HUMULIN® I (Isophane) 100 IU/ml suspension for injection in vial
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.
Do not use Humulin I:
Talk to your doctor, pharmacist, or nurse before using Humulin I.
Skin changes at the injection site:
The injection site should be rotated to prevent skin changes such as lumps under the skin. The insulin may not work well if you inject into a lumpy area (See How to use Humulin I). Contact your doctor if you are currently injecting into a lumpy area before you start injecting into a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Your insulin needs may change if you are taking any of the following:
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.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
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:
Humulin I contains Sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose unit, that is to say essentially ‘sodium-free’.
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 this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
If you use more Humulin I than you should, your blood sugar may become low. Check your blood sugar (see A in Section 4).
If you forget to use Humulin I
If you use less Humulin I than you should, your blood sugar levels may increase. Check your blood sugar. Do not inject a double dose to make up for a forgotten dose.
If you stop using Humulin I
If you use less Humulin I than you should, 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 medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects
Systemic allergy is very rare (affects less than 1 person in 10,000). The symptoms are as follows:
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.
Skin changes at the injection site:
If you inject insulin too often at the same place, the fatty tissue may shrink (lipoatrophy) or thicken (lipohypertrophy) (may affect up to 1 in 100 people). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known). The insulin may not work very well if you inject into a lumpy area. Change the injection site with each injection to help prevent these skin changes.
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.
Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if you:
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:
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.
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:
Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many hours or days. The symptoms include the following:
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:
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, Website: www.hpra.ie, United Kingdom (Great Britain & Northern Ireland): Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach 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 this medicine 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 this medicine if you notice that clumps of material are present or solid white particles stick to the bottom or sides of the vial, giving it a frosted appearance. Check this each time you inject yourself.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
What Humulin I contains
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.
Humulin I in vial is made by:
Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain
The marketing authorisation is held by:
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Huminsulin „Lilly“ Basal (Austria)
Humuline NPH (Belgium, Luxembourg)
Humulin N (Czech Republic)
Huminsulin Basal (NPH) 100 (Germany)
Humulin NPH (Denmark, Greece, Sweden)
Humulina NPH (Spain)
Humulin I (Ireland, Italy, UK) Umuline NPH (France)
For any information about this medicine, please contact the local
representative of the Marketing Authorisation Holder:
Ireland and United Kingdom (Northern Ireland)
Eli Lilly and Company (Ireland) Limited, Tel: + 353-(0) 1 661 4377
United Kingdom (Great Britain)
Eli Lilly and Company Limited, Tel: + 44-(0) 1256 315000