LINAGLIPTIN STADA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Linagliptina Stada 5mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Linagliptina Stada and what is it used for
2. What you need to know before taking Linagliptina Stada
3. How to take Linagliptina Stada
4. Possible side effects
5. Storage of Linagliptina Stada
6. Package contents and additional information

1. What is Linagliptina Stada and what is it used for

Linagliptina Stada contains the active ingredient linagliptina, which belongs to a group of medications known as "oral antidiabetics". Oral antidiabetics are used to treat high blood sugar levels. They work by helping the body to lower its blood sugar level.

Linagliptina is used to treat "type 2 diabetes" in adults, if the disease cannot be adequately controlled with an oral antidiabetic medication (metformin or sulfonylureas) or diet and exercise alone. Linagliptina can be used in combination with other oral antidiabetic medications, e.g., metformin, sulfonylureas (e.g., glimepiride, glipizide), empagliflozin, or insulin.

It is essential that you follow the dietary and exercise advice given by your doctor or nurse.

2. What you need to know before taking Linagliptina Stada

Do not take linagliptina

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take linagliptina if you:

• have type 1 diabetes (your body does not produce insulin) or diabetic ketoacidosis (a complication of diabetes with high blood sugar levels, rapid weight loss, nausea, or vomiting). Linagliptina should not be used to treat these conditions.
• are taking a sulfonylurea medication (e.g., glimepiride, glipizide), your doctor may want to reduce your sulfonylurea dose when taken with linagliptina to avoid too low blood sugar levels.
• have had allergic reactions to any other medication you take to control your blood sugar levels.
• have or have had a pancreatic disease.

If you experience symptoms of acute pancreatitis, such as severe and persistent stomach pain (abdominal pain), you should consult your doctor.

If you find a blister on your skin, it could be a sign of a disease called bullous pemphigoid. Your doctor may advise you to stop taking linagliptina.

Diabetic skin lesions are a common complication of diabetes. Follow the skin and foot care recommendations given by your doctor or nurse.

Children and adolescents

Linagliptina is not recommended for children and adolescents under 18 years of age. It is not effective in children and adolescents between 10 and 17 years of age. The safety and efficacy of this medication when used in children under 10 years of age are unknown.

Other medications and linagliptina

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.

In particular, you should inform your doctor if you are using medications containing any of the following active ingredients:

• carbamazepine, phenobarbital, or phenytoin. These are used to control seizures (convulsions) or chronic pain.
• rifampicin. This is an antibiotic used to treat infections such as tuberculosis.

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 medication.

The use of linagliptina during pregnancy is not recommended, as it is unknown whether it is harmful to the fetus.

It is unknown whether linagliptina passes into breast milk. Your doctor will decide whether to stop breastfeeding or stop/avoid treatment with linagliptina.

Driving and using machines

Linagliptina has no or negligible influence on the ability to drive and use machines.

Taking linagliptina in combination with sulfonylureas and/or insulin may cause too low blood sugar levels (hypoglycemia), which can affect your ability to drive and use machines or work without a secure support. However, more frequent blood glucose tests can be recommended to reduce the risk of hypoglycemia, especially when linagliptina is combined with a sulfonylurea and/or insulin.

3. How to take Linagliptina Stada

Always follow the administration instructions of this medication given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Dose

The recommended dose of linagliptina is one 5 mg tablet once a day.

Method of administration

Take orally. You can take linagliptina with or without food.

Your doctor may prescribe linagliptina in combination with another oral antidiabetic medication. Remember to take all medications as directed by your doctor to achieve the best results for your health.

If you take more Linagliptina Stada than you should

If you take more linagliptina than you should, consult a doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Linagliptina Stada

• do not take a double dose to make up for missed doses. Never take two doses on the same day.

If you stop taking Linagliptina Stada

Do not stop taking linagliptina without consulting your doctor first. Your blood sugar levels may increase when you stop taking linagliptina.

If you have any further questions on the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everybody gets them.

Some symptoms require immediate medical attention

Stop taking linagliptina and consult your doctor immediately if you experience any of the following serious side effects:

Very common(may affect more than 1 in 10 people)

• symptoms of low blood sugar: trembling, sweating, anxiety, blurred vision, tingling of the lips, paleness, mood changes, or confusion (hypoglycemia). Hypoglycemia is a side effect identified when linagliptina is taken with metformin and a sulfonylurea.

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

• severe and persistent abdominal pain (stomach area), which may radiate to the back, as well as nausea and vomiting, as this could be a sign of an inflamed pancreas (pancreatitis).

Stop taking linagliptina and consult your doctor immediately if you experience any of the signs or symptoms of anallergic reaction:

Uncommon(may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity) including wheezing and difficulty breathing (bronchial hyperreactivity)
• rash

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

• hives (urticaria)
• swelling of the face, lips, tongue, and throat that can cause difficulty breathing or swallowing (angioedema)

Your doctor may prescribe a medication to treat your allergic reaction and a different medication for your diabetes.

Other side effects

Common(may affect up to 1 in 10 people)

• high levels of lipase in the blood

• Uncommon(may affect up to 1 in 100 people)
• inflammation of the nose or throat (nasopharyngitis)
• cough
• constipation (in combination with insulin)
• high levels of amylase in the blood

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

• blisters on the skin (bullous pemphigoid)

Reporting of side effects

If you experience any side effects, consult your doctor, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's website https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Linagliptina Stada

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

Do not use this medication after the expiration date stated on the blister and carton after EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of via wastewater or household waste. Return the packaging and any unused medication to a pharmacy for proper disposal. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Linagliptina Stada

The active ingredient is linagliptina. Each film-coated tablet contains 5 mg of linagliptina.

The other ingredients are:

• Core of the tablet: microcrystalline cellulose, hypromellose 2208, crospovidone type A, anhydrous colloidal silica, magnesium stearate
• Coating of the tablet: Hypromellose 2910, titanium dioxide (E171), macrogol (type 3350), red iron oxide (E172).

Appearance of Linagliptina Stada and package contents

Linagliptina Stada 5 mg are film-coated tablets of reddish-gray color, round, biconvex.

The tablets (dimensions of 8 mm x 5 mm) are presented in sealed oPA-Alu-PVC blisters with an aluminum foil.

Package sizes:

Blister packs: 10, 28, 30, 56, 90, 100 tablets

Unit dose blisters: 10x1, 28x1, 30x1, 56x1, 90x1, 100x1 unit doses.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern, Barcelona

Spain

Manufacturer

STADA Arzneimittel AG

Stadastraße 2 -18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

Austria

Clonmel Healthcare Ltd., Ireland

Waterford Road, Clonmel, Co. Tipperary

Ireland

Date of last revision of this package leaflet:October 2024

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