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.
This medicine is new or being taken differently. Please report side effects. See the
full CMI for further details.
1. Why am I taking SEGLUROMET?
SEGLUROMET contains the active ingredients ertugliflozin and metformin. SEGLUROMET
can be used to lower your blood sugar 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 SEGLUROMET?
Do not use if you have ever had an allergic reaction to ertugliflozin or metformin
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 SEGLUROMET and affect how it works.
4. How do I take SEGLUROMET?
Take one tablet two times a day.
5. What should I know while taking SEGLUROMET?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking SEGLUROMET.
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Things you should not do
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Do not stop taking this medicine suddenly unless your doctor tells you.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how SEGLUROMET
affects you.
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Looking after your medicine
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Keep SEGLUROMET in its original packaging in a cool dry place where the temperature
stays below 30°C.
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6. Are there any side effects?
Less serious side effects include yeast infections of the vagina or penis, changes
in urination, low blood sugar if you take SEGLUROMET with insulin or certain other
diabetes medicines
Serious side effects include dehydration (losing too much water from your body), ketoacidosis
(increased ketones in your blood or urine), genital infection or urinary tract infection.
In rare cases, metformin, one of the medicines in SEGLUROMET, can cause lactic acidosis.
Stop taking SEGLUROMET and call your doctor right away if you get the following symptoms:
feeling very weak and tired, dizzy or lightheaded, unusual muscle pain, trouble breathing,
stomach pain with nausea and vomiting, or diarrhoea, cold in your hands or feet, a
slow or irregular heartbeat.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
Active ingredients:
Ertugliflozin pyroglutamic acid/Metformin hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking SEGLUROMET. 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 SEGLUROMET.
Where to find information in this leaflet:
1. Why am I taking SEGLUROMET?
SEGLUROMET contains the active ingredients ertugliflozin and metformin. Ertugliflozin is a medicine called a sodium-glucose co-transporter 2 (SGLT2) inhibitor
and metformin is called a biguanide. Both medicines work together to lower blood sugar
levels in patients with type 2 diabetes mellitus. SEGLUROMET helps remove sugar from
the body through urination and by blocking sugar (glucose) production by the liver.
SEGLUROMET by itself is unlikely to cause low blood sugar because it does not work
when your blood sugar is low.
SEGLUROMET can be used to lower your blood sugar (glucose) alone or in combination
with certain other medicines, along with a recommended diet and exercise program.
2. What should I know before I take SEGLUROMET?
Warnings
Do not take SEGLUROMET if:
you are allergic to ertugliflozin 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.
Some of the symptoms of an allergic reaction may include shortness of breath, wheezing
or difficulty breathing; swelling of the face, lips, tongue or other parts of the
body; rash, itching or hives on the skin or you may feel faint.
you have poorly functioning kidneys since ertugliflozin requires good functioning
kidneys to work well
have or have had increased ketones in the blood and urine (a condition called metabolic
acidosis or diabetic ketoacidosis).
have liver problems
drink alcohol to excess, either every day or only from time to time or in the short
term (" binge" drinking).
have dehydration, severe blood loss, shock
have a severe infection
have gangrene
have heart or blood vessel problems, including a recent heart attack or congestive
heart failure
have severe breathing difficulties
have blood clots in the lungs (symptoms include coughing, shortness of breath, chest
pain and a fast heart rate)
have pancreatitis (symptoms include severe and persistent stomach pain, with or without
vomiting)
Tell your doctor if you:
have type 1 diabetes
are going to have surgery
are eating less due to illness, surgery, or a change in your diet
have a condition that may cause dehydration (losing too much water from your body)
have other kidney problems
have or have had yeast infections of the vagina or penis
take other diabetes medicines; you are more likely to get low blood sugar with certain
medicines
have allergies to any other medicines or other substances such as foods, preservatives
or dyes.
are going to get an injection of dye or contrast agents for an x-ray procedure. SEGLUROMET
may need to be stopped for a short time. Talk to your doctor about when you should
stop SEGLUROMET and when you should start SEGLUROMET again.
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?
SEGLUROMET contains ertugliflozin and metformin. If you have more than one metformin-containing
medicine in your possession, you may accidentally take too much (overdose). Accidentally
taking too much metformin can cause a very serious side effect called lactic acidosis. ACCIDENTAL METFORMIN OVERDOSING IS A SIGNIFICANT SAFETY RISK.
Discard any other medicines containing ertugliflozin or metformin that your doctor
might have prescribed to you in the past and that you may still have in your possession
by taking it to any pharmacy for safe disposal.
Ask your doctor or pharmacist if you are unsure if you have any other medicines containing
metformin. Metformin is sold under many different brand names in Australia. He or
she will know which other medicines also contain metformin.
Pregnancy and breastfeeding
Talk to your doctor if you are pregnant or intend to become pregnant. It is not known
if SEGLUROMET may harm your unborn baby. If you are pregnant, talk with your doctor
about the best way to control your blood sugar while you are pregnant. Do not use SEGLUROMET if you are pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed. It is not known
if SEGLUROMET passes into breast milk. Talk with your doctor about the best way to
feed your baby if you take SEGLUROMET. Do not use SEGLUROMET if you are breast-feeding or plan to breast-feed.
Children
It is not known if SEGLUROMET is safe and effective in children under 18 years of
age.
Elderly
In studies, ertugliflozin worked well in and was generally well-tolerated by older
patients. People 65 years or older were more likely to get dehydrated while taking
SEGLUROMET compared to younger patients. Elderly people are more likely to have kidney
problems. No dose adjustment is necessary based on 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 herbal supplements that you buy without a prescription from
your pharmacy, supermarket or health food shop.
SEGLUROMET may be taken with most medicines.
Some medicines may interfere with SEGLUROMET and affect how it works.
Be sure to tell your doctor if you are taking water pills (diuretics), as you may
be more likely to get dehydrated. See Section 6. Are there any side effects?
When you take SEGLUROMET with certain other diabetes medicines, you are more likely
to get low blood sugar. See Section 6. Are there any side effects?
Tell your doctor or pharmacist if you are taking lithium because SEGLUROMET can lower
the amount of lithium in your blood.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect SEGLUROMET.
4. How do I take SEGLUROMET?
How much to take
Take one tablet two times a day. Your doctor will decide the dose of SEGLUROMET suitable
for you.
Take SEGLUROMET until your doctor tells you to stop.
When to take SEGLUROMET
Take SEGLUROMET at about the same time each day.
Take SEGLUROMET with food to lower your chance of an upset stomach.
If you forget to take SEGLUROMET
SEGLUROMET should be taken regularly at the same times 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 2 doses at the same time to make up for the dose you missed.
If you take too much SEGLUROMET
If you think that you have taken too much SEGLUROMET, 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 SEGLUROMET?
Things you should do
If you are about to be started on any new medicine, tell your doctor and pharmacist
that you are taking SEGLUROMET.
If you become pregnant while taking SEGLUROMET, tell your doctor immediately.
Continue to take SEGLUROMET for as long as your doctor prescribes it so that you can
continue to help control your blood sugar. This medicine helps to control your condition
but will not cure it. It is important to keep taking your medicine even if you feel
well.
Call your doctor straight away if:
your body is under some types of stress, such as fever, trauma (such as a car accident),
infection, or surgery. The amount of diabetes medicine you need may change.
you develop a combination of symptoms of pain, tenderness, redness, or swelling of
the genitals or the area between the genitals and the anus with fever or feeling generally
unwell. These symptoms could be a sign of a rare but serious or even life-threatening
infection, called necrotising fasciitis of the perineum or Fournier’s Gangrene, which
destroys the tissue under the skin. Fournier’s Gangrene has to be treated immediately.
Remind any doctor, dentist or pharmacist you visit that you are taking SEGLUROMET.
Things you should not do
Do not stop taking this medicine suddenly or lower your dosage without checking with
your doctor.
Do not take SEGLUROMET to treat any other complaints unless your doctor tells you
to.
Do not give SEGLUROMET to anyone else, even if they have the same condition as you.
Remember that your doctor has prescribed this medicine only for you.
Foot care
Check your feet regularly and see your doctor if you notice any problems. Follow any
other advice regarding foot care given by your doctor.
Blood tests
Your doctor may do blood tests before you start SEGLUROMET and while you take it.
These tests look to see if your blood sugar level is normal at that moment and how
well you have managed your blood sugar over time (called haemoglobin A1c). Blood tests
may show changes related to kidney function or reduced vitamin B12 level or high levels
of bad cholesterol. Your doctor may change your dose of SEGLUROMET based on the results.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how SEGLUROMET
affects you.
SEGLUROMET has no or negligible influence on the ability to drive and use machines.
Do not drive or use any tools or machines if you feel dizzy while taking SEGLUROMET.
Taking this medicine in combination with insulin or medicines called insulin secretagogues
can cause blood sugar levels to drop too low, which may cause symptoms such as shaking,
sweating and change in vision, and may affect your ability to drive and use machines.
Drinking alcohol
Tell your doctor if you drink alcohol very often or drink a lot of alcohol in the
short term ("binge" drinking).
Looking after your medicine
Keep SEGLUROMET in its original packaging in a cool dry place where the temperature
stays below 30°C.
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 windowsills.
Do not take SEGLUROMET if the packaging is torn or shows signs of tampering.
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
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Less serious side effects
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What to do
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Yeast infections of the vagina or penis
in women, symptoms include bad smell from your vagina, white or yellow discharge coming
out of your vagina that may be lumpy or look like cottage cheese and itchiness.
in men, symptoms include swelling of the penis, red skin, itchiness or rash, bad smell
and discharge coming out of your penis, pain in the skin around your penis. If you
haven't been circumcised, it may be hard to pull back the skin around the tip of your
penis.
Changes in urination
urgent need to urinate more often, in larger amounts, or at night, or thirst
Low blood sugar (hypoglycaemia)
If you take SEGLUROMET with insulin or certain other diabetes medicines, your blood
sugar might get too low. Your doctor might need to lower the dose of your insulin
or other diabetes medicine.
headache
drowsiness, dizziness or confusion, irritability or feeling jittery, sweating, weakness,
fast heartbeat
hunger
Other side effects
Stomach discomfort, diarrhoea, nausea, vomiting
Itching or blisters of the skin or redness or an itchy rash (urticaria)
loss of appetite or changes in taste
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Speak to your doctor if you have any of these 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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Risk of Lactic acidosis
SEGLUROMET may cause a very rare, but very serious side effect called lactic acidosis,
particularly if your kidneys are not working properly. Lactic acidosis is a medical emergency that can cause death and must be treated in
hospital.
The risk of developing lactic acidosis is also increased with uncontrolled diabetes,
serious infections, prolonged fasting or alcohol intake, dehydration, liver problems
and any medical conditions in which a part of the body has a reduced supply of oxygen
(such as acute severe heart disease).
If any of the above apply to you, talk to your doctor for further instructions.
Stop taking SEGLUROMET for a short time if you have a condition that may be associated
with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea,
fever, exposure to heat or if you drink less fluid than normal. Talk to your doctor
for further instructions.
Stop taking SEGLUROMET and call your doctor right away if you get the following symptoms
of lactic acidosis:
feeling very weak and tired, dizzy or lightheaded
unusual (not normal) muscle pain
trouble breathing
stomach pain with nausea and vomiting, or diarrhoea
feeling cold in your hands or feet
a slow or irregular heartbeat
You have a higher chance of getting lactic acidosis if you:
have severe kidney problems or your kidneys are affected by certain x-ray tests that
use injectable dye
drink a lot of alcohol (very often or short-term 'binge' drinking)
have surgery
have a heart attack, severe infection, or stroke
get dehydrated (lose a large amount of body fluids). This can happen if you are sick
with a fever, vomiting or diarrhoea, , exposure to heat, when you sweat a lot with
activity or exercise, or if you drink less fluid than normal.
Stop taking SEGLUROMET for a short time if you have a condition that may be associated
with dehydration and talk to your doctor for further instructions.
Dehydration (losing too much water from your body):
dry mouth, feeling dizzy, light-headed, or weak, especially when you stand up, fainting
You may be more likely to get dehydrated if you:
have kidney problems or take water tablets (diuretics) or
are 65 years or older
Ketoacidosis (increased ketones in your blood or urine)
nausea or vomiting
tiredness or trouble breathing
stomach-area (abdominal) pain
excessive thirst
If possible, check for ketones in your urine, even if your blood sugar is less than
14.0 mmol/L. You may need to be treated in a hospital.
Genital infection
A rare but serious bacterial infection that causes damage to the tissue under the
skin (necrotising fasciitis) in the area between and around the anus and genitals
(perineum). Necrotising fasciitis of the perineum has happened in women and men who
take medicines that lower blood sugar in the same way as one of the medicines in SEGLUROMET.
Necrotising fasciitis of the perineum may lead to hospitalisation, may require multiple
surgeries, and may lead to death. Seek medical attention immediately if you have:
pain or tenderness, swelling, or redness of the skin (erythema) in the area between
and around your anus and genitals
fever or you are feeling very weak, tired or uncomfortable (malaise)
Urinary tract infection
burning or pain when you pass urine, more frequent or urgent need to urinate, fever,
chills, or blood in the urine
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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 SEGLUROMET contains
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Active ingredient
(main ingredient)
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ertugliflozin pyroglutamic acid, and metformin hydrochloride
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Other ingredients
(inactive ingredients)
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Povidone
Microcrystalline cellulose
Crospovidone
Sodium lauryl sulfate
Magnesium stearate
Hypromellose
Hyprolose
Titanium dioxide
Iron oxide red
Carnauba wax
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SEGLUROMET does not contain gluten, sucrose, tartrazine or any other azo dyes.
Do not take this medicine if you are allergic to any of these ingredients.
What SEGLUROMET looks like
SEGLUROMET 2.5 /500 is a pink, oval, film-coated tablet debossed with '2.5/500' on
one side and plain on the other side (AUST R 287636).
SEGLUROMET 2.5/1000 is a pink, oval, film-coated tablet debossed with '2.5/1000' on
one side and plain on the other side (AUST R 287635).
SEGLUROMET 7.5 /500 is a red, oval, film-coated tablet debossed with '7.5/500' on
one side and plain on the other side (AUST R 287633).
SEGLUROMET 7.5 /1000 is a red, oval, film-coated tablet debossed with '7.5/1000' on
one side and plain on the other side (AUST R 287627).
Who distributes SEGLUROMET
Merck Sharp & Dohme (Australia) Pty Limited
Level 1, Building A, 26 Talavera Road, Macquarie Park NSW 2113
This leaflet was prepared in November 2023.
RCN000026204-AU
Copyright © 2023 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates. All rights
reserved.