SITAGLIPTIN TEVA 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sitagliptin Teva 25 mg film-coated tablets EFG

sitagliptin

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

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

Contents of the Package Leaflet

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

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

Sitagliptin Teva contains the active substance 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 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 blood sugar levels, which are too high due to your type 2 diabetes. This medication may be used alone or in combination with other medications (insulin, metformin, sulfonylureas, or glitazones) that reduce blood sugar levels, which you may already be taking for your diabetes, along with your diet and exercise program.

What is type 2 diabetes?

Type 2 diabetes is a disease in which your body does not produce enough insulin, and the insulin it 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 cause serious medical problems, such as heart disease, kidney disease, blindness, and amputation.

2. What you need to know before taking Sitagliptin Teva

Do not take Sitagliptin Teva

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

Warnings and precautions

Tell your doctor or pharmacist before taking Sitagliptin Teva.

There have been reports of pancreatitis (inflammation of the pancreas) in patients treated with 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 Teva.

Tell your doctor if you have or have had:

• a pancreatic disease (such as pancreatitis)
• gallstones, alcohol addiction, or very high blood triglyceride levels. 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).

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 medication that contains sulfonylurea or insulin.

Children and adolescents

Children and adolescents under 18 years of age should not use this medication. It is not effective in children and adolescents between 10 and 17 years of age. It is not known if this medication is safe and effective when used in children and adolescents under 10 years of age.

Taking Sitagliptin Teva with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.

In particular, tell 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 levels if you are taking Sitagliptin Teva.

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 medication.

This medication should not be taken during pregnancy.

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

Driving and using machines

The influence of this medication on the ability to drive or use machines is negligible or minimal. However, dizziness and somnolence have been reported, which may affect your ability to drive or use machines.

Also, taking this medication with medications called sulfonylureas or with insulin may cause hypoglycemia, which may affect your ability to drive and use machines or work without a secure support.

Sitagliptin Teva contains sodium

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

3. How to take Sitagliptin Teva

Follow your doctor's instructions for taking this medication exactly.

If you are unsure, consult 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 medication with or without food and drinks.

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

Diet and exercise can help your body use sugar better. It is essential to follow the diet and exercise recommended by your doctor while taking Sitagliptin Teva.

If you take more Sitagliptin Teva than you should

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

If you forget to take Sitagliptin Teva

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 stop taking Sitagliptin Teva

Continue taking this medication as long as your doctor prescribes it to help control your blood sugar levels. You should not stop taking this medication without consulting your doctor first.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

STOP taking Sitagliptin Teva and see your 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/exfoliative skin, and swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing, stop taking this medication and consult your doctor immediately. Your doctor will prescribe a medication to treat the allergic reaction and change your medication for diabetes treatment.

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 in combination with 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 after approval, alone and/or with other diabetes medications:

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:reduced platelet count

Frequency not known:kidney problems (which may require dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Sitagliptin Teva

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

Do not use this medication after the expiration date stated on the packaging and blister or label on the bottle after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Sitagliptin Teva 25 mg film-coated tablets EFG

• The active substance is sitagliptin.
• Each film-coated tablet (tablet) contains sitagliptin malate equivalent to 25 mg of sitagliptin.
• The other ingredients are: microcrystalline cellulose, calcium hydrogen phosphate, sodium croscarmellose, and magnesium stearate.

Coating contains: hydrolyzed polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc, iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172).

Appearance and packaging of the product

Sitagliptin Teva 25 mg tablets are pink, round, marked with "S25" on one side and smooth on the other side.

Each pack contains 14, 28, 30, 56, 60, 84, 90, 98, 100, and 120 tablets, calendar packs containing 14, 28, 56, and 98 tablets, single-dose packs containing 28x1, 50x1, 56x1, 98x1, 100x1, and 10x1 tablets, or a bottle (including a desiccant bag) containing 100 or 250 mg tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

c/Anabel Segura, 11 Edificio Albatros B 1ª Planta

Alcobendas 28108 Madrid

Spain

Manufacturer

TEVA Gyógyszergyár Zrt.

Debrecen, Pallagi út 13, H-4042

Hungary

or

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80., 31-546 Krakow

Poland

or

Merckle GmbH

Ludwig-Merckle-Straße 3, 89143

Blaubeuren, Baden-Wuerttemberg

Germany

or

Teva Pharma B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

Or

Actavis International Ltd

4, Sqaq tal-Gidi off, Valletta Road,

Luqa LQA 6000

Malta

Or

Balkanpharma-Dupnitsa AD

3 Samokovska Shosse,

Str.Dupnitsa 2600

Bulgaria

This medication is authorized in the Member States of the European Economic Area under the following names:

Austria: Sitagliptin-ratiopharm 25 mg Filmtabletten

Bulgaria: Sitagliptin Teva 25 mg film-coated tablets

Germany: Sitagliptin-ratiopharm 25 mg Filmtabletten

Denmark: Sitagliptin Teva

Estonia: Sitagliptin Teva

Spain: Sitagliptina Teva 25 mg comprimidos recubiertos con película EFG

Finland: Sitagliptin ratiopharm 25 mg tabletti, kalvopäällysteinen

France: Sitagliptine Teva 25 mg comprimé pelliculé

Croatia: Sitagliptin Teva 25 mg filmom obložene tablete

Hungary: Sitagliptin Teva 25 mg filmtabletta

Iceland: Sitagliptin ratiopharm 25 mg filmuhúðaðar töflur

Italy: Sitagliptin Teva 25 mg compresse rivestite con film

Lithuania: Sitagliptin Teva 25 mg plevele dengtos tabletes

Luxembourg: Sitagliptin-ratiopharm 25 mg Filmtabletten

Netherlands: Sitagliptine Teva 25 mg, filmomhulde tabletten

Poland: Sitagliptin Teva

Portugal: Sitagliptina Teva 25 mg Comprimidos revestidos por película

Sweden: Sitagliptin Teva, 25 mg filmdragerad tablett

Slovenia: Sitagliptin Teva 25 mg filmsko obložene tablete

United Kingdom: Sitagliptin Teva 25 mg Film-coated Tablets

Date of the last revision of this package leaflet: September 2020

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