SITAGLIPTIN STADA 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sitagliptina Stada 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, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Sitagliptina Stada and what is it used for
2. What you need to know before you take Sitagliptina Stada
3. How to take Sitagliptina Stada
4. Possible side effects
5. Storage of 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 to increase the amount 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 level, which is 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 disease in which your body does not produce enough insulin, and the insulin it produces 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 you take Sitagliptina Stada

Do not take Sitagliptina Stada

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

Warnings and precautions

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.

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 between 10 and 17 years of age. It is not known if 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 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 your digoxin levels if you are taking sitagliptin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, 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 breastfeeding or planning to breastfeed.

Driving and using machines

The effect of this medicine on your ability to drive or use machines is negligible or minimal. However, dizziness and somnolence have been reported, which may affect your ability to drive or use machines.

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

Sitagliptina Stada 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 Stada

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

Dose

The recommended dose is 100 mg once a day.

Method of administration

It is taken orally. You can take this medicine with or without food and drinks.

Kidney problems

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

Other medicines and recommendations

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

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

If you take more Sitagliptina Stada than you should

If you take more of this medicine than you should, 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 the time of 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 Sitagliptina Stada

Continue taking this medicine while your doctor prescribes it for you to continue helping control your blood sugar levels. You should not stop taking this medicine without first consulting your doctor.

If you have any other questions about the use of this medicine, 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 and contact your doctor immediately if you notice any of the following serious side effects:

Not known(frequency cannot be estimated from the available data)

? 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.

• severe allergic reaction, including skin rash, hives, blisters on the skin/exfoliative skin rash, and swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing.

Your doctor will prescribe a medicine to treat the allergic reaction and change your diabetes medicine.

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 the following side effects when they started taking sitagliptin and metformin together.

Common

• various types of stomach discomfort

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

• reduced number of platelets

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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website (http://www.aemps.gob.es/). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sitagliptina Stada

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 blister, label, and carton after EXP. The expiry date is the last day of the month shown.

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 other information

Composition of Sitagliptina Stada

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

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

Appearance and packaging

The 100 mg film-coated tablets are round, biconvex, approximately 9.8 mm in diameter, beige in color, engraved 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.

Not all 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

Netherlands

This medicine 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 last revision of this leaflet:May 2022

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