Gensulin m30 (30/70): detailed information

Package leaflet: Information for the user

Gensulin M30 (30/70), 100 IU/mL, suspension for injection
Insulinum humanum
Please read all of this leaflet carefully before using this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Gensulin M30 is and what it is used for
Important information before using Gensulin M30
How to use Gensulin M30
Possible side effects
How to store Gensulin M30
Contents of the pack and other information

1. What Gensulin M30 is and what it is used for
Gensulin M30 contains as its active substance human insulin, which is used in the treatment of
diabetes. Diabetes is caused by the inability of the pancreas to produce insulin in amounts sufficient to control blood glucose levels (blood sugar). Gensulin M30 is used to maintain long-term control of glucose levels. It is a mixture of intermediate-acting insulin and fast-acting insulin. The duration of action of this insulin has been prolonged by the addition of protamine sulfate to the suspension.
Your doctor may recommend the use of Gensulin M30 together with a longer-acting insulin. Your doctor will determine the appropriate regimen. When changing insulin, great caution should be exercised. Each type of insulin has a different symbol and color on the packaging, cartridge, and vial, to facilitate differentiation.

2. Important information before using Gensulin M30

Gensulin M30 in 3 mL cartridges is intended exclusively for subcutaneous injection using a reusable injection pen.
Gensulin M30 in 10 mL vials is intended for subcutaneous injection. Although not recommended, Gensulin M30 in vials may also be administered by intramuscular injection. Gensulin M30 in vials must not be administered intravenously.
If insulin needs to be administered by another route, consult your doctor.

When not to use Gensulin M30

if you have symptoms indicating hypoglycemia (low blood glucose). Information on managing mild hypoglycemia is provided later in this leaflet (see section A, "Hypoglycemia" in section 4).
if you are allergic to human insulin or to 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.

If your current treatment provides good glycemic control, the warning symptoms of low blood glucose may not be noticeable. Warning symptoms are listed later in this leaflet. You should carefully plan meal times, frequency of physical activity, and overall activity level. You should also monitor your blood glucose levels regularly by frequently testing blood glucose.
Some people who experienced hypoglycemia (low blood glucose) after switching from animal insulin to human insulin have reported that the warning symptoms of hypoglycemia were less pronounced or completely different than before. If hypoglycemia occurs frequently or if you have difficulty recognizing the warning symptoms, consult your doctor.
Inform your diabetes nurse, doctor, or pharmacist if:
- you have recently had an illness;
- you have kidney or liver disease;
- you increase your physical exertion.
Your insulin requirement may also change after consuming alcohol.
Inform your diabetes nurse, doctor, or pharmacist if you plan to travel abroad. Time zone differences may require adjustments in the timing of injections and meals.
In some patients with type 2 diabetes who have heart disease or a history of stroke, cases of heart failure have been reported when pioglitazone was used concomitantly with insulin. Inform your doctor immediately if symptoms of heart failure occur, such as shortness of breath, sudden weight gain, or localized swelling.

Skin changes at the injection site
You should rotate injection sites to prevent the development of 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, contact your doctor before changing the site.
Your doctor may recommend more frequent monitoring of blood glucose levels and adjustment of insulin or other antidiabetic medication doses.

Gensulin M30 and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Your body's insulin requirement may change when used concomitantly with:

corticosteroids,
thyroid hormone replacement therapy,
oral glucose-lowering medications (antidiabetic drugs),
acetylsalicylic acid (aspirin),
growth hormone,
octreotide, lanreotide,
selective β2-adrenergic receptor agonists (e.g., ritodrine, salbutamol, terbutaline),
β-adrenergic blocking agents (β-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
Insulin requirement usually decreases during the first three months of pregnancy and increases during the following six months. Women who are breastfeeding may require changes in insulin dosage or dietary regimen.
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines
In the case of hypoglycemia (low blood sugar), your concentration and reaction speed may be reduced. You should bear this in mind in all situations where it could pose a risk to yourself or others (e.g., when driving or operating machinery).
Consult your diabetes nurse or doctor about driving if:

you frequently experience hypoglycemia,
you have weak or no warning signs of hypoglycemia.

Gensulin M30 contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, meaning 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 vial or
cartridge when purchasing the medicine at the pharmacy. Make sure it is the Gensulin M30 medicine prescribed
by the doctor.
This medicine must always be used according to the instructions of the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist. To avoid possible transmission of diseases, each
cartridge may only be used by one person, even if the needle has been changed.
Dosage
The attending physician will recommend the appropriate type of insulin, the amount of medicine, and the time and frequency
of its injection. These instructions are intended only for the specific patient. The doctor's recommendations must be strictly followed, and regular visits to the diabetes clinic are recommended.
Changing the type of insulin used (e.g. from animal insulin to human insulin) may
require a reduction or increase in 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 exclusively for subcutaneous injection
using a reusable insulin pen.
Gensulin M30 in vials is intended for subcutaneous injection. Although not
recommended, in exceptional cases it may be administered intramuscularly. Gensulin M30 in vials must not be administered intravenously. If insulin must be administered by another
method, consult a doctor.
Preparation of Gensulin M30 medicine
Before using Gensulin M30 medicine, you should

check on the outer packaging and label of the cartridge or vial whether the name and letter marking of the insulin received match the one prescribed by the doctor.
check the expiry date on the packaging.

Method of use
Inject the insulin dose according to the instructions of the doctor or nurse at the diabetes
clinic.
Always change the injection sites to avoid thickening (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 results in faster
absorption than injections into other sites.
Rotate injection sites so that the same site is not used more often than
approximately once a month.
About ten to fifteen minutes before the planned administration, remove the insulin from the refrigerator to bring it to room temperature (if it is a newly opened vial or cartridge). Used cartridges or vials should be stored at room temperature
for 28 days.
During administration, observe hygiene rules: wash hands before administration,
disinfect the injection site.
Before administration, carefully examine the vial or cartridge containing insulin.
The suspension of Gensulin M30 should be uniformly opaque (homogeneously cloudy or milky). Do not use the medicine if the contents of the vial or cartridge remain
clear after mixing or if there is a sediment of white substance at the bottom. Do not use the medicine also if, after mixing, white clumps float or solid white particles adhere to the walls, giving it a frosted appearance.
Particular attention must be paid to ensure that during insulin injection the needle does not enter a blood vessel.
Administration of Gensulin M30 medicine from vials using a syringe
Gensulin M30 in 10 ml vials is intended for subcutaneous injection; in exceptional cases, it may be administered intramuscularly. Gensulin M30 in vials must not be administered intravenously.
Syringes specially designed for insulin administration, marked with insulin concentration units, should be used. It is recommended to use syringes of the same type and manufacturer. Always check whether the syringe used is calibrated appropriately for the concentration of the insulin being administered.
Before each injection of Gensulin M30 suspension, rotate the vial between the palms 10 times, then invert it 180 degrees 10 times to achieve a uniformly cloudy or milky appearance of the suspension. If this does not occur, repeat the described actions until the components are fully mixed. Do not shake vigorously, as this may cause foaming, which can interfere with accurate dose measurement.
Instructions for use
Immediately before injection:

Remove the protective plastic cap from the stopper (do not tear off the stopper).
Wipe the exposed part of the rubber stopper with alcohol. Do not remove the stopper!
Draw air into the syringe equal in volume to the insulin dose.
Insert the needle attached to the syringe through the rubber stopper and inject the air into the vial.
Turn the vial and syringe upside down.
Ensure the tip of the needle is immersed in the insulin suspension.
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 as you would a pencil. Insert the needle straight into the skin (at a 90° angle). Ensure the needle is fully inserted and properly placed in the subcutaneous fat layer, not in deeper skin layers (in very thin individuals, it may be necessary to insert the needle at an angle instead of perpendicularly). To inject the insulin, push the plunger fully to administer the dose within less than 5 seconds. Hold an alcohol swab close to the needle and withdraw the needle from the skin. Press the alcohol swab gently against the injection site for several seconds. Do not rub the skin at the injection site! To avoid tissue damage, it is recommended to change the injection site with each injection. The next injection site should be at least 1–2 cm away from the previous one.

Administration of Gensulin M30 medicine in cartridges for insulin pens
Gensulin M30 in 3 ml cartridges is intended exclusively for subcutaneous injection using a reusable insulin pen. If insulin must be administered by another method, 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 must be used only with Bioton insulin pens to ensure accurate dose delivery.
For loading the pen, attaching the needle, and injecting the medicine, strictly follow the instructions provided by the pen manufacturer included in the pen packaging.
Before using Gensulin M30 suspension, rotate the cartridges between the palms 10 times, then invert them 180° 10 times to achieve a uniformly cloudy or milky appearance of the suspension.
The cartridges contain a small glass bead that helps mix the components. Do not shake, as this may cause foaming, making accurate dose measurement difficult.
The suspension in the cartridge can be mixed without removing it from the pen.
The design of the cartridges prevents adding any other insulin to the cartridge. Used cartridges must not be refilled.
Administration of a higher than recommended dose of Gensulin M30
If a higher dose of Gensulin M30 than recommended is administered, low blood glucose levels may occur. Check blood glucose levels (see subsection A "Hypoglycaemia" in section 4).
Missing a dose of Gensulin M30
If a lower dose of Gensulin M30 than recommended is administered, high blood glucose levels may occur. Check blood glucose levels. Do not administer a double dose to make up for a missed dose.
Discontinuation of Gensulin M30
If a lower than recommended dose of Gensulin M30 is administered, blood glucose levels may increase. Do not change the insulin being used unless advised by the doctor.
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Human insulin may cause hypoglycaemia (low blood glucose levels). See further information on
hypoglycaemia below under the section "Common problems in diabetes".
Possible adverse reactions
Generalised allergic reaction occurs very rarely (in less than 1 in 10,000 patients).
Symptoms include:

drop in blood pressure,
breathing difficulties,
rapid heartbeat,
rash all over the body,
wheezing,
sweating.

If such symptoms occur while using Gensulin M30, contact your doctor immediately.
Local allergic reaction occurs frequently (in less than 1 in 10 patients). Symptoms may include
redness, swelling or itching of the skin around the injection site. These symptoms usually disappear
after a few days or weeks. If any of the above symptoms occur, inform your doctor.
Skin changes at the injection site
If insulin is injected too frequently into the same site, fatty tissue may shrink (lipoatrophy) or thicken
(lipohypertrophy) ( no more frequently than in 1 in 100 patients ).
Lumps under the skin may also be caused by 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 each time, which helps prevent these skin changes.
Oedema (e.g. swelling of arms, ankles; fluid retention) has been reported, particularly at the beginning
of insulin therapy or during changes in treatment aimed at improving blood glucose control.
Common problems in diabetes
A. Hypoglycaemia
Hypoglycaemia (low blood glucose level) is a condition in which there is too little sugar in the blood. It may occur if the patient:

takes too high a dose of Gensulin M30 or another insulin;
skips or delays a meal, or changes their diet;
exercises or works too intensely just before or after a meal;
is ill (especially with an illness involving diarrhoea or vomiting);
experiences changes in insulin requirements, or
has worsening kidney or liver function.

Alcohol and certain medicines may affect blood glucose levels.
The first symptoms of low blood glucose usually appear quickly and include:

fatigue,
nervousness or trembling,
headache,
rapid heartbeat,
nausea,
cold sweats.

If you are unsure about recognising the warning signs of hypoglycaemia, avoid situations where you might endanger yourself or others (e.g. driving).
Do not use Gensulin M30 if you are experiencing warning signs of hypoglycaemia
(low blood glucose levels).
If blood glucose is low, consume glucose tablets, sugar or a sweet drink. Then eat a piece of fruit, biscuits or a sandwich, as advised by your doctor, and rest. This is usually sufficient in cases of mild hypoglycaemia or minor insulin overdose. If the condition worsens, with shallow breathing and pale skin, contact your doctor immediately. An injection of glucagon may help in cases of moderately severe hypoglycaemia.
After receiving glucagon, consume glucose or sugar. If there is no improvement after glucagon administration, go to hospital immediately. For information about glucagon, consult your doctor.
B. Hyperglycaemia and diabetic ketoacidosis
Hyperglycaemia (excessively high blood glucose levels) means the body is not receiving enough insulin. Hyperglycaemia may be caused by:

not taking Gensulin M30 or another insulin;
injecting less insulin than prescribed by your doctor;
eating very large meals compared to dietary requirements; or
fever, infection, or stressful events.

Hyperglycaemia may lead to diabetic ketoacidosis. The first symptoms develop slowly over several hours or days. These include:

drowsiness,
flushed skin on the face,
thirst,
loss of appetite,
fruity odour of breath,
nausea or vomiting.

Severe symptoms include difficulty breathing and rapid pulse. Seek medical help immediately.
Untreated hypoglycaemia (low blood glucose) or hyperglycaemia (high blood glucose) may lead to serious complications and may cause headache, nausea, vomiting, dehydration, loss of consciousness, coma or even death.
Three simple ways to avoid hypoglycaemia or hyperglycaemia:

Always carry spare syringes 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 associated with nausea or vomiting, the body's insulin requirements may change. People with diabetes need insulin even when they are unable to eat normal meals. Perform urine or blood tests, follow general illness management guidelines, and contact a diabetes nurse or your doctor.
After the medicine was placed on the market, the following adverse reactions have also been reported:

oedema, particularly when previously poor metabolic control improves rapidly with intensive insulin therapy,
weight gain,
injection site reactions such as discolouration, bleeding, induration, nodule or infiltration, pain, rash,
urticaria or blisters,
itching, including generalised itching,
dizziness.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw
Tel: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide 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 first opening the immediate packaging, the medicine may be stored at a temperature not exceeding 25°C for up to 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 may carry them. Gensulin M30 should be protected from high temperatures.
Do not use this medicine after the expiry date stated on the label and outer packaging of the vials or cartridges after "EXP". The expiry date refers to the last day of the stated month.
Do not use this medicine if you notice clumps or white solid particles adhering to the bottom or walls of the cartridge or vial, or if the glass has a cloudy appearance. The appearance of insulin should be checked before each injection.
Medicines must not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Gensulin M30 contains

The active substance is human insulin produced by recombinant DNA technology. 1 ml of suspension contains 100 IU of human insulin. Each vial contains 10 ml, corresponding to a dose of 1000 IU of human insulin. Each cartridge contains 3 ml, corresponding to a dose of 300 IU of human insulin.
Other components (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 contents of the pack
Gensulin M30 (30/70) is a sterile suspension of human insulin with pH 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 aluminium cap and a two-layer rubber disc, and a polypylene screw cap, in a cardboard box.
5 glass cartridges for injection devices containing 3 ml of Gensulin M30, in a cardboard box.
10 glass cartridges for injection devices containing 3 ml of Gensulin M30, in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Bioton S.A.
ul. Starościńska 5
02-516 Warsaw
Poland

Manufacturer:
Bioton S.A.
ul. Starościńska 5
02-516 Warsaw
Poland

This medicinal product is authorised in the European Economic Area member states under the following names:
Poland: Gensulin M30 (30/70)
Malta: Gensulin M30 (30/70), 100 IU/ml, suspension for injection

For further information about this medicinal product, please contact the Marketing Authorisation Holder:
Bioton S.A.
ul. Starościńska 5
02-516 Warsaw
Poland

February 2024