Gensulin N

Leaflet accompanying the packaging: patient information

Gensulin N, 100 IU/ml, suspension for injection
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.
• If you have any doubts, consult your 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 those not listed in this leaflet, 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. Package contents 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' inability to produce insulin in quantities that allow
control of blood glucose levels. 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. 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 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 intravenous administration is necessary, consult your doctor.

When not to use Gensulin N

• if symptoms of hypoglycemia (low blood glucose) occur. Information on how to proceed in case of mild hypoglycemia is provided later in this leaflet (see subsection A "Hypoglycemia" in section 4).
• if the patient is allergic to human insulin or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Gensulin N, discuss it with your doctor, pharmacist, or

nurse.

• If the current treatment provides good blood glucose control, warning signs of excessive blood glucose reduction may not be felt. Warning signs are listed later in the leaflet. It is necessary to plan meals, physical activity, and overall activity level carefully. It is also necessary to 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 than before. If hypoglycemia occurs frequently or there are difficulties in recognizing the warning signs of hypoglycemia, 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 exertion.
• The need for insulin may also change after consuming alcohol.
• You should tell your diabetes nurse, doctor, or pharmacist about your planned trip abroad. The time difference may require you to inject and eat at a different time.
• 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 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 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 blood glucose levels and adjusting the dose of insulin or other anti-diabetic medicines.

Gensulin N and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or 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 (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

The body's need for insulin usually decreases in the first three months of pregnancy and increases over the next six months. In breastfeeding women, it may be necessary to change the insulin dose or diet.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist 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 taken into account in all situations where it could pose a risk to the patient or others (e.g., when driving a vehicle or operating machines).
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

Always check the name and type of insulin on the label and packaging of the cartridge or vial when purchasing the medicine at the pharmacy. Make sure it is the Gensulin N medicine prescribed by your doctor.
This medicine should always be used according to your doctor's or pharmacist's instructions. If you have any doubts, 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. Follow your doctor's instructions carefully and regularly visit the diabetes clinic.
Changing the type of insulin used (e.g., from animal insulin to human insulin) may require a dose adjustment. 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, 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

• 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

Inject the insulin dose according to your doctor's or diabetes nurse's instructions.
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.
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, 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, follow the rules of hygiene: wash your hands before administration, disinfect the injection site.
Before administration, carefully inspect the cartridge or vial with insulin. The Gensulin N suspension should be uniformly cloudy (uniformly turbid or milky). Do 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. Do not use the medicine if, after mixing, white flakes float or white particles stick to the walls, giving it a frozen appearance.
Be careful not to insert the needle into a blood vessel during 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. Always check that the syringe is calibrated to the correct insulin concentration.
Before each injection of Gensulin N suspension, 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, repeat the described actions until the ingredients are mixed. Do not shake vigorously, as this may cause foam to form, which can interfere with the correct measurement of the dose.
Use the syringe to draw air in a volume equal to the insulin dose.

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 insulin dose.

• 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. Re-check the recommended dose and remove the needle from the vial.

Injecting insulin

• Clean the skin at the injection site.
• Stabilize the skin with one hand 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, always introduce the fast-acting insulin - Gensulin R - first. When injecting insulin, 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.

If it is necessary to administer insulin by another method, consult your doctor.
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 ensure the correct dose is administered.
To load the pen, attach the needle, and inject the medicine, follow the manufacturer's instructions for the insulin pen, which are included with the pen's packaging.
Before using the Gensulin N suspension, 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. Do not shake, as this may cause foam to form, making it difficult to measure the dose correctly.
The suspension in the cartridge can be mixed without removing it from the pen.
The design of the cartridges prevents the addition of 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. Check your blood glucose level (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. Check your blood glucose level. Do 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, blood glucose levels may increase. Do not change your insulin unless your doctor recommends it.
If you have any further doubts about using this medicine, 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).
Symptoms are:

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

If you experience such symptoms while using Gensulin N, 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 disappear after a few days or weeks. If you experience any of these symptoms, 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) (less than 1 in 100 patients).
Lumps under the skin can 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. Always change the injection site to prevent these skin changes.
Edema (e.g., swelling of the arms, legs; 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. This can happen if:

• you take too much Gensulin N or other insulin;
• you miss or delay a meal, or change your diet;
• you exercise or work too intensely 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 function disorders that worsen.

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, avoid situations where you could put yourself or others at risk (e.g., driving a car).

Do not use Gensulin N 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, cake, or a sandwich, as your doctor recommends, and rest. This usually helps in case of mild hypoglycemia or minor insulin overdose. If your condition worsens, you experience shallow breathing, and your skin turns pale, contact your doctor immediately. Glucagon injection may help in case of moderate hypoglycemia.
After glucagon injection, eat glucose or sugar. If you do not improve after glucagon injection, go to the hospital. For information on glucagon, ask your doctor.

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 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. 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 syringe and a spare vial of Gensulin N with you.
Always carry something that informs others that you have diabetes.
Always carry sugar cubes with you.

C. Illness

During illness, especially when accompanied by nausea or vomiting, the body's need for insulin may change. Diabetics need insulin even if they are not eating their usual meals.Check your urine or blood, follow the general rules for treating illness, 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,
• reactions at the injection site, such as discoloration, bleeding, hardening, lump, or induration, pain, rash, urticaria, or furuncles,
• itching, including generalized itching
• dizziness.

Reporting side effects

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

Keep the medicine out of the sight and reach of children.
Store the medicine in a refrigerator (2°C – 8°C). Do not freeze.
After opening the immediate packaging, store the medicine at a temperature not above 25°C for 28 days. Protect Gensulin N from light.
Cartridges and vials that are in use or are to be used should not be stored in the refrigerator. The patient may carry them with them. Protect Gensulin N from high temperatures.
Do 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.
Do 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. 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. Package contents 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 package 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
For more detailed information on this medicine, 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