DONUMID 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Donumid 5 mg Film-Coated Tablets EFG

linagliptin

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 or pharmacist.
• 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 or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Donumid and what is it used for

Donumid contains the active ingredient 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 reduce blood sugar levels.

Donumid 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. This medication 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 Donumid

Do not take Donumid

• if you are allergic to linagliptin 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 Donumid 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 antidiabetic medication (e.g., glimepiride, glipizide); your doctor may want to reduce your sulfonylurea dose when taken with Donumid to avoid low blood sugar levels.
• have had allergic reactions to any other medication you take to control 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 this medication.

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

Donumid 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 Donumid

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, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

It is unknown if Donumid is harmful to the fetus. Therefore, it is preferable to avoid using this medication if you are pregnant.

It is unknown if Donumid passes into breast milk. Your doctor must decide whether it is necessary to interrupt breastfeeding or discontinue treatment with this medication.

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 can 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 Donumid in combination with sulfonylureas and/or insulin may produce 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 Donumid

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

The recommended dose of Donumid is one 5 mg tablet once a day. You can take this medication with or without food.

Your doctor may prescribe Donumid 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 Donumid than you should

If you take more Donumid 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 Donumid

• If you forget to take a dose of Donumid, 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 Donumid

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

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

Stop taking Donumid 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 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 Donumid 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 this medication 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 Donumid alone or in combination with other diabetes medications.

STOPtaking this medication 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 Donumid alone or in combination with other diabetes medications:

Common: elevated lipase enzyme levels in the blood.

Uncommon: inflammation of the nose or throat (nasopharyngitis), cough, constipation (in combination with insulin), elevated amylase enzyme 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 package 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 Donumid

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 in doubt, 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 Donumid

-The active ingredient is linagliptin.

Each film-coated tablet contains 5 mg of linagliptin.

-The other ingredients are:

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

Coating of the tablet: 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 package 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/