Sitagliptin Stada 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sitagliptina Stada 50 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on 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, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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 Sitagliptin Stada

DO NOT take Sitagliptin 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 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 pancreatic disease (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 diabetes complication 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 sulphonylurea or with insulin, low blood sugar (hypoglycaemia) may occur. Your doctor may reduce the dose of your sulphonylurea or insulin medicine.

Children and adolescents

Children and adolescents under 18 years of age should not take 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 in children under 10 years of age.

Other medicines and Sitagliptin Stada

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 blood digoxin 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

You should not take this medicine 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 and may affect your ability to drive or use machines.

In addition, taking this medicine together with medicines called sulphonylureas or with insulin may cause hypoglycaemia, which may affect your ability to drive and use machines or work without secure support.

Sitagliptin 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

Follow exactly the instructions for use of this medicine as provided 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 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 to follow the diet and exercise plan 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, 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

Keep taking this medicine for as long as your doctor continues to prescribe 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 experiences them.

STOP taking sitagliptin and contact your doctor immediately if you experience 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), which may extend 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
• diarrhoea
• constipation
• somnolence

Some patients experienced the following adverse effects when starting treatment with 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

• influenza (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 diabetes medicines:

Common

• low blood sugar
• headache
• upper respiratory tract infection
• nasal congestion or runny nose and sore throat
• osteoarthritis
• arm or leg pain

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 effects, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects 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 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. Empty containers and unused medicines should be returned to 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 contains sitagliptin monohydrochloride monohydrate, equivalent to 50 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 50 mg film-coated tablets are round, biconvex, approximately 8 mm in diameter, orange in colour, marked with "C" on one side.

Sitagliptina Stada 50 mg is available in boxes containing 14, 28, 30, 56 and 98 tablets and in bottles containing 100 tablets.

Only some pack sizes may be marketed.

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the following names:

The Netherlands: Sitagliptine CF 50 mg, filmomhulde tabletten
Austria: Sitagliptin STADA 50 mg Filmtabletten
Belgium: Sitagliptin EG 50 mg, filmomhulde tabletten
Greece: σιταγλιπτ?νης STADA 50 mg επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α (SITAGLIPTIN/STADA 50 mg film-coated tablets)
Germany: Sitagliptin STADA 50 mg Filmtabletten
Denmark: Sitagliptin STADA
Spain: Sitagliptina STADA 50 mg comprimidos recubiertos con película EFG
Finland: Sitagliptin STADA 50 mg kalvopäällysteiset tabletit
France: Sitagliptine EG 50 mg, comprimé pelliculé
Iceland: Sitagliptin STADA 50 mg filmuhúðaðar töflur
Luxembourg: Sitagliptin EG 50 mg comprimés pelliculés
Poland: Sitagliptin STADA
Portugal: Sitagliptina Ciclum
Sweden: Sitagliptin STADA 50 mg filmdragerad tablet
Slovenia: Sitagliptin STADA 50 mg filmsko obložene tablete

Date of latest review 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/).