HUMULIN I (ISOPHANE) 100 IU/ML SUSPENSION FOR INJECTION IN VIAL
Active substance(s): INSULIN HUMAN (PRB) / INSULIN HUMAN (PRB) / INSULIN HUMAN (PRB)
Humulin® I (Isophane) 100 IU/ml
suspension for injection in vial
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
- 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.
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 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 vial 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
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 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
Always check the pack and the vial 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.
• 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
• Vials containing Humulin I should be rotated several times in the palms
of the hands before use to resuspend insulin until it appears uniformly
cloudy or milky. If not, repeat the above procedure until contents are mixed.
Do not shake vigorously as this may cause frothing which may interfere
with the correct measurement of the dose. The vials 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 vial, giving it a frosted
appearance. Check each time you inject yourself.
Injecting Humulin I
• First wash your hands.
• Before you make an injection, clean your skin as you have been instructed.
Clean the rubber stopper on the vial, but do not remove the stopper.
• Use a clean, sterile syringe and needle to pierce the rubber stopper and
draw in the amount of Humulin I you want. Your doctor or clinic will tell you
how to do this. Do not share your needles and syringes.
• 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.
• 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.
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Humulin I can cause side effects, although not everybody
Human insulin may cause hypoglycaemia (low blood sugar). See more
information on hypoglycaemia below in the subsection “Common problems
Possible side effects
Systemic allergy is very rare (affects less than 1 person in 10,000). The
symptoms are as follows:
• rash over the whole body
• fall in blood pressure
• 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.
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
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
• 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
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
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
• fruity smell on the breath
• flushed face
• 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.
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, 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.
Before the first use, store your Humulin I in a refrigerator (2°C – 8°C). Do not
freeze. You can keep your ‘in-use’ vial at room temperature (below 30°C) for up
to 28 days. Do not put it near heat or in the sun.
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.
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 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 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
vial contains 1000 units (10 millilitres).
Humulin I 100 IU/ml comes in a pack of 1 vial.
Marketing Authorisation Holder and Manufacturer
Humulin I in vial is made by:
Lilly S.A., Avda. Industria 30, 28108 Alcobendas, Madrid, Spain.
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)
Humulin N (Czech Republic, Hungary, Romania, Slovakia)
Huminsulin Basal (NPH) 100 (Germany)
Humulin NPH (Denmark, Finland, Greece, Norway, Sweden)
Humulina NPH 100 (Spain)
Humulin I (Ireland, Italy, 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)
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.