Package Insert: Information for the User

Sitagliptin pensa 100 mg Film-Coated Tablets

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, 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 called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that reduce blood sugar levels in adult patients with type 2 diabetes mellitus.

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 may 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 pensa

• if you are allergic to sitagliptin or any of the other ingredients 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:

• pancreatitis (such as pancreatitis)
• gallstones, alcohol addiction, or very high levels of triglycerides (a type of fat) 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
• an allergic reaction to this medication (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 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 pensa

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 digoxin level in your blood may need to be checked if you are taking sitagliptin.

Taking Sitagliptina pensa with food, drinks, and alcohol

You can take this medication with or without food and drinks.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or 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 in breastfeeding women 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 medications called sulfonylureas or with insulin may cause hypoglycemia, which may affect your ability to drive and operate machinery or work safely without support.

Sitagliptina pensa 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 lower blood sugar.

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 sitagliptin.

If you take more Sitagliptin pensa 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 pensa

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 of this medication.

If you interrupt treatment with Sitagliptin pensa

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 sitagliptin and see your doctor immediately if you notice any of the following serious side effects:

• Intense and persistent pain in the abdomen (stomach area) that can reach the back with or without nausea and vomiting, as these can 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 can 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 treatment with metformin:

• Frequent (can affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting
• Infrequent (can 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 (can affect more than 1 in 10 people): low blood sugar
• Frequent: constipation

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

• Frequent: flatulence, swelling of hands or feet

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

• Frequent: swelling of hands or feet

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

• Frequent: flu
• Infrequent: 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 medicines:

• Frequent: low blood sugar, headache, upper respiratory tract infection, congestion or nasal mucosity and sore throat, arthritis, arm or leg pain
• Infrequent: dizziness, constipation, itching Rare: reduction in platelet count
• Unknown frequency: kidney problems (which sometimes require dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blister on the skin)

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is possible side effects that do not appear in this prospectus. You can also report them directly through the Spanish System of 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 blister pack and on the carton after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not dispose of medications through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your 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 Sitagliptina pensa

• The active ingredient is sitagliptin. Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 100 mg of sitagliptin.
• The other components (excipients) are: In the tablet core: calcium hydrogen phosphate, microcrystalline cellulose (E460), sodium croscarmellose (E468), anhydrous colloidal silica, sodium stearoyl fumarate, magnesium stearate (E470b).The film coating of the tablet contains: Partially hydrolyzed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol/PEG (E1521), talc (E553b), yellow iron oxide (E172), red iron oxide (E172).

Appearance of the product and content of the container

Sitagliptina pensa are film-coated tablets, round, beige in color.

They are presented in blisters of 14, 28, and 56 film-coated tablets in opaque blisters (PVC/PE/PVDC and aluminum).

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

SAG MANUFACTURING, S.L.U.

Ctra. N-I, Km 36

28750 San Agustin de Guadalix, Madrid

Spain

or

GALENICUM HEALTH, S.L.U.

Sant Gabriel, 50

08950 Esplugues de Llobregat, Barcelona

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain: Sitagliptina pensa 100 mg film-coated tablets EFG

Portugal: Sitagliptina toLife

Italy: Sitagliptin Pensa

Last review date of this leaflet:August 2021.

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