Gensulin R

Leaflet accompanying the packaging: patient information

Gensulin R, 100 IU/ml, solution 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 necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for a particular person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

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

Gensulin R contains human insulin as the active substance, which is used to treat diabetes.
The cause of diabetes is the inability of the pancreas to produce insulin in quantities that allow
control of blood glucose levels. Gensulin R is used to control blood glucose levels in the long term.
This is a fast-acting insulin.
The doctor may recommend using Gensulin R and insulin with a longer duration of action. Each
type of insulin has a different leaflet for the patient. You should not change 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 to make it easier to distinguish.

2. Important information before using Gensulin R

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

Gensulin R in cartridges should not be administered intravenously or intramuscularly.If
administration via a syringe is necessary, a vial should be used.
Gensulin R in vials is intended for subcutaneous injection.
In exceptional cases, Gensulin R in vials can also be administered intramuscularly.
In special cases, it can also be administered intravenously.

When not to use Gensulin R

• if symptoms indicating hypoglycemia (low blood glucose) occur. Information on how to proceed in case of mild hypoglycemia will be provided later in this leaflet (see subsection "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 to use Gensulin R, you should discuss it with your doctor, pharmacist, or nurse.

• If the current treatment ensures good blood glucose control, warning signs of excessive blood glucose reduction may not be felt. Warning signs are listed later in the leaflet. You should plan meals, physical activity, and overall activity level carefully. You should 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 completely different than before. If hypoglycemia occurs frequently or there are difficulties in recognizing the warning signs of hypoglycemia, you should consult a doctor.
• You should inform the diabetes nurse, doctor, or pharmacist if you have recently been ill; if you have kidney or liver disease; if you have increased physical exertion.
• The need for insulin may also change after consuming alcohol.
• You should tell the 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 at the same time. 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 R"). If you are currently injecting insulin into an area with lumps, you should consult your doctor before changing it. The doctor may recommend closer monitoring of blood glucose levels and adjusting the insulin dose or other anti-diabetic medicines.

Gensulin R and other medicines

You should 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.
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, you should 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. You should keep this in mind in all situations where it could be a risk to the patient or others (e.g., when driving a vehicle or operating machines).
You should consult a diabetes nurse or doctor about driving a car if:

• hypoglycemia occurs frequently
• there are weak or no warning signs of hypoglycemia.

Gensulin R contains sodium

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

3. How to use Gensulin R

You should 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. You should make sure it is Gensulin R prescribed by your doctor.
This medicine should always be used according to your doctor's or pharmacist's recommendations. In case of 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

Your doctor will recommend the appropriate type of insulin, amount of medicine, and time and frequency of injection. These instructions are intended only for a specific patient. You should strictly follow your doctor's recommendations 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 apply only to the first injection or may be introduced gradually over several weeks or months.
Gensulin R 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 R in vials is intended for subcutaneous injection. Although it is not recommended, in exceptional cases, it can be administered intramuscularly or intravenously.

Preparing Gensulin R

Before using Gensulin R, 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 according to your doctor's or diabetes nurse's recommendations.
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 take the insulin out of the refrigerator to bring it to room temperature (if it is a new vial or cartridge). Vials and cartridges currently in use should be stored at room temperature for 28 days.
During administration, you should follow the rules of hygiene: wash your hands before administration, disinfect the injection site.
Before administration, you should carefully examine the vial or cartridge with insulin.
The Gensulin R solution should be colorless and clear. It should have the appearance and consistency of water. You should not use the medicine if the solution is cloudy, thick, or discolored.
You should pay special attention to not introducing the needle into a blood vessel during injection.

Administering Gensulin R from vials using syringes

Gensulin R in a vial is intended for subcutaneous injection. Although it is not recommended, in exceptional cases, it can be administered intramuscularly.
In special cases, it can also 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.

Instructions for use

Immediately before injection:

• Remove the plastic protective cap from the cartridge (do not tear off the cartridge).
• Wipe the exposed part of the rubber stopper with an alcohol solution. Do not remove the stopper!
• Draw air into the syringe in a volume equal to the dose of insulin.
• Insert the needle attached to the syringe through the rubber stopper and inject air into the vial.
• Turn the vial with the syringe upside down.
• Make sure the tip of the needle is in the insulin solution.
• 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 like a pencil. Insert the needle straight into the skin (at a 90-degree angle). Make sure the needle is fully inserted and properly 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 straight). To inject the insulin, push the plunger all the way in, injecting the dose in under 5 seconds. Hold a cotton ball with alcohol close to the needle and pull the needle out of the skin. Press the cotton ball with alcohol 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 each time. The next injection site should be at least 1-2 cm away from the previous one.

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

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

Administering Gensulin R in cartridges for injection pens

Gensulin R 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, you should consult your doctor.
Cartridges with a capacity of 3 ml are intended for use with an injection pen marked with the CE sign in accordance with the manufacturer's instructions. Gensulin R cartridges should only be used in insulin pens from Bioton to ensure the correct dose is administered.
To load the pen, attach the needle, and inject the medicine, you should follow the manufacturer's instructions provided with the pen packaging.
The design of the cartridges prevents adding other insulin to the cartridge. Used cartridges cannot be refilled.

Using a higher dose of Gensulin R than recommended

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

Missing a dose of Gensulin R

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

Stopping the use of Gensulin R

If a lower dose of Gensulin R is used than recommended, high blood glucose may occur. You should not change the insulin you are using unless your doctor recommends it.
In case of 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 can 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 R, 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 insulin injection site. These symptoms usually disappear
after a few days or weeks. If you experience any of the above 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
(lipohipertrophy) (less than 1 in 100 patients).
Lumps under the skin can also be caused by the accumulation of a protein called amyloid (skin amyloidosis, frequency of occurrence 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 the patient:

• takes too much Gensulin R or other insulin;
• skips or delays a meal, or changes their diet;
• exercises or works too intensely before or after a meal;
• is ill (especially with diarrhea or vomiting);
• has a change in insulin requirements, or
• has worsening kidney or liver function.

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 R if you experience 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, cake, or a sandwich, as recommended by your doctor, 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 becomes pale, you should contact your doctor immediately. Glucagon injection can help in case 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 information about glucagon, you should 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 R or other insulin;
• injecting less insulin than recommended by the 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 skin on the face,
• thirst,
• loss of appetite,
• fruity breath,
• 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 R 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 when combined with nausea or vomiting, the body's need for insulin may change. Diabetic patients need insulin even if they are not eating their usual meals.You should perform a urine or blood test, follow the general rules for treating illness, and consult a diabetes nurse or doctor.
After the medicine has been on the market, the following side effects have also been reported:

• edema, especially when previously poor metabolic control has improved after intensive insulin therapy,
• weight gain,
• reactions at the injection site, such as discoloration, bleeding, hardening, lump, or infiltration, pain, rash,
• hives or boils,
• itching, including generalized itching,
• dizziness.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should 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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Gensulin R

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 R should be protected from light.
Cartridges and vials that are in use or are to be used should not be stored in the refrigerator. The patient can carry them with them. Gensulin R 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 it is discolored or contains solid particles. Gensulin R can only be used if it looks like water. 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 R contains

• The active substance of the medicine is human insulin, produced by recombinant DNA technology. 1 ml of the solution 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: glycerol, metacresol, hydrochloric acid, sodium hydroxide, water for injections.

What Gensulin R looks like and what the packaging contains

Gensulin R is a clear and colorless aqueous solution of human insulin with a pH of 7.0-7.6.

Packaging

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

Marketing authorization holder and manufacturer

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

Date of last revision of the leaflet:

February 2024