LINAGLIPTIN SANDOZ 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Linagliptina Sandoz 5 mg film-coated tablets EFG

linagliptina

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

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

Linagliptina Sandoz contains the active substance 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 antidiabetic medications, e.g., metformin, sulfonylureas (e.g., glimepiride, glipizide), 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 Sandoz

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 taking it with linagliptina to avoid low blood sugar levels.
• have had allergic reactions to any other medication you take to control your blood sugar levels.
• have or have had pancreatic disease.

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

If you find blisters 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 in children under 10 years of age are unknown.

Other medications and Linagliptina Sandoz

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 that contain any of the following active substances:

• Carbamazepine, phenobarbital, or phenytoin. These may be 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. It is unknown if linagliptina is harmful to the fetus.

It is unknown if linagliptina passes into breast milk. Your doctor must decide whether to stop breastfeeding or stop 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 low blood sugar levels (hypoglycemia), which can affect your ability to drive and use machines or work without a safe 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 Sandoz

Follow the administration instructions of this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

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

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 Sandoz 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 Sandoz

• If you forget to take a dose of linagliptina, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose.
• 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 Sandoz

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 about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible side effects

As with all medications, this medication can cause side effects, although not everyone gets them.

Some symptoms require immediate medical attention

You should stop taking linagliptina and consult your doctor immediately if you experience the following symptoms of low blood sugar: trembling, sweating, anxiety, blurred vision, tingling of the lips, paleness, mood changes, or confusion (hypoglycemia). Hypoglycemia (frequency: very common, may affect more than 1 in 10 people) is a side effect identified when linagliptina is taken with metformin and a sulfonylurea.

Some patients have experienced allergic reactions (hypersensitivity; frequency: uncommon, may affect up to 1 in 100 people) while taking linagliptina alone or in combination with other medications for the treatment of diabetes, which can be severe, including wheezing and shortness of breath (bronchial hyperreactivity; frequency: unknown, frequency cannot be estimated from available data). Some patients have experienced skin rash (frequency: uncommon), hives (urticaria; frequency: rare, may affect up to 1 in 1,000 people), and swelling of the face, lips, tongue, and throat that can cause difficulty breathing or swallowing (angioedema; frequency: rare). If you experience any of the signs of disease mentioned above, stop taking linagliptina and call your doctor immediately. Your doctor may prescribe a medication to treat your allergic reaction and a different medication for your diabetes.

Some patients have experienced pancreatitis (frequency: rare, may affect up to 1 in 1,000 people) while taking linagliptina alone or in combination with other medications for the treatment of diabetes.

STOP taking linagliptina and consult a doctor immediately if you observe any of the following serious side effects:

• 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).

Some patients have experienced the following side effects while taking linagliptina alone or in combination with other medications for the treatment of diabetes:

• Common: elevated lipase levels in the blood.
• Uncommon: inflammation of the nose or throat (nasopharyngitis), cough, constipation (in combination with insulin), elevated amylase levels in the blood.
• Rare: blisters on the skin (bullous pemphigoid).

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, 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 Sandoz

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

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

This medication does not require special storage conditions.

Medications should not be disposed of via wastewater or household waste. Return the packaging and any unused medication to the pharmacy. If in doubt, consult your pharmacist about 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 Sandoz

• The active substance is linagliptina.

Each film-coated tablet (tablet) contains 5 mg of linagliptina.

• The other ingredients are:

Core of the tablet: mannitol (E421), crospovidone (E1202), hypromellose (E464), colloidal anhydrous silica (E551), and magnesium stearate (E470b).

Film coating: hypromellose (E464), titanium dioxide (E171), talc (E553b), macrogol (E1521), and red iron oxide (E172).

Appearance of Linagliptina Sandoz and package contents

Linagliptina Sandoz 5 mg film-coated tablets are light pink, round, biconvex tablets, approximately 8 mm in diameter, marked with "5" on one side.

Linagliptina Sandoz is available in aluminum blisters. The pack sizes are 10, 14, 28, 30, 60, 90, 100, and 120 tablets.

Linagliptina Sandoz is available in single-dose aluminum blisters. The pack sizes are 10 x 1, 14 x 1, 28 x 1, 30 x 1, 60 x 1, 90 x 1, 100 x 1, and 120 x 1 tablets.

Linagliptina Sandoz 5 mg is also available in a plastic bottle with a child-resistant cap and contains a silica gel desiccant. The pack size is 120 tablets.

Not all 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

PharOS MT Ltd

HF62X, Hal Far Industrial Estate,

Birzebbugia BBG3000,

Malta

or

Lek Pharmaceuticals d.d.

Verovškova, 57

1526 Ljubljana

Slovenia

Date of the 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.