Gensulin M30 (30/70)

Leaflet accompanying the packaging: patient information

Gensulin M30 (30/70), 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, you may need to read it again.
• In case of any doubts, 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 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. Package contents and other information

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

Gensulin M30 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 amounts that allow 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 a longer-acting insulin. Each type of insulin has a different leaflet for the patient. Do not change insulin unless advised by a doctor. When changing insulin, 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, consult a doctor.

When not to use Gensulin M30

• if symptoms of hypoglycemia (low blood glucose) occur. Information on how to proceed in case 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, 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. 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.
• 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 than before. If hypoglycemia occurs frequently or there are difficulties in recognizing the warning signs of hypoglycemia, consult a doctor.
• 3. Inform the diabetes nurse, doctor, or pharmacist in case of:
• -recently suffered illness;
• kidney or liver disease;
• increased physical exertion.
• 4. The need for insulin may also change after consuming alcohol.
• 5. Inform the diabetes nurse, doctor, or pharmacist about planned travel abroad. Time zone differences may require injections and meals to be taken 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 together. 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
It is necessary to 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 insulin is currently being injected into an area with lumps, consult a 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 M30 and other medicines

Tell your doctor or pharmacist about all 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 adjust 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 kept in mind in all situations where it could pose a risk to the patient or others (e.g., when driving a vehicle or operating machines).
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 considered "sodium-free"

3. How to use Gensulin M30

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. Make sure it is the Gensulin M30 medicine prescribed by your doctor.
This medicine should always be used as directed by your doctor or pharmacist. In case of doubts, 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 treating doctor will recommend the appropriate type of insulin, amount of medicine, and 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 dose adjustment. This change may only apply 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, consult a doctor.

Preparing Gensulin M30

Before using Gensulin M30

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

Method of use

Inject the dose of insulin as directed by the doctor or diabetes nurse.
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). In the case of a used cartridge or vial, it 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 vial or cartridge with insulin. The Gensulin M30 suspension should be uniformly cloudy or milky. Do not use the medicine if the contents of the vial or cartridge remain clear after mixing or if a white sediment remains at the bottom. Do not use the medicine if, after mixing, white flakes float or stick to the walls, giving it a frozen appearance.
Be careful not to insert 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. Always check that the syringe used is calibrated for the insulin concentration being used.
Before each injection of Gensulin M30 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 proper dosing.

Instructions for use

Immediately before injection:

• 1. Remove the protective plastic cap from the cartridge (do not tear 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. Insert the needle attached to the syringe through 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.
• 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 positioned 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 down, 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 each time. The next injection site should be at least 1-2 cm away from the previous one.

Administering Gensulin M30 from cartridges using an insulin pen

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

Gensulin M30 in cartridges must not be administered intravenously or intramuscularly.If it is necessary to administer insulin by a different method, consult a doctor.
The 3 ml cartridges are designed 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 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 provided with the pen packaging.
Before using the Gensulin M30 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 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 must not 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. 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. Check your blood glucose level. Do 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, blood glucose levels may increase. Do not change your insulin unless advised by a doctor.
In case of any further doubts about using this medicine, 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 below for more information on hypoglycemia in subsection "Common problems in diabetes".

Possible side effects

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

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

If you experience such symptoms while using Gensulin M30, 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 resolve 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) (not more often than in 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, 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 take too much Gensulin M30 or other insulin;
• you miss or delay a meal or snack, 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 needs change, or
• you have kidney or liver problems that worsen.

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,
• 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 M30 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 directed by your doctor, and rest. This usually helps in cases of mild hypoglycemia or minor insulin overdose. If your condition worsens, and you experience shallow breathing, and your skin becomes pale, contact your doctor immediately. Administering glucagon can help in cases of moderate hypoglycemia.
After administering glucagon, eat glucose or sugar. If you do not improve after administering glucagon, go to the hospital. For information about 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 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. 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 M30. Always carry something that informs others that you have diabetes. Always carry sugar cubes.

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.Perform a urine or blood test, follow general illness treatment guidelines, and consult a 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,
• 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, 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
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 marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Gensulin M30

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. 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.
Do 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 month stated.
Do not use this medicine if you notice lumps or white solid particles sticking 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 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 package 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 disk 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 for use 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
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