NOVOMIX 30 FlexPen 100 units/ml

Package leaflet: Information for the user
NovoMix® 30 FlexPen®
100 units/ml suspension for injection in a pre-filled pen
30% soluble insulin aspart and 70% insulin aspart crystallised with protamine
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What NovoMix® 30 is and what it is used for
2. What you need to know before you use NovoMix® 30
3. How to use NovoMix® 30
4. Possible side effects
5. How to store NovoMix® 30
6. Contents of the pack and other information
1. What NovoMix® 30 is and what it is used for
NovoMix® 30 is a modern insulin (insulin analogue) with both a rapid-acting and an intermediateacting effect, in the ratio 30/70. Modern insulin products are improved versions of human insulin.
NovoMix® 30 is used to reduce the high blood sugar level in adults, adolescents and children aged
10 years and above with diabetes mellitus (diabetes). Diabetes is a disease where your body does not
produce enough insulin to control the level of your blood sugar.
NovoMix® 30 will start to lower your blood sugar 10–20 minutes after you inject it, the maximum
effect occurs between 1 and 4 hours after the injection, and the effect lasts for up to 24 hours.
In treatment of type 2 diabetes mellitus, NovoMix® 30 may be used in combination with tablets for
diabetes and/or with injectable antidiabetic products.
2. What you need to know before you use NovoMix® 30
Do not use NovoMix® 30
► If you are allergic to insulin aspart or any of the other ingredients in this medicine (see section
6, Contents of the pack and other information).
► If you suspect hypoglycaemia (low blood sugar) is starting, see a) Summary of serious and very
common side effects in section 4.
► In insulin infusion pumps.
► If FlexPen® is dropped, damaged or crushed.
► If it has not been stored correctly or if it has been frozen, see section 5, How to store NovoMix®
30.
► If the resuspended insulin does not appear uniformly white, cloudy and aqueous.
► If after resuspension, clumps of material are present or if solid white particles stick to the
bottom or the wall of the cartridge.
If any of these apply, do not use NovoMix® 30. Talk to your doctor, nurse or pharmacist for advice.
Before using NovoMix® 30
► Check the label to make sure it is the right type of insulin.
► Always use a new needle for each injection to prevent contamination.
► Needles and NovoMix® 30 FlexPen® must not be shared.
► NovoMix® 30 FlexPen® is only suitable for injecting under the skin. Speak to your doctor if
you need to inject your insulin by another method.
Warnings and precautions
Some conditions and activities can affect your need for insulin. Consult your doctor:
► If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.
► If you exercise more than usual or if you want to change your usual diet, as this may affect your
blood sugar level.
► If you are ill, carry on taking your insulin and consult your doctor.
► If you are going abroad, travelling over time zones may affect your insulin needs and the timing
hereof.
Children and adolescents
• NovoMix® 30 can be used in adolescents and children aged 10 years and above.
• There is limited experience with NovoMix® 30 in children aged 6–9 years.
• No data are available for NovoMix® 30 in children below 6 years of age.
Other medicines and NovoMix® 30
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other
medicines. Some medicines affect your blood sugar level and this may mean that your insulin dose has
to change. Listed below are the most common medicines which may affect your insulin treatment.
Your blood sugar level may fall (hypoglycaemia) if you take:
• Other medicines for the treatment of diabetes
• Monoamine oxidase inhibitors (MAOI) (used to treat depression)
• Beta-blockers (used to treat high blood pressure)
• Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high
blood pressure)
• Salicylates (used to relieve pain and lower fever)
• Anabolic steroids (such as testosterone)
• Sulfonamides (used to treat infections).
Your blood sugar level may rise (hyperglycaemia) if you take:
• Oral contraceptives (birth control pills)
• Thiazides (used to treat high blood pressure or excessive fluid retention)
• Glucocorticoids (such as ‘cortisone’ used to treat inflammation)
• Thyroid hormones (used to treat thyroid gland disorders)
• Sympathomimetics (such as epinephrine [adrenaline], salbutamol or terbutaline used to treat
asthma)
• Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced
influence on the body’s metabolic processes)
• Danazol (medicine acting on ovulation).
Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually
occurs in middle-aged adults, caused by the pituitary gland producing excess growth hormone) may
either increase or decrease your blood sugar level.
Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning
symptoms which help you to recognise low blood sugar.
Pioglitazone (tablets used for the treatment of type 2 diabetes)
Some patients with long-standing type 2 diabetes and heart disease or previous stroke who were
treated with pioglitazone and insulin experienced the development of heart failure. Inform 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).
If you have taken any of the medicines listed here, tell your doctor, nurse or pharmacist.
Drinking alcohol and taking NovoMix® 30
► If you drink alcohol, your need for insulin may change as your blood sugar level may either rise
or fall. Careful monitoring is recommended.
Pregnancy and breast-feeding
► If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor
for advice before taking this medicine. There is limited clinical experience with insulin aspart in
pregnancy. Your insulin dose may need to be changed during pregnancy and after delivery.
Careful control of your diabetes, particularly prevention of hypoglycaemia, is important for the
health of your baby.
► There are no restrictions on treatment with NovoMix® 30 during breast-feeding.
Ask your doctor, nurse or pharmacist for advice before taking any medicine while pregnant or
breast-feeding.
Driving and using machines
► Please ask your doctor whether you can drive a car or operate a machine:
• If you have frequent hypoglycaemia.
• If you find it hard to recognise hypoglycaemia.
If your blood sugar is low or high, it might affect your concentration and ability to react and therefore
also your ability to drive or operate a machine. Bear in mind that you could endanger yourself or
others.
Important information about some of the ingredients in NovoMix® 30
NovoMix® 30 contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoMix® 30 is essentially
‘sodium-free’.
3. How to use NovoMix® 30
Dose and when to take your insulin
Always use your insulin and adjust your dose exactly as your doctor has told you. Check with your
doctor, nurse or pharmacist if you are not sure.
NovoMix® 30 is generally taken immediately before a meal. Eat a meal or snack within 10 minutes of
the injection to avoid low blood sugar. When necessary, NovoMix® 30 can be given soon after a
meal. See How and where to inject, below for information.
Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one
type or brand of insulin to another, your dose may have to be adjusted by your doctor.
When NovoMix® 30 is used in combination with tablets for diabetes and or/with injectable
antidiabetic products your dose may have to be adjusted by your doctor.
Use in children and adolescents
NovoMix® 30 can be used in adolescents and children aged 10 years and above when premixed
insulin is preferred. Limited clinical data exists for children aged 6–9 years. No data are available for
NovoMix® 30 in children below 6 years of age.
Use in special patient groups
If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check
your blood sugar more regularly and discuss changes in your insulin dose with your doctor.
How and where to inject
NovoMix® 30 is for injection under the skin (subcutaneously). Never inject your insulin directly
into a vein (intravenously) or muscle (intramuscularly). NovoMix® 30 FlexPen® is only suitable for
injecting under the skin. Speak to your doctor if you need to inject your insulin by another method.
With each injection, change the injection site within the particular area of skin that you use. This may
reduce the risk of developing lumps or skin pitting (see section 4, Possible side effects). The best
places to give yourself an injection are: the front of your waist (abdomen); your buttocks; the front of
your thighs or upper arms. The insulin will work more quickly if you inject around the waist. You
should always measure your blood sugar regularly.
How to handle NovoMix® 30 FlexPen®
NovoMix® 30 FlexPen® is a pre-filled, colour-coded, disposable pen containing a mixture of rapidacting and intermediate-acting insulin aspart in the ratio 30/70.
Read carefully the instructions for use included in this package leaflet. You must use the pen as
described in the Instructions for use.
Always ensure you use the correct pen before you inject your insulin.
If you take more insulin than you should
If you take too much insulin, your blood sugar gets too low (hypoglycaemia). See a) Summary of
serious and very common side effects in section 4.
If you forget to take your insulin
If you forget to take your insulin, your blood sugar may get too high (hyperglycaemia). See c) Effects
from diabetes in section 4.
If you stop taking your insulin
Do not stop taking your insulin without speaking with a doctor, who will tell you what needs to be
done. This could lead to very high blood sugar (severe hyperglycaemia) and ketoacidosis. See c)
Effects from diabetes in section 4.
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
a) Summary of serious and very common side effects
Low blood sugar (hypoglycaemia) is a very common side effect. It may affect more than 1 in
10 people.
Low blood sugar may occur if you:
• Inject too much insulin.
• Eat too little or miss a meal.
• Exercise more than usual.
• Drink alcohol (see Drinking alcohol and taking NovoMix® 30 in section 2).
Signs of low blood sugar: Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling
very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness
or tremor; feeling anxious; feeling confused; difficulty in concentrating.
Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not
treated, it can cause brain damage (temporary or permanent) and even death. You may recover more
quickly from unconsciousness with an injection of the hormone glucagon given by someone who
knows how to use it. If you are given glucagon, you will need glucose or a sugar snack as soon as you
are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital.
What to do if you experience low blood sugar:
► If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets,
biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets
or high sugar snacks with you, just in case.
► When the symptoms of low blood sugar have disappeared or when your blood sugar level is
stabilised, continue insulin treatment as usual.
► If you have such low blood sugar that it makes you pass out, if you have had the need for an
injection of glucagon, or if you have experienced many incidents of low blood sugar, talk to a
doctor. The amount or timing of insulin, food or exercise may need to be adjusted.
Tell relevant people that you have diabetes and what the consequences may be, including the risk of
passing out (becoming unconscious) due to low blood sugar. Let them know that if you pass out, they
must turn you on your side and get medical help straight away. They must not give you any food or
drink because you may choke.
Serious allergic reactions to NovoMix® 30 or one of its ingredients (called a systemic allergic
reaction) is a very rare side effect, but it can potentially be life-threatening. It may affect less than 1 in
10,000 people.
Seek medical advice immediately:
• If signs of allergy spread to other parts of your body.
• If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty
in breathing; have a rapid heartbeat; feel dizzy.
► If you notice any of these signs, seek medical advice immediately.
b) List of other side effects
Uncommon side effects
May affect less than 1 in 100 people.
Signs of allergy: Local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and
itching) at the injection site may occur. These usually disappear after a few weeks of taking your
insulin. If they do not disappear, see your doctor.
Vision problems: When you first start your insulin treatment, it may disturb your vision, but the
disturbance is usually temporary.
Changes at the injection site (lipodystrophy): The fatty tissue under the skin at the injection site may
shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection reduces the
risk of developing such skin changes. If you notice your skin pitting or thickening at the injection site,
tell your doctor or nurse. These reactions can become more severe, or they may change the absorption
of your insulin, if you inject in such a site.
Swollen joints: When you start taking insulin, water retention may cause swelling around your ankles
and other joints. Normally, this soon disappears. If not, contact your doctor.
Diabetic retinopathy (an eye disease related to diabetes which can lead to loss of vision): If you have
diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse.
Ask your doctor about this.
Rare side effects
May affect less than 1 in 1,000 people.
Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you
may get nerve related pain. This is called acute painful neuropathy and is usually transient.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2
Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: medsafety@hpra.ie
United Kingdom
Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in
the Google Play or Apple App Store
By reporting side effects you can help provide more information on the safety of this medicine.
c) Effects from diabetes
High blood sugar (hyperglycaemia)
High blood sugar may occur if you:
• Have not injected enough insulin.
• Forget to take your insulin or stop taking insulin.
• Repeatedly take less insulin than you need.
• Get an infection and/or a fever.
• Eat more than usual.
• Exercise less than usual.
Warning signs of high blood sugar:
The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your
appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed; dry skin; dry mouth and a
fruity (acetone) smell of the breath.
What to do if you experience high blood sugar:
► If you get any of the above signs: test your blood sugar level, test your urine for ketones if you
can, then seek medical advice immediately.
► These may be signs of a very serious condition called diabetic ketoacidosis (build-up of acid in
the blood because the body is breaking down fat instead of sugar). If you do not treat it, this
could lead to diabetic coma and eventually death.
5. How to store NovoMix® 30
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the FlexPen® label and carton after
‘EXP’. The expiry date refers to the last day of that month.
Always keep the pen cap on your FlexPen® when you are not using it, in order to protect it from light.
NovoMix® 30 must be protected from excessive heat and light.
Before opening: NovoMix® 30 FlexPen® that is not being used must be stored in the refrigerator at
2C to 8C, away from the cooling element. Do not freeze.
Before you use NovoMix® 30 FlexPen®, remove it from the refrigerator. It is recommended to
resuspend the insulin as instructed every time you use a new pen. See Instructions for use.
During use or when carried as a spare: NovoMix® 30 FlexPen® that is being used or carried as a
spare should not be kept in the refrigerator. You can carry it with you and keep it at room temperature
(below 30°C) for up to 4 weeks.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What NovoMix® 30 contains
• The active substance is insulin aspart. NovoMix® 30 is a mixture consisting of 30% soluble
insulin aspart and 70% insulin aspart crystallised with protamine. 1 ml contains 100 units of
insulin aspart. Each pre-filled pen contains 300 units of insulin aspart in 3 ml suspension for
injection.
• The other ingredients are glycerol, phenol, metacresol, zinc chloride, disodium phosphate
dihydrate, sodium chloride, protamine sulfate, hydrochloric acid, sodium hydroxide and water
for injections.
What NovoMix® 30 looks like and contents of the pack
NovoMix® 30 is presented as a suspension for injection in a pre-filled pen. The cartridge contains a
glass ball to facilitate resuspension. After resuspension, the liquid should appear uniformly white,
cloudy and aqueous. Do not use the insulin, if it does not look uniformly white, cloudy and aqueous
after resuspension.
Pack sizes of 1 (with or without needles), 5 (without needles) and 10 (without needles) pre-filled pens
of 3 ml. Not all pack sizes may be marketed.
The suspension is cloudy, white and aqueous.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd, Denmark
Manufacturer
The manufacturer can be identified by the batch number printed on the slip of the carton and on the
label:
• If the second and third characters are S6, P5, K7, R7, VG, FG or ZF, the manufacturer is Novo
Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark.
• If the second and third characters are H7 or T6, the manufacturer is Novo Nordisk Production
SAS, 45 Avenue d’Orléans, F-28000 Chartres, France.
Now turn over for information on how to use your FlexPen®.
This leaflet was last revised in 03/2019
Other sources of information
Detailed information on this medicine is available on the website of the European Medicines Agency
http://www.ema.europa.eu.
NovoMix®, FlexPen®, NovoFine® and NovoTwist®
are trademarks owned by
Novo Nordisk A/S, Denmark
© 2018
Novo Nordisk A/S
Instruction on how to use NovoMix® 30 suspension for injection in FlexPen®.
Read the following instructions carefully before using your FlexPen®. If you do not follow the
instructions carefully, you may get too little or too much insulin, which can lead to too high or too low
blood sugar level.
Your FlexPen® is a pre-filled dial-a-dose insulin pen.
► You can select doses from 1 to 60 units in increments of 1 unit.
► FlexPen® is designed to be used with NovoFine® or NovoTwist® disposable needles up to a
length of 8 mm.
► Always carry a spare insulin delivery device in case your FlexPen® is lost or damaged.
Pen cap
NovoMix® 30 FlexPen® Glass
ball
Cartridge
Pointer
Dose
selector
Pushbutton
Big outer
needle cap
Inner
needle cap
Needle Paper tab
12 units Residual
scale
Needle (example)
Caring for your pen
► Your FlexPen® must be handled with care. If it is dropped, damaged or crushed, there is a risk
of insulin leakage. This may cause inaccurate dosing, which can lead to too high or too low
blood sugar level.
► You can clean the exterior of your FlexPen® by wiping it with a medicinal swab. Do not soak,
wash or lubricate it as it may damage the pen.
► Do not refill your FlexPen®.
Resuspending your insulin
A
Check the name and coloured label of your pen to make sure that it contains the correct type of
insulin. This is especially important if you take more than one type of insulin. If you take the wrong
type of insulin, your blood sugar level may get too high or too low.
Every time you use a new pen
Let the insulin reach room temperature before you use it. This makes it easier to resuspend.
Pull off the pen cap.
A
B
Before your first injection with a new FlexPen®, you must resuspend the insulin:
Roll the pen between your palms 10 times – it is important that the pen is kept horizontal (level with
the ground).
B
C
Then move the pen up and down 10 times between the two positions as shown, so the glass ball
moves from one end of the cartridge to the other.
Repeat rolling and moving the pen until the liquid does appear uniformly white, cloudy and aqueous.
For every following injection
Move the pen up and down between the two positions at least 10 times until the liquid does appear
uniformly white, cloudy and aqueous.
► Always make sure that you have resuspended the insulin prior to each injection. This reduces
the risk of too high or too low blood sugar level. After you have resuspended the insulin,
complete all the following steps of injection without delay.
C
Always check there are at least 12 units of insulin left in the cartridge to allow resuspension. If
there are less than 12 units left, use a new FlexPen®. 12 units are marked on the residual scale.
See the big picture on top of this instruction.
Do not use the pen if the resuspended insulin does not look uniformly white, cloudy and
aqueous.
Attaching a needle
D
Take a new needle and tear off the paper tab.
Screw the needle straight and tightly onto your FlexPen®.
D
E
Pull off the big outer needle cap and keep it for later.
E
F
Pull off the inner needle cap and dispose of it.
Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.
F
Always use a new needle for each injection. This reduces the risk of contamination, infection,
leakage of insulin, blocked needles and inaccurate dosing.
Be careful not to bend or damage the needle before use.
Checking the insulin flow
Prior to each injection, small amounts of air may collect in the cartridge during normal use. To
avoid injection of air and ensure proper dosing:
G
Turn the dose selector to select 2 units.
G
2 units
selected
H
Hold your FlexPen® with the needle pointing upwards and tap the cartridge gently with your finger a
few times to make any air bubbles collect at the top of the cartridge.
H
I
Keeping the needle upwards, press the push-button all the way in. The dose selector returns to 0.
A drop of insulin should appear at the needle tip. If not, change the needle and repeat the procedure no
more than 6 times.
If a drop of insulin still does not appear, the pen is defective, and you must use a new one.
I
Always make sure that a drop appears at the needle tip before you inject. This makes sure that
the insulin flows. If no drop appears you will not inject any insulin, even though the dose
selector may move. This may indicate a blocked or damaged needle.
Always check the flow before you inject. If you do not check the flow, you may get too little
insulin or no insulin at all. This may lead to too high blood sugar level.
Selecting your dose
Check that the dose selector is set at 0.
J
Turn the dose selector to select the number of units you need to inject.
The dose can be corrected either up or down by turning the dose selector in either direction until the
correct dose lines up with the pointer. When turning the dose selector, be careful not to push the pushbutton as insulin will come out.
You cannot select a dose larger than the number of units left in the cartridge.
J
5 units
selected
24 units
selected
Always use the dose selector and the pointer to see how many units you have selected before
injecting the insulin.
Do not count the pen clicks. If you select and inject the wrong dose, your blood sugar level may
get too high or too low. Do not use the residual scale, it only shows approximately how much
insulin is left in your pen.
Making the injection
Insert the needle into your skin. Use the injection technique shown by your doctor or nurse.
K
Inject the dose by pressing the push-button all the way in until 0 lines up with the pointer. Be careful
only to push the push-button when injecting.
Turning the dose selector will not inject insulin.
K
L
► Keep the push-button fully depressed and let the needle remain under the skin for at least
6 seconds. This will make sure you get the full dose.
► Withdraw the needle from the skin, then release the pressure on the push-button.
► Always make sure that the dose selector returns to 0 after the injection. If the dose selector stops
before it returns to 0, the full dose has not been delivered, which may result in too high blood
sugar level.
L
M
Lead the needle into the big outer needle cap without touching it. When the needle is covered,
carefully push the big outer needle cap completely on and then unscrew the needle.
Dispose of it carefully and put the pen cap back on your FlexPen®.
M
Always remove the needle after each injection and store your FlexPen® without the needle
attached. This reduces the risk of contamination, infection, leakage of insulin, blocked needles
and inaccurate dosing.
Further important information
Caregivers must be very careful when handling used needles to reduce the risk of needle sticks
and cross-infection.
Dispose of the used FlexPen® carefully without the needle attached.
Never share your pen or your needles with other people. It might lead to cross-infection.
Never share your pen with other people. Your medicine might be harmful to their health.
Always keep your pen and needles out of sight and reach of others, especially children.