablet contains sitagliptin monohydrochloride 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 monocaprylocaprate, partially hydrolyzed polyvinyl alcohol, iron oxide red (E172), and iron oxide yellow (E172).

Appearance of the product and contents of the pack

Sitagliptin Kern Pharma 25 mg film-coated tablets EFG

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

Sitagliptin Kern Pharma 50 mg film-coated tablets EFG

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

Sitagliptin Kern Pharma 100 mg film-coated tablets EFG

Film-coated tablet, round, pink-orange in colour, marked 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 packed in white PVC/PE/PVdC 250/25/90 // aluminium blisters.

Sitagliptin 25 mg and 50 mg are available in packs of 28 film-coated tablets.

Sitagliptin 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 the most recent review 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/