Humulin N

Leaflet accompanying the packaging: information for the user

Humulin N 100 IU/ml suspension for injection in a cartridge

(Human insulin)

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What Humulin N is and what it is used for
• 2. Important information before using Humulin N
• 3. How to use Humulin N
• 4. Possible side effects
• 5. How to store Humulin N
• 6. Contents of the pack and other information

1. What Humulin N is and what it is used for

Humulin N contains human insulin as the active substance, which is used to treat diabetes.
The cause of diabetes is the pancreas's inability to produce insulin in quantities that allow
control of blood glucose levels (blood sugar). Humulin N is used to control blood glucose levels
in the long term. The duration of action of this insulin has been prolonged by the use of protamine sulfate in the suspension.
Your doctor may recommend using Humulin N and fast-acting insulin. Each type of insulin has a different patient leaflet. You should not change your insulin unless your doctor has told you to. When changing insulin, you should be very careful. Each type of insulin has a different symbol and color on the packaging and cartridge to make it easier to distinguish.

2. Important information before using Humulin N

Humulin N in cartridges is for subcutaneous injection only, using a reusable insulin pen. If you need to inject insulin by another method, consult your doctor.

When not to use Humulin N

• If you are experiencing symptoms of hypoglycemia (low blood glucose).Information on how to handle mild hypoglycemia will be provided later in this leaflet (see subsection A in section 4).
• If you are allergic to human insulin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Humulin N, you should talk to your doctor, pharmacist, or nurse.

• If your current treatment provides good blood glucose control, warning signs of too low blood glucose may not be noticed. Warning signs are listed later in this leaflet. You should plan your meals, physical activity, and overall activity level carefully. You should also check your blood glucose level by doing regular blood glucose tests.
• Some people who have changed from animal insulin to human insulin have reported that the warning signs of hypoglycemia (low blood glucose) were less pronounced or different from before. If hypoglycemia occurs frequently or if you have difficulty recognizing the warning signs of hypoglycemia, you should consult your doctor.
• You should inform your diabetes nurse, doctor, or pharmacist if:
• -you have recently been ill;
• you have kidney or liver disease;
• you have increased physical activity.
• Your insulin needs may also change if you drink alcohol.
• You should tell your diabetes nurse, doctor, or pharmacist if you are planning to travel abroad. Time differences may affect when you inject and eat.
• In some patients with type 2 diabetes who have heart disease or have had a stroke, fluid retention has been reported when using pioglitazone and insulin. You should tell your doctor as soon as possible if you experience symptoms of heart failure such as shortness of breath, rapid weight gain, or local swelling.

Skin changes at the injection site
You should change the injection site to prevent skin changes, such as lumps under the skin. Insulin injected into an area with lumps may not work properly (see "How to use Humulin N"). If you are currently injecting insulin into an area with lumps, you should contact your doctor before changing it. Your doctor may recommend more frequent blood glucose monitoring and adjusting the dose of insulin or other antidiabetic medicines.

Humulin N and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
Your body's need for insulin may change if you are taking:

• corticosteroids,
• thyroid hormone replacement therapy,
• oral medicines that lower blood glucose (antidiabetic medicines),
• acetylsalicylic acid (aspirin),
• growth hormone,
• octreotide, lanreotide,
• selective beta-adrenergic agonists (e.g., ritodrine, salbutamol, terbutaline),
• beta-adrenergic blockers,
• thiazides or certain antidepressants (monoamine oxidase inhibitors),
• danazol,
• certain angiotensin-converting enzyme inhibitors (e.g., captopril, enalapril) or angiotensin II receptor antagonists.

Pregnancy, breastfeeding, and fertility

Your body's need for insulin usually decreases during the first three months of pregnancy and increases during the next six months. Breastfeeding women may need to adjust their insulin dose or diet.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

If you have hypoglycemia (low blood glucose), your ability to concentrate and react may be impaired. You should be aware of this in all situations where it could put you or others at risk (e.g., when driving a car or operating machinery).
You should ask your diabetes nurse or doctor for advice on driving if:

• you frequently have hypoglycemia
• you have few or no warning signs of hypoglycemia.

Important information about some of the ingredients of Humulin N

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e., it is essentially "sodium-free".

3. How to use Humulin N

The 3 ml cartridge is for use in 3 ml pens only. Do not use it in 1.5 ml pens.

You should always check the name and type of insulin on the label and cartridge when you buy your medicine from the pharmacy. Make sure it is the Humulin medicine prescribed by your doctor.

This medicine should always be used as instructed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
To avoid the risk of transmitting diseases, each cartridge can only be used by one person, even if the needle is changed.

Dosage

• Humulin N should be injected like isophane insulin. Your doctor will tell you which insulin to use, how much to use, and when and how often to inject it. These instructions are only for you. You should follow your doctor's instructions carefully and visit your diabetes clinic regularly.
• Changing the type of insulin (e.g., from animal insulin to human insulin) may mean that you need to adjust the dose. This change may only apply to the first injection or may be introduced gradually over several weeks or months.
• Humulin N in cartridges is for subcutaneous injection only, using a reusable insulin pen. If you need to inject insulin by another method, consult your doctor.

Preparing Humulin N

• Before each injection, the Humulin N cartridge should be rolled between your palms 10 times and then inverted 10 times to achieve a uniformly cloudy or milky appearance of the suspension. If this does not happen, you should repeat these steps until the ingredients are mixed. The cartridges contain a small glass ball that helps to mix the ingredients. Do not shake, as this may cause foam to form, making it difficult to measure the correct dose. You should check the appearance of the insulin in the cartridge regularly. Do not use it if you can see clumps or white particles sticking to the bottom or sides of the cartridge, and the glass is cloudy. You should check this before each injection.

Preparing the pen for use

• First, wash your hands. Disinfect the rubber membrane of the cartridge.
• Humulin N cartridges should only be used in Lilly insulin pens to ensure that the correct dose is delivered.They should not be used with any other reusable pen.
• You should follow the instructions provided with the pen. Insert the cartridge into the pen.
• You should set the dose to 1 or 2 units. Then, holding the pen with the needle pointing upwards, tap the pen gently to bring any air bubbles to the top. With the needle still pointing upwards, press the injection mechanism until a drop of Humulin N appears at the needle tip. There may still be a few small air bubbles in the pen. These are harmless, but a large air bubble may affect the accuracy of the dose.

Injecting Humulin N

• Before injecting, you should disinfect the skin as instructed.
• You should inject the medicine under the skin as instructed. Do not inject directly into a vein. After injecting, leave the needle in the skin for 5 seconds to make sure that the full dose has been delivered. Do not rub the injection site. Make sure that the distance from the last injection site is at least 1 cm. Change the injection site as instructed.

Do not inject Humulin N intravenously.

Humulin N should be injected as instructed by your doctor or diabetes nurse.

After injecting

• After injecting, remove the needle from the pen using the outer needle cap. This will keep the medicine sterile and prevent leakage of insulin. It will also prevent air from entering the pen and clogging the needle. Never share your needles or pens with anyone else.Put the needle cap back on the pen.

Further injections

• Leave the cartridge in the pen. Before each injection, select 1 or 2 units and press the injection mechanism, holding the pen with the needle pointing upwards, until a drop of Humulin N appears at the needle tip. You can check how much Humulin N is left by looking at the scale on the side of the cartridge. The distance between the markings on the scale corresponds to about 20 units. If there is less Humulin N left than the prescribed dose, you should change the cartridge.

Do not mix any other insulin in the Humulin N cartridge. After the cartridge is empty, do not use it again.

Using more Humulin N than prescribed

If you inject more Humulin N than prescribed, you may experience low blood glucose. You should check your blood glucose level (see subsection A in section 4)

Missing a dose of Humulin N

If you inject less Humulin N than prescribed, you may experience high blood glucose. You should check your blood glucose level. Do not inject a double dose to make up for a missed dose.

Stopping treatment with Humulin N

If you inject less Humulin N than prescribed, you may experience high blood glucose. Do not change your insulin unless your doctor has told you to.
If you have any further questions about using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Human insulin can cause hypoglycemia (low blood glucose). See further information on hypoglycemia below in subsection "Common problems in diabetes".

Side effects

Generalized allergyis very rare (less than 1 in 10,000 patients). The symptoms are:

• low blood pressure
• difficulty breathing
• rapid heartbeat
• rash all over the body
• wheezing
• sweating

If you experience any of these symptoms while using Humulin N, you should contact your doctor immediately.
Local allergyis common (less than 1 in 10 patients). The symptom may be redness, swelling, or itching at the injection site. These symptoms usually disappear after a few days or weeks. If you experience any of these symptoms, you should tell your doctor.

Skin changes at the injection site

If insulin is injected into the same area too frequently, the fatty tissue may shrink (lipoatrophy) or thicken (lipohypertrophy) (less than 1 in 100 patients).
Lumps under the skin can also be caused by the accumulation of a protein called amyloid (amyloidosis, frequency not known). Insulin injected into an area with lumps may not work properly. You should change the injection site each time to prevent these skin changes.
Swelling (e.g., swelling of the arms, ankles; fluid retention) has been reported, especially at the start of insulin treatment or when changing treatment to improve blood glucose control.

Common problems in diabetes

A. Hypoglycemia

Hypoglycemia (low blood glucose) is a condition in which there is too little glucose in the blood. It can occur if:

• you take too much Humulin N or other insulin;
• you miss or delay a meal or snack;
• you exercise too much or work just before or after a meal;
• you are ill (especially if you have vomiting or diarrhea);
• your insulin needs change, or
• you have kidney or liver problems that are getting worse.

Alcohol and some medicines can affect your blood glucose level.
The first symptoms of low blood glucose usually come on quickly and include:

• rapid heartbeat
• nausea
• cold sweat

If you are not sure about recognizing the warning signs of hypoglycemia, you should avoid situations where you might put yourself or others at risk (e.g., driving a car).

Do not use Humulin N if you are experiencing warning signs of hypoglycemia (low blood glucose).

If your blood glucose level is low, you should eat glucose tablets, sugar, or a sweet drink. Then, you should eat fruit, biscuits, or a sandwich, as your doctor has advised, and rest. This usually works for mild hypoglycemia or a small overdose of insulin. If your condition worsens, or you experience shallow breathing, and your skin becomes pale, you should contact your doctor immediately. An injection of glucagon may help in severe hypoglycemia. After injecting glucagon, you should eat glucose tablets or sugar. If you do not improve after glucagon injection, you should go to the hospital. For more information about glucagon, ask your doctor.

B. Hyperglycemia and diabetic ketoacidosis

Hyperglycemia (high blood glucose) means that your body is not getting enough insulin. Hyperglycemia can be caused by:

• not taking Humulin N or other insulin;
• injecting less insulin than prescribed by your doctor;
• eating large meals compared to your diet;
• having a fever, infection, or stressful events.

Hyperglycemia can lead to diabetic ketoacidosis. The first symptoms develop slowly over a few hours or days. They include:

• drowsiness
• loss of appetite
• redness of the face
• fruity smell from the mouth
• thirst
• nausea or vomiting.

Severe symptoms include difficulty breathing and rapid pulse. You should seek medical help immediately.
Untreated hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) can lead to serious complications and cause headaches, nausea, vomiting, dehydration, loss of consciousness, coma, or even death.
Three simple waysto avoid hypoglycemia or hyperglycemia:

• You should always carry a spare pen and cartridge with Humulin N.
• You should always carry something that tells others that you have diabetes.
• You should always carry sugar cubes.

C. Illness

When you are ill, especially if you have vomiting or diarrhea, your body's need for insulin may change. People with diabetes need insulin even when they are not eating their normal meals.You should do a urine or blood test, follow the general rules for treating illness, and contact your diabetes nurse or doctor.

• fatigue
• irritability or shaking
• headache

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl .
You can also report side effects to the marketing authorization holder or its representative. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Humulin N

Medicines should be kept out of the sight and reach of children.
Before first use, you should store Humulin N in the refrigerator (2°C - 8°C). Do not freeze.
The used pen and cartridge should be kept at room temperature (below 30°C) and used within 28 days. Do not store the used pen or cartridge in the refrigerator.
Do not store them near heat sources or in direct sunlight.
Do not use this medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of that month.
Do not use this medicine if you notice clumps or white particles sticking to the bottom or sides of the cartridge, and the glass is cloudy. You should check the appearance of the insulin before each injection.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Humulin N contains

• The active substance of the medicine is human insulin, produced by recombinant DNA technology. It has the same structure as the natural hormone produced by the pancreas, so it differs from animal insulins. The human insulin in Humulin N forms a suspension with protamine sulfate.
• The other ingredients are: m-cresol, glycerol, phenol, protamine sulfate, disodium phosphate heptahydrate, zinc oxide, water for injections, 10% hydrochloric acid solution, and 10% sodium hydroxide solution (to adjust the pH).

What Humulin N looks like and contents of the pack

Humulin N is a white, sterile suspension of human insulin isophane. One milliliter of the suspension contains 100 international units of insulin (100 IU/ml). Each cartridge contains 300 units (3 ml suspension).
The cartridges are sold in packs of 5.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Netherlands
Manufacturer:
Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France
Eli Lilly Italia S.p.A., Via A. Gramsci 731-733, 50019 Sesto Fiorentino, Italy
To obtain more detailed information, you should contact the representative of the marketing authorization holder:
Eli Lilly Polska Sp.z o.o.
ul. Żwirki i Wigury 18A
02-092 Warsaw
Tel: +48 22 440 33 00

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Huminsulin "Lilly" Basal (Austria)
Humuline NPH (Belgium, Luxembourg, Netherlands)
Humulin N (Bulgaria, Croatia, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovenia)
Humulin N (NPH) Cartridge (Czech Republic, Slovakia)
Huminsulin Basal (NPH) für Pen 3 ml (Germany)
Humulin NPH (Cyprus, Greece, Norway, Portugal, Sweden)
Humulin I (Ireland, Italy, Malta, United Kingdom)
Umuline NPH (France)

Date of last revision of the leaflet: