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Previously assessed against UK PIL dated September 2014 Variation 4: To Register the change in vial description from `glass vial with aluminium seal and orange
2373to `glass vial with a green lid and aluminium strip' with consequential changes to the leaflet.
plastic flip-top
Using other medicines
5: To update
the name
and address
from `Lilly
du colonel
tell your
doctor of
diabetes specialist
if you
are Rue
or haveLilly,
67640 Fegersheim, France.'
SA., other
Avda. medicines,
De lа Industria
З0, 28108
consequential changes
to labels and leaflets. No other changes approved.
(human insulin) Isophane insulin
Your insulin needs may change if you are taking any of the following:
- steroids,
- thyroid hormone replacement therapy,
- oral hypoglycaemics (antidiabetic medication),
Your medicine will be referred to as Humulin I throughout the leaflet.
- acetylsalicylic acid (aspirin),
- growth hormone,
Read all of this leaflet carefully before you start using this medicine.
- octreotide, lanreotide,
- Keep this leaflet. You may need to read it again.
- beta2 stimulants (for example ritodrine, salbutamol or terbutaline),
- If you have any further questions, ask your diabetes specialist nurse,
- beta-blockers,
doctor or pharmacist.
- thiazides or some antidepressants (monoamine oxidase inhibitors),
- This medicine has been prescribed for you. Do not pass it on to others. It
- danazol,
may harm them, even if their symptoms are the same as yours.
- some angiotensin converting (ACE) inhibitors (for example captopril,
- If any of the side effects gets serious, or if you notice any side effects not
enalapril) or angiotensin II receptor blockers.
listed in this leaflet, please tell your diabetes specialist nurse, doctor or
Pregnancy and breast-feeding
Ask your doctor or diabetes specialist nurse for advice before taking any
In this leaflet:
medicine. The amount of insulin you need usually falls during the first three
1. What Humulin I is and what it is used for
months of pregnancy and increases for the remaining six months. If you are
2. Before you use Humulin I
breast-feeding, you may need to alter your insulin intake or diet.
3. How to use Humulin I
4. Possible side effects
Driving and using machines
5. How to store Humulin I
Your ability to concentrate and react may be reduced if you have
6. Further information
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
Humulin I contains the active substance human insulin, which is used to
doctor about the advisability of driving if you have:
treat diabetes. You get diabetes if your pancreas does not make enough
- frequent episodes of hypoglycaemia
insulin to control the level of glucose in your blood (blood sugar). Humulin I
- reduced or absent warning signs of hypoglycaemia.
is used to control glucose in the long term. Its action is prolonged by the
inclusion of protamine sulphate in the suspension.
Always check the pack and the vial label for the name and type of the
Your doctor may tell you to use Humulin I as well as a fast-acting insulin.
insulin when you get it from your pharmacy. Make sure you get the
Each kind of insulin comes with its own patient information leaflet to tell you
Humulin that your doctor has told you to use.
about it. Do not change your insulin unless your doctor tells you to. Be very
Always use Humulin I exactly as your doctor has told you. You should check
careful if you do change insulin. Each type of insulin has a different colour
with your doctor if you are not sure.
and symbol on the pack and the vial so that you can easily tell the
- 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
Do not use Humulin I if you:
inject. These instructions are only for you. Follow them exactly and visit
- think hypoglycaemia (low blood sugar) is starting. Further in this leaflet
your diabetes clinic regularly.
it tells you how to deal with mild hypoglycaemia (see A in Section 4).
- If you change your insulin type (for example from animal to human), you
- are allergic (hypersensitive) to human insulin or any of the other
may have to take more or less than before. This might just be for the first
ingredients of Humulin I (see Section 6).
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
Take special care with Humulin I
different administration route. Under no circumstances should Humulin I
- If your blood sugar levels are well controlled by your current insulin
be given into a vein.
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
Preparing Humulin I
carefully about when to have your meals, how often to exercise and how
- Vials containing Humulin I should be rotated several times in the palms of
much to do. You must also keep a close watch on your blood sugar levels
the hands before use to resuspend insulin until it appears uniformly cloudy
by testing your blood glucose often.
or milky. If not, repeat the above procedure until contents are mixed. Do
- A few people who have had hypoglycaemia (low blood sugar) after
not shake vigorously as this may cause frothing which may interfere with
switching from animal insulin to human insulin have reported that the early
the correct measurement of the dose. The vials should be examined
warning symptoms were less obvious or different. If you often have
frequently and should not be used if clumps of material are present or if
hypoglycaemia or have difficulty recognising the symptoms, please
solid white particles stick to the bottom or sides of the vial, giving it a
discuss this with your doctor.
frosted appearance. Check each time you inject yourself.
- If you answer YES to any of the following questions, tell your diabetes
specialist nurse, doctor or pharmacist.
Injecting Humulin I
- Have you recently become ill?
- First wash your hands.
- Do you have trouble with your kidneys or liver?
- Before you make an injection, clean your skin as you have been
- Are you exercising more than usual?
instructed. Clean the rubber stopper on the vial, but do not remove the
- 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
- Use a clean, sterile syringe and needle to pierce the rubber stopper and
you are planning to go abroad. The time difference between countries
draw in the amount of Humulin I you want. Your doctor or clinic will tell you
may mean that you have to have your injections and meals at different
how to do this. Do not share your needles and syringes.
times to when you are at home.
- Inject under the skin, as you were taught. Do not inject directly into a vein.
- Some patients with long-standing type 2 diabetes mellitus and heart
After your injection, leave the needle in the skin for 5 seconds to make
disease or previous stroke who were treated with pioglitazone and insulin
sure you have taken the whole dose. Do not rub the area you have just
experienced the development of heart failure. Inform your doctor as soon
injected. Make sure you inject at least half an inch (1 cm) from where you
as possible, if you experience signs of heart failure such as unusual
last injected and that you ‘rotate’ the places you inject, as you have been
shortness of breath or rapid increase in weight or localised swelling
- Your doctor will tell you if you have to mix Humulin S with Humulin I. For
example if you do need to inject a mixture, draw the Humulin S into the
syringe before the long acting insulin. Inject the liquid as soon as you have
mixed it. Do the same thing every time. You should not normally mix
Humulin I with a mixture of human insulins. You should never mix Humulin
I with insulins produced by other manufacturers or animal insulins.
- You must not inject Humulin I into a vein. Inject Humulin I as your diabetes
specialist nurse or doctor has taught you.

Humulin I 100 IU/ml
suspension for injection in vial

Previously assessed against UK PIL dated September 2014
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.
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.
If you have any further questions on the use of this product, ask your
diabetes specialist nurse, doctor or pharmacist.
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”.
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
- difficulty in breathing
- fast heart beat
- rash over the whole body
- wheezing
- 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
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
- nervousness or shakiness
- headache
- rapid heartbeat
- 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 I if you think hypoglycaemia (low blood sugar) is
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 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.
Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come
on slowly over many hours or days.
The symptoms include the following:
- feeling sleepy
- flushed face
- thirst
- no appetite
- fruity smell on the breath
- feeling or being sick
Severe symptoms are heavy breathing and a rapid pulse. Get medical help
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 I.
- 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 the Yellow Card Scheme at: By reporting side effects, you can help
provide more information on the safety of this medicine.
Keep out of the sight and reach of children.
Before the first use store between 2 °C and 8 °C (in a refrigerator).
Do not freeze. Do not expose to excessive heat or direct sunlight.
Vial in use may be kept for up to 28 days. Do not use beyond this period.
When in use do not store above 30 °C.
Do not use Humulin I 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 Humulin I, 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.
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.
What Humulin I contains
One vial contains 10 ml equivalent to 1000 IU of isophane insulin.
The active substance is human insulin. It 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 protamine sulphate, metacresol, phenol, glycerol,
dibasic sodium phosphate heptahydrate, zinc oxide and water for injection.
Sodium hydroxide and/or hydrochloric acid may have been used to adjust
What Humulin I looks like and contents of the pack
Humulin I is available as white, sterile suspension for injection in a glass vial
with a green lid and aluminium strip.
Humulin I contains one vial with 10 ml of suspension.
Manufacturer and Product Licence Holder
Manufactured by Lilly S.A., Avda. De la Industria 30, 28108 Alcobendas,
Madrid, Spain. Procured from the EU by Product Licence holder
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex
HA1 1XD. Repackaged by Servipharm Ltd.

PL 20636 / 2373

Leaflet revision and issue date (Ref) 02.03.16[6]
Humulin is trademark of Eli Lilly and Company.

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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.