HUMULIN M3 100 IU/ML SUSPENSION FOR INJECTION IN VIAL

Active substance: INSULIN HUMAN (PRB)

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Humulin® M3 100 IU/ml suspension for injection in vial
(insulin, human)
Your medicine is known by the above name, but will be referred to as
Humulin M3 throughout this:
Patient Information 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 get serious, or if you notice any side effects not
listed in this leaflet, please tell your diabetes specialist nurse, doctor or
pharmacist.






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 breastfeeding, you may need to alter your insulin intake or diet.

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

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.

1) What Humulin M3 is and what it is used for

3) How to use Humulin M3

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:
 steroids,
 thyroid hormone replacement therapy,
 oral hypoglycaemics (antidiabetic medication),
 acetylsalicylic acid (aspirin),
 growth hormone,
 octreotide, lanreotide,
 beta2 stimulants (for example ritodrine, salbutamol or terbutaline),

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.
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
 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 yourself.
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 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”.

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.

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

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
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.




Keep out of the sight and reach of children.
Store in a refrigerator (2°C - 8°C). Do not freeze.
Do not expose to excessive heat or direct sunlight.
Keep the container in the outer carton.
Once in use the vial may be used for up to 28 days.
Do not use beyond this period. When in use the vial should not be stored
above 30°C.
Do not use Humulin M3 after the expiry date which is stated on the label
and 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 vial, giving it a frosted
appearance. Check this each time you inject yourself.
If your medicine becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist who will tell
you what to do.
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.

Common problems of diabetes

6) Further information
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.

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, m-cresol, phenol, glycerol,
dibasic sodium phosphate, zinc oxide, and water for injections. 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 is a white, sterile suspension and contains 100 units of insulin
in each millilitre (100IU/ml).
Each vial contains 1000 units (10 millilitres).
Humulin M3 100 IU/ml suspension for injection comes in a pack of 1 vial.
PL 10383/1907 Humulin M3 100 IU/ml suspension for injection in vial POM
Who makes and repackages your medicine
Your medicine is manufactured by Lilly France S.A.S, rue du Colonel Lilly,
67640 Fegersheim, France. Procured from within the EU and repackaged
by Product Licence Holder: Primecrown Ltd, 4/5 Northolt Trading Estate,
Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 17.07.2012
Humulin® is a registered trademark of Eli Lilly and Company, USA.

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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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