Jentadueto

Patient Information Leaflet

Jentadueto 2.5 mg / 850 mg film-coated tablets, 2.5 mg / 1,000 mg film-coated tablets

linagliptin/metformin hydrochloride
Please read all of this leaflet carefully before taking this medicine, as 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 give it to others, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Jentadueto is and what it is used for
2. What you need to know before taking 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

Jentadueto tablets contain 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". When used together with diet and exercise,
this medicine improves insulin production and insulin effects after a meal, and reduces
the body's production of sugar.
This medicine may be used alone or in combination with certain other antidiabetic medicines such as
sulfonylureas, empagliflozin, or insulin.
What is type 2 diabetes?
Type 2 diabetes is a condition in which the body does not produce enough insulin and in
which the insulin that is produced does not work properly. The body may also produce too much
sugar. When this happens, sugar (glucose) accumulates in the blood. This can lead to serious
medical problems such as heart disease, kidney disease, blindness, and amputation.

2. What you should know before taking Jentadueto

Do not take Jentadueto

• if you are allergic to linagliptin or metformin or to any of the other ingredients of this medicine (listed in section 6).
• if you have severely reduced kidney function.
• if you have uncontrolled diabetes associated, for example, with severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see below “Risk of lactic acidosis”) or ketoacidosis. Ketoacidosis is a condition in which substances called “ketone bodies” accumulate in the blood and may lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or breath with an unusually fruity odour.
• if you have had diabetic pre-coma.
• if you have a serious infection such as a lung or bronchial infection or a kidney infection. Serious infections can cause kidney problems, which may put you at risk of lactic acidosis (see “Warnings and precautions”).
• if you have lost a lot of fluids (dehydration), for example due to severe or prolonged diarrhoea, or if you have vomited repeatedly. Dehydration can cause kidney problems, which may 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 serious circulatory problems (such as shock), or have breathing difficulties. This may lead to inadequate oxygen supply to tissues, which may put 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 “Jentadueto with alcohol”).

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Jentadueto

• if you have type 1 diabetes (your body does not produce insulin). Jentadueto must not be used to treat this condition.
• if you are taking insulin or an antidiabetic medicine known as a “sulphonylurea”, your doctor may decide to reduce your insulin or sulphonylurea dose if you are taking either together with Jentadueto, in order to avoid blood sugar levels becoming too low (hypoglycaemia).
• if you have or have had a disease of the pancreas.

Contact your doctor if you experience symptoms of acute pancreatitis, such as persistent and severe abdominal pain.

If blisters appear on the skin, they may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop treatment with Jentadueto.

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

Skin problems typical of diabetes are a common complication of this disease. It is recommended that you follow the advice given to you by your doctor or nurse regarding skin and foot care.

Risk of lactic acidosis

Due to the metformin component, Jentadueto may cause a very rare but serious complication called lactic acidosis, particularly if the kidneys are not functioning properly. The risk of developing lactic acidosis is also higher in the presence of uncontrolled diabetes, serious infections, prolonged fasting, alcohol consumption, dehydration (see below for further information), liver problems, or any other medical condition characterised by reduced oxygen supply to part of the body (such as severe heart disease).

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

Temporarily stop taking Jentadueto if you have a medical condition that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, heat exposure, or if you are drinking less fluid than normal. Consult your doctor for further instructions.

If you experience any of the symptoms of lactic acidosis, stop taking Jentadueto and seek immediate medical attention at the nearest doctor’s office or hospital, because lactic acidosis can lead to coma.

Symptoms of lactic acidosis include:

• vomiting
• stomach ache (abdominal pain)
• muscle cramps
• a general feeling of discomfort associated with severe fatigue
• difficulty breathing
• decreased body temperature and heart rate

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

If you are undergoing major surgery, you must stop taking Jentadueto during the procedure and for a certain period afterwards. Your doctor will decide when you should stop and when you should restart treatment with Jentadueto.

While being treated with Jentadueto, your doctor will check your kidney function at least once a year, or more frequently if you are elderly and/or if kidney function worsens.

Children and adolescents

This medicine is not recommended for use in children and adolescents under 18 years of age. It is not effective in children and adolescents aged between 10 and 17 years. It is not known whether this medicine is safe and effective when used in children under 10 years of age.

Other medicines and Jentadueto

If you are to receive an iodinated contrast agent injected into the bloodstream, for example for an X-ray procedure, you must stop taking Jentadueto before or at the time of injection. Your doctor will decide when you should stop and when you should restart treatment with Jentadueto.

Tell your doctor if you are taking, have recently taken, or might take any other medicines. You may need to have more frequent blood glucose and kidney function tests, or your doctor may decide to adjust your dose of Jentadueto. It is particularly 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 the amount 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. 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 diseases such as asthma and arthritis (corticosteroids).
• bronchodilators (beta-sympathomimetics) for the treatment of bronchial asthma.
• medicines containing alcohol.

Jentadueto with alcohol

Avoid excessive alcohol consumption while being treated with Jentadueto, as this may increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

You must not take Jentadueto during pregnancy. It is not known whether this medicine is harmful to the unborn baby.

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

Driving and using machines

Jentadueto does not affect or has a negligible effect on the ability to drive and use machines.

However, taking Jentadueto in combination with medicines called sulphonylureas or with insulin may cause blood sugar levels to become too low (hypoglycaemia), which may affect the ability to drive and use machines or to work without protective barriers.

3. How to take Jentadueto

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

How much medicine to take
The amount of Jentadueto you need to take depends on your condition and the dose of metformin and/or the number of individual tablets of linagliptin and metformina you are currently taking. Your doctor will tell you exactly what 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 meals, to reduce the possibility 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 for the entire period prescribed by your doctor to help maintain control of your blood sugar levels. Your doctor may prescribe this medicine in combination with another oral antidiabetic medicine or with insulin. Remember to take all your medicines as prescribed by your doctor to achieve the best possible health outcomes.

While being treated with Jentadueto, continue your diet plan and ensure that carbohydrate intake is evenly distributed throughout the day. If you are overweight, continue your prescribed low-calorie diet. It is unlikely that this medicine alone will cause severe lowering of blood sugar (hypoglycaemia). However, when Jentadueto is used in combination with a medicine containing sulphonylurea or with insulin, low blood sugar levels may occur, and your doctor may reduce your dose of sulphonylurea or insulin.

If you take more Jentadueto than you should
If you take more Jentadueto tablets than prescribed, you may develop lactic acidosis. Symptoms of lactic acidosis are non-specific and include nausea and vomiting, stomach pain associated with muscle cramps, a general feeling of being unwell accompanied by severe tiredness and difficulty breathing. Other symptoms may include a drop in body temperature and slowed heart rate. If you experience these symptoms, immediate treatment in a hospital may be necessary, as lactic acidosis can lead to coma. Stop taking this medicine immediately and contact a doctor or go to the nearest hospital straight away (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, skip the missed dose. Do not take a double dose to make up for the forgotten dose. 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 helps your body keep blood sugar levels under control.

If you have any questions about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some symptoms require immediate medical attention
You must stop taking Jentadueto and contact your doctor immediately if you experience the following symptoms due to low blood sugar levels (hypoglycaemia): tremor, sweating, anxiety, blurred vision, tingling of the lips, paleness, mood changes or confusion.
Hypoglycaemia (frequency: very common, may affect more than 1 in 10 people) is a known side effect of Jentadueto when taken 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 side effect called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking Jentadueto and seek immediate medical help from a doctor or the nearest hospital, because lactic acidosis can lead to coma.
Some patients have experienced inflammation of the pancreas (pancreatitis; frequency: rare, may affect up to 1 in 1,000 people).
STOP taking Jentadueto and contact your doctor immediately if you notice any of the following serious side effects:

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

Other side effects with Jentadueto include:
Some patients have had allergic reactions (frequency: rare), which may be severe and may include wheezing and shortness of breath (bronchial hyperreactivity; frequency: not common, may affect up to 1 in 100 people). Some patients have developed a skin rash (frequency: not common), hives (frequency: rare), swelling of the face, lips, tongue and throat that may cause difficulty breathing or swallowing (angioedema; frequency: rare). If you experience any of the above signs of illness, stop taking Jentadueto and contact your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and a different medicine for diabetes.
Some patients have experienced the following side effects while taking Jentadueto:

• Common (may affect up to 1 in 10 people): diarrhoea, increase in an enzyme in the blood (increased lipase), feeling unwell (nausea).
• Not common: inflammation of the nose or throat (nasopharyngitis), cough, loss of appetite (reduced appetite), feeling unwell (vomiting), increase in a blood enzyme (increased amylase), itching.
• Rare: skin rash with blisters (bullous pemphigoid).

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

• Not common: liver function disorders, constipation

Side effects reported with metformin alone that have not been described for Jentadueto:

• Very common: abdominal pain.
• Common (may affect up to 1 in 10 people): metallic taste (taste disturbance), reduced or low levels of vitamin B12 in the blood (symptoms may include extreme tiredness (fatigue), inflammation and redness of the tongue (glossitis), tingling (paraesthesia), paleness or yellowing of the skin). Your doctor may carry out some tests to determine the cause of these symptoms, as some of them may 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 redness of the skin (erythema).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Jentadueto

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack, bottle, and carton after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature conditions.
Blister packs: Store in the original packaging to protect the medicine from moisture.
Bottle: Keep the bottle tightly closed to protect the medicine from moisture.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Jentadueto contains

• 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, maize starch, 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 appearance of Jentadueto and package contents
Jentadueto 2.5 mg/850 mg are film-coated tablets (tablets), oval, biconvex, light orange in colour, with “D2/850” engraved on one side and the Boehringer Ingelheim logo on the other.
Jentadueto 2.5 mg/1,000 mg are film-coated tablets (tablets), oval, biconvex, light pink in colour, with “D2/1,000” engraved on one side and the Boehringer Ingelheim logo on the other.
Jentadueto is available in unit-dose divisible 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.
Not all pack sizes may be marketed in your country.

Marketing Authorisation 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

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Boehringer Ingelheim SComm Boehringer Ingelheim RCV GmbH & Co KG
Tél/Tel: +32 2 773 33 11 Lietuvos filialas
Tel: +370 5 2595942

България Luxembourg/Luxemburg
Бьорингер Ингелхайм РЦВ ГмБХ и Ко. Boehringer Ingelheim SComm
КГ - клон България Tél/Tel: +32 2 773 33 11
Тел: +359 2 958 79 98

Česká republika Magyarország
Boehringer Ingelheim spol. s r.o. Boehringer Ingelheim RCV GmbH & Co KG
Tel: +420 234 655 111 Magyarországi Fióktelepe
Tel: +36 1 299 8900

Danmark Malta
Boehringer Ingelheim Danmark A/S Boehringer Ingelheim Ireland Ltd.
Tlf: +45 39 15 88 88 Tel: +353 1 295 9620

Deutschland Nederland
Boehringer Ingelheim Pharma GmbH & Co. KG Boehringer Ingelheim B.V.
Tel: +49 (0) 800 77 90 900 Tel: +31 (0) 800 22 55 889

Eesti Norge
Boehringer Ingelheim RCV GmbH & Co KG Boehringer Ingelheim Danmark
Eesti filiaal Norwegian branch
Tel: +372 612 8000 Tlf: +47 66 76 13 00

Ελλάδα Österreich
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε. Boehringer Ingelheim RCV GmbH & Co KG
Tηλ: +30 2 10 89 06 300 Tel: +43 1 80 105-7870

España Polska
Boehringer Ingelheim España, S.A. Boehringer Ingelheim Sp. z o.o.
Tel: +34 93 404 51 00 Tel: +48 22 699 0 699

France Portugal
Boehringer Ingelheim France S.A.S. Boehringer Ingelheim Portugal, Lda.
Tél: +33 3 26 50 45 33 Tel: +351 21 313 53 00

Hrvatska România
Boehringer Ingelheim Zagreb d.o.o. Boehringer Ingelheim RCV GmbH & Co KG
Tel: +385 1 2444 600 Viena - Sucursala Bucureşti
Tel: +40 21 302 28 00

Ireland Slovenija
Boehringer Ingelheim Ireland Ltd. Boehringer Ingelheim RCV GmbH & Co KG
Tel: +353 1 295 9620 Podružnica Ljubljana
Tel: +386 1 586 40 00

Ísland Slovenská republika
Vistor hf. Boehringer Ingelheim RCV GmbH & Co KG
Sími: +354 535 7000 organizačná zložka
Tel: +421 2 5810 1211

Italia Suomi/Finland
Boehringer Ingelheim Italia S.p.A. Boehringer Ingelheim Finland Ky
Tel: +39 02 5355 1 Puh/Tel: +358 10 3102 800

Κύπρος Sverige
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε. Boehringer Ingelheim AB
Tηλ: +30 2 10 89 06 300 Tel: +46 8 721 21 00

Latvija United Kingdom (Northern Ireland)
Boehringer Ingelheim RCV GmbH & Co KG Boehringer Ingelheim Ireland Ltd.
Latvijas filiāle Tel: +353 1 295 9620
Tel: +371 67 240 011

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