HUMULIN I (ISOPHANE) 100 IU/ML SUSPENSION FOR INJECTION IN CARTRIDGE
Active substance(s): HUMAN INSULIN / INSULIN HUMAN (PRB) / HUMAN INSULIN / INSULIN HUMAN (PRB) / HUMAN INSULIN / INSULIN HUMAN (PRB)
• Always keep spare syringes and a spare vial of Humulin I.
• Always carry something to show you are diabetic.
• Always carry sugar with you.
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: firstname.lastname@example.org, Malta: ADR Reporting, Website: www.medicinesauthority.gov.mt/adrportal,
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 I
Keep out of the reach and sight of children.
PACKAGE LEAFLET: INFORMATION FOR THE USER
HUMULIN® I (Isophane) 100 IU/ml
suspension for injection in cartridge
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 gets serious, or if you notice any side effects not listed in this leaflet,
please tell your diabetes specialist nurse, doctor or pharmacist.
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.
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
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.
1. WHAT HUMULIN I IS AND WHAT IT IS USED FOR
Before the first use, store your Humulin I in a refrigerator (2°C – 8°C). Do not freeze. Keep your ‘in-use’ pen
and cartridge at room temperature (below 30°C) for up to 28 days. Do not keep your ‘in-use’ pen or cartridges
in the fridge. Do not put them near heat or in the sun.
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
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 I looks like and contents of the pack
Humulin I (Isophane) 100 IU/ml suspension for injection is a white, sterile suspension and contains 100 units
of insulin in each millilitre (100 IU/ml). Each cartridge contains 300 units (3 millilitres).
The cartridges come in packs of 5 cartridges.
Marketing Authorisation Holder and Manufacturer
Humulin I in cartridge 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“ Basal 100 I.E./ml (Austria)
Humuline NPH (Belgium, Luxembourg, The Netherlands)
Humulin N (Bulgaria, Czech Republic, Cyprus, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia)
Huminsulin Basal (NPH) 100 (Germany)
Humulin NPH (Finland, Greece, Norway, Portugal, Slovenia, Sweden)
Humulin I (Ireland, Italy, Malta, UK)
Umuline NPH (France)
This leaflet was last approved in March 2015.
If you would like a large-print version of this leaflet, please phone 01256 315000 (UK) or 01 6614377 (Ireland)
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
sulfate 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
• 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
• If you answer YES to any of the following questions, tell your diabetes specialist nurse, doctor or
- 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:
• thyroid hormone replacement therapy,
• oral hypoglycaemics (antidiabetic medication),
• acetylsalicylic acid (aspirin),
• growth hormone,
• octreotide, lanreotide,
• beta2 stimulants (for example ritodrine, salbutamol or terbutaline),
• thiazides or some antidepressants (monoamine oxidase inhibitors),
• some angiotensin converting (ACE) inhibitors (for example captopril, enalapril) or angiotensin II
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 breast-feeding, 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
• 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.
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
4. POSSIBLE SIDE EFFECTS
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
• rash over the whole body
• difficulty in breathing
• fast heart beat
If you think you are having this sort of insulin allergy with Humulin I, tell your doctor at once.
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.
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.
Always use Humulin I exactly as your doctor has told you. You should check with your doctor if you are not
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.
• 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
• 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.
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.
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.
• 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.
• 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.
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
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:
• rapid heartbeat
• nervousness or shakiness
• 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 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 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
• no appetite
• flushed face
• fruity smell on the breath
• feeling or being sick
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.
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.