LINAGLIPTIN ALTER 5 mg FILM-COATED TABLETS

Contents of the Leaflet

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

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

Linagliptina Alter 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 Alter

Do not take Linagliptina Alter

• 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 Alter 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 medical 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 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 abdominal 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 discontinue 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 Alter

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 ingredients:

• 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 safety of linagliptina during pregnancy is unknown. Therefore, it is preferable to avoid using linagliptina if you are pregnant.

It is unknown whether linagliptina passes into breast milk. Your doctor must decide whether to discontinue breastfeeding or discontinue treatment with linagliptina.

Driving and using machines

Your ability to concentrate and react may be impaired due to symptoms caused by hypoglycemia or hyperglycemia, such as blurred vision. This may be hazardous in situations where these skills are important (e.g., driving or using machines). Therefore, consult your doctor if it is advisable to drive or 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 may be recommended to reduce the risk of hypoglycemia, especially when linagliptina is combined with a sulfonylurea and/or insulin.

3. How to take Linagliptina Alter

Follow your doctor's instructions for taking this medication exactly. If you are unsure, 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 Alter 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 Alter

• 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 Alter

Do not stop taking this medication 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

Like all medications, this medication can cause side effects, although not everyone will experience 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 diabetes medications, which can be severe, including wheezing and shortness of breath (bronchial hyperreactivity; frequency unknown, cannot be estimated from available data). Some patients have experienced skin rash (frequency uncommon), hives (frequency rare, may affect up to 1 in 1,000 people), and swelling of the face, lips, tongue, and throat, which can cause difficulty breathing or swallowing (angioedema; frequency rare). If you experience any of the above symptoms, 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 diabetes medications.

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 pancreatitis.

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

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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use https://www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Linagliptina Alter

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

Do not use this medication after the expiration date stated on the outer packaging and on the blister pack after "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. Deposit the packaging and any unused medication in the SIGRE collection point at your pharmacy. If you are unsure, 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 Alter

-The active ingredient is linagliptina.

Each film-coated tablet contains 5 mg of linagliptina.

-The other ingredients are:

Core of the tablet: mannitol, pregelatinized starch (from corn), cornstarch, povidone, and magnesium stearate.

Tablet coating: hypromellose, titanium dioxide (E-171), and triacetin.

Appearance of the product and package contents

Round, biconvex tablets, white or slightly beige in color, with a diameter of 8 mm.

Available in blister packs of Polyamide/Aluminum/PVC-Aluminum. Packs of 30 tablets.

Marketing authorization holder and manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036, Madrid

Spain

Date of the last revision of this leaflet: April 2025

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