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 Toujeo SoloStar?
Toujeo SoloStar contains the active ingredient insulin glargine 300 units/mL. Toujeo
SoloStar is used to reduce high blood sugar (hyperglycaemia) in patients 6 years of
age and older, who have diabetes.
2. What should I know before I use Toujeo SoloStar?
Do not use if you have ever had an allergic reaction to insulin or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you:
have diabetic ketoacidosis (often caused by high blood sugar levels)
have any other medical conditions, including kidney or liver problems
take any other medicines
are pregnant, or plan to become pregnant, or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with Toujeo SoloStar and affect how it works.
4. How do I use Toujeo SoloStar?
Toujeo SoloStar should be injected under the skin. Your doctor will tell you when
and how much you need to use each day.
Your doctor may change your dose, depending on your blood sugar levels.
Use Toujeo SoloStar until your doctor tells you to stop. Too much or too little insulin
can cause serious effects.
Toujeo SoloStar should be used once a day, at the same time every day.
5. What should I know while using Toujeo SoloStar?
Things you should do
|
It is very important that you manage your diabetes carefully. Measure your blood sugar
levels regularly.
Tell your doctor if you often have low blood sugar levels or ever lose consciousness
after using Toujeo SoloStar.
Always carry sugary food or drink with you in case you start to have any symptoms
of low blood sugar.
Remind any doctor, dentist, diabetes educator or pharmacist you visit that you are
using Toujeo SoloStar.
|
Drinking alcohol
|
Tell your doctor if you drink alcohol. Drinking alcohol may mask the symptoms of low
blood sugar.
|
Looking after your medicine
|
Keep unopened Toujeo SoloStar pre-filled pens in the fridge between 2-8°C. Do not
freeze.
Before using a new pen, take it out of the fridge and let it come to room temperature
for 1-2 hours.
After you have started using a pen, do not put it back in the fridge. Keep it at room
temperature below 30°C, away from direct heat and light.
Discard any pen you have started using or any spare pen taken out of the fridge within
28 days.
|
6. Are there any side effects?
Serious side effects may include low blood sugar (hypoglycaemia or ‘hypo’) or an allergic
reaction. 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.
Active ingredient:
insulin glargine
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Toujeo SoloStar. 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 Toujeo SoloStar.
Where to find information in this leaflet:
1. Why am I using Toujeo SoloStar?
Toujeo SoloStar contains the active ingredient insulin glargine. Insulin glargine is a modified insulin that is a substitute for the insulin produced
by your pancreas.
Toujeo SoloStar contains 3 times more insulin in 1 mL than standard insulin, which
contains 100 units/mL.
Toujeo SoloStar is used to reduce high blood sugar (hyperglycaemia) in patients 6
years of age and older, with diabetes mellitus (commonly known as 'diabetes').
Toujeo SoloStar is a long-acting insulin. Your doctor may tell you to use a meal-time
insulin or oral anti-diabetic medication in combination with Toujeo SoloStar.
2. What should I know before I use Toujeo SoloStar?
Warnings
Do not use Toujeo SoloStar if:
You have ever had an allergic reaction to a medicine containing insulin, or any of
the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
You have diabetic ketoacidosis (often caused by high blood sugar levels).
Tell your doctor if you:
have any other medical conditions, including any kidney problems or liver problems.
take any medicines for any other condition
drink alcohol
do not eat regular meals
do a lot of exercise
are ill or are feeling unwell.
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. Pregnancy
may make managing your diabetes more difficult.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
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.
Some medicines may interfere with Toujeo SoloStar and affect how it works.
Medicines that may
increase
the blood sugar lowering effect of Toujeo SoloStar include:
oral anti-diabetic medicines for type 2 diabetes
some blood pressure, blood flow, cholesterol and heart medications
some medications for pain and inflammation
some antidepressants
certain antibiotics that contain sulfur
Medicines that may
reduce
the blood sugar lowering effect of Toujeo SoloStar include:
hormonal therapies, such as corticosteroids, glucagon
oral contraceptives and gynaecological medications
some fluid and glaucoma medications
some medicines to treat tuberculosis and HIV/AIDS
some psychiatric medications
adrenaline and asthma medications such as salbutamol, terbutaline
Medicines that may mask the symptoms of low blood sugar (hypoglycaemia or ‘hypo’)
include:
certain heart medications, especially beta-blockers.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Toujeo SoloStar.
4. How do I use Toujeo SoloStar?
How much to use
Your doctor will tell you how much Toujeo SoloStar you need to use each day.
Follow the instructions provided and use Toujeo SoloStar until your doctor tells you
to stop.
Your doctor may change your dose, depending on your blood sugar levels.
When to use Toujeo SoloStar
Your doctor will tell you what time of day to use Toujeo SoloStar.
Toujeo SoloStar should be used once a day, at the same time every day.
How to inject Toujeo SoloStar
Toujeo SoloStar should be injected under the skin, being careful not to inject it
into a muscle or vein.
Inject Toujeo SoloStar into your thighs, upper arms or the front of your waist (abdomen).
Change the place within the area you inject each day. This will reduce the risk of
skin shrinking or thickening or lumps at the site (see "Side effects").
Do not use the exact same spot for each injection.
Do not inject where the skin has pits, is thickened, or has lumps.
Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged
skin.
Always check the label on your Toujeo SoloStar pre-filled pen before using it to make
sure you have the correct insulin.
Make sure that ‘U300’ is highlighted in honey gold colour on the label of your Toujeo
SoloStar pre-filled pen.
Use a new needle each time you inject Toujeo SoloStar.
This helps to avoid under-dosing or over-dosing due to blockages.
Toujeo SoloStar should be injected under the skin. Inject the full dose of Toujeo
SoloStar by pushing the plunger as far as it will go. Your doctor or diabetes educator
will have shown you how to use Toujeo SoloStar.
Do not try to withdraw Toujeo SoloStar from the cartridge of the pre-filled pen into
a syringe.
Use a different injection site for each injection so that the same site is not used
more often than once a month. This will reduce the chance of local skin reactions
developing.
If you develop skin changes at the injection site: The injection site should be rotated
to prevent skin changes such as lumps under the skin. The insulin may not work very
well if you inject into a lumpy area. Contact your doctor if you are currently injecting
into a lumpy area before you start injecting in a different area. Your doctor may
tell you to check your blood sugar more closely, and to adjust your insulin or your
other antidiabetic medications dose.
If you forget to use Toujeo SoloStar
Toujeo SoloStar is a long-acting insulin and should be used regularly at the same
time each day. If you forget to take your insulin dose at the usual time, your blood
sugar levels may become high (hyperglycaemia).
If you miss a dose and are not sure what to do, contact your doctor or pharmacist
for specific advice.
Do not take a double dose of insulin.
If you use too much Toujeo SoloStar
If you think that you have used too much Toujeo SoloStar, your blood sugar level may
become too low (hypoglycaemia or 'hypo'). You may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26 in Australia or 0800 764 766 in New Zealand), 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 using Toujeo SoloStar?
Things you should do
Measure your blood sugar level regularly. It is important that you manage your diabetes carefully. Too much or too little
insulin can cause serious side effects.
Call your doctor straight away if you:
often have low blood sugar levels
ever lose consciousness after using Toujeo SoloStar.
Your doctor may need to adjust your dose of Toujeo SoloStar or of other medicines
you are taking.
Remind any doctor, dentist, diabetes educator or pharmacist you visit that you are
using Toujeo SoloStar.
Tell your relatives, carers, friends and close workmates that you have diabetes.
Low blood sugar levels and what to do
You may experience low blood sugar if your levels are reduced too much. Early symptoms
of mild to moderate low blood sugar can come on suddenly and may include:
cold sweat, cool pale skin
fatigue, drowsiness, unusual tiredness and weakness
nervousness, anxious feeling, tremor, rapid heartbeat
confusion, difficulty concentrating
excessive hunger
vision changes
headache, nausea.
Always carry some sugary food or drink with you.
If you start to get any symptoms of low blood sugar:
have some sugary food or drink, and
follow up with extra carbohydrates once the initial symptoms have stopped.
Make sure people close to you know how to recognise the symptoms of low blood sugar,
and that they need to get you medical help immediately if you become unconscious.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Toujeo
SoloStar affects you. Be careful not to let your blood sugar levels fall too low.
Drinking alcohol
Tell your doctor if you drink alcohol.
Alcohol may mask the symptoms of hypoglycaemia.
Looking after your medicine
Follow the instructions in the carton on how to take care of your medicine properly.
Keep unopened Toujeo SoloStar pre-filled pens in the fridge between 2-8°C. Do not
freeze.
Before using a new pen, take it out of the fridge and let it come to room temperature
for 1 to 2 hours.
After you have started using a pen, do not put it back in the fridge. Keep it at room
temperature below 30°C, away from direct heat and light.
Keep it where young children cannot reach it.
When to discard your medicine
Discard any pre-filled pen you have started using or any spare pen taken out of the
fridge, after 28 days.
Discard any pens that are frozen or have been frozen.
Getting rid of any unwanted medicine
Your doctor, pharmacist or diabetes educator will show you how to safely dispose of
your needles and pre-filled pens once they are empty.
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
Skin changes at the injection site:
If you inject insulin too often at the same place, the fatty tissue may either shrink
(lipoatrophy) or thicken (lipohypertrophy). Lumps under the skin may also be caused
by build-up of a protein called amyloid (localized cutaneous amyloidosis). The insulin
may not work very well if you inject into a lumpy area. Change the injection site
with each injection to help prevent these skin changes.
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.
Always speak to your doctor or pharmacist before you decide to stop taking any of
your medicines.
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
in Australia or in New Zealand at https://pophealth.my.site.com/carmreportnz/s/.
By reporting side effects, you can help provide more information on the safety of
this medicine.
7. Product details
This medicine is only available with a doctor's prescription.
What Toujeo SoloStar contains
Active ingredient
(main ingredient)
|
Insulin glargine (300 units/mL)
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Other ingredients
(inactive ingredients)
|
meta-cresol
glycerol
zinc chloride
hydrochloric acid
sodium hydroxide
water for injection
|
Do not take this medicine if you are allergic to any of these ingredients.
You can get more information about diabetes and insulin from:
Diabetes Australia:
freecall helpline 1300 136 588
Diabetes NZ:
freecall helpline: 0800 342 238
What Toujeo SoloStar looks like
Toujeo SoloStar is a pre-filled disposable pen containing a 1.5 mL cartridge of Toujeo
SoloStar.
Who distributes Toujeo SoloStar
Distributed in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall: 1800 818 806
Distributed in New Zealand by:
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
PO Box 62027
Sylvia Park Auckland 1644
Freecall: 0800 283 684
This leaflet was prepared in October 2024
Toujeo SoloStar-ccdsv5-cmiv9-17oct24