Leaflet: information for the user

Sitagliptin Aurovitas 25 mg film-coated tablets

Sitagliptin Aurovitas 50 mg film-coated tablets

Sitagliptin Aurovitas 100 mg film-coated tablets

Read this 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, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Sitagliptin Aurovitas and what it is used for

2.What you need to know before starting to take Sitagliptin Aurovitas

3.How to take Sitagliptin Aurovitas

4.Possible side effects

5.Storage of Sitagliptin Aurovitas

6.Contents of the pack and additional information

SitagliptinaAurovitascontains 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 that it produces not functioning 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 takeSitagliptinAurovitas

•If you are allergic tositagliptinor to any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to takesitagliptin.

Cases of pancreatitis have been reported in patients treated withsitagliptin(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 takingsitagliptin.

Inform your doctor if you have or have had:

•pancreatitis.

•gallstones, alcohol addiction, or very high levels of triglycerides (a type of fat) in the 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 sitagliptin (see section 4).

This medication is unlikely to 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 andSitagliptinAurovitas

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 level if you are taking 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.

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

SitagliptinAurovitas contains sodium

This medication contains less than 1 mmol of sodium (23 mg) 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 recommended usual dose is:

•one film-coated tablet of 100 mg.

•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 takingsitagliptina.

If you take moreSitagliptina Aurovitas 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 takeSitagliptina Aurovitas

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 usual schedule. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Sitagliptina Aurovitas

Continue taking this medication as long as your doctor prescribes it for you to continue helping control your blood sugar. Do 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.

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.

Poorly frequent (can affect up to 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness.

Some patients experienced different types of stomach discomfort when initiating the combination of sitagliptin and metformin together (frequency 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.

Poorly frequent: dry mouth.

Some patients experienced the following side effects while taking sitagliptin alone 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 throat pain, arthritis, arm or leg pain.

Poorly frequent: 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 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: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 carton, bottle, and blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

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. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition ofSitagliptinAurovitas

-The active ingredient is sitagliptin.

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

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

Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 100 mg of sitagliptin.

-The other components are:

Core of the tablet:microcrystalline cellulose (grade 102), calcium hydrogen phosphate, croscarmellose sodium, stearate of sodium and fumarate, and magnesium stearate.

Coating of the tablet:polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the product and contents of the package

Sitagliptin Aurovitas 25 mg film-coated tablets EFG[approximate size 6.2 mm]

Film-coated tablets of pink color, round, biconvex, with the marks “SG” on one face and “25” on the other.

Sitagliptin Aurovitas 50 mg film-coated tablets EFG[approximate size 8 mm]

Film-coated tablets of light beige color, round, biconvex, with the marks “SG” on one face and “50” on the other.

Sitagliptin Aurovitas 100 mg film-coated tablets EFG[approximate size 9.9 mm]

Film-coated tablets of beige color, round, biconvex, with the marks “SG” on one face and “100” on the other.

Sitagliptin Aurovitas25 mg, 50 mg, and 100 mg film-coated tablets EFG are available in blister packs and in HDPE bottles.

Pack sizes:

Blister packs:10, 14, 28, 30, 56, 60, 84, 90, 98, 100, 112, and 120 film-coated tablets.

HDPE bottles:30, 500, and 1,000 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Responsible manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

O

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

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

Germany:Sitagliptin PUREN 25 mg/50 mg/100 mg Filmtabletten

Belgium:Sitagliptine AB 25 mg/50 mg/100 mg filmomhulde tabletten / comprimés pelliculés / Filmtabletten

Spain:Sitagliptina Aurovitas 25 mg/50 mg/100 mg comprimidos recubiertos con película EFG

France:Sitagliptine Arrow 50 mg/100 mg comprimé pelliculé

Netherlands:Sitagliptine Aurobindo 25 mg/50 mg/100 mg, filmomhulde tabletten

Poland:Sitagliptin Aurovitas

Romania:Sitagliptina Aurobindo 50 mg/100 mg comprimate filmate

Date of the last review of this leaflet: May 2022

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).