JANUMET helps to lower blood sugar levels in patients with type 2 diabetes mellitus along with diet and exercise. JANUMET can be used alone, or in combination with sulfonylurea medicines such as glimepiride, gliclazide and glibenclamide.
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 resulting in high blood sugar (hyperglycaemia). 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 foot amputation.
High blood sugar can be lowered by diet and exercise and by certain medicines.
JANUMET contains two active ingredients, sitagliptin (as phosphate monohydrate) and metformin hydrochloride. Sitagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), and metformin belongs to a class of medicines called biguanides. Sitagliptin and metformin work together to control blood sugar levels in patients with type 2 diabetes mellitus.
Do not take JANUMET if:
If you are not sure whether you should start taking JANUMET, 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 or liver problems or any past or present medical problems.
5. you have or have had an allergic reaction to sitagliptin (JANUVIA), metformin, or JANUMET, or you have any allergies to any other medicines or any other substances such as foods, preservatives or dyes.
6. you drink excessive alcohol (all the time or short term "binge" drinking).
7. you are going to get or receive an injection of dye or contrast agent for an X-ray procedure, or if you plan to have surgery.
If you have not told your doctor about any of the above, tell him/her before you take any JANUMET.
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.
JANUMET may affect how well other drugs work and some drugs can affect how well JANUMET works.
Take JANUMET only when prescribed by your doctor.
Your doctor will tell you how many JANUMET tablets to take and how often you should take them.
Take JANUMET with meals to lower your chance of an upset stomach.
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.
Continue to take JANUMET 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 JANUMET.
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 JANUMET 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 JANUMET. Do this even if there are no signs of discomfort or poisoning.
If you become pregnant while taking JANUMET, tell your doctor immediately.
If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking JANUMET.
Make sure that you, your friends, family and work colleagues can recognise the symptoms of hypoglycaemia and hyperglycaemia and know how to treat them.
JANUMET does not normally cause hypoglycaemia, although you may experience it if you take certain other medicines.
Signs of hypoglycaemia may include:
If not treated quickly, these symptoms may progress to:
At the first signs of hypoglycaemia, you need to raise your blood glucose quickly.
You can do this by taking one of the following:
Unless you are within 10 to 15 minutes of your next meal or snack, follow up with extra carbohydrates such as plain biscuits, fruit or milk.
Taking this extra carbohydrate will prevent a second drop in your blood glucose level.
If you notice the return of any signs of hyperglycaemia, contact your doctor immediately.
The risk of hyperglycaemia is increased in the following situations:
Tell your doctor if you:
Your blood glucose may become difficult to control at these times. You may also be at greater risk of developing a serious condition called lactic acidosis. During these times, your doctor may temporarily replace JANUMET with insulin.
Do not give JANUMET to anyone else, even if they have the same condition as you.
Do not skip meals while taking JANUMET.
Do not stop taking JANUMET or change your dose without checking with your doctor.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking JANUMET.
Like all prescription medicines, JANUMET may cause side effects. In studies, side effects were usually mild and did not cause patients to stop taking JANUMET.
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:
Tell your doctor immediately or go to the accident and emergency at your nearest hospital if you notice any of the following:
IN RARE CASES, METFORMIN, ONE OF THE MEDICINES IN JANUMET, CAN CAUSE A SERIOUS SIDE EFFECT CALLED LACTIC ACIDOSIS. LACTIC ACIDOSIS IS A MEDICAL EMERGENCY THAT CAN CAUSE DEATH AND MUST BE TREATED IN THE HOSPITAL. LACTIC ACIDOSIS IS CAUSED BY A BUILD-UP OF LACTIC ACID IN YOUR BLOOD.
STOP TAKING JANUMET IF YOU GET ANY OF THE FOLLOWING SYMPTOMS OF LACTIC ACIDOSIS AND SEE YOUR DOCTOR IMMEDIATELY:
Additional side effects have been reported in general use with JANUMET or sitagliptin, one of the medicines in JANUMET. These side effects have been reported when JANUMET or sitagliptin have been used by themselves 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 JANUMET 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 JANUMET or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
JANUMET comes as three strengths of tablets:
A box of JANUMET contains 56 tablets. JANUMET tablets may also be supplied in packs of 14 tablets to start treatment.
Ingredients of film-coating:
JANUMET does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.