Gensulin M40 (40/60)

Package Leaflet: Information for the Patient

Gensulin M40 (40/60),100 IU/ml, suspension for injection
Gensulin M50 (50/50),100 IU/ml, suspension for injection
Human Insulin

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package 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 pack 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 inability of the pancreas to produce insulin in quantities that allow blood glucose control. Gensulin M40 and M50 are used to control blood glucose levels in the long term. They are 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 different patient leaflet. Do not change your insulin unless your doctor has told you to. When changing insulin, be very careful.

2. Important information before using Gensulin M40 and M50

Gensulin M40 and M50 in 3 ml cartridges are only for injection under the skin using a multiple dose injector.

Gensulin M40 and M50 must always be used exactly as your doctor has instructed.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 are experiencing symptoms of hypoglycemia (low blood sugar).Information on how to treat mild hypoglycemia can be found later in this leaflet (see section 4, "Hypoglycemia").
• 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 this with your doctor, pharmacist, or nurse.
If your current treatment provides good blood sugar control, warning signs of too low blood sugar may not be noticed. Warning signs are listed later in this leaflet. You should plan your meals, physical activity, and overall activity level carefully. You should also check your blood sugar levels regularly by doing blood sugar tests.
Some people who have changed from animal insulin to human insulin have reported that the warning signs of low blood sugar are less pronounced or different than before. If low blood sugar occurs frequently or if you have trouble recognizing the warning signs of low blood sugar, you should talk to 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 needs may also change if you drink alcohol. You should tell your diabetes nurse, doctor, or pharmacist if you are planning to travel abroad. Time differences may affect when you inject and eat.

Gensulin M40 and M50 with 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 hypoglycemic agents (diabetes medications),
• 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 during the next six months. Breastfeeding women may need to adjust their insulin dose or diet.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

If you have low blood sugar (hypoglycemia), your ability to concentrate and react may be impaired. This can happen in all situations, which could put you or others at risk (e.g., when driving a car or operating machinery).
You should ask your diabetes nurse or doctor for advice on driving if:

• you frequently have low blood sugar
• you have few or no warning signs of low blood sugar.

Gensulin M40 and M50 contain sodium

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

3. How to use Gensulin M40 and M50

Always check the name and type of insulin on the label and cartridge when you buy your medicine from the pharmacy. Make sure it is the Gensulin M40 and M50 that your doctor has prescribed.

This medicine must always be used exactly as your doctor has instructed.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 tell you which insulin to use, how much, and when and how often to inject. These instructions are only for you. Follow your doctor's instructions and regularly visit your diabetes clinic.
Changing the type of insulin (e.g., from animal to human insulin) may mean that you need to adjust your dose. This change may apply only to the first injection or may be introduced gradually over several weeks or months.
Gensulin M40 and M50 in cartridges are only for injection under the skin using a multiple dose injector. If you need to inject insulin by a different method, talk to your doctor.

Preparing Gensulin M40 and M50

Before using Gensulin M40 and M50, you should

• check the external packaging and the cartridge label to ensure that the name and letter code of the insulin match what your doctor has prescribed.
• check the expiration date on the packaging.

How to use

Inject the dose of insulin as instructed 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 abdomen, buttocks, front of the thigh, or upper arm. Injecting into the abdomen gives faster absorption than injecting into other areas.
Change the injection site so that the same area is not used more often than about once a month.
About 15-30 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 cartridge that has been in use, store it at room temperature for 28 days.
When injecting, follow the rules of hygiene: wash your hands before injecting, disinfect the injection site.
Before injecting, always check the cartridge for insulin.

Administering Gensulin M40 and M50 in cartridges

Gensulin M40 and M50 in 3 ml cartridges are only for injection under the skin using a multiple dose injector.

Do not inject Gensulin M40 and M50 intravenously or intramuscularly.
If you need to inject insulin by a different method, talk to your doctor.
The 3 ml cartridges are designed to be used with a CE-marked injector, in accordance with the manufacturer's instructions. Gensulin M40 and M50 cartridges should only be used in Bioton insulin injectors to ensure the correct dose is delivered.
To load the injector, attach the needle, and inject the insulin, follow the manufacturer's instructions provided with the injector packaging.
Before each injection, turn the cartridge up and down at least 10 times until the liquid is uniformly cloudy or milky. Do not shake, as this may cause foam to form, making it difficult to measure the correct dose.
The cartridge can be mixed without removing it from the injector.
The design of the cartridges prevents the addition of any other insulin to the cartridge. Used cartridges must not be refilled.

Using more Gensulin M40 and M50 than prescribed

If you inject more Gensulin M40 and M50 than prescribed, you may experience low blood sugar. Check your blood sugar level (see section 4, "Hypoglycemia").

Missing a dose of Gensulin M40 and M50

If you inject less Gensulin M40 and M50 than prescribed, you may experience high blood sugar. Check your blood sugar level. Do not take a double dose to make up for a forgotten dose.

Stopping Gensulin M40 and M50 treatment

If you inject less Gensulin M40 and M50 than prescribed, you may experience high blood sugar. Do not change your insulin unless your doctor tells you to.
If you have any further questions on the use of this product, ask 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 low blood sugar (hypoglycemia). See below for more information on hypoglycemia.

Other possible side effects

Generalized allergic reactionsare very rare (less than 1 in 10,000 patients).
Symptoms include:

• 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 reactionsare common (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, tell your doctor.

Injection site reactions

If insulin is injected into the same spot too often, the fatty tissue under the skin 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 (cutaneous amyloidosis, frequency not known). Insulin injected into an area with lumps may not work properly. Always change the injection site to avoid these skin changes.

Common problems in diabetes

A. Hypoglycemia (low blood sugar)

Hypoglycemia is a condition in which there is too little sugar in the blood. It can happen if:

• you take too much Gensulin M40 and M50 or other insulin;
• you miss or delay a meal or snack;
• you exercise too much or work just 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 get worse.

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

• feeling tired
• feeling nervous or shaky
• headache
• rapid heartbeat
• nausea
• cold sweats

If you are not sure about recognizing the warning signs of hypoglycemia, avoid situations where you might put yourself or others at risk (e.g., driving a car).

Do not use Gensulin M40 and M50 if you experience warning signs of hypoglycemia (low blood sugar).

If your blood sugar is low, eat glucose tablets, sugar, or a sweet drink. Then eat fruit, biscuits, or a sandwich, as your doctor has advised, and rest. This usually works for mild hypoglycemia or a small overdose of insulin. If your condition worsens, or you experience shallow breathing, and your skin becomes pale, contact your doctor immediately. An injection of glucagon may help in the case of moderate hypoglycemia. After the glucagon injection, eat glucose tablets or sugar. If you do not improve after the glucagon injection, go to the hospital. Ask your doctor about glucagon.

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 prescribed by your doctor;
• eating very large meals compared to your diet requirements; or
• having a fever, infection, or stressful events.

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

• feeling sleepy
• redness of the face
• thirst
• loss of appetite
• fruity smell from the mouth
• nausea or vomiting

Severe symptoms include difficulty breathing and rapid pulse. Seek medical help immediately.
Untreated low blood sugar (hypoglycemia) or high blood sugar (hyperglycemia) can lead to serious problems and cause headaches, nausea, vomiting, dehydration, loss of consciousness, coma, or even death.
Three simple waysto avoid hypoglycemia or hyperglycemia:
Always carry a spare injector and Gensulin M40 and M50 cartridge with you
Always carry something that lets others know 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 normal meals.Do 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 when previous 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 abscess,
• itching, including generalized itching,
• dizziness.

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Drug Safety Monitoring of the 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
You can also report side effects 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 room temperature (up to 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 Gensulin M40 and M50 medicinal product 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 month stated.
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 frosted 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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Gensulin M40 and M50 contain

• The active substance is human insulin produced by recombinant biotechnology using Escherichia colibacteria. 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.
• The other ingredients 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 contents of the pack

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

Gensulin M50:

• 5 glass cartridges for injectors, containing 3 ml of Gensulin M50, in a cardboard box.
• 10 glass cartridges for injectors, 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 on 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: