Package Insert: Patient Information

Sitagliptin Viso Pharmaceutical 50 mg Film-Coated Tablets EFG

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 may have the same symptoms as you, as it may harm them.
• If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is not listed in this package insert. See section 4.

Sitagliptina contains the active ingredient sitagliptin, which belongs to a class of medications called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that reduces 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 reduce your blood sugar level, 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 levels, and which you may already be taking for your diabetes along with a diet and exercise plan.

What is type 2 diabetes?

Type 2 diabetes is a disease in which the body does not produce enough insulin and the insulin it produces does not work as well as it should. The body may also produce too much sugar. When this occurs, 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 Viso Farmacéutica:

• 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 taking sitagliptin (see section 4).

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

Inform your doctor if you have or have had:

• pancreatitis (such as pancreatitis)
• gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in your blood.

These conditions may increase your risk of developing pancreatitis (see section 4).

• type 1 diabetes mellitus
• diabetic ketoacidosis (a complication of diabetes with high blood sugar levels, rapid weight loss, nausea, or vomiting)
• any past or present kidney problems.
• an allergic reaction to sitagliptin (see section 4).

It is unlikely that this medication will cause low blood sugar, as it does not act when blood sugar levels are low. However, when this medication is used in combination with a sulfonylurea or with insulin, hypoglycemia may occur. Your doctor may reduce the dose of your sulfonylurea or insulin.

Children and adolescents

Children and adolescents under 18 years old should not take this medication. It is not effective in children and adolescents between 10 and 17 years old. The safety and efficacy of this medication in children under 10 years old are unknown.

Other medications and Sitagliptina Viso Farmacéutica

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Inform your doctor especially if you are taking digoxin (a medication used to treat irregular heartbeat and other heart problems). Your doctor may need to monitor your digoxin levels if you take it with sitagliptin.

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.

You should not take this medication during pregnancy.

The safety of this medication in breastfeeding women is unknown. You should 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 and operate machinery is negligible. However, dizziness and somnolence have been reported, which may affect your ability to drive or operate machinery.

The use of this medication in combination with sulfonylureas or insulin may cause hypoglycemia, which may affect your ability to drive or operate machinery or work safely without support.

Sitagliptina Viso Farmacéutica contains sodium

Sodium:

This medication contains less than 1 mmol of sodium (23 mg) per film-coated 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 recommended dose is:

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 or drink.

Your doctor may prescribe this medication alone or with other medications that 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 sitagliptin.

If you take more Sitagliptina Viso Farmacéutica than you should

If you take more than the prescribed dose of this medication, contact your doctor immediately, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Sitagliptina Viso Farmacéutica

If you have forgotten to take a dose, take it as soon as you remember. If you do not remember until the time of the next dose, skip the missed dose and return to your regular schedule. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Sitagliptina Viso Farmacéutica

Continue taking this medication as long as your doctor prescribes it so that you can continue to help control your blood sugar level. Do not stop taking this medication before consulting your doctor.

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

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

STOP taking sitagliptin and contact a doctor immediately if you notice any of the following serious side effects:

• Severe and persistent abdominal pain (stomach area) that could reach the back with or without nausea and vomiting, as they could be signs of pancreatitis inflammation.

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 medication and call your doctor immediately. Your doctor may prescribe a medication to treat the allergic reaction and another for diabetes.

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

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 have experienced different types of stomach discomfort when starting the combination of sitagliptin and metformin (frequency classified as frequent).

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

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

Frequent: constipation.

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

Frequent: flatulence, swelling of hands or feet.

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

Frequent: swelling of hands or feet.

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

Frequent: flu.

Infrequent: dry mouth.

Some patients have experienced the following side effects when taking sitagliptin alone in clinical studies, or during its use after approval alone and/or with other medications for diabetes:

Frequent: low blood sugar, headache, upper respiratory tract infection, congestion or nasal secretion, and throat pain, osteoarthritis, arm or leg pain.

Infrequent: dizziness, constipation, itching.

Rare: reduction in platelet count.

Unknown frequency: kidney problems (sometimes requiring 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 side effects, consult your doctor, pharmacist, or nurse, even if they are 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 medication.

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, on the bottle label, and on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unusedmedicines at the SIGRE collection pointat the pharmacy. If in doubt, ask yourpharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Sitagliptin Viso Pharmaceutical

• The active ingredient is sitagliptin.

Sitagliptin 50 mg:

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

• The other components are:

Tablet core:Calcium phosphate, microcrystalline cellulose, sodium croscarmellose, sodium stearate fumarate, magnesium stearate

Film coating (50 mg):Polyvinyl alcohol, titanium dioxide, macrogol/polyethylene glycol, talc, yellow iron oxide, red iron oxide.

Appearance of the product and contents of the package

Sitagliptin Viso Pharmaceutical 50 mg film-coated tablets EFG: Orange-colored, round, biconvex, approximately 8 mm in diameter, and marked with “C” on one face and smooth on the other face.

Sitagliptin Viso Pharmaceutical 50 mg film-coated tablets EFG are packaged in:

• Blister packs of PVC/PVDC-aluminum: 10, 14, 28, 30, 56, 98, and 100 tablets.
• White high-density polyethylene (HDPE) bottles with silica gel desiccant in the polypropylene (PP) cap and tamper-evident ring: 100 tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Glenmark Arzneimittel GmbH

Industriestr. 31,

82194 Gröbenzell,

Germany

Responsible manufacturer:

Laboratorios Liconsa, S.A

Avda. Miralcampo, nº 7, Pol. Ind.

Azuqueca de Henares

19200 Guadalajara

Spain

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Viso Farmacéutica, S.L.U

c/ Retama 7, 7ª Planta

28045 Madrid

Spain

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

Last review date of this leaflet: August 2021

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/