Gensulin n: detailed information

Package leaflet: Information for the patient

Gensulin N, 100 IU/ml, suspension for injection
Insulinum humanum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

What Gensulin N is and what it is used for
Important information before using Gensulin N
How to use Gensulin N
Possible side effects
How to store Gensulin N
Contents of the package and other information

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

Gensulin N contains human insulin as the active substance, which is used in the treatment of diabetes.
Diabetes is caused by the inability of the pancreas to produce insulin in amounts sufficient to
control blood glucose (blood sugar) levels. Gensulin N is used for long-term
control of glucose levels. The duration of action of this insulin has been prolonged by the addition of protamine sulfate to the suspension.
Your doctor may recommend using Gensulin N together with a fast-acting insulin. For each type of
insulin, follow your doctor's instructions. When switching insulin types, great caution must be exercised. Each type of insulin has a different symbol and color on the outer packaging, as well as on the label and vial, to facilitate differentiation.

2. Important information before using Gensulin N

Gensulin N in cartridges is intended exclusively for subcutaneous injection using a reusable insulin pen.
Gensulin N in cartridges must not be administered intravenously or intramuscularly. If administration via syringe is required, a vial should be used. Gensulin N in vials is available on the market.
Gensulin N in vials is intended for subcutaneous injection. Although not recommended, Gensulin N in vials may also be administered intramuscularly. Gensulin N in vials must not be administered intravenously. If insulin needs to be administered by another method, consult a doctor.

When not to use Gensulin N

if symptoms indicating hypoglycaemia (low blood glucose levels) are present. Information on managing mild hypoglycaemia is provided later in this leaflet (see section A “Hypoglycaemia” in section 4).
if the patient is allergic to human insulin or to 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 current treatment provides good glycaemic control, warning symptoms of low blood glucose levels may become less noticeable. Warning symptoms are listed later in this leaflet. It is important to carefully plan meal times, frequency of physical activity, and overall activity level. Blood glucose levels should also be monitored frequently by regular blood glucose testing.
Some individuals who experienced hypoglycaemia (low blood glucose) after switching from animal to human insulin have reported that the warning symptoms were less pronounced or different than before. If hypoglycaemia occurs frequently or if you have difficulty recognizing its warning symptoms, consult your doctor.
Inform your diabetes nurse, doctor, or pharmacist if you:
- have recently had an illness;
- have kidney or liver disease;
- have increased physical exertion.
Insulin requirements may also change after consuming alcohol.
Inform your diabetes nurse, doctor, or pharmacist if you plan to travel abroad. Time zone differences may require adjustments to the timing of injections and meals.
In some patients with type 2 diabetes who have heart disease or a history of stroke, cases of heart failure have been reported when pioglitazone was used together with insulin. Contact your doctor immediately if symptoms of heart failure occur, such as shortness of breath, sudden weight gain, or localized swelling.

Skin changes at the injection site
Rotate injection sites to prevent the development of skin changes, such as lumps under the skin. Insulin injected into an area with such lumps may not be properly absorbed (see “How to use Gensulin N”). If insulin is currently being injected into an area with lumps, contact your doctor before changing the injection site. Your doctor may recommend more frequent blood glucose monitoring and adjustment of the insulin dose or other antidiabetic medications.

Gensulin N and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Your body's insulin requirement may change when taking the following medicines concomitantly:

corticosteroids,
thyroid hormone replacement therapy,
oral glucose-lowering agents (antidiabetic drugs),
acetylsalicylic acid (aspirin),
growth hormone,
octreotide, lanreotide,
selective β2-adrenergic receptor agonists (e.g. ritodrine, salbutamol, terbutaline),
β-adrenolytic agents (β-blockers),
thiazides or certain antidepressants (monoamine oxidase inhibitors),
danazol,
certain angiotensin-converting enzyme (ACE) inhibitors (e.g. captopril, enalapril) or angiotensin II receptor antagonists.

Pregnancy and breastfeeding
Insulin requirements usually decrease during the first three months of pregnancy and increase during the following six months. Breastfeeding women may require adjustments in insulin dose or dietary regimen.
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery
In the case of hypoglycaemia (low blood sugar), your ability to concentrate and reaction speed may be reduced. This should be taken into account in any situation where it could pose a risk to yourself or others (e.g. when driving or operating machinery).
Consult your diabetes nurse or doctor about driving if:

you experience frequent hypoglycaemia;
you have weak or no warning symptoms of hypoglycaemia.

Gensulin N contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, meaning the medicine is considered “sodium-free.”

3. How to use Gensulin N

Always check the name and type of insulin on the label and outer packaging of the vial or
cartridge 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 as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist. To avoid possible transmission of diseases, each
cartridge may be used only by one person, even if the needle has been changed.
Dosage
Gensulin N should be injected as isophane insulin. Your doctor will recommend
the appropriate type of insulin, the amount of medicine, and the timing and frequency of injections. These
instructions are intended only for the specific patient. Follow your doctor's advice strictly and
visit the diabetes clinic regularly.
Changing the type of insulin used (e.g., from animal insulin to human insulin) may
require a decrease or increase in dose. This change may apply to
the first injection only or may be introduced gradually over several weeks
or months.
Gensulin N in cartridges is intended exclusively for subcutaneous injection
using a reusable injection pen. If insulin needs to be administered by another method, consult your doctor.
Gensulin N in vials is intended for subcutaneous injection. Although not recommended, in exceptional cases it may be administered intramuscularly.
Before using Gensulin N medicine, you should

check the outer packaging and label of the cartridge or vial to confirm that the name and letter marking of the insulin received match the prescription given by the doctor.
check the expiry date on the packaging.

Method of use
Inject the insulin dose as directed by your doctor or diabetes nurse.
Always rotate injection sites to avoid thickening of the skin (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 results in faster absorption than injections into other sites.
Rotate injection sites so that the same site is not used more frequently than approximately once per month.
Approximately ten to fifteen minutes before planned administration, remove the insulin from the refrigerator to allow it to reach room temperature (if it is a newly opened vial or cartridge).
The vial or cartridge currently in use should be stored at room temperature for 28 days.
Maintain hygiene during administration: wash your hands before injecting and disinfect the injection site.
Before administration, carefully inspect the vial or cartridge.
The suspension of Gensulin N should be uniformly opaque (consistently cloudy or milky). Do not use the medicine if, after mixing, the contents of the vial or cartridge remain clear or if a sediment of white substance remains at the bottom. Do not use the medicine if, after mixing, white clumps float in the liquid or if solid white particles adhere to the walls, giving it a frosted appearance.
Take particular care to avoid inserting the needle into a blood vessel during insulin injection.
Administration of Gensulin N from vials using syringes
Gensulin N in vials is intended for subcutaneous injection. Although not recommended, in exceptional cases it may be administered intramuscularly. Gensulin N in vials must not be administered intravenously.
Syringes specifically marked with insulin concentration units are intended for insulin administration. It is recommended to use syringes of the same type and manufacturer. Always check that the syringe used is calibrated appropriately for the concentration of insulin being used.
Before each injection of Gensulin N suspension, rotate the vial between your palms 10 times, then invert it 10 times by 180° to obtain a uniformly cloudy or milky appearance of the suspension. If this is not achieved, repeat the described steps until the components are fully mixed. Do not shake vigorously, as this may cause foaming, which could interfere with accurate dose measurement.
Instructions for use
Immediately before injection:

Remove the protective plastic cap from the cap (do not tear off the cap).
Wipe the exposed rubber stopper with an alcohol solution. Do not remove the stopper!
Draw air into the syringe equal in volume to the insulin dose.
Insert the needle attached to the syringe through the rubber stopper and inject the air into the vial.
Turn the vial with the syringe upside down.
Ensure that the tip of the needle is immersed in the insulin suspension.
Draw the correct volume of insulin into the syringe.
Remove air bubbles from the syringe.
Recheck the recommended dose and remove the needle from the vial.

Injecting insulin

Disinfect 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 as you would a pencil. Insert the needle straight into the skin (at a 90° angle). Ensure that the needle is fully inserted and properly placed in the subcutaneous fat layer, not in deeper tissue layers (in very thin individuals, it may be necessary to insert the needle at an angle rather than perpendicularly). To inject the insulin, push the plunger fully to deliver the dose within less than 5 seconds. Keep an alcohol swab close to the needle and withdraw the needle from the skin. Press the alcohol swab gently against the injection site for several seconds. Do not rub the skin at the injection site! To avoid tissue damage, it is recommended to change the injection site with 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 may only be made by
a doctor. When preparing the mixture into a syringe, always draw up the fast-acting insulin – Gensulin R – first. Administer the insulin as described above.
Administration of Gensulin N in cartridges for injection pens
Gensulin N in 3 ml cartridges is intended exclusively for subcutaneous injection using a reusable injection pen. If insulin needs to be administered by another method, consult your doctor.
The 3 ml cartridges are intended for use with a pen device marked with the CE symbol, in accordance with the manufacturer's instructions. Gensulin N cartridges should be used exclusively with Bioton insulin pens to ensure accurate dose delivery.
For loading the pen, attaching the needle, and injecting the medicine, strictly follow the instructions provided by the pen manufacturer included in the pen packaging.
Before using Gensulin N suspension, rotate the cartridge between your palms 10 times, then invert it 10 times by 180° to achieve a uniformly cloudy or milky appearance of the suspension.
The cartridges contain a small glass bead to help mix the components. Do not shake, as this may cause foaming, which could interfere with accurate dose measurement.
The suspension in the cartridge can be mixed without removing it from the pen.
The design of the cartridges prevents adding another insulin to the cartridge. Used cartridges must not be refilled.
Administration of a higher than recommended dose of Gensulin N
If a higher dose of Gensulin N than recommended is administered, low blood glucose levels may occur. Check your blood glucose level (see subsection A "Hypoglycaemia" in section 4).
Missing a dose of Gensulin N
If a lower dose of Gensulin N than recommended is administered, high blood glucose levels 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 than recommended dose of Gensulin N is administered, blood glucose levels may increase. Do not change the insulin being used unless advised by your doctor.
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Human insulin may cause hypoglycaemia (low blood glucose levels). See further information on hypoglycaemia below under the section "Common problems in diabetes".
Possible side effects
Generalised allergic reaction is very rare (in less than 1 in 10,000 patients).
Symptoms include:

drop in blood pressure,
breathing difficulties,
rapid heartbeat,
rash all over the body,
wheezing,
sweating.

If any of these symptoms occur while using Gensulin N, contact your doctor immediately.
Local allergic reaction is common (in less than 1 in 10 patients). Symptoms may include
redness, swelling or itching of the skin around the injection site. These symptoms usually
disappear after a few days or weeks. If any of the above symptoms occur, inform your doctor.
Skin changes at the injection site
If insulin is injected too frequently into the same site, fatty tissue may shrink (lipoatrophy) or
thicken (lipohypertrophy) (less than 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. Always rotate injection sites, as this helps prevent these skin changes.
Oedema (e.g. swelling of arms, ankles; fluid retention) has been reported, particularly at the
beginning of insulin treatment or during changes in therapy aimed at improving blood glucose control.
Common problems in diabetes
A. Hypoglycaemia
Hypoglycaemia (low blood glucose) is a condition in which there is too little sugar in the blood. This may occur if the patient:

takes too high a dose of Gensulin N or another insulin;
skips or delays a meal, or changes their diet;
exercises excessively or works too hard just before or after a meal;
is ill (especially with an illness involving diarrhoea or vomiting);
has changing insulin requirements, or
has worsening kidney or liver dysfunction.

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

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

If you are unsure about recognising the warning signs of hypoglycaemia, avoid situations where you might endanger yourself or others (e.g. driving a car).
Do not use Gensulin N if you are experiencing warning signs of hypoglycaemia (low blood glucose).
If blood glucose is low, eat glucose tablets, sugar or drink a sweet beverage. Then eat a piece of fruit, biscuits or a sandwich as advised by your doctor, and rest. This is usually sufficient in cases of mild hypoglycaemia or minor insulin overdose. If the condition worsens, with shallow breathing and pale skin, contact your doctor immediately. An injection of glucagon may help in cases of moderately severe hypoglycaemia.
After administering glucagon, eat glucose or sugar. If there is no improvement after glucagon administration, go to hospital immediately. For information about glucagon, consult your doctor.
B. Hyperglycaemia and diabetic ketoacidosis
Hyperglycaemia (excessively high blood glucose) means the body is not receiving enough insulin. Hyperglycaemia may be caused by:

not taking Gensulin N or another insulin;
injecting less insulin than prescribed by your doctor;
eating very large meals compared to dietary requirements; or
fever, infection, or stressful events.

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

drowsiness,
flushed skin on the face,
thirst,
loss of appetite,
fruity odour of breath,
nausea or vomiting.

Severe symptoms include laboured breathing and rapid pulse. Seek medical help immediately.
Untreated hypoglycaemia (low blood glucose) or hyperglycaemia (high blood glucose) may lead to serious disturbances and cause headache, nausea, vomiting, dehydration, loss of consciousness, coma or even death.
Three simple ways to avoid hypoglycaemia or hyperglycaemia:
Always carry spare syringes and a spare vial of Gensulin N.
Always carry something that informs others that you have diabetes.
Always carry sugar cubes.
C. Illness
During illness, especially when associated with nausea or vomiting, the body's insulin requirements may change. People with diabetes need insulin even when they are unable to eat normal meals. Perform urine or blood tests, follow general illness management guidelines, and contact your diabetes nurse or doctor.
The following side effects have also been reported after the medicine was placed on the market:

oedema, especially when previous poor metabolic control has improved with intensive insulin therapy,
weight gain,
injection site reactions such as discolouration, bleeding, hardening, lump or infiltration, pain, rash, urticaria or blisters,
itching, including generalised itching,
dizziness.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse.
Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Side effects can also be reported to the responsible entity.
Reporting side effects helps provide 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.
Store the medicine in a refrigerator (2°C – 8°C). Do not freeze.
After first opening the immediate packaging, the medicine may be stored at a temperature up to 25°C for up to 28 days. Gensulin N should be protected from light.
Cartridges and vials in use or intended for use should not be stored in the refrigerator.
The patient may carry them at room temperature. Gensulin N should be protected from high temperatures.
Do not use this medicine after the expiry date stated on the label and outer packaging of the cartridges and vials after “EXP”. The expiry date refers to the last day of the specified month.
Do not use this medicine if you notice clumps or white solid particles adhering to the bottom or walls of the cartridge or vial, or if the glass appears cloudy. The appearance of insulin should be checked before each injection.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Gensulin N contains

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

What Gensulin N looks like and contents of the pack
Gensulin N is a sterile suspension of white crystalline isophane human insulin in an isotonic phosphate buffer at pH 7.0–7.6.
Packaging

1 glass vial containing 10 ml of Gensulin N, sealed with an aluminium cap with a two-layer rubber disc and a polypropylene flip-off cap, in a cardboard box.
5 glass cartridges containing 3 ml of Gensulin N for injection devices, in a cardboard box.
10 glass cartridges containing 3 ml of Gensulin N for injection devices, in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Bioton S.A.
ul. Starościńska 5
02-516 Warsaw
Poland

Manufacturer:
Bioton S.A.
ul. Starościńska 5
02-516 Warsaw
Poland

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Gensulin N
Malta: Gensulin N, 100 IU/ml, suspension for injection

For further information about this medicinal product, please contact the representative of the Marketing Authorisation Holder:
Bioton S.A.
ul. Starościńska 5
02-516 Warsaw
Poland
February 2024