Gensulin M50 (50/50)

Leaflet accompanying the packaging: patient information

Gensulin M40 (40/60),100 IU/ml, suspension for injection
Gensulin M50 (50/50),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 as yours.
• 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 Gensulin M40 (40/60) and Gensulin M50 (50/50) are and what they are used for
• 2. Important information before using Gensulin M40 and M50
• 3. How to use Gensulin M40 and M50
• 4. Possible side effects
• 5. How to store Gensulin M40 and M50
• 6. Contents of the packaging and other information

1. What Gensulin M40 and M50 are and what they are used for

Gensulin M40 and M50 contain human insulin produced by recombinant DNA technology using Escherichia colibacteria, which is identical to the insulin produced by the human body.
Human insulin is used to treat diabetes. The cause of diabetes is the pancreas's inability to produce insulin in sufficient quantities to control blood glucose levels. Gensulin M40 and M50 are used to control blood glucose levels in the long term. It is a mixture of fast-acting and intermediate-acting insulin. 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 M40 and M50 and a longer-acting insulin. Each type of insulin has a separate patient leaflet. Do not change your insulin unless your doctor recommends it. When changing insulin, be very careful. Each type of insulin has a different symbol and color on the packaging and cartridge to make it easier to distinguish.

2. Important information before using Gensulin M40 and M50

Gensulin M40 and M50 in 3 ml cartridges are intended for subcutaneous injection only using a reusable insulin pen.

Always use this medicine exactly as your doctor or pharmacist has told you.If you are not sure, ask 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.

When not to use Gensulin M40 and M50

• If you have symptoms of hypoglycemia (low blood sugar).Information on how to handle mild hypoglycemia can be found later in this leaflet (see subsection "Hypoglycemia" in section 4).
• If you are 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 M40 and M50, discuss it with your doctor, pharmacist, or nurse.
If your current treatment provides good blood sugar control, warning signs of excessive blood sugar reduction may not be noticeable. Warning signs are listed later in this leaflet. You should plan your meals, physical activity, and overall activity level carefully. You should also monitor your blood sugar levels by performing frequent blood glucose tests.
Some people who have changed from animal insulin to human insulin have reported that the warning signs of hypoglycemia were less pronounced or different from before. If hypoglycemia occurs frequently or if you have trouble 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 activity. Your insulin requirements 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 insulin and eat at different times. 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 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 M40 and M50"). If you are currently injecting insulin into an area with lumps, you should contact your doctor before changing it. Your doctor may recommend closer monitoring of your blood sugar levels and adjusting your insulin dose or other diabetes medications.

Gensulin M40 and M50 and other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.

• 1. Your body's need for insulin may change if you are taking:
• corticosteroids,
• thyroid hormone replacement therapy,
• oral medicines that lower blood sugar (diabetes 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

Your body's need for insulin usually decreases during 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, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

In the event of hypoglycemia (low blood sugar), your ability to concentrate and react may be impaired. Remember this in all situations where it could be a hazard for you or others (e.g., when driving a car or operating machinery).
You should seek the advice of your diabetes nurse or doctor about driving if:

• you often have hypoglycemia
• you have weak or no warning signs of hypoglycemia.

Gensulin M40 and M50 contain sodium

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

3. How to use Gensulin M40 and M50

Always check the name and type of insulin on the label and packaging of the cartridge when purchasing the medicine at the pharmacy. Make sure it is the Gensulin M40 and M50 prescribed by your doctor.

Use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask 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, the amount of medicine, and the time and frequency of injection. These instructions are intended only for a specific patient. 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 adjusting the dose. This change may only apply to the first injection or may be introduced gradually over several weeks or months.
Gensulin M40 and M50 in cartridges are intended for subcutaneous injection only using a reusable insulin pen. If it is necessary to administer insulin by a different method, consult your doctor.

Preparing Gensulin M40 and M50

Before using Gensulin M40 and M50, you should

• check the outer packaging and the label on the cartridge for the insulin to ensure that the name and lettering match what your doctor prescribed.
• check the expiration date on the packaging.

Method of use

Inject the dose of insulin as recommended by your 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 15-20 minutes before the planned injection, take the insulin out of the refrigerator to bring it to room temperature (if it is a new cartridge). If it is a used cartridge, it should be stored at room temperature for 28 days.
During administration, follow the rules of hygiene: wash your hands before administration, and disinfect the injection site.
Before administration, carefully inspect the cartridge in the insulin pen.
The Gensulin M40 and M50 suspension should be uniformly cloudy (uniformly turbid or milky). Do not use it if the contents of the cartridge remain clear after mixing or if there is a white deposit at the bottom. Do not use it 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 when injecting insulin.

Administering Gensulin M40 and M50 in cartridges

Gensulin M40 and M50 in 3 ml cartridges are intended for subcutaneous injection only using a reusable insulin pen.

Do not administer Gensulin M40 and M50 intravenously or intramuscularly.
If it is necessary to administer insulin by a different method, consult your doctor.
The 3 ml cartridges are designed for use with a CE-marked pen, in accordance with the manufacturer's instructions. Gensulin M40 and M50 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.
Shake the Gensulin M40 and M50 suspension before each injection by turning the cartridge upside down and back at least 10 times or by rolling it between your palms until the liquid is uniform. Shaking should continue until a uniformly cloudy or milky appearance is achieved. 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 contents of the cartridge can be mixed without removing it from the pen.
The design of the cartridges prevents adding other insulin to the cartridge. Used cartridges cannot be refilled.

Using a higher dose of Gensulin M40 and M50 than recommended

If a higher dose of Gensulin M40 and M50 is administered than recommended, hypoglycemia (low blood sugar) may occur. Check your blood sugar level (see subsection "Hypoglycemia" in section 4).

Missing a dose of Gensulin M40 and M50

If a lower dose of Gensulin M40 and M50 is administered than recommended, high blood sugar levels may occur. Check your blood sugar level. Do not take a double dose to make up for a missed dose.

Stopping treatment with Gensulin M40 and M50

If a lower dose of Gensulin M40 and M50 is administered than recommended, high blood sugar levels may occur. 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 can cause hypoglycemia (low blood sugar). See below for more information on hypoglycemia in subsection "Common problems in diabetes".

Other 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 any of these symptoms while using Gensulin M40 and M50, contact your doctor immediately.
Local allergic reactionoccurs frequently (in less than 1 in 10 patients). Symptoms may include redness, swelling, or itching at the injection site. These symptoms usually go away 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 (lipohipertrophy) (in 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 sugar control.

Common problems in diabetes

A. Hypoglycemia

Hypoglycemia (low blood sugar) is a condition in which there is too little sugar in the blood. It can occur if:

• you take too much Gensulin M40 and M50 or other insulin;
• you miss or delay a meal, or change your diet;
• you exercise too intensely or work 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 problems that worsen.

Blood sugar levels can be affected by alcohol and some medicines.
The first symptoms of low blood sugar usually develop 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 M40 and M50 if you have warning signs of hypoglycemia (low blood sugar).

If your blood sugar level is low, eat glucose tablets, sugar, or a sweet drink. Then, eat fruit, cake, or a sandwich, as your doctor recommended, 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. Glucagon injection may help in cases of moderate hypoglycemia.
After glucagon injection, eat glucose tablets or sugar. If you do not improve after glucagon injection, go to the hospital. For more information about glucagon, ask your doctor.

B. Hyperglycemia and diabetic ketoacidosis

Hyperglycemia (high blood sugar) means that your body is not getting enough insulin. Hyperglycemia can be caused by:

• not taking Gensulin M40 and M50 or other insulin;
• injecting less insulin than recommended by your doctor;
• eating very large meals compared to your dietary needs; or
• having a fever, infection, or stressful experiences.

Hyperglycemia can lead to diabetic ketoacidosis. The first symptoms develop slowly over several hours or days and include:

• drowsiness
• redness of the face
• thirst
• loss of appetite
• fruity breath odor
• nausea or vomiting

Severe symptoms include difficulty breathing and rapid pulse. You should seek medical help immediately.
Untreated hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar) 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 insulin pen and Gensulin M40 and M50 cartridge with you
Always carry something that informs others that you have diabetes
Always carry sugar cubes with you

C. Illness

When you are ill, especially if you have diarrhea or vomiting, your body's need for insulin may change. People with diabetes 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 your diabetes nurse or doctor.
After the introduction of Gensulin M40 and M50 to the market, the following side effects have also been reported:

• edema, especially in cases where poor metabolic control has improved due to intensive insulin therapy,
• weight gain,
• injection site reactions such as discoloration, bleeding, hardening, lump, or nodule, pain, rash, urticaria, or abscesses,
• 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, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 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 provide more information on the safety of this medicine.

5. How to store Gensulin M40 and M50

Keep this medicine out of the sight and reach of children.
Store in a refrigerator at 2°C to 8°C. Do not freeze.
After opening the immediate packaging, store the medicine at a temperature not above 25°C for 28 days. Protect from light.
Cartridges that are in use or are to be used should not be stored in the refrigerator. They can be carried with you. The medicinal product Gensulin M40 and M50 should be protected from high temperatures.
Do not use this medicine after the expiration date stated on the label and on the outer packaging of the Gensulin M40 and M50 cartridge 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 sticking to the bottom or walls of the cartridge, 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. Contents of the packaging and other information

What Gensulin M40 and M50 contain

• The active substance of the medicine is human insulin produced by biotechnological recombinant DNA technology. 1 ml of the suspension contains 100 IU of human insulin. Each cartridge contains 3 ml, which corresponds to a dose of 300 IU of human insulin.
• Other ingredients (excipients) are: Gensulin M40:metacresol, glycerol, phenol, protamine sulfate, zinc oxide, disodium phosphate dodecahydrate, hydrochloric acid, sodium hydroxide, water for injections Gensulin M50:metacresol, glycerol, phenol, protamine sulfate, zinc oxide, disodium phosphate dodecahydrate, hydrochloric acid, sodium hydroxide, water for injections

What Gensulin looks like and what the packaging contains

Gensulin M40is a sterile suspension of human insulin with a pH of 7-7.6, containing 40% soluble insulin and 60% isophane insulin.
Gensulin M50is a sterile suspension of human insulin with a pH of 7-7.6, containing 50% soluble insulin and 50% isophane insulin.

Packaging

Gensulin M40:

• 5 glass cartridges for insulin pens, containing 3 ml of Gensulin M40, in a cardboard box.
• 10 glass cartridges for insulin pens, containing 3 ml of Gensulin M40, in a cardboard box.

Gensulin M50:

• 5 glass cartridges for insulin pens, containing 3 ml of Gensulin M50, in a cardboard box.
• 10 glass cartridges for insulin pens, containing 3 ml of Gensulin M50, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bioton S.A.
ul. Starościńska 5
02-516 Warsaw

Manufacturer

Bioton S.A.
Macierzysz, ul. Poznańska 12
05-850 Ożarów Mazowiecki
To obtain more detailed information about this medicine, contact the marketing authorization holder:
Bioton S.A.
ul. Starościńska 5
02-516 Warsaw
Phone: +48 (22) 721 40 00
bioinfo@bioton.com

Date of last revision of the leaflet: