HUMULIN I 100IU/ML SUSPENSION FOR INJECTION IN CARTRIDGE

Active substance: INSULIN HUMAN (PRB)

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Humulin® I 100 IU/ml Suspension for Injection in Cartridge
(Human Isophane Insulin)
Your medicine is known by the above name, but will be referred to as
Humulin I 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.
In this leaflet:
1) What Humulin I is and what it is used for
2) Before you use Humulin I
3) How to use Humulin I
4) Possible side effects
5) How to store Humulin I
6) Further information

1) What Humulin I is and what it is used for
Humulin I 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 I
is used to control glucose in the long term. Its action is prolonged by the
inclusion of protamine sulphate in the suspension.
Your doctor may tell you to use Humulin I as well as a fast-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 I
Do not use Humulin I 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 I (see Section 6).
Take special care with Humulin I
 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
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 have:
 frequent episodes of hypoglycaemia
 reduced or absent warning signs of hypoglycaemia.

3) How to use Humulin I
The 3 ml cartridge is only for use in 3ml pens. It is not for use in 1.5 ml
pens.
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.
Always use Humulin I exactly as your doctor has told you. You should
check with your doctor if you are not sure.
Dosage
 You should normally inject Humulin I as your basal insulin. 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 I under the skin. You should not administer it using a
different administration route. Under no circumstances should Humulin I
be given into a vein.
Preparing Humulin I
 Cartridges containing Humulin I 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 I cartridges in compatible CE marked
pens. Please make sure that Humulin I 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 I 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 I
 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.
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 I comes out of the needle. You can see how much Humulin I 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.

Do not mix any other insulin in a Humulin I cartridge. Once the
cartridge is empty, do not use it again.
If you take more Humulin I than you need
If you take more Humulin I than you need, your blood sugar may become
low. Check your blood sugar (see A in Section 4).
If you forget to use Humulin I
If you take less Humulin I than you need, your blood sugar levels may
increase. Check your blood sugar.

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 I 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.

If you stop using Humulin I
If you take less Humulin I than you need, your blood sugar levels may
become too high. Do not change your insulin unless your doctor tells you to.

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

If you have any further questions on the use of this product, ask your
diabetes specialist nurse, doctor or pharmacist.

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

4) Possible side effects

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.

Like all medicines, Humulin I 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”.

Three simple steps to avoid hypoglycaemia or hyperglycaemia are:
 Always keep spare syringes and a spare vial of Humulin I.
 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
If you think you are having this sort of insulin allergy with Humulin I, 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 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 I 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 I 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.

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 I
 Keep all medicines out of the sight and reach of children.
 Store between 2°C and 8°C (in a refrigerator). Do not freeze. Do not
expose to excessive heat or direct sunlight. Keep the cartridges in the
outer carton. When in use cartridges may be kept for up to 28 days. Do
not use beyond this period. When in use the cartridges should not be
stored above 30°C.
 Do not use Humulin I 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 I, 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.
 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.

6) Further information
What Humulin I 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. The human insulin in Humulin I is available in
a suspension together with protamine sulphate.
The other ingredients are glycerol, protamine sulphate, dibasic sodium
phosphate, zinc oxide with m-cresol and phenol as preservatives in water
for injections. Sodium hydroxide and/or hydrochloric acid may have been
used during manufacture to adjust the acidity.
What Humulin I looks like and contents of the pack
Humulin I is a white, sterile suspension. Each 1ml contains 100 IU human
isophane insulin (human insulin [prb]).
Each cartridge contains 3ml (300 IU) of suspension in a glass cartridge with
a rubber plunger head at the bottom and a rubber disc seal at the top.
Each carton contains 5 x 3ml cartridges in a sealed blister.
PL 10383/1490

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Lilly France SAS, 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: 18.09.2012

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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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