Gensulin N

Leaflet accompanying the packaging: patient information

Gensulin N, 100 IU/ml, suspension for injection
Human insulin

You should carefully read the contents of the 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 doubts, you should 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 you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

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

Gensulin 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). Gensulin 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 Gensulin N and fast-acting insulin. Each type of insulin has a different leaflet for the patient. You should not change your insulin unless your doctor recommends it. When changing insulin, you should be very careful. Each type of insulin has a different symbol and color on the outer packaging and on the cartridge and vial, making it easier to distinguish.

2. Important information before using Gensulin N

Gensulin N in cartridges is intended for subcutaneous injection only using a reusable insulin pen.

Gensulin N in cartridges must not be administered intravenously or intramuscularly. If administration via a syringe is necessary, a vial should be used. Gensulin N is available in vials on the market.
Gensulin N in vials is intended for subcutaneous injection. Although it is not recommended, Gensulin N in vials can also be administered intramuscularly. Gensulin N in a vial must not be administered intravenously. If it is necessary to administer insulin by another method, you should consult a doctor.

When not to use Gensulin N

• if symptoms of hypoglycemia (low blood glucose) occur. Information on how to proceed in the event of mild hypoglycemia will be provided later in this leaflet (see subsection A "Hypoglycemia" 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 Gensulin N, you should discuss it with your doctor, pharmacist, or

nurse.

• If your current treatment provides good blood glucose control, warning signs of excessive blood glucose reduction may not be felt. Warning signs are listed later in this leaflet. You should plan your meals, physical activity, and overall activity level carefully. You should also monitor your 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, you should consult a 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 exertion.
• Your insulin requirements may also change after consuming alcohol.
• You should tell your diabetes nurse, doctor, or pharmacist about your planned trip abroad. Time zone differences may require you to inject and eat at different times.
• In some patients with type 2 diabetes who have heart disease or have had a stroke, cases of heart failure have been reported when using pioglitazone and insulin together. You should inform your doctor as soon as possible if you experience symptoms of heart failure, such as shortness of breath, sudden weight gain, or localized 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 Gensulin N"). If you are currently injecting insulin into an area with lumps, you should consult your doctor before changing it. Your doctor may recommend closer monitoring of your blood glucose levels and adjusting your insulin dose or other anti-diabetic medicines.

Gensulin 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 insulin requirements may change when using:

• corticosteroids,
• thyroid hormone replacement therapy,
• oral medicines that lower blood glucose levels (anti-diabetic medicines),
• acetylsalicylic acid (aspirin),
• growth hormone,
• octreotide, lanreotide,
• selective β2-adrenergic receptor agonists (e.g., ritodrine, salbutamol,

terbutaline),

• β-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 and breastfeeding

Your body's insulin requirements usually decrease in the first three months of pregnancy and increase over the next six months. In breastfeeding women, it may be necessary to adjust the insulin dose or diet.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.

Driving and using machines

In the event of hypoglycemia (low blood glucose), your ability to concentrate and react may be impaired. You should keep this in mind in all situations where it could be a hazard to you or others (e.g., when driving a vehicle or operating machines).
You should consult your diabetes nurse or doctor about driving a car if:

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

Gensulin N contains sodium

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

3. How to use Gensulin N

You should always check the name and type of insulin on the label and outer packaging of the cartridge or vial when purchasing the medicine at the pharmacy. You should make sure it is the Gensulin N medicine prescribed by your doctor.
This medicine should always be used as directed by your doctor or pharmacist. If you have any doubts, you should consult your 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

Gensulin N should be injected like isophane insulin. Your doctor will recommend the appropriate type of insulin, amount of medicine, and time and frequency of injection. These instructions are intended for a specific patient only. You should follow your doctor's recommendations closely and regularly visit the diabetes clinic.
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.
Gensulin N in cartridges is intended for subcutaneous injection only using a reusable insulin pen. If it is necessary to administer insulin by another method, you should consult your doctor.
Gensulin N in vials is intended for subcutaneous injection. Although it is not recommended, it can be administered intramuscularly in exceptional cases.

Before using Gensulin N, you should

• check the packaging and label of the cartridge or vial for consistency with the insulin prescribed by your doctor.
• check the expiration date on the packaging.

Method of use

You should inject the dose of insulin as directed by your doctor or diabetes nurse.
You should always change the injection site to avoid lumps (see section 4. Possible side effects). It is best to inject insulin into the abdominal area, buttocks, front of the thigh, or upper arm. Injecting insulin into the abdominal area causes faster absorption than injecting into other areas.
You should change the injection site so that the same site is not used more than once a month.
About 15-30 minutes before the planned injection, you should remove the insulin from the refrigerator to bring it to room temperature (if it is a new vial or cartridge).
The currently used cartridge or vial should be stored at room temperature for 28 days.
During administration, you should follow hygiene rules: wash your hands before administration, disinfect the injection site.
Before administration, you should carefully examine the cartridge or vial with insulin.
The Gensulin N suspension should be uniformly cloudy (uniformly turbid or milky). You should not use the medicine if the contents of the vial or cartridge remain clear after mixing or if a white precipitate remains at the bottom. You should not use the medicine if, after mixing, white flakes float or white particles stick to the walls, giving it a frozen appearance.
You should pay special attention to avoiding injecting air into a blood vessel during insulin injection.

Administering Gensulin N from vials using syringes

Gensulin N in a vial is intended for subcutaneous injection. Although it is not recommended, it can be administered intramuscularly in exceptional cases. Gensulin N in a vial must not be administered intravenously.
Special syringes with insulin concentration markings are intended for administering insulin. It is recommended to use syringes of the same type and manufacturer. You should always check that the syringe is calibrated correctly for the insulin concentration being used.
Before each injection of Gensulin N suspension, you should rotate the vial between your hands 10 times, then turn it upside down 10 times to achieve a uniformly cloudy or milky appearance of the suspension. If this does not happen, you should repeat the described actions until the ingredients are mixed. You should not shake vigorously, as this may cause foam to form, which can interfere with proper dosing.

Instructions for use

Immediately before injection:

• 1. Remove the plastic protective cap from the cartridge (do not tear off the cartridge).
• 2. Wipe the exposed part of the rubber stopper with an alcohol solution. Do not remove the stopper!
• 3. Draw air into the syringe in a volume equal to the dose of insulin.

• 4. With the needle attached to the syringe, puncture the rubber stopper and inject air into the vial.
• 5. Turn the vial with the syringe upside down.
• 6. Make sure the tip of the needle is in the insulin suspension.
• 7. Draw the correct volume of insulin into the syringe.
• 8. Remove air bubbles from the syringe.
• 9. Recheck the recommended dose and remove the needle from the vial.

Injecting insulin

• Disinfect the skin at the injection site.
• With one hand, stabilize the skin by stretching or pinching a large area to create a skin fold. Hold the syringe in the other hand like a pencil. Insert the needle straight into the skin (at a 90° angle). Make sure the needle is fully inserted and well-placed in the subcutaneous fat layer, not in the deeper skin layers (in very thin people, it may be necessary to insert the needle at an angle instead of perpendicular). To inject the insulin, push the plunger to the end, injecting the dose in under 5 seconds. Hold an alcohol swab close to the needle and pull the needle out of the skin. Press the swab against the injection site for a few seconds. Do not rub the skin at the injection site! To avoid tissue damage, it is recommended to change the injection site for each injection. The next injection site should be at least 1-2 cm away from the previous one.

Mixing Gensulin N suspension in vials with Gensulin R solution in vials

The decision to mix Gensulin R solution with Gensulin N suspension can only be made by your doctor. When preparing the mixture for injection, you should always introduce the fast-acting insulin - Gensulin R - first. When injecting insulin, you should follow the same procedure as described above.

Administering Gensulin N in cartridges using insulin pens

Gensulin N in 3 ml cartridges is intended for subcutaneous injection only using a reusable insulin pen.

Gensulin N in cartridges should not be administered by any other method.If it is necessary to administer insulin by another method, you should consult your doctor.
The 3 ml cartridges are intended for use with an insulin pen marked with the CE symbol, in accordance with the manufacturer's instructions. Gensulin N cartridges should only be used with insulin pens from Bioton, to allow for the correct dose to be administered.
To load the pen, attach the needle, and inject the medicine, you should follow the manufacturer's instructions for the insulin pen, which are included with the pen's packaging.
Before using the Gensulin N suspension, you should rotate the cartridge between your hands 10 times, then turn it upside down 10 times to achieve a uniformly cloudy or milky appearance of the suspension. The cartridges contain a small glass ball that helps mix the ingredients. You should not shake vigorously, as this may cause foam to form, which can interfere with proper dosing.
The suspension in the cartridge can be mixed without removing it from the pen.
The design of the cartridges prevents adding other insulin to the cartridge. Used cartridges cannot be refilled.

Using a higher dose of Gensulin N than recommended

If a higher dose of Gensulin N is administered than recommended, hypoglycemia (low blood glucose) may occur. You should check your blood glucose levels (see subsection A "Hypoglycemia" in section 4)

Missing a dose of Gensulin N

If a lower dose of Gensulin N is administered than recommended, hyperglycemia (high blood glucose) may occur. You should check your blood glucose levels. You should not take a double dose to make up for a missed dose.

Stopping treatment with Gensulin N

If a lower dose of Gensulin N is administered than recommended, your blood glucose levels may increase. You should not change your insulin unless your doctor recommends it.
If you have any further doubts about using this medicine, you should consult 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 may cause hypoglycemia (low blood glucose). See below for more information on hypoglycemia in subsection "Common problems in diabetes" in section 4.

Possible side effects

Generalized allergic reactionoccurs very rarely (in 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 Gensulin N, you should contact your doctor immediately.
Local allergic reactionoccurs frequently (in less than 1 in 10 patients). The symptom may be redness, swelling, or itching of the skin at the injection site. These symptoms usually go away after a few days or weeks. If you experience any of these symptoms, you should inform your doctor.

Skin changes at the injection site

If insulin is injected into the same site too frequently, the fatty tissue may shrink (lipoatrophy) or thicken (lipohypertrophy) (not more often than in 1 in 100 patients).
Lumps under the skin may also be caused by the accumulation of a protein called amyloid (cutaneous amyloidosis, frequency unknown). Insulin injected into an area with lumps may not work properly. You should always change the injection site to prevent these skin changes.
Edema (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 sugar in the blood. It can occur if:

• you take too much Gensulin N or other insulin;
• you miss or delay a meal, or change your diet;
• you exercise too intensely before or after a meal;
• you are ill (especially if you have diarrhea or vomiting);
• your insulin requirements change, or
• you have worsening kidney or liver problems.

Blood glucose levels can be affected by alcohol and some medicines.
The first symptoms of low blood glucose usually occur quickly and include:

• fatigue,
• nervousness or trembling,
• headache,
• rapid heartbeat,
• nausea,
• cold sweats.

If you are unsure about recognizing the warning signs of hypoglycemia, you should avoid situations where you could put yourself or others at risk (e.g., driving a car).

You should not use Gensulin N if you experience warning signs of hypoglycemia (low blood glucose).

If your blood glucose levels are low, you should eat glucose tablets, sugar, or a sweet drink. Then, you should eat fruit, cake, or a sandwich, as recommended by your doctor, and rest. This usually helps in cases of mild hypoglycemia or minor insulin overdose. If your condition worsens, you experience shallow breathing, and your skin becomes pale, you should contact your doctor immediately. Glucagon injection can help in cases of moderate hypoglycemia.
After glucagon injection, you should eat glucose or sugar. If you do not improve after glucagon injection, you should go to the hospital. For more information about glucagon, you should 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 Gensulin N or other insulin;
• injecting less insulin than recommended by your doctor;
• eating very large meals compared to dietary requirements; or
• having a fever, infection, or stressful experiences.

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

• drowsiness,
• redness of the face,
• thirst,
• loss of appetite,
• fruity breath odor,
• 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 syringe and a spare vial of Gensulin N with you.
You should always carry something that informs others that you have diabetes.
You should always carry sugar cubes with you.

C. Illness

During illness, especially if you have nausea or vomiting, your insulin requirements may change. People with diabetes need insulin even if they are not eating their usual meals.You should perform a urine or blood test, follow general illness treatment guidelines, and consult your diabetes nurse or doctor.
After the medicine was placed on the market, the following side effects have also been reported:

• edema, especially when previously poor metabolic control has improved with intensive insulin therapy,
• weight gain,
• injection site reactions, such as discoloration, bleeding, induration, lump, or nodule, pain, rash, urticaria, or furuncles,
• itching, including generalized itching
• dizziness.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C,
02-222 Warsaw
phone: +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.
By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Gensulin N

The medicine should be stored out of sight and reach of children.
The medicine should be stored in a refrigerator (2°C – 8°C). Do not freeze.
After opening the immediate packaging, the medicine can be stored at a temperature not above 25°C for 28 days. Gensulin N should be protected from light.
Cartridges and vials that are in use or are to be used should not be stored in the refrigerator. You can carry them with you. Gensulin N should be protected from high temperatures.
You should not use this medicine after the expiration date stated on the label and outer packaging of the vials and cartridges after "EXP". The expiration date refers to the last day of the specified month.
You should not use this medicine if you notice lumps or white particles stuck to the bottom or walls of the cartridge or vial, and the glass has a dull appearance. You should check the appearance of the insulin before each injection.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Gensulin N contains

• The active substance of the medicine is human insulin, produced by recombinant DNA technology. 1 ml of the suspension contains 100 IU of human insulin. Each vial contains 10 ml, which corresponds to a dose of 1000 IU of human insulin. Each cartridge contains 3 ml, which corresponds to a dose of 300 IU of human insulin.
• The other ingredients (excipients) are: phenol, glycerol, protamine sulfate, metacresol, zinc oxide, hydrochloric acid, disodium phosphate dodecahydrate, water for injections.

What Gensulin N looks like and what the packaging contains

Gensulin N is a white crystalline suspension of human isophane insulin in an isotonic phosphate buffer with a pH of 7.0–7.6.

Packaging

• 1 glass vial containing 10 ml of Gensulin N, closed with an aluminum cap with a two-layer rubber disk and a polypropylene cap, in a cardboard box.
• 5 glass cartridges containing 3 ml of Gensulin N, in a cardboard box
• 10 glass cartridges containing 3 ml of Gensulin N, in a cardboard box

Marketing authorization holder and manufacturer

Marketing authorization holder:
Bioton S.A.
Starościńska 5
02-516 Warsaw
Manufacturer:
Bioton S.A.
Starościńska 5
02-516 Warsaw

This medicine is authorized for use in the Member States of the European Economic Area under the following names:

Poland: Gensulin N
Malta: Gensulin N, 100 IU/ml, suspension for injection
To obtain more detailed information on this medicine, you should contact the representative of the marketing authorization holder:
Bioton S.A.
Starościńska 5
02-516 Warsaw
Poland

Date of last revision of the leaflet:

February 2024