JANUVIA is used to lower blood sugar levels in patients with type 2 diabetes mellitus alone or in combination with certain other medicines (metformin, medicines such as rosiglitazone and pioglitazone, or a sulfonylurea medicine such as glimepiride, gliclazide and glibenclamide), when diet plus exercise or the other medicine(s) do not provide adequate blood sugar level control.
Type 2 diabetes mellitus
Type 2 diabetes mellitus is a condition in which your body does not make enough insulin and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems.
The main goal of treating diabetes is to lower your blood sugar to a normal level. Lowering and controlling blood sugar may help prevent or delay complications of diabetes, such as heart disease, kidney disease, blindness and amputation.
High blood sugar can be lowered by diet and exercise and by certain medicines.
JANUVIA is a member of a class of medicines you take by mouth called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in patients with type 2 diabetes mellitus. Type 2 diabetes mellitus is also called non-insulin-dependent diabetes mellitus, or NIDDM.
Do not take JANUVIA if:
If you are not sure whether you should start taking JANUVIA, talk to your doctor.
Tell your doctor if:
1. you are pregnant or intend to become pregnant.
2. you are breastfeeding or plan to breastfeed.
3. you have or have had type 1 diabetes mellitus or a condition called diabetic ketoacidosis (increased ketones in the blood or urine).
4. you have any kidney problems or any past or present medical problems.
5. you have an allergic reaction to JANUVIA or you have any allergies to any other medicines or other substances such as foods, preservatives or dyes.
If you have not told your doctor about any of the above, tell him/her before you take any JANUVIA.
Tell your doctor if you are taking any other medicines, including medicines and herbal supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
JANUVIA can be taken with most other medicines.
Take JANUVIA only when prescribed by your doctor.
The recommended dose is to take:
If you have kidney problems, your doctor may prescribe lower doses, and monitor your kidney function.
Your doctor may prescribe JANUVIA on its own, or with certain other medicines that lower blood sugar.
Follow all directions given to you by your doctor and pharmacist carefully.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.
Take your JANUVIA at about the same time each day.
Taking your tablet(s) at the same time each day will have the best effect. It will also help you remember when to take the tablets.
Continue to take JANUVIA as long as your doctor prescribes it so you can continue to help control your blood sugar.
Diet and exercise can help your body use its blood sugar better. It is important to stay on your doctor's recommended diet, exercise and weight loss program while taking JANUVIA.
If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule.
If you are not sure whether to skip the dose, talk to your doctor or pharmacist.
Do not take a double dose of JANUVIA to make up for the dose that you missed.
If you have trouble remembering to take your tablet, ask your pharmacist for some hints.
Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26), or go to accident and emergency at your nearest hospital, if you think that you or anyone else may have taken too much JANUVIA. Do this even if there are no signs of discomfort or poisoning.
If you become pregnant while taking JANUVIA, tell your doctor immediately.
If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking JANUVIA.
Do not give JANUVIA to anyone else, even if they have the same condition as you.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking JANUVIA.
Like all prescription medicines, JANUVIA may cause side effects. In studies, side effects usually were mild and did not cause patients to stop taking JANUVIA.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice or have any of the following and they worry you:
JANUVIA may occasionally cause stomach discomfort and diarrhoea.
Tell your doctor immediately if you notice any of the following:
Tell your doctor immediately or go to the accident and emergency at your nearest hospital if you notice any of the following:
Additional side effects have been reported in general use with JANUVIA, by itself and/or with other diabetes medicines:
Tell your doctor if you notice any other effects.
Other side effects not listed above may also occur in some patients.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
Keep your tablets in the blister pack until it is time to take them.
If you take the tablets out of the blister pack they may not keep well.
Keep JANUVIA in a cool dry place where the temperature stays below 30°C. Do not store it or any other medicine in the bathroom or near a sink.
Do not leave it in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor tells you to stop taking JANUVIA or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
JANUVIA comes as three strengths of tablets:
A box of JANUVIA contains 28 tablets. JANUVIA 100 mg tablets may also be supplied in packs of 7 tablets to start treatment.
Sitagliptin 25, 50 or 100 mg per tablet (as free base)
Ingredients of film-coating:
JANUVIA does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.