LINAGLIPTIN INTAS 5 mg FILM-COATED TABLETS

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

This medication contains the active substance linagliptin, 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.

This medication 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 Intas

Do not take Linagliptina Intas

• 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 this medication 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). This medication 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 this medication 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 (abdominal pain), you should consult your doctor.

If you notice a blister on your skin, it could be a sign of a disease called bullous pemphigoid. Your doctor may advise you to stop treatment with this medication.

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

Children and Adolescents

This medication is not recommended for children and adolescents under 18 years of age.

Other Medications and Linagliptina Intas

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 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.

It is not known if this medication is harmful to the fetus. Therefore, it is preferable to avoid using this medication if you are pregnant.

It is not known if this medication passes into breast milk. Your doctor will decide whether to stop breastfeeding or stop/avoid treatment with this medication.

Driving and Using Machines

The influence of this medication on the ability to drive and use machines is negligible or minimal.

Taking this medication in combination with sulfonylurea and/or insulin medications 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 this medication is combined with a sulfonylurea and/or insulin.

3. How to take Linagliptina Intas

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

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

You can take this medication 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 Intas than you should

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

If you forget to take Linagliptina Intas

• If you forget to take a dose of this medication, 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 Intas

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

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 gets them.

Some symptoms require immediate medical attention.

You should stop taking this medication and see 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 this medication 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 this medication alone or in combination with other diabetes medications, which can be severe, including wheezing and difficulty breathing (bronchial hyperreactivity; frequency: unknown, 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, which can cause difficulty breathing or swallowing (angioedema; frequency: rare). If you experience any of the above symptoms, stop taking this medication and see 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 this medication alone or in combination with other diabetes medications.

Stop taking this medication and consult a doctor immediately if you notice 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 this medication alone or in combination with other diabetes medications:

• Frequent: 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 not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Linagliptina Intas

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

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

No special storage conditions are required.

Do not use this medication if the packaging is damaged or shows signs of tampering.

Medications should not be disposed of via wastewater or household waste. Return the packaging and any unused medication to a pharmacy for proper disposal. By doing so, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Linagliptina Intas

• The active substance is linagliptin.

Each film-coated tablet contains 5 mg of linagliptin.

• The other ingredients are:

Tablet core: mannitol (E-41), corn starch, copovidone, magnesium stearate (E-470b).

Coating: hypromellose 2910, 5 mPa·s (E-464), titanium dioxide (E171), talc (E-553b), macrogol (6000), red iron oxide (E172).

Appearance of Linagliptina Intas and Package Contents

• Linagliptina Intas 5 mg film-coated tablets are light red, round, 8 mm in diameter, biconvex, with beveled edges, engraved with "L5" on one side and plain on the other.

• This medication is available in single-dose aluminum/aluminum blister packs. The pack sizes are 10 x 1, 14 x 1, 14 x 2 (28), 10 x 3 (30), 14 x 4 (56), 10 x 6 (60), 14 x 6 (84), 10 x 9 (90), 14 x 7 (98), 10 x 10 (100) tablets.

Not all pack sizes may be marketed in your country.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Intas Third Party Sales 2005, S.L.,

World Trade Center, Moll Barcelona s/n, Edifici Est, 6th Floor

08039, Barcelona

Spain

Manufacturer

Laboratori Fundació Dau

C/ C, 12-14 Pol. Ind. Zona Franca

08040, Barcelona

Spain

or

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park

3000, Paola

Malta

This medication is authorized in the Member States of the European Economic Area under the following names:

Greece: Linagliptin Intas 5mg film-coated tablets

Poland: Linagliptin Intas, 5 mg, film-coated tablets

Netherlands: Linagliptin Intas 5 mg film-coated tablets

Italy: Linagliptin Intas 5 mg film-coated tablets

Spain: Linagliptina Intas 5 mg film-coated tablets EFG

Malta: Linagliptin Accord 5mg film-coated tablets

Date of Last Revision of this Package Leaflet

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/