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HUMULIN I

Active substance(s): INSULIN ISOPHANE HUMAN (PRB)

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Previously assessed against UK PIL dated March
2015 PACKAGE LEAFLET: INFORMATION FOR THE USER
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up

HUMULIN® I 100 IU/ml
suspension for injection in vial
(insulin human (prb))
To correct
manufacturer
Your medicine is known as the above but will be referred to as Humulin
I throughout the following leaflet.
details

By Carthika Kanagasabai at

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.
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 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
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.
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
• 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 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
• 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 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.
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
• thirst
• 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.
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:
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 sight and reach of children.
Store in refrigerator (2°C - 8°C). When in use, do not store above 30°C.
Keep container in outer carton. Do not put it near heat or in the sun.
Do not freeze.
A vial, once in use, may be kept for up to 28 days.
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 is a white suspension in a glass vial of 10ml with a rubber
stopper with an aluminium seal, which is covered by an green plastic
flip-off cap. Each vial contains 1000 units (10 milliliters).
Humulin I 100 IU/ml comes in a pack of 1 vial.
POM
PL No: 41103/0062
This product is manufactured by either:
Lilly Pharma Fertigung and Distribution GmbH & Co. KG, Teichweg 3,
35396 Giessen, Germany or
Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.
Procured from within the EU and repackaged by the Product Licence
holder: Community Pharmacy Supplies Ltd., Unit 20/21 Easter Park,
Ferry Lane South, Rainham, Essex, RM13 9BP.
Leaflet revision date (Ref.) 24.01.2017
Humulin is a registered trade mark of Eli Lilly & Company, USA.

RML169 V2

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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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