SITAGLIPTIN TEVA 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet:information for the user

Sitagliptin Teva 50 mg film-coated tablets EFG

sitagliptin

Read all of 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 further questions, ask your doctor or pharmacist or nurse.

• This medicine has been prescribed for you only, and you should not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Sitagliptin Teva and what is it used for
2. What you need to know before you take Sitagliptin Teva
3. How to take Sitagliptin Teva
4. Possible side effects

5 Conservation of Sitagliptin Teva

1. 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 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 amounts 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 levels, which are 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, 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 condition where 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 cause serious medical problems, such as heart disease, kidney disease, blindness, and amputation.

2. What you need to know before you take Sitagliptin Teva

Do not take Sitagliptin Teva

• if you are allergic to sitagliptin or any of the other ingredients of this medicine (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 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 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 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 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 10 to 17 years. It is not known if this medicine is safe and effective when used in children and adolescents under 10 years of age.

Taking Sitagliptin Teva with other medicines

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 Teva.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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 breast-feeding or planning to breast-feed.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, dizziness and somnolence have been reported, which may affect your ability to drive or use machines.

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

Sitagliptin Teva contains sodium

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

3. How to take Sitagliptin Teva

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose is:

• one 100 mg film-coated tablet
• once a day
• by mouth

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

The tablets can be divided into equal doses.

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 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 medicine than you should, 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 your next dose, then skip the missed dose and continue with your regular schedule. DO NOT take a double dose of this medicine.

If you stop taking Sitagliptin Teva

Keep taking this medicine while your doctor prescribes it for you to help control your blood sugar levels. You should not stop taking this medicine without first talking to your doctor.

If you have any further questions on the use of this product, 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 Teva and contact 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, urticaria, blisters on the skin/exfoliative skin conditions, and swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor immediately. Your doctor will prescribe a medicine to treat the allergic reaction and change your medicine 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 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: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 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 via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Sitagliptin Teva

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 and blister or label of the bottle 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 further information

Composition of Sitagliptin Teva 50 mg film-coated tablets EFG

• The active substance is sitagliptin.
• Each film-coated tablet (tablet) contains sitagliptin malate equivalent to 50 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, red iron oxide (E172), yellow iron oxide (E172).

Appearance of the product and contents of the pack

Sitagliptin Teva 50 mg tablets are beige, round, marked with “S|50” and with a score line on one side, and a break line 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, unit dose packs containing 28x1, 50x1, 56x1, 98x1, 100x1, and 10x1 tablets, or a bottle (including a desiccant bag) containing 100 and 250 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Austria: Sitagliptin-ratiopharm 50 mg Filmtabletten

Bulgaria: Sitagliptin Teva 50 mg film-coated tablets

Germany: Sitagliptin-ratiopharm 50 mg Filmtabletten

Denmark: Sitagliptin Teva

Estonia: Sitagliptin Teva

Spain: Sitagliptina Teva 50 mg comprimidos recubiertos con película EFG

Finland: Sitagliptin ratiopharm 50 mg tabletti, kalvopäällysteinen

France: Sitagliptine Teva 50 mg, comprimé pelliculé

Croatia: Sitagliptin Teva 50 mg filmom obložene tablete

Hungary: Sitagliptin Teva 50 mg filmtabletta

Iceland: Sitagliptin ratiopharm 50 mg filmuhúðaðar töflur

Italy: Sitagliptin Teva 50 mg compresse rivestite con film

Luxembourg: Sitagliptin-ratiopharm 50 mg Filmtabletten

Netherlands: Sitagliptine Teva 50 mg, filmomhulde tabletten

Poland: Sitagliptin Teva

Portugal: Sitagliptina Teva 50 mg Comprimidos revestidos por película

Sweden: Sitagliptin Teva, 50 mg filmdragerad tablett

Slovenia: Sitagliptin Teva 50 mg filmsko obložene tablete

Slovakia: Sitagliptin Teva 50 mg

United Kingdom: Sitagliptin Teva 50 mg Film-coated Tablets

Date of last revision of this leaflet: September 2020

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