Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I taking JANUMET XR?
JANUMET XR contains the active ingredients sitagliptin (as phosphate monohydrate)
and metformin (as hydrochloride). JANUMET XR is used to lower blood sugar levels in
adults with type 2 diabetes mellitus.
2. What should I know before I take JANUMET XR?
Do not use if you have ever had an allergic reaction to JANUMET XR or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with JANUMET XR and affect how it works.
4. How do I take JANUMET XR?
Take your JANUMET XR tablets once a day with a meal.
5. What should I know while taking JANUMET XR?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking JANUMET XR.
Call your doctor straight away if you if you become pregnant while taking JANUMET
XR.
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Things you should not do
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Do not stop taking this medicine suddenly.
Do not give JANUMET XR to anyone else, even if they have the same condition as you.
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Drinking alcohol
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Tell your doctor if you drink alcohol.
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Looking after your medicine
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Keep your tablets in the bottle until it is time to take them.
Store JANUMET XR in a cool dry place away from moisture, heat or sunlight.
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6. Are there any side effects?
Serious side effects in particular that need to be noted are:
Allergic reactions including rash, hives, swelling of the face, lips, tongue, and
throat with difficulty in breathing or swallowing.
Severe and persistent stomach pain, often with nausea and vomiting.
Blisters or the breakdown of your skin (erosion).
Low blood sugar when used in combination with a sulfonylurea medicine or with insulin.
Kidney problems (sometimes requiring dialysis).
Active ingredient(s):
Sitagliptin (as phosphate monohydrate)/Metformin (as hydrochloride)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking JANUMET XR. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking JANUMET XR.
Keep this leaflet with the medicine.
You may need to read it again.
Where to find information in this leaflet:
1. Why am I taking JANUMET XR?
JANUMET XR contains two active ingredients: sitagliptin and metformin. Sitagliptin is a member of a class of medicines you take by mouth called DPP-4 inhibitors
(dipeptidyl peptidase-4 inhibitors) and metformin which belongs to a class of medicines
called biguanides. Sitagliptin and metformin work together to control blood sugar
levels in adults with type 2 diabetes mellitus.
JANUMET XR is used to lower blood sugar levels in adults with type 2 diabetes mellitus
along with diet and exercise. JANUMET XR can be used alone or in combination with
certain other medicines that lower blood sugar along with a recommended diet and exercise
program.
2. What should I know before I take JANUMET XR?
Warnings
Do not take JANUMET XR if:
you are allergic to sitagliptin or metformin, or any of the ingredients listed at
the end of this leaflet.
Always check the ingredients to make sure you can take this medicine.
Check with your doctor if you:
have or have had type 1 diabetes mellitus or
have or have had increased ketones in the blood or urine (diabetic ketoacidosis).
have or have had severe kidney problems
you have any liver or heart problems including congestive heart failure, or any past
or present medical problems.
drink excessive alcohol (all the time or short term "binge" drinking).
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. Talk to your doctor about when to stop JANUMET XR
and when to start again.
take any medicines for any other condition
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant. JANUMET XR
is not recommended for use during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed. You should not
take JANUMET XR while breastfeeding or if planning to breastfeed.
Children
Children and adolescents below 18 years should not use this medicine. JANUMET XR is
not effective in children and adolescents 10 to 17 years of age with type 2 diabetes.
JANUMET XR has not been studied in children younger than 10 years of age.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
JANUMET XR may affect how well other drugs work and some drugs can affect how well
JANUMET XR works.
Medicines that may cause low blood sugar when used in combination with JANUMET XR
include:
Sulfonylureas
Insulin
A reduction in the amount of the sulfonylurea or insulin may be required.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect JANUMET XR.
4. How do I take JANUMET XR?
How much to take
Your doctor will tell you how many JANUMET XR tablets to take.
Take your JANUMET XR tablets once a day with a meal to lower your chance of an upset
stomach.
Swallow JANUMET XR tablets whole with a glass of water. Do not chew, cut, or crush
the tablets. Tell your doctor if you cannot swallow JANUMET XR whole.
When to take JANUMET XR
Take your JANUMET XR at about the same time each day.
You may see something that looks like the JANUMET XR tablet in your stool (bowel movement).
If you see tablets in your stool several times, talk to your doctor. Do not stop taking
JANUMET XR without talking to your doctor.
Continue to take JANUMET XR as long as your doctor prescribes it so you can continue
to help control your blood sugar.
Make sure you keep enough JANUMET XR to last over weekends and holidays.
If you forget to take JANUMET XR
JANUMET XR should be taken regularly at the same time each day. If you miss your dose
at the usual time, take it as soon as you remember.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you take too much JANUMET XR
If you think that you have taken too much JANUMET XR, you may need urgent medical
attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
If you take too much JANUMET XR, you may feel sick, vomit, have trouble breathing
and have stomach pain or diarrhoea. These may be the early signs of a serious condition
called lactic acidosis.
If you experience any of these symptoms, immediately get medical help.
5. What should I know while taking JANUMET XR?
Things you should do
Call your doctor straight away if you:
Become pregnant while taking JANUMET XR, or
Tell your doctor if you:
Become ill
Become dehydrated
Are injured
Have a fever
Have a serious infection
Plan to have surgery
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 XR with insulin.
Low blood sugar or high blood sugar
Make sure that you, your friends, family and work colleagues can recognise the symptoms
of low blood sugar and high blood sugar and know how to treat them.
Low blood sugar
Signs of low blood sugar may include:
weakness, trembling or shaking
sweating
light-headedness, dizziness, headache or lack of concentration
irritability, tearfulness or crying
hunger
numbness around the lips and tongue.
If not treated quickly, these symptoms may progress to:
loss of co-ordination
slurred speech
confusion
fits or loss of consciousness
At the first signs of low blood sugar, you need to raise your blood glucose quickly.
You can do this by taking one of the following:
5 -7 jelly beans
3 teaspoons of sugar or honey
half a can of non-diet soft drink
2-3 concentrated glucose tablets
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.
High blood sugar
If you notice any signs of high blood sugar, contact your doctor immediately.
The risk of high blood sugar is increased with:
uncontrolled diabetes
illness, infection or stress
taking less JANUMET XR than prescribed
taking certain other medicines
too little exercise
eating more carbohydrates than normal.
Your blood sugar 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 XR with insulin.
Stop taking JANUMET XR if you have symptoms of lactic acidosis, such as feeling very
weak and tired, unusual (not normal) muscle pain, trouble breathing, stomach pain
with nausea and vomiting, or diarrhoea, feeling cold, especially in your arms and
legs, feeling dizzy or lightheaded, a slow or irregular heart beat or your medical
condition suddenly changes.
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 XR.
Make sure you check your blood sugar levels regularly.
Visit your doctor for regular checks of your eyes, feet, kidneys, heart, circulation,
blood and blood pressure.
See you doctor once a year for a check on your body's level of vitamin B12.
If you are about to be started on any new medicine, tell your doctor and pharmacist
that you are taking JANUMET XR.
Remind any doctor, dentist or pharmacist you visit that you are taking JANUMET XR.
Things you should not do
Do not stop taking this medicine or change your dose without checking with your doctor.
Do not skip meals while taking JANUMET XR.
Do not give JANUMET XR to anyone else, even if they have the same condition as you.
Driving or using machines
There is no information to suggest that JANUMET XR affects your ability to drive a
car or operate machinery.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Keep your tablets in the bottle until it is time to take them.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What JANUMET XR contains
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Active ingredient
(main ingredient)
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Sitagliptin 50 or 100 mg and metformin 500 or 1000 mg per tablet
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Other ingredients
(inactive ingredients)
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Povidone
Hypromellose
Silica - colloidal anhydrous
Sodium stearylfumarate
Propyl gallate
Macrogol 3350
Kaolin
JANUMET XR 50/500 also contains
Microcrystalline cellulose
Hydroxypropylcellulose
Titanium dioxide
Indigo Carmine
Carnauba wax
JANUMET XR 50 mg/1000 mg also contains iron oxide yellow.
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Do not take this medicine if you are allergic to any of these ingredients.
What JANUMET XR looks like
JANUMET XR 50mg/500 mg is a light blue, bi-convex oval, film coated tablet, with "78"
on one side and plain on the other (AUST R 205316). * not currently marketed.
JANUMET XR 50 mg/1000 mg is a light green, bi-convex oval, film coated tablet, with
"80" on one side and plain on the other (AUST R 205317).
JANUMET XR 100 mg/1000 mg is a blue, bi-convex oval, film coated tablet, with "81"
on one side and plain on the other (AUST R 205318).
Who distributes JANUMET XR
Merck Sharp & Dohme (Australia) Pty Limited
Level 1, Building A, 26 Talavera Road
Macquarie Park NSW 2113
This leaflet was prepared in October 2021.
WPPI-MK0431A-T-042021
RCN000013428
Copyright © (2021) Merck & Co., Inc., Kenilworth, NJ, USA, and its affiliates. All
rights reserved.