Jentadueto (Linagliptin, metformin)

How does it work?

Jentadueto tablets contain two active ingredients, linagliptin and metformin. These are both medicines used to help control blood sugar levels in people with type 2 diabetes.

People with diabetes mellitus have a deficiency or absence of a hormone produced by the pancreas called insulin. Insulin is the main hormone responsible for the control of sugar (glucose) in the blood. In type 2 diabetes the pancreas does not produce sufficient insulin, and the cells of the body are resistant to the low levels of insulin circulating in the blood. Insulin would normally make the cells remove sugar from the blood; hence in type 2 diabetes blood sugar levels can rise too high.

Metformin is a type of antidiabetic medicine known as a biguanide. It works in a number of ways to decrease the amount of sugar in the blood. Firstly, it reduces the amount of sugar produced by cells in the liver. Secondly, it increases the sensitivity of muscle cells to insulin. This enables these cells to remove sugar from the blood more effectively. Finally, it also delays absorption of sugar from the intestines into the bloodstream after eating.

Linagliptin is a type of antidiabetic medicine known as a dipeptidyl peptidase-4 (DPP-4) inhibitor. It helps to reduce blood sugar levels by preventing the breakdown of two incretin hormones, called glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP). These hormones are normally produced naturally by the body in response to food intake. They stimulate the pancreas to produce insulin in response to increasing levels of glucose in the blood, and they also reduce the production of glucagon, which is a hormone that normally increases glucose production by the liver. These actions help control blood sugar levels. By stopping the breakdown of these hormones in the body linagliptin increases their effect on controlling blood sugar.

This combination of medicines helps control blood sugar levels both directly after meals and between meals.

What is it used for?

  • Type 2 diabetes (non-insulin dependent diabetes) in adults aged 18 years and over.

Jentadueto tablets are licensed for use in people with type 2 diabetes whose blood sugar is not controlled by the maximum tolerated dose of metformin alone or who are already taking metformin and linagliptin as separate tablets.

They are also licensed for use in combination with a sulphonylurea medicine (eg gliclazide) when one of these combined with metformin has not controlled blood sugar well enough.

How do I take it?

  • One Jentadueto tablet should be taken twice a day (with breakfast and evening meal). The tablet should be taken with food.
  • If you forget to take your Jentadueto tablet at your usual time, take it with food as soon as you remember. However, if it is nearly time for your next dose, leave out the forgotten dose. Do not take a double dose to make up for a missed dose.

Warning!

  • It is important that you continue to follow the diet and exercise advice given to you by your doctor or nurse while you are using this medicine. This medicine only helps to control your blood sugar levels and should not be used as a substitute for eating healthily and taking regular exercise.
  • Hypoglycaemia (low blood glucose) has been very commonly reported when this medicine is used in combination with sulphonylurea medicines, eg glibenclamide. Symptoms of hypoglycaemia usually occur suddenly and may include cold sweats, cool pale skin, tremor, anxious feeling, unusual tiredness or weakness, confusion, difficulty in concentration, excessive hunger, temporary vision changes, headache, nausea and palpitations. If you are taking a sulphonylurea with this medicine you should talk to your doctor or diabetes specialist about this and make sure you know what to do if you experience these symptoms. Your doctor may need to adjust your doses.
  • Your ability to concentrate or react may be reduced if you have low blood sugar, and this can cause problems driving or operating machinery. You should take precautions to avoid low blood sugar when driving - discuss this with your doctor. This medicine may also cause dizziness or fatigue. If affected you should take care driving or operating machinery.
  • Your doctor may want you to check your blood sugar level from time to time while you are taking this medicine. Make sure you discuss how to do this and how often with your GP, pharmacist or diabetes specialist.
  • You should avoid drinking alcohol while you are taking this medicine, as it can increase the risk of low blood sugar (hypoglycaemia) and lactic acidosis (see below).
  • Metformin can cause a rare but serious condition called lactic acidosis, which is an excess of lactic acid in the blood. It is more likely to occur in people with decreased kidney function. Drinking excessive amounts of alcohol while taking this medicine, particularly on an empty stomach or if you have liver problems, can also increase the risk of lactic acidosis. Your doctor will monitor you for this side effect, but symptoms that might indicate its development include rapid and/or deep breathing and non-specific symptoms such as feeling weak, sick or generally unwell, vomiting, abdominal pain, or unusual muscle pains or discomfort. You should stop taking this medicine and consult your doctor if you experience any of these.
  • Your kidney function should be monitored regularly while you are taking this medicine. Your doctor will usually want to check your kidney function once or twice a year, or more frequently if you are elderly or have any existing kidney problems.
  • A few cases of inflammation of the pancreas (acute pancreatitis) have been reported in people taking linagliptin and other medicines of this type. Symptoms of pancreatitis include unexplained, persistent, severe abdominal pain, sometimes spreading to the back. You should tell your doctor if you experience these symptoms while taking this medicine, so they can be investigated.
  • Your doctor will ask you to stop taking this medicine temporarily if you are going to have a certain type of X-ray involving an injection of iodinated dye (contrast agent). Tell your doctor that you are taking this medicine if you are due to have this type of X-ray. You should not start taking this medicine again until 48 hours after the X-ray, and only after your kidney function has been tested and found to be normal.
  • Consult your doctor about your diabetes treatment if you are due to have surgery under a general anaesthetic. In these situations blood sugar is normally controlled by insulin, so your doctor may ask you to stop taking this medicine 48 hours before surgery.

Use with caution in

  • People over 80 years of age.

Not to be used in

  • People with type 1 diabetes.
  • Diabetic ketoacidosis.
  • Diabetic pre-coma (due to ketoacidosis in severe and inadequately treated diabetes).
  • People with decreased kidney function or kidney failure.
  • People with decreased liver function.
  • Dehydration.
  • People with severe infections or blood poisoning (sepsis).
  • People with reduced blood flow to vital internal organs (shock).
  • People with conditions that cause breathing to be ineffective, ie to not effectively oxygenate the blood or remove carbon dioxide from the lungs (respiratory failure).
  • Acute heart failure.
  • People who have recently had a heart attack.
  • Alcohol poisoning.
  • Alcoholism.
  • Pregnancy.
  • Breastfeeding.
  • This medicine is not recommended for children and adolescents under 18 years of age because it has not been studied in this age group.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

  • The safety of linagliptin for use during pregnancy has not been established. It should not be used during pregnancy. Diabetes mellitus is usually controlled using insulin during pregnancy, because this provides a more stable control of blood sugar. Metformin many also sometimes be used. However, as Jentadueto contains a combination of metformin and linagliptin it should not be used during pregnancy. If you get pregnant while taking this medicine, or are planning a pregnancy, you should seek medical advice from your doctor.
  • It is not known if linagliptin passes into breast milk. Metformin does pass into breast milk. The manufacturer states that Jentadueto should not be used by breastfeeding mothers. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Very common (affect more than 1 in 10 people)

  • Low blood sugar levels (when used with a sulphonylurea such as glibenclamide).

Uncommon (affect between 1 in 100 and 1 in 1000 people)

  • Cough.
  • Inflammation of the nose and throat, causing a blocked or runny nose and sore throat (nasopharyngitis).
  • Allergic reactions.
  • Disturbances of the gut such as nausea, vomiting, diarrhoea.
  • Decreased appetite.
  • Itching.
  • Raised levels of the enzyme amylase in the blood.

Unknown frequency

  • Inflammation of the pancreas (pancreatitis). See the warning section above.
  • Other side effects have been reported with both metformin and linagliptin used on their own. Although these were not reported in the clinical trials of Jentadueto, these side effects are also possible with Jentadueto. You can read more about the possible side effects of the individual ingredients in our factsheets on Trajenta (linagliptin) and Glucophage (metformin).

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

When Jentadueto is taken with other antidiabetic medicines, such as sulphonylureas (eg gliclazide, glibenclamide), there will be an enhanced blood sugar lowering effect. Your blood sugar level may need to be monitored if you are taking Jentadueto in combination with other antidiabetic medicines. Ask your doctor for advice.

Cimetidine and rilpivirine may increase the blood level of metformin, which could increase the risk of its side effects. Your doctor may need to reduce your dose of this medicine if you regularly take one of these medicines as well.

Medicines that increase blood sugar levels as a side effect may make this medicine less effective at controlling blood sugar. Medicines that can increase blood sugar levels include the following:

  • antipsychotic medicines, such as chlorpromazine, olanzapine, risperidone
  • beta-2-agonists, such as salbutamol, salmeterol
  • corticosteroids, such as prednisolone
  • glucosamine
  • oestrogens and progestogens, such as those found in oral contraceptives
  • thiazide diuretics, such as bendroflumethiazide.

Your blood sugar should be monitored more frequently if you start or stop treatment with any of these while taking this medicine, and if necessary your doctor may alter your dose of this medicine.

Low blood sugar levels (hypoglycaemia) may occur, sometimes unpredictably, if disopyramide or ACE inhibitors such as captopril are taken with this medicine. Your doctor may want you to temporarily check your blood sugar more frequently if you start treatment with one of these while taking this medicine.

MAOI antidepressants, such as phenelzine, tranylcypromine or isocarboxazid, may enhance the blood sugar lowering effect of this medicine. Your doctor may ask you to monitor your blood sugar more frequently if you are prescribed an MAOI antidepressant with this medicine.

A drop in the number of blood cells called platelets in the blood has been seen in some people taking the antihistamine ketotifen in combination with metformin. The manufacturer of ketotifen recommends that it should be avoided in people taking metformin.

The following medicines may increase the breakdown of linagliptin and so could reduce its effect at controlling blood sugar:

  • carbamazepine
  • phenobarbital
  • phenytoin
  • rifampicin.

If you take any of these in combination with linagliptin, your doctor may want to monitor your blood sugar level more frequently and your dose may need to be adjusted.

Other medicines containing the same active ingredients

There are currently no other medicines available in the UK that contain both linagliptin and metformin as the active ingredients, however these medicines are available separately.

Trajenta contains just linagliptin.

Glucophage contains just metformin, and metformin is also available on its own without a brand name, ie as the generic medicine.