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 using VELMETIA?
VELMETIA contains the active ingredients sitagliptin (as phosphate monohydrate) and
metformin (as hydrochloride). VELMETIA is used to lower blood sugar levels in adults
with diabetes mellitus.
2. What should I know before I take VELMETIA?
Do not take if you have ever had an allergic reaction to VELMETIA 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 VELMETIA and affect how it works.
4. How do I take VELMETIA?
Your doctor will tell you how many VELMETIA tablets to take and how often to take
them.
Take VELMETIA with meals to lower your chance of an upset stomach.
5. What should I know while taking VELMETIA?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using VELMETIA.
Call your doctor straight away if you if you become pregnant while taking VELMETIA.
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Things you should not do
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Do not stop taking this medicine suddenly.
Do not give VELMETIA 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 VELMETIA 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 phosphate monohydrate)/Metformin (as hydrochloride)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking VELMETIA. 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 VELMETIA.
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 VELMETIA?
VELMETIA 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.
VELMETIA is used to lower blood sugar levels in adults with type 2 diabetes mellitus.
VELMETIA 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 VELMETIA?
Warnings
Do not take VELMETIA 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 VELMETIA 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. VELMETIA
is not recommended for use during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed. You should not
take VELMETIA while breastfeeding or if planning to breastfeed.
Children
Children and adolescents below 18 years should not use this medicine. VELMETIA is
not effective in children and adolescents 10 to 17 years of age with type 2 diabetes.
VELMETIA 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.
VELMETIA may affect how well other drugs work and some drugs can affect how well VELMETIA
works.
Medicines that may cause low blood sugar when used in combination with VELMETIA 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 VELMETIA.
4. How do I take VELMETIA?
How much to take
Your doctor will tell you how many VELMETIA tablets to take and how often to take
them.
Take VELMETIA with meals to lower your chance of an upset stomach.
When to take VELMETIA
Take your VELMETIA at about the same time each day.
If you forget to take VELMETIA
VELMETIA 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 VELMETIA
If you think that you have taken too much VELMETIA, 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 VELMETIA?
Things you should do
Call your doctor straight away if you:
Become pregnant while taking VELMETIA, 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 VELMETIA 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 VELMETIA than prescribed
taking certain other medicines
too little exercise
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 VELMETIA with insulin.
Stop taking VELMETIA 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
VELMETIA.
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 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 VELMETIA.
Remind any doctor, dentist or pharmacist you visit that you are taking VELMETIA.
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 VELMETIA.
Do not give VELMETIA to anyone else, even if they have the same condition as you.
Driving or using machines
There is no information to suggest that VELMETIA 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.
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 VELMETIA contains
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Active ingredients
(main ingredients)
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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
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Do not take this medicine if you are allergic to any of these ingredients.
What VELMETIA looks like
VELMETIA 50/500 is a light pink, film coated tablet with "575" on one side and plain
on the other (AUST R 220155).
VELMETIA 50/850 is a pink, film coated tablet with "515" on one side and plain on
the other (AUST R 220156).
VELMETIA 50/1000 is a red, film coated tablet with "577" on one side and plain on
the other (AUST R 220157).
Who distributes VELMETIA
Merck Sharp & Dohme (Australia) Pty Limited
Level 1, Building A, 26 Talavera Road
MACQUARIE PARK NSW 2113
This leaflet was prepared in July 2022.
RCN000013428
Copyright © (2022) Merck & Co., Inc., Rahway, NJ, USA, and its affiliates. All rights
reserved.