HUMULIN M3 100IU/ML SUSPENSION FOR INJECTION IN VIAL
Active substance(s): INSULIN HUMAN (PRB)
HUMULIN M3 100IU/ml SUSPENSION FOR INJECTION IN VIAL
This product is available as the above name but will be referred to as Humulin M3 throughout the remainder of this leaflet.
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
vial 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:
• thyroid hormone replacement therapy,
• oral hypoglycaemics (antidiabetic medication),
• acetylsalicylic acid (aspirin),
• growth hormone,
• octreotide, lanreotide,
• beta2 stimulants (for example ritodrine, salbutamol or terbutaline),
• thiazides or some antidepressants (monoamine oxidase inhibitors),
• some angiotensin converting (ACE) inhibitors (for example captopril, enalapril) or angiotensin II receptor
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 breastfeeding, 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
• frequent episodes of hypoglycaemia
• reduced or absent warning signs of hypoglycaemia.
3. HOW TO USE HUMULIN M3
Always check the pack and the vial 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.
Always use Humulin M3 exactly as your doctor has told you. You should check with your doctor if you are not sure.
• 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
• Vials containing Humulin M3 should be rotated several times in the palms of the hands before use to resuspend
insulin until it appears uniformly cloudy or milky. If not, repeat the above procedure until contents are mixed. Do
not shake vigorously as this may cause frothing which may interfere with the correct measurement of the dose.
The vials 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 vial, giving it a frosted appearance. Check each time you inject
Injecting Humulin M3
• First wash your hands.
• Before you make an injection, clean your skin as you have been instructed. Clean the rubber stopper on the
vial, but do not remove the stopper.
• Use a clean, sterile syringe and needle to pierce the rubber stopper and draw in the amount of Humulin M3 you
want. Your doctor or clinic will tell you how to do this. Do not share your needles and syringes.
• 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.
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
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
• fast heart beat
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.
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 the Yellow Card Scheme at:
By reporting side effects you can help provide more information on the safety of this medicine.
Common problems of diabetes
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:
● rapid heartbeat
• nervousness or shakiness
● feeling sick
● 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
● 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.
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
• Store in refrigerator (2-8°C). Do not freeze. Keep container in the outer carton, in order to protect it from light.
• Avoid exposure to excessive heat or direct sunlight. When in use do not store above 30°C.
• Vial in use may be kept for up to 28 days. Do not use beyond this period.
• Keep out of the sight and reach of children.
• Do not use Humulin M3 after the expiry date which is stated on the carton or the vial label. 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 vial, giving it a frosted appearance. Check this each time you inject yourself.
• If the liquid in the vial become discoloured you should seek the advice of your pharmacist who will tell you what
• 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 glycerol, dibasic sodium phosphate, protamine sulphate, zinc oxide with m-cresol and
phenol as preservatives in water for injections. Sodium hydroxide and/or hydrochloric acid may have been used to
What Humulin M3 looks like and contents of the pack
Humulin M3 is a suspension of white crystals in a glass vial with a rubber stopper with aluminium seal which is
covered by an orange plastic flip-top. One vial contains 10ml equivalent to 1000IU of biphasic isophane insulin –
30% soluble insulin / 70% isophane insulin.
PL No: 15814/0969
Manufactured by Lilly Industrial Centre, 120-1555 Kentucky Avenue, Indianapolis, IN56285, America. Procured
from with in the EU and repackaged by the Product Licence holder: OPD Laboratories Ltd, Unit 6 Colonial Way,
Watford, Herts WD24 4PR.
Humulin is a registered trademark of Eli Lilly and Company (USA).
Leaflet revision and issue date (ref): 05.12.2014
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.
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.