JENTADUETO 2.5 mg / 1000 mg FILM-COATED TABLETS

Introduction

Package Leaflet:information for the patient

Jentadueto2.5mg / 850mg film-coated tablets

Jentadueto2.5mg / 1,000mg film-coated tablets

linagliptin/metformin hydrochloride

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 not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

1. What is Jentadueto and what is it used for

The name of your tablet is Jentadueto. It contains two different active substances: linagliptin and metformin.

• Linagliptin belongs to a class of medications called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors).
• Metformin belongs to a class of medications called biguanides.

How Jentadueto works

The two active substances work together to control blood sugar levels in adult patients with a form of diabetes called "type 2 diabetes mellitus". Along with diet and exercise, this medication helps improve insulin levels and effects after a meal and reduces the amount of sugar produced by your body.

This medication can be used alone or with certain diabetes medications such as sulfonylureas, empagliflozin, or insulin.

What is type 2 diabetes?

Type 2 diabetes is a disease in which your body does not produce enough insulin, and the insulin your body produces does not work as well as it should. Your body may also produce too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems, such as heart disease, kidney disease, blindness, and amputations.

2. What you need to know before taking Jentadueto

Do not take Jentadueto

• if you are allergic to linagliptin or metformin or any of the other ingredients of this medication (listed in section 6).
• if you have severe kidney function impairment.
• if you have uncontrolled diabetes with, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see "Risk of lactic acidosis" below), or ketoacidosis. Ketoacidosis is a disorder in which substances called "ketone bodies" accumulate in the blood, which can lead to diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or an unusual fruity odor on the breath.
• if you have ever had diabetic precoma.
• if you have a severe infection such as a lung or bronchial infection, or kidney infection. Severe infections can lead to kidney problems, which can put you at risk of lactic acidosis (see "Warnings and precautions").
• if you have lost a large amount of body water (dehydration), for example, due to severe or prolonged diarrhea, or if you have vomited several times in a row. Dehydration can lead to kidney problems, which can put you at risk of lactic acidosis (see "Warnings and precautions").
• if you are being treated for acute heart failure or have recently had a heart attack, have severe circulatory problems (such as "shock"), or breathing difficulties. This can lead to a lack of oxygen supply to the tissues, which can put you at risk of lactic acidosis (see "Warnings and precautions").
• if you have liver problems.
• if you drink excessive alcohol, either daily or from time to time (see section "Taking Jentadueto with alcohol").

Do not take Jentadueto if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before starting to take this medication.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Jentadueto

• if you have type 1 diabetes (your body does not produce any insulin). Jentadueto should not be used to treat this disease.
• if you are taking insulin or an oral antidiabetic medication known as a "sulfonylurea", your doctor may want to reduce your dose of insulin or sulfonylurea when taking either of them with Jentadueto to avoid low blood sugar levels (hypoglycemia).
• if you 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 stop taking Jentadueto.

If you are unsure whether any of the above applies to you, consult your doctor, pharmacist, or nurse before starting to take Jentadueto.

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

Risk of lactic acidosis

Jentadueto may cause a very rare but serious side effect called lactic acidosis, especially if your kidneys do not work properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting, or alcohol consumption, dehydration (see more information below), liver problems, and any medical condition in which a part of the body has a reduced oxygen supply (such as severe and acute heart disease).

If any of the above applies to you, consult your doctor for further instructions.

Stop taking Jentadueto for a short period if you have a condition that may be associated with dehydration(significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you drink less fluid than usual. Consult your doctor for further instructions.

Stop taking Jentadueto and contact a doctor or the nearest hospital immediately if you experience any symptoms of lactic acidosis, as this condition can lead to coma.

The symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• a general feeling of discomfort, with intense fatigue
• difficulty breathing
• reduction in body temperature and heart rate

Consult your doctor promptly to determine how to proceed

• If you know you have a genetic disorder that affects the mitochondria (the energy-producing components within cells), such as MELAS syndrome (mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• If you experience any of the following symptoms after starting treatment with metformin: seizure, cognitive impairment, difficulty with body movements, symptoms indicative of nerve damage (e.g., pain or numbness), migraine, and hearing loss.

Lactic acidosis is a medical emergency and should be treated in a hospital.

If you need to undergo major surgery, you should stop taking Jentadueto during the procedure and for a period after it. Your doctor will decide when you should stop taking Jentadueto and when you can restart it.

During treatment with Jentadueto, your doctor will check your kidney function at least once a year or more frequently if you are an elderly patient and/or if your kidney function is worsening.

Children and adolescents

This medication 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. It is not known if this medication is safe and effective when used in children under 10 years of age.

Other medications and Jentadueto

If you need to be given an injection of a contrast medium containing iodine into your bloodstream, for example, in the context of an X-ray or other imaging examination, you should stop taking Jentadueto before the injection or at the time of the injection. Your doctor will decide when you should stop taking Jentadueto and when you can restart it.

Tell your doctor if you are taking, have recently taken, or might take any other medication. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of Jentadueto. It is especially important to mention the following:

• medications that increase urine production (diuretics).
• medications used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib).
• certain medications for treating high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).
• medications that may alter metformin levels in the blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).
• 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.
• medications used to treat diseases involving inflammation, such as asthma and arthritis (corticosteroids).
• bronchodilators (β-sympathomimetics) for the treatment of bronchial asthma.
• medications containing alcohol.

Taking Jentadueto with alcohol

Avoid excessive alcohol consumption while taking Jentadueto, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medication.

You should not use Jentadueto if you are pregnant. It is not known if this medication is harmful to the fetus.

Metformin passes into breast milk in small amounts. It is not known if linagliptin passes into breast milk. Consult your doctor if you want to breastfeed while taking this medication.

Driving and using machines

The influence of Jentadueto on the ability to drive and use machines is negligible or nonexistent.

However, taking Jentadueto in combination with medications called sulfonylureas or with insulin may cause low blood sugar (hypoglycemia), which can affect your ability to drive and use machines or work without a secure support.

3. How to take Jentadueto

Follow the instructions for taking this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

How much to take

The amount of Jentadueto you take will vary depending on your situation and the doses of metformin and/or individual tablets of linagliptin and metformin you are currently taking. Your doctor will tell you exactly what dose of this medication you should take.

How to take this medication

• one tablet twice a day by mouth at the dose prescribed by your doctor.
• with food to reduce the likelihood of stomach upset.

Do not exceed the maximum recommended daily dose of 5 mg of linagliptin and 2,000 mg of metformin hydrochloride.

Continue taking Jentadueto as long as your doctor prescribes it to help control your blood sugar levels. Your doctor may prescribe this medication along with other oral antidiabetic medications or insulin. Remember to take all medications as directed by your doctor to achieve the best results for your health.

During treatment with Jentadueto, you should continue with your diet and be careful to distribute your carbohydrate intake evenly throughout the day. If you are overweight, continue with your low-calorie diet as directed. It is unlikely that this medication alone will cause abnormally low blood sugar (hypoglycemia). When Jentadueto is used with a medication containing a sulfonylurea or with insulin, low blood sugar can occur, and your doctor may reduce the dose of your sulfonylurea or insulin.

If you take more Jentadueto than you should

If you take more Jentadueto tablets than you should, you may experience lactic acidosis. The symptoms of lactic acidosis are nonspecific, such as nausea, vomiting, stomach pain with muscle cramps, a general feeling of discomfort with intense fatigue, and difficulty breathing. Other symptoms include reduced body temperature and heart rate. If this happens, you may need immediate hospital treatment, as lactic acidosis can lead to coma. Stop taking this medication immediately and contact a doctor or the nearest hospital immediately (see section 2). Bring the medication packaging with you.

If you forget to take Jentadueto

If you forget to take a dose, 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 at the same time (morning or evening).

If you stop taking Jentadueto

Continue taking Jentadueto until your doctor tells you to stop. This will help keep your blood sugar levels under control.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Some symptoms require immediate medical attention

Stop taking Jentadueto and quickly consult your doctor if you experience the following symptoms of low blood sugar levels (hypoglycemia): trembling, sweating, anxiety, blurred vision, tingling in the lips, paleness, mood changes, or confusion. Hypoglycemia (frequency: very frequent [may affect more than 1 in 10 people]) is an adverse effect identified for the combination of Jentadueto with sulfonylurea and for the combination Jentadueto with insulin.

Jentadueto may cause a very rare (may affect up to 1 in 10,000 people) but very serious adverse effect called lactic acidosis (see section "Warnings and Precautions"). If this happens to you, you must stop taking Jentadueto and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

Some patients have experienced pancreatitis (frequency rare, may affect up to 1 in 1,000 people).

STOPtaking Jentadueto and consult a doctor immediately if you observe any of the following serious adverse 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).

Other adverse effects of Jentadueto include:

Some patients have presented allergic reactions (frequency rare), which can be serious, including wheezing ("whistling" when breathing) and difficulty breathing (bronchial hyperreactivity; frequency infrequent [may affect up to 1 in 100 people]). Some patients presented with exanthema (skin reaction; frequency infrequent), hives (urticaria; frequency rare), 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 aforementioned disease signs, stop taking Jentadueto and quickly call your doctor. Your doctor may prescribe a medication to treat your allergic reaction and a different medication for your diabetes.

Some patients have experienced the following adverse effects while taking Jentadueto:

• Frequent (may affect up to 1 in 10 people): diarrhea, increased blood enzyme levels (increased lipase), feeling unwell (nausea).
• Infrequent: inflammation of the nose or throat (nasopharyngitis), cough, loss of appetite (decreased appetite), vomiting, increased blood enzyme levels (increased amylase), itching (pruritus).
• Rare: blisters on the skin (bullous pemphigoid).

Some patients have experienced the following adverse effects while taking Jentadueto with insulin:

• Infrequent: liver function disorders, constipation.

Adverse effects when taking metformin alone, not described for Jentadueto:

• Very frequent: abdominal pain.
• Frequent (may affect up to 1 in 10 people): metallic taste (taste alteration), decreased or low vitamin B12 levels in the blood (symptoms may include extreme fatigue, inflamed and reddened tongue [glossitis], tingling sensation [paresthesia], or pale or yellowish skin). Your doctor may request certain tests to identify the cause of your symptoms, as some of them can also be caused by diabetes or other unrelated health problems.
• Very rare (may affect up to 1 in 10,000 people): hepatitis (a liver problem), skin reactions such as skin redness (erythema).

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Jentadueto

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date shown on the blister, bottle, and box after EXP. The expiration date is the last day of the month indicated.

This medicine does not require any special storage temperature.

Blister: Store in the original packaging to protect it from moisture.

Bottle: Keep the bottle tightly closed to protect it from moisture.

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

Medicines should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Jentadueto

• The active ingredients are linagliptin and metformin hydrochloride.
• Each film-coated tablet of Jentadueto 2.5 mg/850 mg contains 2.5 mg of linagliptin and 850 mg of metformin hydrochloride.
• Each film-coated tablet of Jentadueto 2.5 mg/1,000 mg contains 2.5 mg of linagliptin and 1,000 mg of metformin hydrochloride.
• The other components are:

• Tablet core: arginine, copovidone, magnesium stearate, cornstarch, and anhydrous colloidal silica.
• Film coating: hypromellose, titanium dioxide (E171), talc, propylene glycol.

The film-coated tablets of Jentadueto 2.5 mg/850 mg also contain red iron oxide (E172) and yellow iron oxide (E172).

The film-coated tablets of Jentadueto 2.5 mg/1,000 mg also contain red iron oxide (E172).

Appearance of the Product and Package Contents

Jentadueto 2.5 mg/850 mg are film-coated tablets (tablets) of light orange color, oval, and biconvex. They are engraved with the inscription "D2/850" on one side and the Boehringer Ingelheim logo on the other.

Jentadueto 2.5 mg/1,000 mg are film-coated tablets (tablets) of light pink color, oval, and biconvex. They are engraved with the inscription "D2/1,000" on one side and the Boehringer Ingelheim logo on the other.

Jentadueto is available in precut unit-dose blisters with 10 × 1, 14 × 1, 28 × 1, 30 × 1, 56 × 1, 60 × 1, 84 × 1, 90 × 1, 98 × 1, 100 × 1, and 120 × 1 film-coated tablets and multiple packages containing 120 × 1 (2 packs of 60 × 1), 180 × 1 (2 packs of 90 × 1), 180 × 1 (3 packs of 60 × 1), and 200 × 1 (2 packs of 100 × 1) film-coated tablets.

Jentadueto is also available in plastic bottles with a plastic screw cap and a silica gel desiccant. The bottles contain 14, 60, or 180 film-coated tablets.

Not all package sizes may be marketed in your country.

Marketing Authorization Holder

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Boehringer Ingelheim Hellas Single Member S.A.

5th km Paiania – Markopoulo

Koropi Attiki, 19441

Greece

Dragenopharm Apotheker Püschl GmbH

Göllstraße 1

84529 Tittmoning

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of the Last Revision of this Prospectus:

Detailed information about this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.