Sitagliptin Sandoz 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Sitagliptin Sandoz 25 mg film-coated tablets EFG

Sitagliptin Sandoz 50 mg film-coated tablets EFG

Sitagliptin Sandoz 100 mg film-coated tablets EFG

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 or pharmacist.

• 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

2. What you need to know before taking Sitagliptin Sandoz

3. How to take Sitagliptin Sandoz

4. Possible side effects

5. Storage of Sitagliptin Sandoz

6. Contents of the pack and other information

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

Sitagliptina Sandoz 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 decrease 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 Sitagliptin Sandoz

Do not take Sitagliptin Sandoz:

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

Warnings and precautions

Talk to your doctor or pharmacist before you start taking sitagliptin.

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 condition called bullous pemphigoid. Your doctor may ask you to stop taking sitagliptin.

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-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 Sitagliptin Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to 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 digoxin blood levels 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 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 drowsiness have been reported, which may affect your ability to drive or use machines.

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

Sitagliptin Sandoz contains sodium

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

3. How to take Sitagliptina Sandoz

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

The usual recommended dose is:

• one 100 mg film-coated tablet
• once daily
• taken 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 beverages.

Your doctor may prescribe this medicine alone or together with other medicines that also lower blood sugar. Diet and exercise may help your body use sugar more effectively. It is important to follow the diet and exercise plan recommended by your doctor while taking sitagliptin.

If you take more Sitagliptina Sandoz 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 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Sitagliptina Sandoz

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 a missed dose.

If you stop taking Sitagliptina Sandoz

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 will experience them.

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

• Severe and persistent pain in the abdomen (stomach area) which may radiate 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, skin blisters/skin peeling, and swelling of the face, lips, tongue, and throat that 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 your diabetes treatment to another medicine.

Some patients experienced the following adverse effects after adding sitagliptin to metformin treatment:

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 sitagliptin and metformin together (frequency classified as common).

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-like illness.

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 in combination with other antidiabetic 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 (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, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Sitagliptina Sandoz

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

Do not use this medicine after the expiry date stated on the blister and carton after CAD/EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Open the blister pack just before taking the tablets.

Do not use this medicine if you notice any visible signs of tampering with the tamper-evident system.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sitagliptin Sandoz

• The active substance is sitagliptin.

Sitagliptin Sandoz 25 mg film-coated tablets EFG

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

Sitagliptin Sandoz 50 mg film-coated tablets EFG

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

Sitagliptin Sandoz 100 mg film-coated tablets EFG

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

• The other excipients are: calcium hydrogen phosphate (E341), microcrystalline cellulose (E460), sodium croscarmellose (E468), magnesium stearate (E470b), stearoyl fumarate and sodium, hypromellose (E464), hydroxypropylcellulose (E463), macrogol (E1521), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172) (only applicable for the 100 mg dose), and talc (E553b).

Appearance of the product and contents of the pack

Sitagliptin Sandoz 25 mg film-coated tablets EFG

Film-coated tablet, biconvex, round, pink in colour, marked “ST 25” on one side. With a diameter of 5.7 – 6.6 mm.

Sitagliptin Sandoz 50 mg film-coated tablets EFG

Film-coated tablet, biconvex, round, light pink in colour, marked “ST 50” on one side. With a diameter of 7.7 – 8.6 mm.

Sitagliptin Sandoz 100 mg film-coated tablets EFG

Film-coated tablet, biconvex, round, light brown in colour, marked “ST 100” on one side. With a diameter of 9.7 – 10.6 mm.

Sitagliptin Sandoz is available in:

OPA/Al/PVC//Al blisters and transparent PVC/PE/PVDC//Al blisters containing 28, 30, 50, 56, 60, 84, 90, 98, 100, 105, 108, 110, 112, 120, 168, 180, 196, 198 or 200 film-coated tablets.

Perforated unit dose blister packs containing 28x1, 30x1, 50x1, 56x1, 84x1, 90x1, 98x1 film-coated tablets.

HDPE bottles with polypropylene child-resistant cap containing 30, 100 or 120 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte
Edificio Roble
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturer

Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava
Slovenia

or

Lek Pharmaceuticals d.d.
Verovškova, 57
SLO-1526 Ljubljana
Slovenia

or

Lek S.A.
ul. Podlipie 16,
Strykow, 95-010
Poland

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Austria: Sitagliptin Sandoz 25 mg – Filmtabletten
Sitagliptin Sandoz 50 mg – Filmtabletten
Sitagliptin Sandoz 100 mg – Filmtabletten

Belgium: Sitagliptin Sandoz 25 mg filmomhulde tabletten
Sitagliptin Sandoz 50 mg filmomhulde tabletten
Sitagliptin Sandoz 100 mg filmomhulde tabletten

Denmark: Sitagliptin Sandoz

Finland: Sitagliptin Sandoz 25 mg kalvopäällysteiset tabletit
Sitagliptin Sandoz 50 mg kalvopäällysteiset tabletit
Sitagliptin Sandoz 100 mg kalvopäällysteiset tabletit

France: SITAGLIPTINE SANDOZ 50 mg, comprimé pelliculé
SITAGLIPTINE SANDOZ 100 mg, comprimé pelliculé

Hungary: Sitagliptin Sandoz 25 mg, 50 mg, 100 mg filmtabletta

Iceland: Sitagliptin Sandoz 25 mg filmuhúðaðar töflur
Sitagliptin Sandoz 50 mg filmuhúðaðar töflur
Sitagliptin Sandoz 100 mg filmuhúðaðar töflur

Italy: Sitagliptin Sandoz

Norway: Sitagliptin Sandoz 25 mg filmdrasjerte tabletter
Sitagliptin Sandoz 50 mg filmdrasjerte tabletter
Sitagliptin Sandoz 100 mg filmdrasjerte tabletter

Netherlands: Sitagliptine Sandoz 25 mg, filmomhulde tabletten
Sitagliptine Sandoz 50 mg, filmomhulde tabletten
Sitagliptine Sandoz 100 mg, filmomhulde tabletten

Portugal: Sitagliptina Sandoz

Northern Ireland: Sitagliptin Sandoz 25mg film-coated tablets
Sitagliptin Sandoz 50mg film-coated tablets
Sitagliptin Sandoz 100mg film-coated tablets

Sweden: Sitagliptin Sandoz 25 mg filmdragerade tabletter
Sitagliptin Sandoz 50 mg filmdragerade tabletter
Sitagliptin Sandoz 100 mg filmdragerade tabletter

Date of the most recent review of this package leaflet: February 2021

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/