Jentadueto 2,5 mg/ 1000 mg comprimidos recubiertos con pelicula

Prospecto:information for the patient

Jentadueto2,5mg / 850mg film-coated tablets

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

linagliptin/hydrochloride of metformin

Read this prospectus carefully before starting to take this medication, as it contains important information for you.

-Keep this prospectus, as you may need to read it again.

-If you have any doubts, consult your doctor, pharmacist, or nurse.

-This medication has been prescribed only to you, and you should not give it to others who have the same symptoms as you, as it may harm them.

-If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospectus. See section4.

1.What isJentaduetoand for what it is used

2.What you need to know before starting to takeJentadueto

3.How to takeJentadueto

4.Possible adverse effects

5.Storage of Jentadueto

6.Contents of the package and additional information

The name of your tablet isJentadueto. It contains two distinct active ingredients: linagliptina and metformin.

• Linagliptina 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 ingredients work together to control blood sugar levels in adult patients with a form of diabetes called “type2 diabetes mellitus”. Along with diet and exercise,this medicationhelps to improve insulin levels and effects after a meal and reduces the amount of sugar produced by your body.

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

What is type2 diabetes?

Type2 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 occurs, sugar (glucose) accumulates in the blood. This can lead to serious medical problems, such as heart diseases, kidney diseases, blindness, and amputations.

Do not take Jentadueto

• if you are allergic to linagliptin or metformin or any of the other ingredients of this medicine (listed in section 6).
• if you have a severe reduction in kidney function.
• if you have uncontrolled diabetes, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or ketoacidosis.Lactic acidosis is a condition 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 a fruity-smelling 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 difficulty breathing.This can lead to a lack of oxygen supply to tissues, which can put you at risk of lactic acidosis (see "Warnings and precautions").
• if you have liver problems.
• if you drink excessive amounts of alcohol, either daily or occasionally (see section "Taking Jentadueto with alcohol").

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

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 condition.
• if you are taking insulin or a diabetes medication known as "sulfonylurea", your doctor may want to reduce your insulin or sulfonylurea dose when taking either of them with Jentadueto to avoid low blood sugar (hypoglycemia).
• if you have or have had a pancreatic disease.

If you have 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 condition called bullous pemphigoid. Your doctor may advise you to stop taking Jentadueto.

If you are unsure whether you are affected by any of the above circumstances, 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 rare but serious side effect called lactic acidosis, especially if your kidneys are not functioning properly.The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see below), liver problems and any medical condition in which a part of the body has a reduced oxygen supply (such as acute and severe heart disease).

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

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

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

The symptoms of lactic acidosis include:

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

If you need to undergo major surgery, stop taking Jentadueto while the procedure is being performed and for a period of time afterwards. Your doctor will decide when to stop and when to restart treatment with Jentadueto.

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 deteriorating.

Children and adolescents

This medicine is not recommended for children and adolescents under 18 years of age.Jentadueto is not effective in children and adolescents aged 10 to 17 years. The safety and efficacy of this medicine in children under 10 years of age have not been established.

Other medicines and Jentadueto

If you need to be administered an injection of a contrast medium containing iodine, for example, in the context of a radiograph or other imaging examination, stop taking Jentadueto before the injection or at the time of the injection.Your doctor will decide when to stop and when to restart treatment with Jentadueto.

Inform your doctor if you are taking, have taken recently or may need to take any other medicine. 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:

• diuretics that increase urine production.
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib).
• some medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).
• medicines that can modify the levels of metformin 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. Thesemay be used to control seizures (convulsions) or chronic pain.
• rifampicin. This is an antibiotic used to treat infections such as tuberculosis.
• medicines used to treat diseases that involve inflammation, such as asthma and arthritis (corticosteroids).
• bronchodilators (β-sympathomimetics)for the treatment of bronchial asthma.
• medicines that contain alcohol.

Taking Jentadueto with alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

You should not use Jentadueto if you are pregnant. The safety of this medicine for the fetus has not been established.

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

Driving and operating machinery

The influence of Jentadueto on the ability to drive and operate machinery is negligible or insignificant.

However, taking Jentadueto in combination with sulfonylureas or insulin can cause low blood sugar (hypoglycemia), which can affect your ability to drive and operate machinery or work safely without a secure support.

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

How much to take

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

How to take this medication

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

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

Continue taking Jentadueto as prescribed by your doctor to help control your blood sugar level.Your doctor may prescribe this medication along with other oral antidiabetic medications or insulin. Remember to take all your medications as instructed by your doctor for the best results for your health.

During treatment with Jentadueto, continue with your diet and make sure that carbohydrate intake is evenly distributed throughout the day. If you are overweight, continue with your low-calorie diet as instructed.It is unlikely that this medication will only cause an abnormal drop in blood sugar (hypoglycemia). When Jentadueto is used with a medication containing a sulfonylurea or with insulin, a drop in blood sugar may 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 non-specific, such as nausea, vomiting, stomach pain with muscle cramps, a general feeling of discomfort with intense fatigue and difficulty breathing.Other symptoms are reduced body temperature and heart rate.If this occurs, 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 there is little time left for your next dose, do not take the missed dose. Do not take a double dose to compensate for the missed doses. Never take two doses at once (morning or evening).

If you interrupt treatment with Jentadueto

Continue taking Jentadueto until your doctor tells you to stop. This will help you maintain control of your blood sugar.

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

Like all medicines,this medicinecan cause side effects, although not everyone will experience them.

Some symptoms require immediate medical attention

Stop taking Jentadueto andseek medical help immediatelyif you experience the following symptoms oflow blood sugar (hypoglycemia):shaking, sweating, anxiety, blurred vision,tingling in the lips, paleness, mood changes or confusion.Hypoglycemia (frequency: very common[may affect more than 1 in 10people]) is an identified adverse effect for the combination of Jentadueto plus sulfonylurea and for the combination Jentadueto plus insulin.

Jentadueto may cause a rare but serious side effect called lactic acidosis (see section “Warnings and precautions”). If this occurs,stop taking Jentadueto and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

Some patients have experienced inflammation of the pancreas (pancreatitis;rare frequency, may affect up to 1 in 1,000 people).

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

• Intense 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 side effects of Jentadueto include:

Some patients have presented allergic reactions (rare frequency), which can be severe, including wheezing (“whistling” when breathing)and difficulty breathing (bronchial hyperreactivity; infrequent frequency[may affect up to 1 in 100people]). Some patients presented exanthema (skin reaction; infrequent frequency), urticaria (hives; rare frequency) and swelling of the face, lips, tongue, and throat that can cause difficulty breathing or swallowing (angioedema; rare frequency). If you experience any of the signs of illness mentioned above, stop taking Jentadueto and call your doctor quickly. Your doctor may prescribe a medication to treat your allergic reaction and a different medication for your diabetes.

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

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

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

• Infrequent: liver function disorders, constipation.

Side effects when taking metformin alone, which were not described for Jentadueto:

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack, bottle, and box after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

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

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

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

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Jentadueto

• The active ingredients are linagliptina and metformin hydrochloride.
• Each Jentadueto 2.5 mg/850 mg film-coated tablet contains 2.5 mg of linagliptina and 850 mg of metformin hydrochloride.
• Each Jentadueto 2.5 mg/1 000 mg film-coated tablet contains 2.5 mg of linagliptina 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 Jentadueto 2.5 mg/850 mg film-coated tablets also contain iron oxide red (E172) and iron oxide yellow (E172).

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

Appearance of the product and contents of the pack

Jentadueto 2.5 mg/850 mg are orange-yellow, oval-shaped, biconvex film-coated tablets with the inscription “D2/850” on one side and the Boehringer Ingelheim logo on the other.

Jentadueto 2.5 mg/1 000 mg are pink, oval-shaped, biconvex film-coated tablets with the inscription “D2/1 000” on one side and the Boehringer Ingelheim logo on the other.

Jentadueto is available in:

Pre-cut single-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.

Multi-pack containers 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 screw-cap of plastic and a silica gel desiccant. The bottles contain 14, 60 or 180 film-coated tablets.

Only some pack sizes may be marketed in your country.

Marketing authorisation holder

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Responsible for manufacturing

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

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics:

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.