Gensulin M30 (30/70)

Leaflet accompanying the packaging: patient information

Gensulin M30 (30/70), 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 necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for one 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 is Gensulin M30 and what is it used for
• 2. Important information before using Gensulin M30
• 3. How to use Gensulin M30
• 4. Possible side effects
• 5. How to store Gensulin M30
• 6. Contents of the packaging and other information

1. What is Gensulin M30 and what is it used for

Gensulin M30 contains human insulin as an active substance, which is used to treat diabetes. The cause of diabetes is the pancreas's inability to produce insulin in amounts that allow for blood glucose control. Gensulin M30 is used to control blood glucose levels in the long term. It is a mixture of intermediate-acting and fast-acting insulin. The duration of action of this insulin has been prolonged by the use of protamine sulfate in the suspension. The doctor may recommend using Gensulin M30 and insulin with a longer duration of action. Each type of insulin has a different leaflet for the patient. You should not change your insulin unless your doctor advises you to do so. When changing insulin, you should be very careful. Each type of insulin has a different symbol and color on the packaging and on the cartridge and vial, to make it easier to distinguish.

2. Important information before using Gensulin M30

Gensulin M30 in 3 ml cartridges is intended for subcutaneous injection only, using a reusable insulin pen.

Gensulin M30 in a 10 ml vial is intended for subcutaneous injection. Although it is not recommended, Gensulin M30 in vials can also be administered intramuscularly. Gensulin M30 in a vial must not be administered intravenously.
If it is necessary to administer insulin by a different method, you should consult a doctor.

When not to use Gensulin M30

• 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 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 treatment with Gensulin M30, you should discuss it with your doctor, pharmacist, or nurse.

• 1. 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. 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.
• 2. 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.
• 3. You should inform the diabetes nurse, doctor, or pharmacist if:
• -you have recently been ill;
• you have kidney or liver disease;
• you have increased physical exertion.
• 4. The need for insulin may also change after consuming alcohol.
• 5. 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.
• 6. 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 M30"). 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 dose of insulin or other anti-diabetic medicines.

Gensulin M30 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 dose of insulin 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), the patient's ability to concentrate and react may be impaired. You should keep this in mind in all situations where it could pose a risk to yourself 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 M30 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 M30

You should 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. You should make sure it is the Gensulin M30 medicine prescribed by your doctor.
This medicine should always be used in accordance with the doctor's or pharmacist's recommendations. In case of doubts, you should 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

The attending doctor will recommend the appropriate type of insulin, the amount of medicine, and the time and frequency of injection. These instructions are intended only for the specific patient. The doctor's recommendations should be followed strictly, and the diabetes clinic should be visited regularly.
Changing the type of insulin used (e.g., from animal insulin to human insulin) may require a reduction or increase in the dose. This change may apply only to the first injection or may be introduced gradually over several weeks or months.
Gensulin M30 in cartridges is intended for subcutaneous injection only, using a reusable insulin pen.
Gensulin M30 in a vial is intended for subcutaneous injection. Although it is not recommended, it can be administered intramuscularly in exceptional cases. Gensulin M30 in a vial must not be administered intravenously. If it is necessary to administer insulin by a different method, you should consult a doctor.

Preparing Gensulin M30

Before using Gensulin M30, you should

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

Method of use

You should inject the dose of insulin according to the 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). In the case of a used cartridge or vial, it 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 M30 suspension should be uniformly cloudy 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 or solid white particles adhere to the walls, giving it a frozen appearance.
You should pay particular attention to not introducing the needle into a blood vessel during injection.

Administering Gensulin M30 from vials using a syringe

Gensulin M30 in a 10 ml vial is intended for subcutaneous injection, and in exceptional cases, it can be administered intramuscularly. Gensulin M30 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 used is calibrated to the concentration of the insulin being used.
Before each injection of Gensulin M30 suspension, the vial should be rotated between the palms of the hands 10 times, then turned 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 the proper measurement of the dose.

Instructions for use

Immediately before injection:

• 1. Remove the protective plastic 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. Re-check 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-degree angle). Make sure the needle is fully inserted and well-placed in the subcutaneous fat layer, not in the deeper skin layers (in the case of very thin people, it may be necessary to insert the needle at an angle instead of perpendicular). To inject the insulin, you should push the plunger to the end, injecting the dose in under 5 seconds. Hold an alcohol swab close to the needle and withdraw the needle from 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.

Administering Gensulin M30 in cartridges

Gensulin M30 in 3 ml cartridges is intended for subcutaneous injection only, using a reusable insulin pen.

Gensulin M30 in a cartridge must not be administered intravenously. If it is necessary to administer insulin by a different method, you should consult a 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 M30 cartridges should only be used with Bioton insulin pens 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 pen, which are included with the pen's packaging.
Before using the Gensulin M30 suspension, the cartridges should be rotated between the palms of the hands 10 times, then turned upside down 10 times to achieve a uniformly cloudy or milky appearance of the suspension. The cartridges contain a small glass bead that helps mix the ingredients. You should not shake vigorously, 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 M30 than recommended

If a higher dose of Gensulin M30 is administered than recommended, hypoglycemia (low blood glucose) may occur. You should check your blood glucose level (see subsection A "Hypoglycemia" in section 4).

Missing a dose of Gensulin M30

If a lower dose of Gensulin M30 is administered than recommended, hyperglycemia (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 treatment with Gensulin M30

If a lower dose of Gensulin M30 is administered than recommended, an increase in blood glucose levels may occur. You should not change your insulin unless your doctor advises you to do so.
In case of any further doubts about using this medicine, you should 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 may cause hypoglycemia (low blood glucose). See further information on hypoglycemia below in subsection "Common problems in diabetes".

Possible side effects

Generalized allergic reactionoccurs very rarely (in less than 1 in 10,000 patients).
The symptoms are:

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

If you experience such symptoms while using Gensulin M30, 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 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 (lipohypertrophy) (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 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 glucose in the blood. It can occur if:

• you have taken too much Gensulin M30 or other insulin;
• you have missed or delayed a meal, or changed your diet;
• you have exercised or worked too intensely before or after a meal;
• you have been ill (especially with diarrhea or vomiting);
• your insulin requirements have changed, or
• you have worsening kidney or liver problems.

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

• fatigue,
• irritability or shakiness,
• 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).

Do not use Gensulin M30 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 the case of mild hypoglycemia or slight insulin overdose. If your condition worsens, you experience shallow breathing, and your skin becomes pale, you should contact your doctor immediately. Injecting glucagon may help in the case of moderate hypoglycemia.
After injecting glucagon, you should eat glucose or sugar. If you do not improve after administering glucagon, you should go to the hospital. To get 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 M30 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 odor from the mouth,
• 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 M30 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 accompanied by 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 contact 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 with intensive insulin therapy,
• weight gain,
• reactions at the injection site, such as discoloration, bleeding, hardening, lump, or induration, 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 the leaflet, you should inform 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Gensulin M30

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 M30 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 M30 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 or 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 solid particles adhering 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 used. This will help protect the environment.

6. Contents of the packaging and other information

What Gensulin M30 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: metacresol, glycerol, phenol, protamine sulfate, zinc oxide, disodium phosphate dodecahydrate, hydrochloric acid, sodium hydroxide, water for injections.

What Gensulin M30 looks like and what the packaging contains

Gensulin M30 (30/70) is a sterile suspension of human insulin with a pH of 7.0-7.6, containing 30% soluble insulin and 70% isophane insulin.

Packaging

• 1 glass vial containing 10 ml of Gensulin M30, closed with an aluminum cap with a two-layer rubber stopper and a polypropylene cap, in a cardboard box.
• 5 glass cartridges containing 3 ml of Gensulin M30, in a cardboard box.
• 10 glass cartridges containing 3 ml of Gensulin M30, 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 in the Member States of the European Economic Area under the following names:

Poland: Gensulin M30 (30/70)
Malta: Gensulin M30 (30/70), 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 the last update of the leaflet:

February 2024