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HUMULIN M3 100 IU/ML SUSPENSION FOR INJECTION IN CARTRIDGE

Active substance: INSULIN HUMAN (PRB)

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PA003ITAA00
PACKAGE LEAFLET: INFORMATION FOR THE USER

HUMULIN M3 (Mixture 3) 100 IU/ml
®

suspension for injection in cartridge
(insulin, human)

PA003ITAA00

Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your diabetes specialist nurse,
doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your diabetes specialist nurse, doctor
or pharmacist.
In this leaflet:
1. What Humulin M3 is and what it is used for
2. Before you use Humulin M3
3. How to use Humulin M3
4. Possible side effects
5. How to store Humulin M3
6. Further information

1. WHAT HUMULIN M3 IS AND WHAT IT IS
USED FOR
Humulin M3 contains the active substance human insulin, which is used to treat
diabetes. You get diabetes if your pancreas does not make enough insulin to
control the level of glucose in your blood (blood sugar). Humulin M3 is used to
control glucose in the long term. It is a premixed suspension of rapid and long
acting insulin. Its action is prolonged by the inclusion of protamine sulphate in
the suspension.
Your doctor may tell you to use Humulin M3 as well as a longer-acting insulin.
Each kind of insulin comes with its own patient information leaflet to tell you
about it. Do not change your insulin unless your doctor tells you to. Be very
careful if you do change insulin. Each type of insulin has a different colour and
symbol on the pack and the cartridge so that you can easily tell the difference.

2. BEFORE YOU USE HUMULIN M3
Do not use Humulin M3 if you:
- think hypoglycaemia (low blood sugar) is starting. Further in this leaflet
it tells you how to deal with mild hypoglycaemia (see A in Section 4).
- are allergic (hypersensitive) to human insulin or any of the other
ingredients of Humulin M3 (see Section 6).
Take special care with Humulin M3
• If your blood sugar levels are well controlled by your current insulin
therapy, you may not feel the warning symptoms when your blood sugar is
falling too low. Warning signs are listed later in this leaflet. You must think
carefully about when to have your meals, how often to exercise and how
much to do. You must also keep a close watch on your blood sugar levels
by testing your blood glucose often.

• A few people who have had hypoglycaemia (low blood sugar) after switching
from animal insulin to human insulin have reported that the early warning
symptoms were less obvious or different. If you often have hypoglycaemia or
have difficulty recognising the symptoms, please discuss this with your doctor.
• If you answer YES to any of the following questions, tell your diabetes
specialist nurse, doctor or pharmacist.
- Have you recently become ill?
- Do you have trouble with your kidneys or liver?
- Are you exercising more than usual?
• The amount of insulin you need may also change if you drink alcohol.
• You should also tell your diabetes specialist nurse, doctor or pharmacist if
you are planning to go abroad. The time difference between countries may
mean that you have to have your injections and meals at different times to
when you are at home.
• Some patients with long-standing type 2 diabetes mellitus 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).
Using other medicines
Please tell your doctor or diabetes specialist nurse, if you are taking or have recently
taken any other medicines, including medicines obtained without a prescription.
Your insulin needs may change if you are taking any of the following:
• steroids,
• thyroid hormone replacement therapy,
• oral hypoglycaemics (antidiabetic medication),
• acetylsalicylic acid (aspirin),
• growth hormone,
• octreotide, lanreotide,
• beta2 stimulants (for example ritodrine, salbutamol or terbutaline),
• beta-blockers,
• thiazides or some antidepressants (monoamine oxidase inhibitors),
• danazol,
• some angiotensin converting (ACE) inhibitors (for example captopril,
enalapril) or angiotensin II receptor blockers.
Pregnancy and breast-feeding
Ask your doctor or diabetes specialist nurse for advice before taking any medicine.
The amount of insulin you need usually falls during the first three months of
pregnancy and increases for the remaining six months. If you are
breast-feeding, you may need to alter your insulin intake or diet.
Driving and using machines
Your ability to concentrate and react may be reduced if you have
hypoglycaemia (low blood sugar). Please remember this in all situations where
you might put yourself and others at risk (e.g. driving a car or operating
machinery). You should contact your diabetes specialist nurse or doctor about
the advisability of driving if you have:
• frequent episodes of hypoglycaemia,
• reduced or absent warning signs of hypoglycaemia.

Dosage
• Your doctor has told you which insulin to use, how much, when and how
often to inject. These instructions are only for you. Follow them exactly
and visit your diabetes clinic regularly.
• If you change your insulin type (for example from animal to human), you
may have to take more or less than before. This might just be for the first
injection or it may be a gradual change over several weeks or months.
• Inject Humulin M3 under the skin. You should not administer it using a
different administration route. Under no circumstances should Humulin
M3 be given into a vein.
Preparing Humulin M3
• Cartridges containing Humulin M3 should be rotated in the palms of the
hands 10 times and inverted 10 times immediately before use to resuspend
insulin until it appears uniformly cloudy or milky. If not, repeat the above
procedure until contents are mixed. Cartridges contain a small glass bead to
assist mixing. Do not shake vigorously as this may cause frothing which may
interfere with the correct measurement of the dose. The cartridges should be
examined frequently and should not be used if clumps of material are present
or if solid white particles stick to the bottom or sides of the cartridge, giving
it a frosted appearance. Check each time you inject yourself.
Getting the pen ready to use
• First wash your hands. Disinfect the rubber membrane of the cartridge.
• You must only use Humulin M3 cartridges in compatible CE marked
pens. Please make sure that Humulin M3 or Lilly cartridges are
mentioned in the leaflet accompanying your pen. The 3 ml cartridge
only fits the 3 ml pen.
• Follow the instructions that come with the pen. Put the cartridge into the pen.
• You will set the dose to 1 or 2 units. Then hold the pen with the needle
pointing up and tap the side of the pen so that any bubbles float to the top.
With the pen still pointing up, press the injection mechanism. Do this until
a drop of Humulin M3 comes out of the needle. There may still be some
small air bubbles left in the pen. These are harmless, but if the air bubble is
too big, it may make the dose of your injection less accurate.
Injecting Humulin M3
• Before you make an injection, clean your skin as you have been instructed.
Inject under the skin, as you were taught. Do not inject directly into a vein.
After your injection, leave the needle in the skin for 5 seconds to make sure
you have taken the whole dose. Do not rub the area you have just injected.
Make sure you inject at least half an inch (1 cm) from where you last injected
and that you ‘rotate’ the places you inject, as you have been taught.
After injecting
• As soon as you have done the injection, unscrew the needle from the pen
using the outer needle cap. This will keep the insulin sterile and prevent
leaking. It will also stop air going back into the pen and the needle clogging
up. Do not share your needles or your pen. Replace the cap on your pen.

Always check the pack and the cartridge label for the name and type of the
insulin when you get it from your pharmacy. Make sure you get the
Humulin that your doctor has told you to use.

Further injections
• Leave the cartridge in the pen. Before every injection, dial 1 or 2 units and
press the injection mechanism with the pen pointing up until a drop of
Humulin M3 comes out of the needle. You can see how much Humulin M3
is left by looking at the gauge on the side of the cartridge. The distance
between each mark on the gauge is about 20 units. If there is not enough
for your dose, change the cartridge.

Always use Humulin M3 exactly as your doctor has told you. You should check
with your doctor if you are not sure.

Do not mix any other insulin in a Humulin M3 cartridge. Once the
cartridge is empty, do not use it again.

3. HOW TO USE HUMULIN M3
The 3 ml cartridge is only for use in 3 ml pens. It is not for use in 1.5 ml pens.

If you take more Humulin M3 than you need
If you take more Humulin M3 than you need, your blood sugar may become
low. Check your blood sugar (see A in Section 4).
If you forget to use Humulin M3
If you take less Humulin M3 than you need, your blood sugar levels may
increase. Check your blood sugar.
If you stop using Humulin M3
If you take less Humulin M3 than you need, your blood sugar levels may
become too high. Do not change your insulin unless your doctor tells you to.
If you have any further questions on the use of this product, ask your diabetes
specialist nurse, doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Humulin M3 can cause side effects, although not everybody
gets them.
Human insulin may cause hypoglycaemia (low blood sugar). See more
information on hypoglycaemia below in the subsection “Common
problems of diabetes”.
Possible side effects
Systemic allergy is very rare (affects less than 1 person in 10,000). The
symptoms are as follows:
• fall in blood pressure
• rash over the whole body
• difficulty in breathing
• wheezing
• fast heart beat
• sweating
If you think you are having this sort of insulin allergy with Humulin M3, tell
your doctor at once.
Local allergy is common (affects less than 1 person in 10). Some people get redness,
swelling or itching around the area of the insulin injection. This usually clears up in
anything from a few days to a few weeks. If this happens to you, tell your doctor.
Lipodystrophy (thickening or pitting of the skin) is uncommon (affects less
than 1 person in 100). If you notice your skin thickening or pitting at the
injection site, change your injection site and tell your doctor.
Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported,
particularly at the start of insulin therapy or during a change in therapy to
improve control of your blood glucose.
If any of the side effects gets serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor or pharmacist.
Common problems of diabetes
A. Hypoglycaemia
Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood.
This can be caused if you:
• take too much Humulin M3 or other insulin;
• miss or delay meals or change your diet;
• exercise or work too hard just before or after a meal;
• have an infection or illness (especially diarrhoea or vomiting);
• have a change in your need for insulin; or
• have trouble with your kidneys or liver which gets worse.
Alcohol and some medicines can affect your blood sugar levels.

The first symptoms of low blood sugar usually come on quickly and include the
following:
• tiredness
• rapid heartbeat
• nervousness or shakiness
• feeling sick
• headache
• cold sweat
Until you become confident in recognising your warning symptoms, avoid situations
such as driving a car, in which you or others would be put at risk by hypoglycaemia.
Do not use Humulin M3 if you think hypoglycaemia (low blood sugar) is starting.
If your blood sugar is low, eat glucose tablets, sugar or drink a sugary drink. Then
eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some
rest. This will often get you over mild hypoglycaemia or a minor insulin overdose.
If you get worse and your breathing is shallow and your skin gets pale, tell your
doctor at once. A glucagon injection can treat quite severe hypoglycaemia. Eat
glucose or sugar after the glucagon injection. If you do not respond to glucagon,
you will have to go to hospital. Ask your doctor to tell you about glucagon.
B. Hyperglycaemia and diabetic ketoacidosis
Hyperglycaemia (too much sugar in the blood) means that your body does not
have enough insulin. Hyperglycaemia can be brought about by:
• not taking your Humulin M3 or other insulin;
• taking less insulin than your doctor tells you to;
• eating a lot more than your diet allows; or
• fever, infection or emotional stress.
Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on
slowly over many hours or days. The symptoms include the following:
• feeling sleepy
• no appetite
• flushed face
• fruity smell on the breath
• thirst
• feeling or being sick
Severe symptoms are heavy breathing and a rapid pulse. Get medical help
immediately.
If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) are
not treated they can be very serious and cause headaches, nausea, vomiting,
dehydration, unconsciousness, coma or even death.
Three simple steps to avoid hypoglycaemia or hyperglycaemia are:
• Always keep spare syringes and a spare vial of Humulin M3.
• Always carry something to show you are diabetic.
• Always carry sugar with you.
C. Illness
If you are ill, especially if you feel sick or are sick, the amount of insulin you
need may change. Even when you are not eating normally, you still need
insulin. Test your urine or blood, follow your ‘sick rules’, and tell your diabetes
specialist nurse or doctor.

5. HOW TO STORE HUMULIN M3
Keep out of the reach and sight of children.
Before the first use, store your Humulin M3 in a refrigerator (2°C – 8°C).
Do not freeze. Keep your ‘in-use’ pen and cartridge at room temperature (below
30°C) for up to 28 days. Do not keep your ‘in-use’ pen or cartridges in the fridge.
Do not put them near heat or in the sun.

Do not use Humulin M3 after the expiry date which is stated on the label and
the carton. The expiry date refers to the last day of that month.
Do not use Humulin M3, if clumps of material are present or if solid white
particles stick to the bottom or sides of the cartridge, giving it a frosted
appearance. Check this each time you inject yourself.
Medicines should not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6. FURTHER INFORMATION
What Humulin M3 contains
The active substance is human insulin. Human insulin is made in the laboratory
by a ‘recombinant DNA technology’ process. It has the same structure as the
natural hormone made by the pancreas. It is therefore different from animal
insulins. Humulin M3 is a premixed suspension which contains 30 % insulin
dissolved in water and 70% insulin with protamine sulphate.
The other ingredients are protamine sulphate, metacresol, phenol, glycerol,
dibasic sodium phosphate 7H2O, zinc oxide and water for injection. Sodium
hydroxide or hydrochloric acid may have been used during manufacture to
adjust the acidity.
What Humulin M3 looks like and contents of the pack
Humulin M3 (Mixture 3) suspension for injection is a white, sterile suspension
and contains 100 units of insulin in each millilitre (100 IU/ml). Each cartridge
contains 300 units (3 millilitres).
The cartridges come in packs of 5 cartridges.
Marketing Authorisation Holder and Manufacturer
Humulin M3 in cartridge is made by:
Eli Lilly Italia S.p.A., Via A. Gramsci, 731-733, 50019 Sesto Fiorentino, Italy.
The marketing authorisation is held by: Eli Lilly and Company Limited, Lilly
House, Priestley Road, Basingstoke, Hampshire RG24 9NL, U.K.
It is distributed in the Republic of Ireland by Eli Lilly and Company (Ireland)
Limited, Hyde House, 65 Adelaide Road, Dublin 2, Ireland.
This medicinal product is authorised in the Member States of the EEA
under the following names:
Huminsulin „Lilly“ Profil III 100 I.E./ml (Austria)
Humuline 30/70 (Belgium, Luxembourg, The Netherlands)
Huminsulin Profil III (Germany)
Humulin M3 (Estonia, Ireland, Latvia, Lithuania, Malta, Poland, Portugal, UK)
Humulin Mix 30/70 (Sweden)
Humulin 30/70 (Italy)
Umuline profil 30 (France)
Humulin M3 (30/70) (Bulgaria, Czech Republic, Greece, Hungary, Romania,
Slovakia, Slovenia)
This leaflet was last approved in June 2012.
If you would like a large-print version of this leaflet, please phone
01256 315000 (UK) or 01 6614377 (Ireland)

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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