Sitagliptin Aurovitas 25 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

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 the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Sitagliptina 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 increase insulin levels produced after a meal and decreases the amount of sugar produced by the body.

Your doctor has prescribed this medicine to help you lower your blood sugar, which is too high due to your type 2 diabetes. This medicine may be used alone or in combination with other blood sugar-lowering medicines (insulin, metformin, sulfonylureas, or glitazones) 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 condition in which your body does not produce enough insulin, and the insulin it does produce 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 starting to take Sitagliptina Aurovitas

Do not take Sitagliptina Aurovitas

• If you are allergic to sitagliptin or to 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.

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

If you develop blisters on the skin, this 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:

• a disease of the pancreas (such as 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 diabetes complication causing high blood sugar levels, rapid weight loss, nausea or vomiting).
• any kidney problems currently or 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 act when blood sugar levels are low. However, when this medicine is used in combination with a medicine containing a sulfonylurea or with insulin, low blood sugar (hypoglycemia) may occur. Your doctor may reduce the dose of your sulfonylurea-containing medicine or insulin.

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 unknown whether this medicine is safe and effective when used in children under 10 years of age.

Other medicines and Sitagliptina Aurovitas

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

In particular, inform your doctor if you are taking digoxin (a medicine used to treat irregular heartbeat and other heart problems). The level of digoxin in your blood may need to be monitored if you are taking sitagliptin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine should not be taken during pregnancy.

It is unknown whether this medicine passes into breast milk. You should not take this medicine if you are breastfeeding or plan to breastfeed.

Driving and use of machines

The effect of this medicine on the ability to drive or operate machinery is negligible or none. However, dizziness and drowsiness have been reported, which may affect your ability to drive or operate machinery.

In addition, taking this medicine together with medicines called sulfonylureas or with insulin may cause hypoglycemia, which may affect your ability to drive and use machines or work without a secure support.

Sitagliptina Aurovitas contains sodium

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

3. How to take Sitagliptin Aurovitas

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended usual dose is:

• one 100 mg film-coated tablet.
• once daily.
• orally.

If you have kidney problems, your doctor may prescribe you lower doses (such as 25 mg or 50 mg).

You may take this medicine with or without food and drinks.

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

Diet and exercise can help your body use sugar more effectively. It is important that you follow the diet and exercise regimen recommended by your doctor while taking sitagliptin.

If you take more Sitagliptin Aurovitas than you should

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

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

If you forget to take Sitagliptin Aurovitas

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

If you stop taking Sitagliptin Aurovitas

Keep taking this medicine for as long as your doctor continues to prescribe it, so it can continue helping control your blood sugar. You should not stop taking this medicine without first consulting your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

STOP taking sitagliptin and contact your doctor immediately if you experience any of the following serious adverse effects:

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

If you have a severe allergic reaction (frequency not known), including skin rash, hives, blistering or peeling of the skin, and swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor immediately. Your doctor will prescribe treatment for the allergic reaction and switch you to another medicine for the treatment of diabetes.

Some patients experienced the following adverse effects when sitagliptin was added to 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, diarrhoea, constipation, drowsiness.

Some patients experienced various types of stomach discomfort when starting treatment with sitagliptin and metformin together (classified as common frequency).

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

Common: flatulence, swelling of hands or legs.

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

Common: swelling of hands or legs.

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

Common: flu-like symptoms.

Uncommon: dry mouth.

Some patients experienced the following adverse effects while taking sitagliptin alone during clinical trials, or during post-approval use alone and/or in combination with other diabetes medicines:

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

Uncommon: dizziness, constipation, itching.

Rare: reduction in platelet count.

Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin condition).

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse 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 stated on the outer packaging, bottle, and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sitagliptin Aurovitas

• The active substance is sitagliptin.

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

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

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

• The other components are:

Tablet core: microcrystalline cellulose (grade 102), calcium hydrogen phosphate, croscarmellose sodium, stearic fumarate and sodium, and magnesium stearate.

Tablet coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E172), and red iron oxide (E172).

Nature of the product and contents of the pack

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

Pink, round, biconvex film-coated tablets, marked with “SG” on one side and “25” on the other.

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

Light beige, round, biconvex film-coated tablets, marked with “SG” on one side and “50” on the other.

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

Beige, round, biconvex film-coated tablets, marked with “SG” on one side 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.

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 certain 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

Tel.: 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 medicinal product 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 the latest revision of this leaflet: May 2022

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