Sitagliptin Teva 50 mg film-coated tablets EFG

Package leaflet: Information for the user

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 questions, ask your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

2. What you need to know before taking Sitagliptin Teva

3. How to take Sitagliptin Teva

4. Possible side effects

5. How to store Sitagliptin Teva

6. Contents of the pack and other information

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

Sitagliptina 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 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 taking Sitagliptina Teva

Do not take Sitagliptina Teva

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

Warnings and precautions

Tell your doctor or pharmacist before taking Sitagliptina Teva.

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

If you develop blisters on your skin, this may be a sign of a disease called bullous pemphigoid. Your doctor may ask you to stop taking Sitagliptina Teva.

Tell your doctor if you have or have had:

• a disease of the pancreas (such as pancreatitis)
• gallstones, alcohol addiction, or very high blood levels of triglycerides (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 causing 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 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 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 whether this medicine is safe and effective when used in children and adolescents under 10 years of age.

Taking Sitagliptina Teva with other medicines

Tell 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). Your digoxin blood levels may need to be monitored if you are taking Sitagliptina Teva.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 using machines

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

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 at heights without secure support.

Sitagliptina 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

Follow exactly the instructions for use of this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The usual recommended 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).

The tablets may be divided into equal doses.

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 plan 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 prescribed, contact your doctor immediately.

If you forget to take Sitagliptin Teva

If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, 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 for as long as your doctor prescribes 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 may cause adverse effects, although not everyone will experience them.

STOP taking Sitagliptin Teva and contact your doctor immediately if you notice 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 which 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 will switch you to a different medicine for the treatment of diabetes.

Some patients experienced the following adverse effects after adding sitagliptin 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: influenza

Uncommon: dry mouth

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

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

Uncommon: dizziness, constipation, itching

Rare: reduction in platelet count

Frequency not known: kidney problems (which sometimes require 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sitagliptin Teva

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

Do not use this medicine after the expiry date stated on the packaging and blister or label of the bottle after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over at a pharmacy’s SIGRE collection point. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sitagliptina Teva 50 mg film-coated tablets EFG

• The active substance is sitagliptin.
• Each film-coated tablet (tablet) contains sitagliptin maleate equivalent to 50 mg of sitagliptin.
• The other components are: microcrystalline cellulose, calcium hydrogen phosphate, sodium croscarmellose, and magnesium stearate.

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

Appearance of the product and contents of the pack

Sitagliptina Teva 50 mg tablets are beige, round, film-coated tablets marked with “S|50” and a score line on one side, and scored on the other side.

Each pack contains 14, 28, 30, 56, 60, 84, 90, 98, 100 or 120 tablets. Calendar packs contain 14, 28, 56 and 98 tablets. Unit dose packs contain 28x1, 50x1, 56x1, 98x1, 100x1 and 10x1 tablets. Alternatively, a bottle (including a bag with desiccant) contains 100 or 250 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U.
c/Anabel Segura, 11 Edificio Albatros B 1st Floor
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

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 medicinal product is authorised 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 the most recent revision of this leaflet: September 2020

Detailed and up-to-date 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