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The eMC  

Last Updated 18 Nov 2014

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Januvia 100mg tablets

Januvia (Jan-oo-vee-ah) is a medicine which is used in diabetes mellitus. Januvia contains sitagliptin. It is supplied by Merck Sharp & Dohme Limited.

The information in this Medicine Guide for Januvia varies according to the condition being treated and the particular preparation used.

There are 3 preparations of Januvia available. If Januvia 100mg tablets is not the preparation you are looking for, please select from the drop down list below.

Select your preparation (type) of Januvia

Januvia 100mg tablets

Information specific to Januvia 100mg tablets when used in diabetes mellitus

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Your medicine

Diabetes leads to problems controlling blood sugar levels. Januvia can help certain people with diabetes to keep their blood sugar level under control by encouraging the body to use blood sugar more effectively. Januvia may be used on its own or in combination with other medicines which also help to control blood-sugar levels.

It is very important that your blood sugar level is well controlled. Blood sugar levels which are too high or too low can be dangerous. Your prescriber or a member of your diabetes team will be able to give you information on how to recognise the warning signs of high and low blood sugar levels. They will also be able to tell you what to do if either of these occurs.

Warning signs can vary from person to person. If the usual warning signs of poorly controlled blood sugar levels change or disappear, you should contact your prescriber or a member of your diabetes team.

The amount of Januvia you need to control your blood sugar levels will be worked out by your prescriber or your diabetes team. They may also advise you to measure your blood sugar regularly – they will show you how to do this. If you are having problems controlling or measuring your blood sugar, you should contact your prescriber or a member of your diabetes team.

Do not share your medicine with other people. It may not be suitable for them and may harm them.

The pharmacy label on your medicine tells you how much medicine you should take. It also tells you how often you should take your medicine. This is the dose that you and your prescriber have agreed you should take. You should not change the dose of your medicine unless you are told to do so by your prescriber.

If you feel that the medicine is making you unwell or you do not think it is working, then talk to your prescriber.

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When to take your medicine

Some medicines work best if they are taken at a specific time of day. Getting the most from your medicine can also be affected by what you eat, when you eat and the times at which you take other medicines. Make sure you follow any specific instructions given to you by your prescriber or that are in the Patient Information Leaflet that comes with this medicine.

In the case of Januvia:

  • if you miss a dose of Januvia take it as soon as you remember. If you don't remember until it is time for your next dose, skip the missed dose and carry on as usual. You should not take a double dose of Januvia on the same day
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How to take your medicine

Some medicines have specific instructions about how to take them. This is because they work better when taken correctly. These instructions can include getting the right dose and special instructions for preparing the medicine.

In the case of Januvia:

  • this medicine can be taken with or without food

If you are having problems taking this form of Januvia, you should talk to your prescriber or pharmacist. They may be able to give you advice on other ways to take your medicine or other preparations that are easier for you to take.

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Taking too much of your medicine

Taking extra doses of some medicines can be harmful. In some cases even one extra dose can cause you problems. If you take extra doses of your medicine, you must get medical advice immediately. You may need a test to assess the effect of taking extra doses. This is because the effects of taking too much medicine are very complex so it is very important that you seek medical advice.

Contact your prescriber, pharmacist, specialist clinic or call 111 for advice.

Make sure you take all of your medicine containers with you if you are advised to go to hospital.

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Stopping your medicine

Suddenly stopping your medicine may cause very high blood sugar levels. This can be very dangerous. This is why you must speak to your prescriber or a member of your diabetes team if you are having any problems taking your medicine.

If you are not having any problems taking this medicine, do not stop taking it unless advised to do so by your prescriber or a member of your diabetes team.

If you are in any doubt, contact your prescriber, pharmacist, specialist clinic or call 111.

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Looking after your medicine

The instructions on how you should keep your medicine are on the pharmacy label. You should keep your medicine in the original container. This will help to keep your medicine in the best condition and also allow you to check the instructions. Do not take the medicine if the packaging appears to have been tampered with or if the medicine shows any signs of damage. Make sure that the medicine is out of the sight and reach of children.

In the case of Januvia:

  • there are no special instructions on how to look after your medicine

You must not take the medicine after the expiry date shown on the packaging. If you have any unused medicine, return it to your pharmacist who will dispose of it safely.

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Whether this medicine is suitable for you

Januvia is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing this medicine knows your full medical history.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

Furthermore the prescriber may only prescribe this medicine with special care or may not prescribe it at all for someone who is under the age of 18 years.

As part of the process of assessing suitability to take this medicine a prescriber may also arrange tests:

  • to determine whether or not the medicine is suitable and whether it must be prescribed with extra care
  • to check that this medicine is not having any undesired effects
  • to confirm that this is the right dose

Over time it is possible that Januvia can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Januvia has become unsuitable, it is important that the prescriber is contacted immediately.

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Side-effects

A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.

Once a medicine has been licensed, information on the medicine's effects, both intended and unintended, is continuously recorded and updated.

Some side-effects may be serious while others may only be a mild inconvenience.

Everyone's reaction to a medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, or whether you will have any side-effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.

As part of treatment, this medicine may be used in combination with other medicines. There may be more information about the side-effects caused by the combination of this medicine with other medicines in the Patient Information Leaflet or Summary of Product Characteristics for Januvia.

Common: More than 1 in 100 people who take Januvia:

  • decreased blood sugar levels
  • headaches
  • inflammation of the nose and throat
  • joint problems
  • painful extremities
  • respiratory tract infection

Uncommon: More than 1 in 1000 people who take Januvia:

The frequency of these side-effects is unknown:

  • back pain
  • hypersensitivity reactions including anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome - seek medical advice if you develop any hypersensitivity reactions
  • joint pain
  • kidney problems
  • lung problems
  • muscle pain or tenderness
  • pancreatitis - this may be fatal. Seek medical advice if you have stomach pain
  • skin rash or rashes
  • urticaria
  • vasculitis
  • vomiting

The reported frequency of these side-effects varies depending on the other medicines that are taken with Januvia, so the frequency has not been stated. :

If you feel unwell or if you have concerns about a side-effect, you will need to seek advice. If you feel very ill, get medical help straight away. Contact your prescriber, pharmacist, nurse or call 111.

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Taking other medicines

If you are taking more than one medicine they may interact with each other. At times your prescriber may decide to use medicines that interact, in other cases this may not be appropriate.

The decision to use medicines that interact depends on your specific circumstances. Your prescriber may decide to use medicines that interact, if it is believed that the benefits of taking the medicines together outweigh the risks. In such cases, it may be necessary to alter your dose or monitor you more closely.

Tell your prescriber the names of all the medicines that you are taking so that they can consider all possible interactions. This includes all the medicines which have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist. You must also tell your prescriber about medicines which you have bought over the counter without prescriptions.

The following medicines may interact with Januvia:

The following types of medicine may interact with Januvia:

If you are taking Januvia and one of the above medicines or types of medicines, make sure your prescriber knows about it.

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Complementary preparations and vitamins

Medicines can interact with complementary preparations and vitamins. In general, there is not much information available about interactions between medicines and complementary preparations or vitamins.

If you are planning to take or are already taking any complementary preparations and vitamins you should ask your prescriber whether there are any known interactions with Januvia.

Your prescriber can advise whether it is appropriate for you to take combinations that are known to interact. They can also discuss with you the possible effect that the complementary preparations and vitamins may have on your condition.

If you experience any unusual effects while taking this medicine in combination with complementary preparations and vitamins, you should tell your prescriber.

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Driving and operating machinery

When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.

In the case of Januvia:

  • this medicine could affect your ability to drive or operate machinery
  • your ability to drive or operate machinery may be affected if your blood sugar levels are low

You should see how this medicine affects you before you judge whether you are safe to drive or operate machinery. If you are in any doubt about whether you should drive or operate machinery, talk to your prescriber.

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Diet

Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.

In the case of Januvia:

  • Januvia is not known to interact with food. You should continue on the diet advised by your dietician or prescriber

For more advice speak to your prescriber, nutritionist or pharmacist.

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Alcohol

Alcohol can interact with certain medicines.

In the case of Januvia:

  • there are no known interactions between alcohol and Januvia
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Family planning and pregnancy

Most medicines, in some way, can affect the development of a baby in the womb. The effect on the baby differs between medicines and also depends on the stage of pregnancy that you have reached when you take the medicine.

In the case of Januvia:

  • do not take this medicine during pregnancy

People with diabetes may start to have insulin instead of Januvia to control their blood sugar during pregnancy. If you are taking Januvia and are planning to become pregnant, become pregnant or think that you are pregnant, talk to a member of your diabetes team. For more information on managing your diet and your diabetes during your pregnancy, talk to your prescriber or a member of your diabetes or antenatal team.

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Breast-feeding

Certain medicines can pass into breast milk and may reach your baby through breast-feeding.

In the case of Januvia:

  • women who are breast-feeding must not take this medicine

Before you have your baby you should discuss breast-feeding with your doctor or midwife. If you wish to breast-feed you should discuss with your prescriber whether there are any other medicines you could take which would also allow you to breast-feed. You should not stop this medicine without taking advice from your doctor.

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Ingredients of your medicine

Medicines contain active ingredients. They may also contain other, additional ingredients that help ensure the stability, safety and effectiveness of the medicine. They are also added to improve the medicine's taste and appearance and to make it easier to take. Some may be used to prolong the life of the medicine.

You should check that you are able to take the ingredients in your medicine, especially if you have any allergies.

Januvia contains:

  • anhydrous calcium hydrogen phosphate (E341)
  • croscarmellose sodium (E468)
  • macrogol 3350
  • magnesium stearate (E470b)
  • microcrystalline cellulose E460
  • polyvinyl alcohol
  • red iron oxide (E172)
  • sodium stearyl fumarate
  • talc (E553b)
  • titanium dioxide (E171)
  • yellow iron oxide (E172)

If you are not able to take any of the ingredients in your medicine, talk to your prescriber or pharmacist to see if they can suggest an alternative medicine. If you have reacted badly to Januvia before, do not take Januvia. Talk to your prescriber, pharmacist or nurse as soon as possible.

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Januvia, Version 17, last updated 18 Nov 2014