Package Leaflet: Information for the User

Sitagliptin Teva 25 mg Film-Coated Tablets

sitagliptin

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 or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist or nurse.

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

2. What you need to know before you start taking Sitagliptin Teva

3. How to take Sitagliptin Teva

4. Possible side effects

5. Storage of Sitagliptin Teva

6. Contents of the pack and additional information

Sitagliptina Teva contains 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 insulin levels 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 which 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 it does produce 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 take Sitagliptina Teva

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

Warnings and precautions

Inform your doctor or pharmacist before taking Sitagliptina Teva.

Cases of pancreatitis have been reported in patients treated with sitagliptin (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 taking Sitagliptina Teva.

Inform your doctor if you have or have had:

• pancreatitis (such as pancreatitis)
• gallstones, alcohol addiction, or very high levels of triglycerides in the blood (a type of fat). 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 problem 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 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. It is not known if this medication is safe and effective in children and adolescents under 10 years old.

Taking Sitagliptina Teva with other medications

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 heartbeats and other heart problems). You may need to have your digoxin level checked in your blood if you are taking Sitagliptina Teva.

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.

It is unknown if this medication passes into breast milk. Do not take this medication if you are breastfeeding or plan to breastfeed.

Driving and operating machinery

The influence of this medication on the 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 medications called sulfonylureas or with insulin may cause hypoglycemia, which may affect your ability to drive and operate machinery or work without a secure support point.

Sitagliptina Teva contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor.

If in doubt, consult your doctor or pharmacist again.

The usual recommended 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 lower 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 Sitagliptina Teva.

If you take more Sitagliptina Teva than you should

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

If you forget to take Sitagliptina 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 interrupt treatment with Sitagliptina Teva

Continue taking this medication as long as your doctor prescribes it for you to continue helping to control your blood sugar. You should 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 Sitagliptina Teva and see your doctor immediatelyif 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 of the pancreas).

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 withmetformin:

Frequent(can affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting.

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

Some patients experienced different types of stomach discomfort when they started taking sitagliptin and metformin together (frequency classified as frequent).

Some patients experienced the following side effects while taking sitagliptin in combination with asulfonilureaandmetformin:

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

Frequent:constipation

Some patients experienced the following side effects while takingsitagliptinandpioglitazona:

Frequent: flatulence, swelling of hands or feet

Some patients experienced the following side effects while taking sitagliptin in combination withpioglitazonaandmetformin:

Frequent:swelling of hands or feet

Some patients experienced the following side effects while taking sitagliptin in combination withinsulina(with or withoutmetformin):

Frequent:flu

Infrequent:dry mouth

Some patients experienced the following side effects while taking sitagliptinonlyduring clinical trials, or during use after approvalonlyand/or withother diabetes medicines:

Frequent:low blood sugar, headache, upper respiratory tract infection, congestion or nasal mucus and sore throat, arthritis, arm or leg pain

Infrequent: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 leaflet. You can also report them directly through the Spanish System for the 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 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 packaging and blister or label of the bottle after CAD. 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 through drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Sitagliptina Teva25 mg film-coated tablets

• The active ingredient is sitagliptin.
• Each film-coated tablet contains sitagliptin malate equivalent to 25 mg of sitagliptin.
• The other components are: microcrystalline cellulose, calcium hydrogenphosphate, croscarmellose sodium and magnesium stearate.

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

Appearance of the product and contents of the package

Sitagliptina Teva 25 mg tablets are pink, round, marked with “S25” on one face and smooth on the other face.

Each package contains 14, 28, 30, 56, 60, 84, 90, 98, 100 and 120 tablets, the calendar packages that contain 14, 28, 56 and 98 tablets, the single-dose packages that contain 28x1, 50x1, 56x1, 98x1, 100x1 and 10x1 tablets, or a bottle (which includes a desiccant bag) that contains 100 or 250 mg tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

c/Anabel Segura, 11 Edificio Albatros B 1st Floor

Alcobendas 28108 Madrid

Spain

Responsible for manufacturing

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 medicine is authorized in the member states of the European Economic Area with 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 film-coated tablets

Finland: Sitagliptin ratiopharm 25 mg tabletti, kalvopäällysteinen

France:Sitagliptine Teva 25 mg comprimé pelliculé

Croatia: SitagliptinTeva25 mg filmom obložene tablete

Hungary: Sitagliptin Teva 25 mg filmtabletta

Iceland:Sitagliptin ratiopharm 25 mg filmúðar teflur

Italy: SitagliptinTeva25 mg compresse rivestite con film

Lithuania:Sitagliptin Teva 25 mg plevele dengtos tabletės

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

Last review date of thisleaflet: September 2020

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