SITAGLIPTIN Aurovitas 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sitagliptin Aurovitas 25 mg film-coated tablets EFG

Sitagliptin Aurovitas 50 mg film-coated tablets EFG

Sitagliptin Aurovitas 100 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Sitagliptin Aurovitas is and what it is used for
2. What you need to know before you take Sitagliptin Aurovitas
3. How to take Sitagliptin Aurovitas
4. Possible side effects
5. Storage of Sitagliptin Aurovitas
6. Contents of the pack and other information

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

Sitagliptin Aurovitas contains the active substance sitagliptin, which belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that reduce blood sugar levels in adult patients with type 2 diabetes mellitus.

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

Your doctor has prescribed this medicine to help you reduce your blood sugar level, which is too high due to your type 2 diabetes. This medicine can be used alone or in combination with other medicines (insulin, metformin, sulfonylureas, or glitazones) that reduce blood sugar levels, and that you may already be taking for your diabetes, together with a diet and exercise program.

What is type 2 diabetes?

Type 2 diabetes is a condition where your body does not produce enough insulin, and the insulin that your body produces 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 you take Sitagliptin Aurovitas

Do not takeSitagliptinAurovitas

• If you are allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take sitagliptin.

There have been reports of pancreatitis (inflammation of the pancreas) in patients taking sitagliptin (see section 4).

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

Tell your doctor if you have or have had:

• a disease of the pancreas (such as pancreatitis).
• gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood. These medical problems 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 problem that you have now 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 work when your blood sugar levels are low. However, when this medicine is used in combination with a medicine that contains a sulfonylurea or with insulin, low blood sugar (hypoglycemia) may occur. Your doctor may reduce the dose of your sulfonylurea or insulin medicine.

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 not known if this medicine is safe and effective when used in children under 10 years of age.

Other medicines andSitagliptinAurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 doctor may need to check the level of digoxin in your blood if you are taking sitagliptin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

This medicine should not be taken during pregnancy.

It is not known if 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 effect of this medicine on your ability to drive or use machines is negligible. However, dizziness and somnolence have been reported, which may affect your ability to drive or use machines.

Also, taking this medicine with sulfonylurea or insulin medicines may cause low blood sugar (hypoglycemia), which may affect your ability to drive or use machines or work without a secure support.

SitagliptinAurovitas contains sodium

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

3. How to take Sitagliptin Aurovitas

Follow exactly the instructions of your doctor for taking this medicine. If you are not sure, ask your doctor or pharmacist again.

The 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 medicine with or without food and drinks.

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

Diet and exercise may help your body use sugar better. It is important that you follow the diet and exercise recommended by your doctor while taking sitagliptin.

If you take moreSitagliptinAurovitas than you should

If you take more of this medicine than you should, contact your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to takeSitagliptinAurovitas

If you forget a dose, take it as soon as you remember. If you do not remember until the time of your next dose, then skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for missed doses.

If you stop taking Sitagliptin Aurovitas

Continue taking this medicine while your doctor prescribes it for you to continue helping control your blood sugar levels. Do not stop taking this medicine without consulting your doctor first.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Severe and persistent abdominal pain (in the stomach area) that may radiate to the back, with or without nausea and vomiting, as these may be signs of pancreatitis.

If you have a severe allergic reaction (frequency not known), including skin rash, hives, blisters on the skin/peeling of the skin, 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 your medicine for the treatment of diabetes.

Some patients experienced the following side effects after adding sitagliptin to their 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, diarrhea, constipation, somnolence.

Some patients experienced different types of stomach discomfort when starting the combination of sitagliptin and metformin together (frequency classified as common).

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

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

Common: constipation.

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

Common: flatulence, swelling of hands or feet.

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

Common: swelling of hands or feet.

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

Common: flu.

Uncommon: 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:

Common: low blood sugar, headache, upper respiratory tract infection, nasal congestion or runny nose, and sore throat, arthrosis, pain in the arm or leg.

Uncommon: dizziness, constipation, itching.

Rare: reduction in the number of platelets.

Frequency not known: kidney problems (which may 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sitagliptin Aurovitas

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

Do not use this medicine after the expiry date which is stated on the carton, bottle, and blister after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition ofSitagliptinAurovitas

• The active substance 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 ingredients are:

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

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 and packaging of the product

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

Film-coated tablets are pink, 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 are light beige, 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 are beige, round, biconvex, with the marks "SG" on one face and "100" on the other.

Sitagliptin Aurovitas 25 mg, 50 mg, and 100 mg film-coated tablets EFG are available in blister packs and HDPE bottles.

Package sizes:

Blister: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.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This medicine is authorized in the Member States of the European Economic Area under 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 last revision of this leaflet: May 2022

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