How does it work?

Januvia tablets contain the active ingredient sitagliptin, whichis a type of medicine called a dipeptidyl peptidase 4 (DPP-4) inhibitor. It isused to treat people with type 2 or non-insulin dependent diabetes(NIDDM).

Sitagliptin works by increasing the amount of two incretinhormones found in the body, called glucagon-like peptide-1 (GLP-1) andglucose-dependent insulinotropic peptide (GIP). These hormones are normallyproduced naturally by the body in response to food intake. Their function is tohelp control blood sugar (glucose) levels.

GLP-1 and GIP have four main actions that help to control bloodglucose.

Firstly, they stimulate the pancreas to produce insulin inresponse to increasing levels of glucose in the blood. (Insulin is the mainhormone responsible for controlling sugar levels in the blood. It causes cellsin the body to remove sugar from the blood.)

GLP-1 also reduces the production of glucagon. (Glucagon is ahormone that normally increases glucose production by the liver.)

GLP-1 and GIP also reduce the rate at which food passes from thestomach into the intestines, which slows down the absorption of glucose fromthe gut into the bloodstream. Finally, they act on the brain to cause a feelingof fullness that reduces further food intake.

GLP-1 and GIP are normally broken down by an enzyme in the bodycalled dipeptidyl peptidase 4. Sitaglipin works by binding to this enzyme andpreventing it from breaking down the GLP-1 and GIP. This increases the levelsof these hormones in the body and so increases their effect on controllingblood sugar.

Januvia is taken once daily, with or without food.If you forget to take a tablet then it can be taken as soon as you remember.However, two tablets should not be taken on the same day.

What is it used for?

• Type 2 diabetes (non-insulin dependent diabetes).

Januvia can be used on its own to improve blood sugar control in people whose blood sugar is not controlled by changes to their diet and exercise alone and who can't take metformin.

Januvia is also used for people with type 2 diabetes whose bloodsugar is not sufficiently controlled by other antidiabetic medicines. It can be added to treatment with metformin, a sulphonylurea (for example gliclazide) or another type of antidiabeticmedicine known as a thiazolidinedione (for example pioglitazone orrosiglitazone). It can also be used for people who are using insulin.

Warning!

• Hypoglycaemia (low blood glucose) has been commonly reported when this medicine is used in combination with sulphonylurea medicines, eg gliclazide or glibenclamide, or with glitazone medicines, such as rosiglitazone or pioglitazone. 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. You should talk to your doctor about this and make sure you know what to do if you experience these symptoms.
• 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 uncommonly cause dizziness or drowsiness. If affected you should take care driving or operating machinery.

Use with caution in

• People over 75 years of age.

Not to be used in

• Type 1 diabetes.
• Diabetic ketoacidosis.
• This medicine is not recommended for people receiving dialysis or who have moderate to severe kidney disease.
• 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 havepreviously experienced such an allergy.

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

Pregnancy and breastfeeding

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

• The safety of this medicine 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. 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 this medicine passes into breast milk. The manufacturer states that it should not be used by breastfeeding mothers. Seek medical advice from your doctor.

Side effects

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

• Nausea.
• Excess gas in the stomach and intestines (flatulence).
• Low blood glucose levels (hypoglycaemia - when used with a sulphonylurea, glitazone or insulin).
• Headache.
• Swelling of feet or ankles (peripheral oedema).
• Inflammation of the nose and throat, causing a blocked or runny nose and sore throat (nasopharyngitis).
• Upper respiratory tract infection.
• Blocked nose.
• Sore throat.
• Pain in the arms or legs.
• Osteoarthritis.
• Constipation.
• Abdominal pain.
• Loss of appetite.
• Diarrhoea.
• Weight loss.
• Dizziness.
• Drowsiness.
• Severe blistering skin reaction affecting the tissues of the eyes, mouth, throat and genitals (Stevens-Johnson Syndrome).
• Inflammation of the pancreas (pancreatitis). Tell your doctor if you get persistant severe abdominal pain while taking this medicine.

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

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

How can this medicine affect other medicines?

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

Sitagliptin may cause a small increase in the amount of digoxinin the blood when both medicines are being taken together. If you are takingdigoxin, your doctor may want you to have regular blood tests to monitor theamount of digoxin in your blood after you start treatment with thismedicine.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK thatcontain sitagliptin as the only active ingredient.

Janumet contains sitagliptin in combination with metformin.