2. What should I know before I use Levemir® FlexPen®?
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.
Do not use if you are experiencing low blood sugar ("hypo") when your dose is due.
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 insulin and affect how it works.
4. How do I use Levemir® FlexPen®?
Carefully follow all instructions given to you by your doctor, nurse educator and
pharmacist regarding how to use your medicine, including preparing and injecting it.
5. What should I know while using Levemir® FlexPen®?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using insulin.
Monitor your blood sugar levels regularly
Carry some sugary food or fruit juice with you, in case you experience hypoglycaemia
("a hypo").
|
|
Things you should not do
|
Do not stop using this medicine unless directed by your doctor to.
Do not share your insulin or needles with anyone.
|
|
Driving or using machines
|
If your blood sugar is low or high, your concentration and ability to react might
be affected, and, therefore, also your ability to drive or operate machines.
|
|
Drinking alcohol
|
Alcohol may mask the symptoms of hypos. If you drink alcohol, your need for insulin
may change.
|
|
Looking after your medicine
|
Store Levemir® FlexPen® that are not being used in the fridge between 2 and 8°C
You can keep the Levemir® FlexPen® that you are using, or that you are carrying as
a spare, either below 30°C or in a refrigerator. Discard any unused insulin after
4 weeks.
|
6. Are there any side effects?
The most common side effect when using insulin is low blood sugar levels (a hypo).
Tell your relatives, friends, close workmates, teachers or carers that you have diabetes.
It is important that they can recognise the signs and symptoms of a hypo.
Active ingredient:
insulin detemir (rys)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Levemir® FlexPen®. 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 Levemir® FlexPen®.
Where to find information in this leaflet:
1. Why am I using Levemir® FlexPen®?
Levemir® FlexPen® contains the active ingredient insulin detemir (rys). Levemir® is a basal (background) insulin. The abbreviation "rys" indicates the method
of genetic engineering used to manufacture this insulin.
Levemir® is a long-acting insulin used to treat diabetes mellitus.
Diabetes mellitus is a condition where your pancreas does not produce enough insulin
to control your blood sugar (glucose) level. Extra insulin is therefore needed.
There are two types of diabetes mellitus:
Type 1 diabetes
Type 2 diabetes.
Patients with type 1 diabetes always require insulin to control their blood sugar
levels.
Some patients with type 2 diabetes may also require insulin if initial treatment with
diet, exercise and tablets is not enough.
Levemir® can be used with a fast-acting insulin in Type 1 diabetes, and as add-on
therapy to some Type 2 diabetes medicines.
Levemir® lowers your blood sugar level after injection. The effect may last for up
to 24 hours.
FlexPen® is a pre-filled dial-a-dose insulin pen able to deliver from 1 to 60 units
of Levemir® in increments of 1 unit.
As with all insulins, the duration of action will vary according to the dose, injection
site, blood flow, temperature and level of physical activity.
Insulin is not addictive. Insulin is available only with a doctor’s prescription.
2. What should I know before I use Levemir® FlexPen®?
Warnings
Do not use Levemir® FlexPen® if:
you are allergic to insulin detemir, or any of the ingredients listed at the end of
this leaflet.
If you are experiencing a low blood sugar level (a hypo) when your dose is due.
If the expiry date printed on the pack has passed, or if the packaging is torn or
shows signs of tampering.
in insulin pumps
Do not inject Levemir® directly into a vein or muscle.
Check with your doctor if you:
are experiencing a lot of hypos, and follow their advice
have any other medical conditions, such as: kidney liver, adrenal gland, pituitary
gland or thyroid gland problems
take any medicines for any other condition
have an infection or fever
are planning to travel
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
can make managing your diabetes more difficult, and may require adjustment of how
much insulin you need.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Heart disease or a history of stroke
Tell your doctor as soon as possible if you experience signs of heart failure such
as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
Some patients with long-standing type 2 diabetes mellitus and heart disease or previous
stroke, and who are treated with a class of medicines known as thiazolidinediones
in combination with insulin can develop heart failure.
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 insulin and affect how it works.
Medicines that may
increase
the effect of insulin, and therefore reduce insulin requirements include:
other medicines used to treat type 2 diabetes
octreotide - used to treat gastrointestinal endocrine tumours and enlargement of parts
of the body (e.g. hands, feet, head) caused by abnormal growth hormone levels
lanreotide - used to treat enlargement of parts of the body (e.g. hands, feet, head)
caused by abnormal hormone levels
monoamine oxidase inhibitors (MAOIs) - used to treat depression
non-selective beta-blockers - used to treat certain heart conditions and high blood
pressure
alpha-blockers - used to treat high blood pressure and to relieve difficulty in passing
urine caused by an enlarged prostate
angiotensin converting enzyme (ACE) inhibitors - used to treat certain heart conditions,
high blood pressure and elevated protein/albumin in the urine
salicylates, e.g. aspirin - used to relieve pain and lower fever
anabolic steroids - used to promote growth
quinine - used to treat malaria and relieve muscle cramps
quinidine - used to treat heart problems
sulphonamides - a type of antibiotic used to treat bacterial infections.
Medicines that may
reduce
the effect of insulin, and increase insulin requirements include:
oral contraceptives ("the pill") - used for birth control
thiazides, frusemide or ethacrynic acid - used to treat high blood pressure or fluid
retention (oedema)
glucocorticoids (except when applied locally) - used to treat inflammatory conditions
thyroid hormones - used to treat malfunction of the thyroid gland
sympathomimetics - used to treat asthma
octreotide - used to treat gastrointestinal endocrine tumours and enlargement of parts
of the body (e.g. hands, feet, head) caused by abnormal growth hormone levels
lanreotide - used to treat enlargement of parts of the body (e.g. hands, feet, head)
caused by abnormal hormone levels
growth hormone - used to treat growth disorders
diazoxide - used to treat high blood pressure
asparaginase - used to treat leukaemia and lymph gland tumours
nicotinic acid - used to treat high cholesterol levels in the blood
oxymetholone - used to treat certain blood disorders
danazol - used to treat endometriosis, menorrhagia, fibrocystic breast disease and
hereditary angioedema.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Levemir®.
4. How do I use Levemir® FlexPen®?
How much to use
Carefully follow all instructions given to you by your doctor, nurse educator and
pharmacist regarding how to use your medicine.
Your doctor or diabetes education nurse will tell you how much of this medicine you
need to use each day.
It is very important that you manage your diabetes carefully. Too much or too little
insulin can cause serious effects.
When to use Levemir® FlexPen®
Levemir® is either injected once or twice daily. If you require twice daily dosing,
the evening dose can be administered either with the evening meal, at bedtime, or
12 hours after the morning dose. Your doctor will tell you when to inject your medicine.
How to use Levemir® FlexPen®
Follow the detailed instructions on how to inject Levemir® FlexPen® in the instructions
for use supplied with the product. These instructions are also available via the following
hyperlinks:
Levemir® FlexPen®
https://medsinfo.com.au/media/noilevfp
Your doctor or diabetes education nurse will tell you when and how often to inject
your insulin.
Inject insulin under the skin (subcutaneous injection) as shown by your doctor or
diabetes education nurse
Check the name and coloured label of your pen to make sure that it contains the correct
type of insulin.
Always use a new needle for each injection. This reduces the risk of contamination,
infection, leakage of insulin, blocked needles and inaccurate dosing.
Do not to bend or damage the needle before use.
Do not use your Levemir FlexPen® unless the insulin appears clear and colourless.
Do not use it if the insulin appears thick, coloured, or has solid bits in it.
Checking for insulin flow
Always check your Levemir FlexPen® for insulin flow (priming) before each injection,
as described in the Instructions for Use.
The priming procedure may highlight a malfunction with your insulin delivery device.
Priming also removes any air bubbles and helps indicate whether or not a needle is
broken.
Only dial up your required dose after you see a drop of insulin at the needle tip.
After priming, if you need to put the insulin delivery device down, make sure the
needle does not touch anything.
Choose a site for injection
Inject the medicine into the abdomen, thighs, upper arms or buttocks.
Change the injection site so that the same position is not used more often than once
a month. This reduces the risk of developing lumps or skin pitting.
Pinch the skin between two fingers, push the needle into the raised skin, and inject
the full dose of insulin under the skin.
Slowly count to 6 before pulling the needle out.
Keep the push button fully depressed until the needle has been withdrawn.
Apply gentle pressure over the injection site for several seconds
Do not rub the area
After injecting
Dispose of your used needle safely into a yellow plastic sharps container after each
injection.
Always remove the needle after each injection and store your FlexPen® without the
needle attached.
Do not share needles, insulin or insulin delivery devices.
How long to use Levemir® FlexPen®
Do not stop using Levemir® FlexPen® unless your doctor tells you to.
If you forget to inject your insulin - hyperglycaemia
Levemir® FlexPen® must be used strictly as advised by your doctor or nurse educator.
If you forget your insulin dose, test your blood sugar level as soon as possible.
If you are not sure what to do, talk to your doctor, diabetes education nurse or pharmacist.
Do not use a double dose of your insulin.
If it is almost time for your next dose, skip the dose you missed and inject your
next dose when you are meant to.
Otherwise, use it as soon as you remember and then go back to using it as you would
normally.
If you use too much insulin - hypoglycaemia
If you think that you have used too much insulin, 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 using Levemir® FlexPen®?
Hypoglycaemia
Your blood sugar level may become too low (you may experience hypoglycaemia (a hypo)
if you:
accidentally use too much of this medicine
have too much or unexpected exercise
delay eating meals or snacks
eat too little food
are ill.
The first symptoms of mild to moderate hypos can come on suddenly. They may include:
cold sweat, cool pale skin
fatigue, drowsiness, unusual tiredness and weakness
nervousness, feeling anxious, tremor, rapid heart beat
confusion, difficulty concentrating
excessive hunger
vision changes
headache, nausea.
Always carry some sugary food or fruit juice with you.
Do not inject any insulin if you feel a hypo coming on.
Tell your relatives, friends, close workmates or carers that you have diabetes. It
is important that they recognise the signs and symptoms of a hypo.
Make sure they know to give you some sugary food or fruit juice for mild to moderate
symptoms of a hypo.
If you lose consciousness, make sure they know:
to turn you on your side and get medical help immediately
not to give you anything to eat or drink as you may choke.
An injection of the hormone glucagon may speed up recovery from unconsciousness. This
can be given by a relative, friend, workmate or carer who knows how to give it.
If glucagon is used, eat some sugary food or have a sugary drink as soon as you are
conscious again.
If you do not feel better after this, contact your doctor, diabetes education nurse,
or the closest hospital.
See your doctor if you keep having hypo reactions, or if you have ever become unconscious
after using insulin.
Your insulin dose may need to be changed.
If a severe hypo is not treated, it can cause convulsions, brain damage and even death.
Hyperglycaemia
Your blood sugar levels may become high (hyperglycaemia) if you:
miss doses of insulin or use less insulin than you need
have uncontrolled diabetes
exercise less than usual
eat more carbohydrates than usual
are ill or stressed.
High blood sugar levels over a long period of time can lead to too much acid in the
blood (diabetic ketoacidosis).
Contact your doctor immediately if your blood sugar level is high or you recognise
any of the following symptoms.
Symptoms of mild to moderate hyperglycaemia include:
drowsy feeling
flushed face
thirst, loss of appetite
fruity odour on the breath
blurred vision
passing larger amounts of urine than usual
getting up at night more often than usual to pass urine
high levels of glucose and acetone in the urine.
Symptoms of severe hyperglycaemia include:
heavy breathing
fast pulse
nausea, vomiting
dehydration
loss of consciousness.
Severe hyperglycaemia can lead to unconsciousness and in extreme cases death if untreated.
Things you should do
Measure your blood sugar levels regularly.
Make sure all friends, relatives, workmates or carers know that you have diabetes.
If your child has diabetes, it is important to tell their teachers and carers.
Keep using your insulin even if you feel well. It helps to control your diabetes, but does not cure it.
Always carry some sugary food or fruit juice with you.
Tell your doctor if you are feeling sick, especially if you are experiencing nausea
or vomiting.
Tell your doctor if you have trouble recognising the symptoms of hypos.
Remind any doctor, dentist or pharmacist you visit that you are using Levemir FlexPen.
Tell your doctor if your diet changes or you are exercising more.
Tell your doctor if you notice any skin changes at the injection site.
The injection site should be rotated to help prevent changes to the fatty tissue under
the skin, such as skin thickening, skin shrinking or lumps under the skin. The insulin
may not work very well if you inject into a lumpy, shrunken or thickened area. Change
the injection site with each injection to help prevent these skin changes.
Tell your doctor, diabetes education nurse or pharmacist if you are travelling. Ask them for a letter explaining why you are taking injecting devices with you. Each
country you visit will need to see this letter, so you should take several copies.
You may need to inject your insulin and eat your meals at different times because
of time differences in and between countries.
You may not be able to get the same type of insulin in the country you are visiting.
Your doctor, diabetes education nurse or pharmacist can provide you with some helpful
information.
Things you should not do
Do not stop using your insulin unless your doctor tells you to.
Do not give your insulin to anyone else, even if they have diabetes.
Do not share needles or pens.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how the insulin
affects you.
If your blood sugar is low or high your concentration and ability to react might be
affected, and therefore also your ability to drive or operate a machine.
Bear in mind that you could endanger yourself or others. Please ask your doctor whether
you can drive a car, especially if:
• you have frequent hypos
• you find it hard to recognise hypos.
Drinking alcohol
Tell your doctor if you drink alcohol.
Alcohol may mask the signs of a hypo. Carefully monitor your blood sugar levels when
drinking.
Looking after your medicine
Store Levemir® FlexPen® that are not being used between 2°C and 8°C in the refrigerator
(away from the cooling element).
Keep the Levemir® FlexPen® that you are using, or that you are carrying as a spare,
either below 30°C or in a refrigerator (2°C - 8°C).
Protect the insulin in FlexPen® from light by keeping the pen cap on when not in use.
Do not allow Levemir® FlexPen® to be frozen, or exposed to excessive heat and light.
Never use Levemir® FlexPen® if the solution is not clear and colourless.
Keep it where young children cannot reach it.
When to discard your medicine
You can use Levemir® FlexPen® for up to 4 weeks after taking it out of the refrigerator
if kept below 30°C.
Discard Levemir® FlexPen® after 4 weeks even if there is still some insulin left in
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.
Never use insulin after the expiry date printed on the FlexPen® label and carton after
'Expiry'. The expiry date refers to the last day of that month.
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 Levemir® FlexPen® contains
|
Active ingredient
(main ingredient)
|
insulin detemir (rys) 100 U/mL
|
|
Other ingredients
(inactive ingredients)
|
glycerol
phenol
metacresol
zinc acetate
dibasic sodium phosphate dihydrate
sodium chloride
Water for Injection
hydrochloric acid and sodium hydroxide to adjust the pH
|
|
Potential allergens
|
metacresol
|
Do not take this medicine if you are allergic to any of these ingredients.
What Levemir® FlexPen® looks like
Levemir® is a clear, colourless solution for subcutaneous injection. Levemir® FlexPen®
is a 3mL pre-filled glass cartridge contained in a dial-a-dose insulin pen.
(AUST R 172234)
Who distributes Levemir® FlexPen®
Levemir® FlexPen® is supplied in Australia by:
Novo Nordisk Pharmaceuticals Pty Ltd
Level 10
118 Mount Street
North Sydney NSW 2060
Australia
Levemir® FlexPen® is supplied in New Zealand by:
Novo Nordisk Pharmaceuticals Ltd.
PO Box 51-268
Pakuranga
Auckland
New Zealand
Further information
For further information call Novo Nordisk Medical Information on 1800 668 626 (Australia)
or 0800 733 737 (New Zealand).
You can also get more information about diabetes from
Diabetes Australia:
freecall helpline 1300 136 588
Diabetes New Zealand:
freecall helpline 0800 342 238
Levemir® and FlexPen® are registered trademarks of
Novo Nordisk A/S.
© 2025
Novo Nordisk A/S
This leaflet was prepared in October 2025.