Humulin R

Leaflet attached to the packaging: information for the user

Humulin R, 100 IU/ml
(Human Insulin)

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Humulin R 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 amounts that allow
control of blood glucose levels. Humulin R is used to control blood glucose levels in the long term.
Humulin R is a fast-acting insulin.
The doctor may recommend using Humulin R and insulin with a longer duration of action.
A different leaflet for the patient is provided for each type of insulin. Do not change insulin unless
your doctor recommends it. When changing insulin, 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 R

Humulin R in cartridges is intended for subcutaneous injection only using a reusable insulin pen.
If it is necessary to administer insulin by a different method, consult a doctor.

When not to use Humulin R

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

Warnings and precautions

Before starting to use Humulin R, talk to your doctor, pharmacist, or nurse.

• If the current treatment provides good blood glucose control, warning signs of too low blood glucose may not be felt. Warning signs are listed later in this leaflet. It is necessary to plan meals, physical activity, and overall activity level carefully and also monitor blood glucose levels by performing frequent blood glucose tests.
• Some people who have changed from animal insulin to human insulin and have experienced hypoglycemia (low blood glucose) have reported that the warning signs of hypoglycemia were weaker or different from before. If hypoglycemia occurs frequently or there are difficulties in recognizing the warning signs of hypoglycemia, consult a doctor.
• Tell the diabetes nurse, doctor, or pharmacist if:
• -you have recently been ill;
• you have kidney or liver disease;
• you have increased physical activity.
• The need for insulin may also change after consuming alcohol.
• Tell the diabetes nurse, doctor, or pharmacist if you are planning to travel abroad. The time difference may require you to inject and eat at different times.
• In some patients with type 2 diabetes who have been treated for a long time and have heart disease or have had a stroke, cases of heart failure have been reported when using pioglitazone and insulin at the same time. Tell your doctor as soon as possible if you experience symptoms of heart failure, such as shortness of breath, sudden weight gain, or swelling.

Skin changes at the injection site
It is necessary to 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 R"). If insulin is currently being injected into an area with lumps, consult a doctor before changing it. The doctor may recommend closer monitoring of blood glucose levels and adjusting the dose of insulin or other diabetes medicines.

Humulin R and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
The body's need for insulin may change when using:

• corticosteroids,
• thyroid hormone replacement therapy,
• oral medicines that lower blood glucose levels (diabetes medicines),
• acetylsalicylic acid (aspirin),
• growth hormone,
• octreotide, lanreotide,
• selective beta-adrenergic receptor agonists (e.g., ritodrine, salbutamol, terbutaline),
• beta-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

The body's need for insulin usually decreases during the first three months of pregnancy and increases over the next six months. In breastfeeding women, it may be necessary to adjust the dose of insulin 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 using this medicine.

Driving and using machines

In case of hypoglycemia (low blood glucose), the patient's ability to concentrate and react may be impaired. This should be kept in mind in all situations where it could be a hazard for the patient or others (e.g., when driving a car or operating machinery). Consult a diabetes nurse or doctor about driving if:

• you experience hypoglycemia frequently
• you have weak or no warning signs of hypoglycemia.

Important information about some of the ingredients of Humulin R

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

3. How to use Humulin R

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

Always check the name and type of insulin on the label and cartridge when buying the medicine at the pharmacy. Make sure it is the Humulin medicine prescribed by your doctor.

This medicine should always be used according to the doctor's or pharmacist's recommendations. In case of doubts, consult a doctor or pharmacist. To avoid the risk of transmitting diseases, each cartridge can only be used by one person, even if the needle has been changed.

Dosage

• Your doctor will recommend the appropriate type of insulin, the amount of medicine, and when and how often to inject it. These instructions are intended only for a specific patient. Follow your doctor's recommendations carefully and visit the diabetes clinic regularly.
• Changing the type of insulin used (e.g., from animal insulin to human insulin) may require adjusting the dose. This change may only apply to the first injection or may be introduced gradually over several weeks or months.
• Humulin R in cartridges is intended for subcutaneous injection only using a reusable insulin pen. If it is necessary to administer insulin by a different method, consult a doctor.

Preparing Humulin R

• Humulin R is already dissolved in water and does not need to be mixed. Use it onlyif it looks like water. It must be clear, colorless, and free of particles. Check this before each injection.

Preparing the pen for use

• First, wash your hands. Disinfect the rubber membrane of the cartridge.
• Humulin R cartridges should only be used in Lilly insulin pens to ensure the correct dose is delivered.They must not be used with any other reusable pen.
• Follow the instructions provided with the pen. Insert the cartridge into the pen.
• Set the dose to 1 or 2 units. Then, holding the pen with the needle pointing upwards, tap the sides of the pen to make any air bubbles rise to the top. With the needle still pointing upwards, press the injection mechanism until a drop of Humulin R appears at the needle tip. There may still be a few small air bubbles inside the pen, but they are harmless. However, a large air bubble can cause an incorrect dose to be delivered.

Injecting Humulin R

• Before injecting, disinfect the skin according to the instructions received.
• Inject the medicine under the skin according to the instructions received. Do notinject the medicine directly into a vein. After injecting, leave the needle in the skin for five seconds to ensure the full dose has been delivered. Do not rub the injection site. Make sure the distance from the previous injection site is at least 1 cm. Change the injection sites as instructed.

Do not administer Humulin R intravenously.

Humulin R should be injected according to the doctor's or diabetes nurse's instructions.

After injection

• After injecting the medicine, remove the needle from the pen using the outer needle cap. This will keep the medicine sterile and prevent insulin from leaking out. It will also prevent air from entering the pen and clogging the needle. Do not lend your needles or pens to anyone.Put the cap back on the pen.

Subsequent 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 R appears at the needle tip. You can check how much Humulin R is left by looking at the gauge on the side of the cartridge. The distance between the gauge marks corresponds to approximately 20 units. If the amount of medicine left is less than the prescribed dose, change the cartridge.

Do not mix any other insulin in the Humulin R cartridge. After the cartridge is empty, do not reuse it.

Using a higher dose of Humulin R than recommended

If a higher dose of Humulin R than recommended is used, low blood glucose may occur. Check your blood glucose level (see subsection A in section 4)

Missing a dose of Humulin R

If a lower dose of Humulin R than recommended is used, high blood glucose may occur. Check your blood glucose level. Do not inject a double dose to make up for a missed dose.

Stopping the use of Humulin R

If a lower dose of Humulin R than recommended is used, high blood glucose may occur. Do not change your insulin unless your doctor recommends it.
In case of any further doubts about using this medicine, consult a 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 below for more information on hypoglycemia in subsection "Common problems in diabetes".

Side effects

Generalized allergic reactionsare 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 R, contact a doctor immediately.
Local allergic reactionsare common (less than 1 in 10 patients). The symptom may be redness, swelling, or itching of the skin around the injection site. These symptoms usually go away after a few days or weeks. If you experience any of these symptoms, tell your doctor.

Skin changes at the injection site

If insulin is injected into the same spot too often, the fatty tissue may shrink (lipoatrophy) or thicken (lipohipertrophy) (less than 1 in 100 patients).
Lumps under the skin can also be caused by the accumulation of a protein called amyloid (amyloidosis of the skin, frequency unknown). Insulin injected into an area with lumps may not work properly. Always change the injection site to prevent these skin changes.
Swelling (e.g., swelling of the arms, ankles; fluid retention) has been reported, especially at the start of insulin therapy 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 R 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 diarrhea or vomiting);
• your insulin requirements change, or
• you have kidney or liver problems that get worse.

Alcohol and some medicines can affect blood glucose levels.
The first symptoms of low blood glucose usually appear quickly and include:

• rapid heartbeat
• nausea
• cold sweats

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

• fatigue
• irritability or shakiness
• headache

Do not use Humulin R if you experience warning signs of hypoglycemia (low blood glucose).

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

B. Hyperglycemia and diabetic ketoacidosis

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

• not taking Humulin R or other insulin;
• injecting less insulin than recommended by the doctor;
• eating very large meals compared to dietary needs; or
• having a fever, infection, or stressful experiences.

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

• drowsiness
• loss of appetite
• flushing of the face
• fruity odor from the mouth
• thirst
• nausea or vomiting.

Severe symptoms include difficulty breathing and rapid pulse. 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:

• Always carry a spare pen and cartridge with Humulin R insulin.
• Always carry something that informs others that you have diabetes.
• Always carry sugar cubes.

C. Illness

During illness, especially if you have diarrhea or vomiting, your need for insulin may change. People with diabetes need insulin even if they are not eating their normal meals.Perform a urine or blood test, follow the general rules for treating illness, and contact a diabetes nurse or doctor.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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 .
Side effects can also be reported 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 R

Keep the medicine out of the sight and reach of children.
Before first use, store Humulin R in a 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 cartridges in a refrigerator.
Do not put 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 it is discolored or particles are visible.
Humulin R can only be used if it looks like water. 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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Humulin R contains

• The active substance is human insulin, which is 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 other ingredients are: m-cresol, glycerol, water for injections, 10% hydrochloric acid solution, and 10% sodium hydroxide solution (to adjust the pH).

What Humulin R looks like and contents of the pack

Humulin R is a clear, colorless, sterile, aqueous solution of human insulin.
One milliliter of the solution contains 100 international units (100 IU/ml) of insulin.
Each cartridge contains 300 units (3 ml of solution).
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, 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" Normal (Austria)
Umuline Rapide 100 UI/ml (France)
Humuline Regular (Belgium, Luxembourg, Netherlands)
Huminsulin Normal für Pen 3 ml (Germany)
Humulin Regular (Cyprus, Greece, Portugal, Sweden)
Humulin S (Malta, Ireland, United Kingdom)
Humulin R (Bulgaria, Croatia, Estonia, Hungary, Latvia, Lithuania, Italy, Poland, Romania, Slovenia)
Humulin R Cartridge (Czech Republic, Slovakia)

Date of last revision of the leaflet: