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HUMULIN M3 KWIKPEN 100 IU/ML SUSPENSION FOR INJECTION

Active substance(s): HUMAN INSULIN / HUMAN INSULIN

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NL024DAAA00

Package leaflet: Information for the user

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

(Insulin human)
NL024DAAA00

Package leaflet: Information for the user

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

(Insulin human)

FPO

FPO

FPO
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.

Your insulin needs may change if you are taking any of the following:

After injecting




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,

-

Keep this leaflet. You may need to read it again.



-

If you have any further questions, ask your doctor, pharmacist or nurse.



thiazides or some antidepressants (monoamine oxidase inhibitors),

-

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.



danazol,

-

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.



some angiotensin converting (ACE) inhibitors (for example captopril, enalapril)
or angiotensin II receptor blockers.

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

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:





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.

-

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.



Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.



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.

reduced or absent warning signs of hypoglycaemia.

4.

3.

How to use Humulin M3 KwikPen

Like all medicines, this medicine can cause side effects, although not everybody
gets them.

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

Possible side effects

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



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.

If you think you are having this sort of insulin allergy with Humulin M3, tell your
doctor at once.



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.

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.

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.

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.
Common problems of diabetes

Getting the KwikPen ready to use (Please see user manual)

A.



First wash your hands.



Read the instructions on how to use your pre-filled insulin pen. Please follow
the instructions carefully.

Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This
can be caused if you:

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

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.



If you answer YES to any of the following questions, tell your diabetes
specialist nurse, doctor or pharmacist.
Have you recently become ill?



frequent episodes of hypoglycaemia

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.

-

Further injections



Talk to your doctor, pharmacist, or nurse before using Humulin M3 KwikPen.


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.



take too much Humulin M3 or other insulin;

Here are some reminders.



miss or delay meals or change your diet;

-

Use a clean needle. (Needles are not included).



exercise or work too hard just before or after a meal;

-

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.



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.

Injecting Humulin M3


Hypoglycaemia

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.

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

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FPO

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:

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.



feeling sleepy



no appetite

Marketing Authorisation Holder and Manufacturer



flushed face



fruity smell on the breath



thirst



feeling or being sick

Humulin M3 KwikPen is made by: Lilly France S.A.S., Rue du Colonel Lilly,
67640 Fegersheim, France.

Severe symptoms are heavy breathing and a rapid pulse. Get medical help
immediately.

The marketing authorisation is held by: Eli Lilly and Company Limited, Lilly
House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, U.K.

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.

It is distributed in the Republic of Ireland by Eli Lilly and Company (Ireland)
Limited, Hyde House, 65 Adelaide Road, Dublin 2, Ireland.

Three simple steps to avoid hypoglycaemia or hyperglycaemia are:

C.



Always keep spare syringes and a spare vial of Humulin M3.



Always carry something to show you are diabetic.



Always carry sugar with you.

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.
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.
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.

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)
NL024DAAA00

LILLY INDIANAPOLIS PPD SITE

COLORS:
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INDYDRY

X PDAP

OTHER REGULATED ITEMS: N/A

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OTHER
GRAPHICS

ALRP INFORMATION

PACKAGING SITE:

CREATED BY: EF

DATE: 11 Nov 2016

ITEM CODE & VERSION NO: NL024DAAA00_P1V1
SUPERSEDES: N/A
NON HR BARCODE: N/A

DIE ID

TEMPLATE NO: L-0239_A
FLAT DIMENSIONS: 13.25" x 20"
FOLDED DIMENSIONS: 4.5" x 2.25"

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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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