Sitagliptin Stada 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sitagliptina Stada 100 mg film-coated tablets EFG

Read the entire 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 must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Sitagliptina Stada is and what it is used for
2. What you need to know before taking Sitagliptina Stada
3. How to take Sitagliptina Stada
4. Possible side effects
5. How to store Sitagliptina Stada
6. Contents of the pack and other information

1. What is Sitagliptina Stada and what is it used for?

Sitagliptina Stada 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 your body 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 Stada

DO NOT take Sitagliptina Stada

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

Warnings and precautions

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

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

Inform 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 likelihood 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 currently or 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 unknown whether this medicine is safe and effective when used in children under 10 years of age.

Other medicines and Sitagliptina Stada

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). The level of digoxin in your blood 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 plan 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 operate machinery is negligible or none. However, dizziness and drowsiness have been reported, which may affect your ability to drive or use machinery.

Also, taking this medicine together with medicines called sulfonylureas or with insulin may cause hypoglycemia, which may affect your ability to drive and use machinery or work without a secure support.

Sitagliptina Stada contains sodium

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

3. How to take Sitagliptina Stada

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

Dose

The recommended dose is 100 mg once daily.

Method of administration

This medicine is taken orally. You may take this medicine with or without food and drinks.

Kidney problems

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

Other medicines and recommendations

Your doctor may prescribe this medicine alone or together with other medicines that also reduce blood sugar.

Diet and exercise can help the body use sugar more effectively. It is important that you follow the diet and exercise regimen recommended by your doctor while taking sitagliptin.

If you take more Sitagliptina Stada than you should

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

If you forget to take Sitagliptina Stada

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 usual schedule. Do not take a double dose of this medicine.

If you stop taking Sitagliptina Stada

Keep taking this medicine for as long as your doctor prescribes it so that it can continue helping to 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:

Not known (frequency cannot be estimated from available data)

? severe and persistent pain in the abdomen (stomach area), possibly radiating to the back, with or without nausea and vomiting, as these may be signs of inflammation of the pancreas (pancreatitis).

• severe allergic reaction, including skin rash, hives, skin blistering or peeling, and swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing.

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
• diarrhea
• constipation
• drowsiness

Some patients experienced the following adverse effects when starting sitagliptin and metformin together:

Common

• Various types of stomach discomfort

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

• flu

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 and sore throat
• osteoarthritis
• pain in the arm or leg

Uncommon

• dizziness
• constipation
• itching

Rare (may affect up to 1 in 1,000 people)

• reduction in platelet count

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 adverse effect, talk to your doctor, pharmacist, or nurse, 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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sitagliptin Stada

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

Do not use this medicine after the expiry date stated on the blister, the label of the bottle, and the carton, 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. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sitagliptina Stada

• The active substance is sitagliptin. Each film-coated tablet (tablet) contains sitagliptin hydrochloride monohydrate, equivalent to 100 mg of sitagliptin.
• The other components are: calcium hydrogen phosphate, microcrystalline cellulose, sodium croscarmellose, sodium stearyl fumarate, magnesium stearate.

The film-coating material contains: polyvinyl alcohol, titanium dioxide (E171), macrogol/polyethylene glycol, talc, yellow iron oxide (E172), red iron oxide (E172).

Appearance of the product and contents of the pack

The 100 mg film-coated tablets are round, biconvex, approximately 9.8 mm in diameter, beige in colour, marked with "L" on one side.

Sitagliptina Stada 100 mg is available in packs of 14, 28, 30, 56 and 98 tablets and in bottles of 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Laboratorios Liconsa S.A.

Avda. Miralcampo, Nº 7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

or

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Wien

Austria

or

Centrafarm Services B.V.

Van de Reijtstraat 31 E

NL-4814 Breda

The Netherlands

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

Netherlands Sitagliptine CF 100 mg, filmomhulde tabletten

Austria Sitagliptin STADA 100 mg Filmtabletten

Belgium Sitagliptin EG 100 mg, filmomhulde tabletten

Greece σιταγλιπτ?νης STADA 100 mg επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α (SITAGLIPTIN/STADA 100 mg film-coated tablets)

Czech Republic Sitagliptin STADA

Germany Sitagliptin STADA 100 mg Filmtabletten

Denmark Sitagliptin STADA

Spain Sitagliptina STADA 100 mg comprimidos recubiertos con película EFG

Finland Sitagliptin STADA 100 mg kalvopäällysteiset tabletit

France Sitagliptine EG 100 mg, comprimé pelliculé

Iceland Sitagliptin STADA 100 mg filmuhúðaðar töflur

Luxembourg Sitagliptin EG 100 mg comprimés pelliculés

Poland Sitagliptin STADA

Portugal Sitagliptina Ciclum

Sweden Sitagliptin STADA 100 mg filmdragerad tablet

Slovenia Sitagliptin STADA 100 mg filmsko obložene tablete

Slovakia Sitagliptin STADA 100 mg filmom obalené tablety

Date of the most recent revision of this leaflet: May 2022

Detailed 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/).