2.5 mg / 850 mg and 2.5 mg / 1,000 mg film-coated tablets
linagliptin / metformin hydrochloride

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 group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors).
  • Metformin belongs to a group of medicines called biguanides.

How Jentadueto works

The two active substances together help to regulate blood sugar levels in adult patients with a type of diabetes called “diabetes mellitus type 2”. Together with diet and exercise, this medicine helps to improve the level and effect of insulin after a meal and reduces the amount of sugar formed by your body.

This medicine can be taken alone or in combination with certain other medicines for diabetes such as sulphonylureas, empagliflozin or insulin.

What is type 2 diabetes?

Type 2 diabetes is a condition that means that your body does not produce enough insulin and that the insulin that the body produces does not work as well as it should. Your body can also produce too much sugar. When this happens, sugar ( glucose ) accumulates in the blood. It can lead to serious medical problems such as heart disease, kidney disease, blindness and amputation.

What you need to know before using Jentadueto

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 severe renal impairment.
  • if you have uncontrolled diabetes with, for example, severe hyperglycaemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis . Ketoacidosis 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 that your breath has a different, fruity odor.
  • if you have ever had diabetes coma ( ketoacidosis ).
  • if you have a severe infection such as an infection of the lungs or bronchi or kidneys. Severe infections can cause kidney problems, which can put you at risk for lactic acidosis (see “Warnings and Precautions”).
  • if you have lost a lot of water (dehydration), e.g. due to prolonged or severe diarrhea, or if you have vomited several times in a row. Dehydration can cause kidney problems, which can put you at risk for 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 have difficulty breathing. This can lead to a lack of oxygen supply to the tissues , and it can increase the risk of lactic acidosis (see section “Warnings and precautions”).
  • if you have liver problems.
  • if you drink too much alcohol either if you do it every day or only periodically (see the section “Girl duo with alcohol”).

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

Warnings and cautions

Talk to Jentadueto with your doctor, pharmacist or nurse:

  • if you have type 1 diabetes (your body does not make insulin ). Jentadueto should not be used in the treatment of this condition.
  • If you are taking insulin or a diabetes medicine called “sulphonylurea”, your doctor may want to reduce your dose of insulin or sulphonylurea when you take one of them with Jentadueto to avoid low blood sugar ( hypoglycaemia ).
  • if you have or have had a disease of the pancreas.

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

If you get blisters on your skin, it could be a sign of a condition called bullous pemphigoid. Your doctor may tell you to stop taking Jentadueto.

If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before taking Jentadueto.

Diabetic skin problems are a common complication of diabetes. You should follow the recommendations for skin and foot care from your doctor or nurse.

Risk of lactic acidosis

Because metformin content can Jentadueto cause the very rare, but very serious side effect a lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased in uncontrolled diabetes, severe infections, prolonged fasting or alcohol intake, dehydration (see more information below), liver problems and conditions where part of the body has reduced oxygen supply (including acute severe heart disease).

If any of the above apply to you, talk to your doctor for further information.

Stop taking Jentadueto for a short time if you have a condition that may be associated with dehydration, such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal. Talk to a doctor for further instructions.

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

The symptoms of lactic acidosis include:

  • vomiting
  • abdominal pain (stomach pain)
  • muscle cramps
  • a general feeling of not feeling well and pronounced fatigue
  • hard to breathe
  • lowered body temperature and heart rate

Lactic acidosis is an acute medical condition that must be treated in a hospital.

If you are going to undergo a major operation, you must stop taking Jentadueto during the operation and a certain time after it. Your doctor will decide when you need to stop taking Jentadueto and when you should start taking it again.

During treatment with Jentadueto, your doctor will check your kidney function at least once a year or more often if you are older and/or if your kidney function is deteriorating.

Children and young people

This medicine is not recommended for children and adolescents under 18 years of age.

Other medicines and Jentadueto

If you need to get an injection in the blood with contrast media that contain iodine, for example in connection with X-rays or computed tomography, you must stop taking Jentadueto before or at the time of injection. Your doctor will decide when you need to stop taking Jentadueto and when you should start taking it again.

Tell your doctor if you are taking, have recently taken or might take any other medicines. You may need to do more blood sugar and kidney function tests, or your doctor may need to adjust the dose of Jentadueto. You must mention the following:

  • drugs that increase urine production ( diuretics )
  • drugs used to treat pain and inflammation ( NSAIDs and COX 2 inhibitors, such as ibuprofen and celecoxib)
  • certain medicines for the treatment of high blood pressure ( ACE inhibitors and angiotensin II receptor antagonists).
  • medicines that may alter the amount of metformin in your blood, especially if you have impaired kidney function (eg verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).
  • carbamazepine, phenobarbital or phenytoin . These are medications used for seizures or chronic pain.
  • rifampicin. It is an antibiotic used to treat infections such as tuberculosis .
  • drugs used in the treatment of diseases with inflammation such as asthma and arthritis ( corticosteroids ).
  • bronchodilators (β‑ sympathomimetics ) used in the treatment of asthma .
  • medicines containing alcohol.

Girl duo with alcohol

Avoid high alcohol intake while taking Jentadueto as alcohol 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, ask your doctor or pharmacist for advice before taking this medicine.

You should not use Jentadueto during pregnancy. It is not known if this medicine is harmful to the unborn baby.

Metformin is excreted in small amounts in breast milk. It is not known whether linagliptin is excreted in human milk. Talk to your doctor if you want to breastfeed while taking this medicine.

Driving and using machines

Jentadueto has no or negligible effect on the ability to drive and use machines. However, the use of Jentadueto with medicines called sulphonylureas or with insulin may cause low blood sugar ( hypoglycaemia ), which may affect your ability to drive and use machines and work without a secure foothold.

How to use Jentadueto

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Dosage

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

How to take this medicine

  • take one tablet twice a day by mouth according to the dose prescribed by your doctor.
  • in connection with a meal to reduce the risk of stomach upset.

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

Continue to take Jentadueto for as long as your doctor prescribes it so that you can continue to control your blood sugar. Your doctor may prescribe this medicine together with another oral diabetes medicine or insulin. Remember to use all medications as directed by your doctor to achieve the best results for your health.

You should continue with your diet during treatment with Jentadueto and ensure that your carbohydrate intake is evenly distributed throughout the day. If you are overweight, continue your calorie-restricted diet according to the instructions. This medicine alone is unlikely to cause abnormally low blood sugar ( hypoglycaemia ). However, when Jentadueto is used with a sulphonylurea or with insulin, low blood sugar may occur and your doctor may reduce the dose of one of your sulphonylurea or insulin.

If you take more Jentadueto than you should

If you take more Jentadueto tablets than you should, you may get lactic acidosis. The symptoms of lactic acidosis are non-specific such as malaise or nausea, vomiting, stomach pain with muscle cramps, general malaise with severe fatigue, and difficulty breathing. Additional symptoms are decreased body temperature and heart rate. If you get such symptoms, you may need immediate hospitalization, as lactic acidosis can lead to coma. Stop taking this medicine immediately and contact your doctor or 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. If it is soon time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose. 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 is to keep control of your blood sugar.

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

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some symptoms require immediate medical attention

You should stop using Jentadueto and see a doctor immediately if you experience the following symptoms of low blood sugar ( hypoglycaemia ): tremors, sweating, anxiety, blurred vision, tingling in the lips, paleness, mood swings or confusion. Hypoglycaemia (frequency: very common (may affect more than 1 user in 10)) is an identified side effect of the combination of Jentadueto and sulphonylurea and the combination of Jentadueto and insulin.

Jentadueto can cause the very rare (may affect up to 1 user in 10,000), but very serious side effects a lactic acidosis (see section “Warnings and precautions”). If this happens to you, you must stop taking Jentadueto and contact a doctor or nearest hospital immediately as lactic acidosis may lead to coma.

Some patients have developed inflammation of the pancreas ( pancreatitis, rare, may occur in up to 1 in 1,000 users).

STOP taking Jentadueto and contact a doctor immediately if you notice any of the following serious side effects:

  • Severe and persistent pain in the abdomen (stomach) that may radiate to the back, as well as nausea and vomiting, as this may be a sign of inflammation of the pancreas ( pancreatitis ).

Other side effects of Jentadueto include:

Some patients have experienced allergic reactions (frequency: rare) which may be severe, including wheezing and shortness of breath (bronchial hyperreactivity, frequency: uncommon (may affect up to 1 in 100 people)). Some patients have experienced skin rash (frequency: uncommon), hives ( urticaria, frequency: rare) and swelling of the face, lips, tongue and throat which may cause difficulty breathing or swallowing ( angioedema, frequency: rare). If you get any of the symptoms listed above, stop taking Jentadueto and contact your doctor immediately. Your doctor may prescribe a medicine to treat your allergic reaction and another medicine for your diabetes.

Some patients experienced the following side effects while using Jentadueto:

  • Common (may affect up to 1 in 10 people): diarrhea, increase in enzyme and lipase in the blood, nausea
  • Uncommon: inflammation of the nose or throat ( nasopharyngitis ), cough, loss of appetite (decreased appetite), vomiting, increase of an enzyme in the blood (amylase), itching ( pruritus )
  • Rare: blistering of the skin (bullous pemphigoid )

Some patients experienced the following side effects when using Jentadueto with insulin

  • Uncommon: disorders of the liver function, constipation.

Side effects are when using metformin alone, not described for Jentadueto :

  • Very common: stomach pain.
  • Common (may affect up to 1 in 10 people): a metallic taste in the mouth (taste changes).
  • Very rare (may affect up to 1 in 10,000 people): decreased vitamin B12
  • levels, hepatitis (liver disease), skin reactions such as redness of the skin ( erythema ).

How to store 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, jar and carton after EXP. The expiration date is the last day of the specified month.

No special temperature instructions.

Blister: Store in the original package. Moisture sensitive.

Jar: Close the jar tightly. Moisture sensitive.

Do not use this medicine if the package 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 medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

  • The active substances are linagliptin and metformin hydrochloride.
  • Each Jentadueto 2.5 mg / 850 mg film-coated tablet contains 2.5 mg linagliptin and 850 mg metformin hydrochloride.
  • Each Jentadueto 2.5 mg / 1,000 mg film-coated tablet contains 2.5 mg linagliptin and 1,000 mg metformin hydrochloride.
  • Other ingredients are:
  • Tablet core: arginine , copovidone, magnesium stearate, corn 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).

What the medicine looks like and contents of the pack

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

Jentadueto 2.5 mg / 1,000 mg are oval, biconvex, light pink, film-coated tablets (tablets). They are embossed with “D2 / 1000” on one side and embossed with the Boehringer Ingelheim logo on the other.

Jentadueto is available in perforated single-dose blisters with 10 x 1, 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1, 100 x 1 and 120 x 1 film-coated tablets and multipacks containing 120 x 1 (2 cartons of 60 x 1), 180 x 1 (2 cartons of 90 x 1), 180 x 1 (3 cartons of 60 x 1) and 200 x 1 (2 cartons of 100 x 1) ) film-coated tablets.

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Boehringer Ingelheim International GmbH

Binger Strasse 173

D-55216 Ingelheim am Rhein

Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Strasse 173

D-55216 Ingelheim am Rhein

Germany

Boehringer Ingelheim Ellas AE

5th km Paiania – Markopoulo

Koropi Attiki, 194 00

Greece

Dragenopharm Apotheker Püschl GmbH

Göllstraße 1

84529 Tittmoning

Germany

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Muhammad Nadeem

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