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 SITAGLIPTIN/METFORMIN MYLAN?
SITAGLIPTIN/METFORMIN MYLAN contains the active ingredient Sitagliptin (as hydrochloride
monohydrate) and metformin (as hydrochloride). SITAGLIPTIN/METFORMIN MYLAN is used
to lower blood sugar levels in adults with diabetes mellitus.
2. What should I know before I take SITAGLIPTIN/METFORMIN MYLAN?
Do not use if you have ever had an allergic reaction to SITAGLIPTIN/METFORMIN MYLAN
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 SITAGLIPTIN/METFORMIN MYLAN and affect how it works.
4. How do I take SITAGLIPTIN/METFORMIN MYLAN?
Your doctor will tell you how many SITAGLIPTIN/METFORMIN MYLAN tablets to take and
how often to take them.
Take SITAGLIPTIN/METFORMIN MYLAN with meals to lower your chance of an upset stomach.
5. What should I know while taking SITAGLIPTIN/METFORMIN MYLAN?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using SITAGLIPTIN/METFORMIN
MYLAN.
Call your doctor straight away if you become pregnant while taking SITAGLIPTIN/METFORMIN
MYLAN.
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Things you should not do
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Do not stop taking this medicine suddenly.
Do not give SITAGLIPTIN/METFORMIN MYLAN to anyone else, even if they have the same
condition as you.
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Driving or using machines
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There is no information to suggest that SITAGLIPTIN/METFORMIN MYLAN affects your ability
to drive a car or operate machinery.
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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 blister pack until it is time to take them.
Store it 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 hydrochloride monohydrate) and metformin (as hydrochloride)]
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking SITAGLIPTIN/METFORMIN MYLAN.
You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using SITAGLIPTIN/METFORMIN MYLAN.
Where to find information in this leaflet:
1. Why am I taking SITAGLIPTIN/ METFORMIN MYLAN?
SITAGLIPTIN/METFORMIN MYLAN 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.
SITAGLIPTIN/METFORMIN MYLAN is used to lower blood sugar levels in adults with type
2 diabetes mellitus. SITAGLIPTIN/METFORMIN MYLAN can be taken 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 SITAGLIPTIN/METFORMIN MYLAN?
Warnings
Do not take SITAGLIPTIN/METFORMIN MYLAN 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
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 SITAGLIPTIN/METFORMIN
MYLAN 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. SITAGLIPTIN/METFORMIN
MYLAN is not recommended for use during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed. You should not
take SITAGLIPTIN/METFORMIN MYLAN while breastfeeding or if planning to breastfeed.
Children
Children and adolescents below 18 years should not use this medicine. SITAGLIPTIN/METFORMIN
MYLAN is not effective in children and adolescents 10 to 17 years of age with type
2 diabetes. SITAGLIPTIN/METFORMIN MYLAN 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.
Medicines that may cause low blood sugar when used in combination with SITAGLIPTIN/METFORMIN
MYLAN include:
Sulfonylureas
Insulin
A reduction in the amount of the sulfonylurea or insulin may be required.
Some medicines may interfere with SITAGLIPTIN/ METFORMIN MYLAN and affect how it works.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect SITAGLIPTIN/METFORMIN MYLAN.
4. How do I take SITAGLIPTIN/METFORMIN MYLAN?
How much to take
Your doctor will tell you how many SITAGLIPTIN/ METFORMIN MYLAN tablets to take and
how often to take them.
Take SITAGLIPTIN/METFORMIN MYLAN with meals to lower your chance of an upset stomach.
Follow the instructions provided and use SITAGLIPTIN/ METFORMIN MYLAN until your doctor
tells you to stop.
When to take SITAGLIPTIN/METFORMIN MYLAN
SITAGLIPTIN/METFORMIN MYLAN should be used at about the same time each day.
If you forget to take SITAGLIPTIN/METFORMIN MYLAN
SITAGLIPTIN/METFORMIN MYLAN 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 SITAGLIPTIN/METFORMIN MYLAN
If you think that you have used too much SITAGLIPTIN/METFORMIN MYLAN, 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.
5. What should I know while taking SITAGLIPTIN/METFORMIN MYLAN?
Things you should do
Call your doctor straight away if you:
Become pregnant while taking SITAGLIPTIN/ METFORMIN MYLAN, 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 SITAGLIPTIN/ METFORMIN MYLAN with insulin.
Remind any doctor, dentist or pharmacist you visit that you are using SITAGLIPTIN/METFORMIN
MYLAN.
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 SITAGLIPTIN/METFORMIN MYLAN than prescribed
Taking certain other medicines
Too little exercises
Eating more carbohydrates than normal.
Your blood glucose 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 SITAGLIPTIN/METFORMIN MYLAN with
insulin.
Stop taking SITAGLIPTIN/METFORMIN MYLAN 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
SITAGLIPTIN/METFORMIN MYLAN.
Make sure you check your blood glucose sugar levels regularly.
Visit your doctor for regular checks of your eyes, feet, kidneys, heart, circulation,
blood and blood pressure.
See your 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 SITAGLIPTIN/METFORMIN MYLAN.
Remind any doctor, dentist or pharmacist you visit that you are taking SITAGLIPTIN/METFORMIN
MYLAN.
Things you should not do
Do not stop using this medicine suddenly or change your dose without checking with
your doctor.
Do not skip meals while taking SITAGLIPTIN/ METFORMIN MYLAN.
Do not give SITAGLIPTIN/METFORMIN MYLAN to anyone else, even if they have the same
condition as you.
Driving or using machines
There is no information to suggest that SITAGLIPTIN/ METFORMIN MYLAN 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 blister pack until it is time to take them.
Follow the instructions in the carton on how to take care of your medicine properly.
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 use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use 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
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Less serious side effects
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What to do
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Signs of an infection of the breathing passages, including runny nose, sore throat,
cough
Nausea, vomiting, stomach discomfort, diarrhoea or constipation
Headache
Muscle aches or joint, arm, leg or back pain
Itching or blisters
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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Allergic reactions including rash, hives, and swelling of the face, lips, tongue,
and throat that may cause difficulty in breathing or swallowing.
Severe and persistent stomach pain, often with nausea and vomiting. These may be symptoms
of pancreatitis. Pancreatitis can be a serious, potentially life-threatening medical
condition.
Kidney problems (sometimes requiring dialysis)
Itching, blisters or the breakdown of your skin (erosion) to serious AEs.
Low blood sugar when SITAGLIPTIN/ METFORMIN MYLAN is used in combination with a sulfonylurea
medicine or with insulin.
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Stop taking SITAGLIPTIN/ METFORMIN MYLAN.
Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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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 SITAGLIPTIN/METFORMIN MYLAN contains
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Active ingredient
(main ingredient)
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Sitagliptin 50 mg and metformin 500, 850 or 1000 mg per tablet
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Other ingredients
(inactive ingredients)
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Microcrystalline cellulose
Povidone
Sodium lauryl sulfate
Sodium stearylfumarate
Polyvinyl alcohol
Macrogol 3350
Purified talc
Titanium dioxide
Iron oxide red
Iron oxide black
Iron oxide yellow
Hypromellose
Triacetin
Lactose monohydrate
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Potential allergens
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50 mg/850 mg tablet strength
lactose
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Do not take this medicine if you are allergic to any of these ingredients.
What SITAGLIPTIN/METFORMIN MYLAN looks like
SITAGLIPTIN/METFORMIN MYLAN 50 mg/500 mg – Oval-shaped, orange colour biconvex film-coated
tablets debossed with "S475" on one side and plain on other side. (AUST R 386880)
SITAGLIPTIN/METFORMIN MYLAN 50 mg/850 mg – Oval-shaped, pink colour biconvex, film-coated
tablets debossed with "S476" on one side and plain on other side. (AUST R 386881)
SITAGLIPTIN/METFORMIN MYLAN 50 mg/1000 mg – Oval-shaped, brown colour biconvex, film
coated tablets debossed with "S477" on one side and plain on other side (AUST R 386882)
Sponsor
Maple Healthcare Pty Ltd
Level 8, 555 Bourke Street
Melbourne VIC 3000
Australia
Distributor
SITAGLIPTIN/METFORMIN MYLAN is distributed in Australia by:
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30 - 34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in February 2024.