Package Insert: Information for the Patient

Sitagliptin Kern Pharma 25 mg Film-Coated Tablets

Sitagliptin Kern Pharma 50 mg Film-Coated Tablets

Sitagliptin Kern Pharma 100 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you and should not be given to others, 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 not listed in this package insert. See section 4.

This medication contains the active ingredient sitagliptin, which belongs to a class of medications known as DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that reduce blood sugar levels in adult patients with type 2 diabetes.

This medication helps to increase the levels of insulin produced after a meal and decreases the amount of sugar produced by the body.

Your doctor has prescribed this medication to help you reduce your blood sugar, which is too high due to your type 2 diabetes. This medication can be used alone or in combination with other medications (insulin, metformin, sulfonylureas, or thiazolidinediones) that reduce blood sugar, and 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 disease that consists of your body not producing enough insulin, and the insulin it produces not working as well as it should. Your body may also produce too much sugar. When this happens, sugar (glucose) accumulates in the blood. This can cause serious medical problems, such as heart disease, kidney disease, blindness, and amputation.

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

Cases of pancreatitis have been reported in patients treated with sitagliptin (see section 4).

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

Inform your doctor if you have or have had:

• a pancreatic disease (such as pancreatitis)
• gallstones, alcohol addiction, or very high levels of triglycerides in your 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 kidney problems you currently have or have had in the past
• a reaction to sitagliptin (see section 4)

It is unlikely that this medication will cause low blood sugar because it does not act when blood sugar levels are low. However, when this medication is used in combination with a medication containing a sulfonylurea or with 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 old should not use this medication. It is not effective in children and adolescents aged 10 to 17 years. The safety and efficacy of this medication in children under 10 years old are unknown.

Other medications and Sitagliptina Kern Pharma

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

Particularly, inform 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, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

This medication should not be taken during pregnancy.

The safety of this medication during breastfeeding is unknown. Do not take this medication if you are breastfeeding or plan to breastfeed.

Driving and operating machinery

The influence of this medication on your ability to drive or operate machinery is negligible. However, dizziness and somnolence have been reported, which may affect your ability to drive or operate machinery.

Additionally, taking this medication with sulfonylureas or insulin may cause hypoglycemia, which may affect your ability to drive and operate machinery or work safely without support.

This medication contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The usual recommended dose is:

• one 100 mg film-coated tablet
• once a day
• by mouth

If you have kidney problems, your doctor may prescribe lower doses (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.

Diet and exercise can help your body use blood 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 doses 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 Toxicological 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 the missed doses.

If you interrupt treatment with sitagliptin

Continue taking this medication as long as your doctor prescribes it for you to continue helping control your blood sugar. You should not stop taking this medication without first consulting your doctor.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

STOP taking this medicine and see your doctor immediately if you notice any of the following serious side effects:

• Intense and persistent abdominal pain (stomach area) that can reach the back with or without nausea and vomiting, as these may be signs of pancreatitis (inflammation of the pancreas).

If you have a severe allergic reaction (unknown frequency), including skin rash, urticaria, blisters on the skin/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 change the medicine for diabetes treatment.

Some patients experienced the following side effects after adding sitagliptin to metformin treatment:

Frequent(may affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting

Infrequent(may affect up to 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness.

Some patients experienced different types of stomach discomfort when they started taking sitagliptin and metformin together (classified as frequent).

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

Very frequent(may affect more than 1 in 10 people): low blood sugar

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

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

Frequent(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:

Frequent(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):

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

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

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

Frequent(may affect up to 1 in 10 people): low blood sugar, headache, upper respiratory tract infection, congestion or nasal mucosity, and throat pain, arthritis, arm or leg pain

Infrequent(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

Unknown frequency(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 of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after

CAD. The expiration date is the last day of the month indicated.

This medication does not require special conservation conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Sitagliptin Kern Pharma

• The active ingredient is sitagliptin.

Sitagliptin Kern Pharma 25 mg film-coated tablets EFG

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

Sitagliptin Kern Pharma 50 mg film-coated tablets EFG

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

Sitagliptin Kern Pharma 100 mg film-coated tablets EFG

Each tablet contains sitagliptin hydrochloride monohydrate equivalent to 100mg 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 monocaprinate, partially hydrolyzed polyvinyl alcohol, red iron oxide (E172) and yellow iron oxide (E172).

Appearance of the product and contents of the package

Sitagliptin Kern Pharma 25 mg film-coated tablets EFG

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

Sitagliptin Kern Pharma 50 mg film-coated tablets EFG

Film-coated tablet, round, pale pink, with “50” on one side and a notch 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, orange-pink, with “100” on one side and a notch 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.

Sitagliptin 25 mg and 50 mg are presented in packages of 28 film-coated tablets.

Sitagliptin 100 mg is presented in packages of 28 or 56 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet:December 2023

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