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HUMULIN M3 KWIKPEN 100 IU/ML SUSPENSION FOR INJECTION

Active substance(s): HUMAN INSULIN

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Package leaflet: Information for the user

HUMULIN® M3 (Mixture 3) KwikPen™
100 IU/ml suspension for injection
(Insulin human)

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, pharmacist or nurse.
- 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, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Humulin M3 KwikPen is and what it is used for
2. What you need to know before you use Humulin M3 KwikPen
3. How to use Humulin M3 KwikPen
4. Possible side effects
5. How to store Humulin M3 KwikPen
6. Contents of the pack and other information

1. What Humulin M3 KwikPen is and what it is used for
Humulin M3 KwikPen is a pre-filled pen containing 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 sulfate in the suspension.
Your doctor may tell you to use Humulin M3 KwikPen 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 pen so that you can easily tell the difference.

2. What you need to know before you use Humulin M3 KwikPen
Do not use Humulin M3 KwikPen:
- 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).
- If you are allergic to human insulin or any of the other ingredients of this
medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Humulin M3 KwikPen.
• 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).
Other medicines and Humulin M3 KwikPen
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
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, breast-feeding and fertility
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.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice before using this medicine.
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.

3. How to use Humulin M3 KwikPen
Always check the pack and the label of the pre-filled pen for the name and
type of the insulin when you get it from your pharmacy. Make sure you get
the Humulin KwikPen that your doctor has told you to use.
Always use this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure. To prevent the possible
transmission of disease, each pen must be used by you only, even if the needle
is changed.
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 KwikPen
• The KwikPen 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 in the pen 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 in the pen 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 KwikPen ready to use (Please see user manual)
• First wash your hands.
• Read the instructions on how to use your pre-filled insulin pen. Please follow
the instructions carefully.
Here are some reminders.
- Use a clean needle. (Needles are not included).
- Prime your KwikPen before each use. This checks that insulin comes out
and clears the air bubbles from your KwikPen. There may still be some
small air bubbles left in the KwikPen - 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
KwikPen using the outer needle cap. This will keep the insulin sterile and
prevent leaking. It will also stop air going back into the KwikPen and
the needle clogging up. Do not share your needles or your KwikPen.
Replace the cap on the KwikPen.
Further injections
• Every time you use a KwikPen you must use a new needle. Before every
injection, clear any air bubbles. You can see how much insulin is left by
holding the KwikPen with the needle pointing down. The scale on the
cartridge shows about how many units you have left.
• Do not mix any other insulin in your disposable pen. Once the KwikPen
is empty, do not use it again. Please get rid of it carefully - your diabetes
specialist nurse or pharmacist will tell you how to do this.

If you use more Humulin M3 than you should
If you use more Humulin M3 than you should, your blood sugar may become
low. Check your blood sugar (see A in Section 4).
If you forget to use Humulin M3 KwikPen
If you use less Humulin M3 than you should, your blood sugar levels may
increase. Check your blood sugar. Do not inject a double dose to make up for
a forgotten dose.
If you stop using Humulin M3 KwikPen
If you use less Humulin M3 than you should, 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 medicinal product, ask your
doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine 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.

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.
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. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Humulin M3 KwikPen
Keep this medicine out of the sight and reach children.
Before the first use store your Humulin M3 KwikPen in a refrigerator
(2°C – 8°C). Do not freeze. Keep your ‘in use’ Humulin M3 KwikPen at room
temperature (below 30°C) for up to 28 days. Do not keep your ‘in use’ pen in the
fridge. Do not put it near heat or in the sun.
Do not use this medicine after the expiry date which is stated on the label and the
carton. The expiry date refers to the last day of that month.

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.

Do not use this medicine if you notice that clumps of material are present or solid
white particles stick to the bottom or sides of the cartridge, giving it a frosted
appearance. Check this each time you inject yourself.

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.

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 to protect the environment.

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
• cold sweat
• headache
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 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:
• no appetite
• feeling sleepy
• flushed face
• fruity smell on the breath
• feeling or being sick
• thirst

6. Contents of the pack and other information
What Humulin M3 KwikPen 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 sulfate.
- The other ingredients are protamine sulfate, 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 KwikPen looks like and contents of the pack
Humulin M3 (Mixture 3) KwikPen 100 IU/ml suspension for injection is a white,
sterile suspension and contains 100 units of insulin in each millilitre (100 IU/ml).
Each Humulin M3 KwikPen contains 300 units (3 millilitres).
The Humulin M3 KwikPen comes in a pack of 5.
The Humulin M3 in your KwikPen is the same as the Humulin M3, which comes
in separate Humulin M3 cartridges. The KwikPen simply has a built in cartridge.
When the KwikPen is empty you cannot use it again.
Marketing Authorisation Holder and Manufacturer
Humulin M3 KwikPen is made by: Lilly France S.A.S., Rue du Colonel Lilly,
67640 Fegersheim, France.
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 KwikPen (Austria)
Humuline 30/70 KwikPen (Belgium, Luxembourg)
Huminsulin Profil III KwikPen (Germany)
Humulina 30:70 KwikPen 100 UI/ml (Spain)
Humulin M3 KwikPen (Estonia, Ireland, Latvia, Lithuania, Poland, Romania, UK)
Umuline profil 30 KwikPen 100 UI/ml (France)
Humulin M3 (30/70) KwikPen (Greece, Slovenia)
This leaflet was last revised in May 2016
If you would like a large-print version of this leaflet, please phone
01256 315000 (UK) or 01 661 4377 (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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