Jentadueto 2.5 mg/1000 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Jentadueto 2.5 mg / 850 mg film-coated tablets

Jentadueto 2.5 mg / 1,000 mg film-coated tablets

linagliptin/metformin hydrochloride

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet; you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Jentadueto is and what it is used for
2. What you need to know before you take Jentadueto
3. How to take Jentadueto
4. Possible side effects
5. How to store Jentadueto
6. Contents of the pack and other information

1. What Jentadueto is and what it is used for

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

• Linagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors).
• Metformin belongs to a class of medicines 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 medicine helps to improve insulin levels and effects after a meal and reduces the amount of sugar produced by your body.

This medicine may be used alone or in combination with certain diabetes medications such as sulfonylureas, empagliflozin, or insulin.

What is type 2 diabetes?

Type 2 diabetes is a condition 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 starting Jentadueto

Do not take Jentadueto

• if you are allergic to linagliptin or metformin or any of the other components of this medicine (listed in section 6).
• if you have severely reduced kidney function.
• if you have uncontrolled diabetes with, for example, severe hyperglycemia (high blood glucose), 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 may lead to diabetic pre-coma. Symptoms include stomach pain, deep and rapid breathing, drowsiness, or breath with an unusual fruity odor.
• if you have ever had diabetic pre-coma.
• if you have a serious infection such as an infection affecting the lungs or bronchial system, or kidneys. Serious infections may lead to kidney problems, putting 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 repeatedly. Dehydration may lead to kidney problems, putting 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. These conditions may lead to inadequate oxygen supply to tissues, putting you at risk of lactic acidosis (see “Warnings and precautions”).
• if you have liver problems.
• if you drink alcohol excessively, either daily or occasionally (see section “Taking Jentadueto with alcohol”).

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting Jentadueto

• if you have type 1 diabetes (your body produces no insulin). Jentadueto must not be used to treat this condition.
• if you are taking insulin or an antidiabetic medicine known as a “sulfonylurea,” your doctor may wish to reduce your insulin or sulfonylurea dose when taken together with Jentadueto to avoid low blood sugar levels (hypoglycemia).
• if you have or have had a disease of the pancreas.

If you experience symptoms of acute pancreatitis, such as severe and persistent abdominal pain, you should consult your doctor.

If you develop blisters on the skin, this could be a sign of a condition called bullous pemphigoid. Your doctor may advise you to stop taking Jentadueto.

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

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

Risk of lactic acidosis

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

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

Stop taking Jentadueto temporarily if you develop an illness that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you are drinking less fluid than usual. Consult your doctor for further instructions.

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

Symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general feeling of being unwell, with marked fatigue
• difficulty breathing
• decreased body temperature and heart rate

Contact your doctor promptly for guidance

• If you are known to have a genetic mitochondrial disease (the components responsible for energy production within cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, 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: seizures, cognitive decline, difficulty with body movements, symptoms indicating nerve damage (e.g., pain or numbness), migraine, or deafness.

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

If you need to undergo major surgery, you must stop taking Jentadueto during the procedure and for some time afterward. Your doctor will decide when to interrupt and when to restart treatment with Jentadueto.

During treatment with Jentadueto, your doctor will monitor your kidney function at least once a year, or more frequently if you are elderly 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. It is not effective in children and adolescents aged 10 to 17 years. It is unknown whether this medicine is safe and effective when used in children under 10 years of age.

Other medicines and Jentadueto

If you need to receive an intravenous injection of an iodine-containing contrast agent, for example during an X-ray or other imaging procedure, you must stop taking Jentadueto before or at the time of the injection. Your doctor will decide when to interrupt and when to restart treatment with Jentadueto.

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

• medicines that increase urine production (diuretics).
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib).
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).
• medicines 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 may be used to control epileptic seizures or chronic pain.
• rifampicin. This is an antibiotic used to treat infections such as tuberculosis.
• medicines used to treat inflammatory conditions such as asthma and arthritis (corticosteroids).
• bronchodilators (β-sympathomimetics) for the treatment of bronchial asthma.
• medicines 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

You must not use Jentadueto if you are pregnant. It is unknown whether this medicine is harmful to the fetus.

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 using machines

The effect of Jentadueto on the ability to drive and use machines is negligible or none.

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

3. How to take Jentadueto

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

How much to take

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

How to take this medicine

• One tablet twice daily by mouth at the dose prescribed by your doctor.
• With food to reduce the likelihood of stomach discomfort.

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

Keep taking Jentadueto for as long as your doctor prescribes it to help control your blood sugar levels. Your doctor may prescribe this medicine along with other oral antidiabetic medicines or insulin. Remember to take all your medicines exactly as your doctor has instructed to achieve the best results for your health.

While being treated with Jentadueto, you should continue your diet and ensure that carbohydrate intake is evenly distributed throughout the day. If you are overweight, continue your calorie-restricted diet as advised. It is unlikely that this medicine alone will cause abnormally low blood sugar (hypoglycemia). However, when Jentadueto is used together with a medicine containing a sulfonylurea or with insulin, low blood sugar may occur, and your doctor may reduce your dose of 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. Symptoms of lactic acidosis are nonspecific and include nausea, vomiting, stomach pain with muscle cramps, a general feeling of discomfort with profound fatigue, and difficulty breathing. Other symptoms include lowered body temperature and slowed heart rate. If this happens, you may require immediate hospital treatment, as lactic acidosis can lead to coma. Stop taking this medicine immediately and contact a doctor or go to the nearest hospital immediately (see section 2). Take the medicine pack 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 forgotten doses. Never take two doses at the same time (morning or evening).

If you stop taking Jentadueto

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Some symptoms require immediate medical attention

Stop taking Jentadueto and contact your doctor immediately if you experience the following symptoms of low blood sugar (hypoglycaemia): trembling, sweating, anxiety, blurred vision, tingling of the lips, pallor, mood changes or confusion. Hypoglycaemia (frequency: very common [may affect more than 1 in 10 people]) is an identified adverse effect when Jentadueto is used in combination with sulphonylurea or 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 occurs, you must stop taking Jentadueto and contact a doctor or go to 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 experience any of the following serious adverse effects:

• Severe, persistent pain in the abdomen (stomach area), which may radiate to the back, along with nausea and vomiting, as this could be a sign of an inflamed pancreas (pancreatitis).

Other adverse effects of Jentadueto include:

Some patients have experienced allergic reactions (rare frequency), which may be severe, including wheezing (whistling breath sounds) and difficulty breathing (bronchial hyperreactivity; uncommon frequency [may affect up to 1 in 100 people]). Some patients developed rash (skin reaction; uncommon frequency), hives (urticaria; rare frequency), or swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing (angioedema; rare frequency). If you experience any of the signs of illness mentioned above, stop taking Jentadueto and contact your doctor immediately. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.

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

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

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

• Uncommon: liver function disorders, constipation.

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

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

Reporting of adverse effects

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

5. Storage of Jentadueto

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

Do not use this medicine after the expiry date which is stated on the blister pack, bottle, and carton after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage temperature conditions.

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

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

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Jentadueto

• The active substances 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, corn starch, and colloidal anhydrous silica.

• Film coating: hypromellose, titanium dioxide (E171), talc, propylene glycol.

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

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

Description of the product and contents of the pack

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

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

Jentadueto is available in single-dose, pre-perforated blisters containing 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 in multiple packs 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.

Please note that only certain pack 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 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 regarding this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent revision of this leaflet: (MM/YYYY)

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