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SITAGLIPTIN MYLAN
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
SITAGLIPTIN MYLAN contains the active ingredient Sitagliptin hydrochloride monohydrate.
SITAGLIPTIN MYLAN is used to lower blood sugar levels in adults with type 2 diabetes
mellitus.
For more information, see Section 1. Why am I taking SITAGLIPTIN MYLAN? in the full CMI.
Do not use if you have ever had an allergic reaction to SITAGLIPTIN 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.
For more information, see Section 2. What should I know before I take SITAGLIPTIN MYLAN? in the full CMI.
Some medicines may interfere with SITAGLIPTIN MYLAN and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
Take SITAGLIPTIN MYLAN once a day by mouth, with or without food.
More instructions can be found in Section 4. How do I take SITAGLIPTIN MYLAN? in the full CMI.
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking SITAGLIPTIN
MYLAN.
Call your doctor straight away if you become pregnant while taking SITAGLIPTIN 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 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 MYLAN affects your ability to
drive or use machines.
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Drinking alcohol
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There is no information available.
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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 SITAGLIPTIN MYLAN in a cool dry place away from moisture, heat or sunlight.
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For more information, see Section 5. What should I know while taking SITAGLIPTIN MYLAN? in the full CMI.
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.
Low blood sugar when used in combination with a sulfonylurea medicine or with insulin.
Blisters or the breakdown of your skin (erosion).
Kidney problems.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
SITAGLIPTIN MYLAN
Active ingredient(s):
[Sitagliptin hydrochloride monohydrate]
Consumer Medicine Information (CMI)
This leaflet provides important information about taking SITAGLIPTIN 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 taking SITAGLIPTIN MYLAN.
Where to find information in this leaflet:
SITAGLIPTIN MYLAN contains the active ingredient Sitagliptin hydrochloride monohydrate.
SITAGLIPTIN MYLAN 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 adults
with type 2 diabetes mellitus.
SITAGLIPTIN MYLAN is used to
lower blood sugar levels in adults with type 2 diabetes mellitus. SITAGLIPTIN MYLAN
can be used alone or in combination with certain other medicines that lower blood
sugar along with a recommended diet and exercise program.
Do not use SITAGLIPTIN MYLAN if:
you are allergic to Sitagliptin hydrochloride monohydrate, or any of the ingredients
listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
have or have had type 1 diabetes mellitus.
have or have had increased ketones in the blood or urine (diabetic ketoacidosis).
have or have had any kidney problems or any past or present medical problems.
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
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 MYLAN while breastfeeding or if planning to breastfeed.
Children
Children and adolescents below 18 years should not use this medicine. SITAGLIPTIN
MYLAN is not effective in children and adolescents 10 to 17 years of age with type
2 diabetes. SITAGLIPTIN MYLAN has not been studied in children younger than 10 years
of age.
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.
Some medicines may interfere with SITAGLIPTIN MYLAN and affect how it works.
Medicines that may cause low blood sugar when used in combination with SITAGLIPTIN
MYLAN include:
Sulfonylurea
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 SITAGLIPTIN MYLAN.
How much to take
Take once a day by mouth, with or without food.
If you have kidney problems, your doctor may prescribe lower doses, and monitor your
kidney function. Your doctor may prescribe on its own, or with certain other medicines
that lower blood sugar.
Follow the instructions provided and use SITAGLIPTIN MYLAN until your doctor tells
you to stop.
If you forget to take SITAGLIPTIN MYLAN
SITAGLIPTIN 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 MYLAN
If you think that you have taken too much SITAGLIPTIN MYLAN, you may need urgent medical
attention.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26), or
(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.
Things you should do
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 MYLAN.
Call your doctor straight away if you:
If you become pregnant while taking SITAGLIPTIN MYLAN.
If you are about to be started on any new medicine, tell your doctor and pharmacist
that you are taking SITAGLIPTIN MYLAN.
Remind any doctor, dentist or pharmacist you visit that you are taking SITAGLIPTIN
MYLAN.
Things you should not do
Do not stop taking this medicine suddenly. Continue to take SITAGLIPTIN MYLAN as long
as your doctor prescribes it so it can continue to help control your blood sugar.
Do not give SITAGLIPTIN 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 MYLAN affects your ability to
drive a car or operate machinery.
Drinking alcohol
Tell your doctor if you drink alcohol.
No information available about the use of alcohol.
Looking after your medicine
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; 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.
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, soreness in the back of the nose and throat and discomfort when swallowing,
headache, flu-like symptoms:
Stomach discomfort and vomiting, diarrhea or constipation.
Muscle aches or pain in the joints, back, arm, or leg
Itching, or blisters or the breakdown of your skin (erosion).
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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.
Low blood sugar when SITAGLIPTIN MYLAN is used in combination with a sulfonylurea
medicine or with insulin.
Severe blistering or the breakdown of your skin (erosion).
Kidney problems (sometimes requiring dialysis).
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Stop taking SITAGLIPTIN 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.
This medicine is only available with a doctor's prescription.
What SITAGLIPTIN MYLAN contains
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Active ingredient
(main ingredient)
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Sitagliptin hydrochloride monohydrate 25, 50 or 100 mg per tablet
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Other ingredients
(inactive ingredients)
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Microcrystalline cellulose
Calcium hydrogen phosphate Croscarmellose sodium Magnesium stearate
Sodium stearyl fumarate
Film coating
25 mg tablet strength
Lactose monohydrate Hypromellose
Titanium dioxide
Triacetin
Iron oxide red
50 mg and 100 mg tablet strength
Polyvinyl alcohol
Macrogol 3350
Purified talc
Titanium dioxide
Iron oxide red
Iron oxide yellow
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Potential allergens
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25 mg tablet strength
lactose
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Do not take this medicine if you are allergic to any of these ingredients.
What SITAGLIPTIN MYLAN looks like
SITAGLIPTIN MYLAN 25 mg is a round shaped, biconvex pink film coated tablets debossed
with “LC” on one side and plain on other side. (AUST R 384800)
SITAGLIPTIN MYLAN 50 mg is a round shaped, biconvex orange film coated tablets debossed
with “C” on one side and plain other side. (AUST R 384801)
SITAGLIPTIN MYLAN 100 mg is a round shaped, biconvex beige film coated tablets debossed
with “L” on one side and plain on other side. (AUST R 384802)
