Humulin M3 (30/70)

Leaflet accompanying the packaging: information for the user

Humulin M3 (30/70) 100 IU/ml suspension for injection in a cartridge

(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.
• 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 as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What Humulin M3 (30/70) is and what it is used for
• 2. Important information before using Humulin M3 (30/70)
• 3. How to use Humulin M3 (30/70)
• 4. Possible side effects
• 5. How to store Humulin M3 (30/70)
• 6. Contents of the packaging and other information

1. What Humulin M3 (30/70) is and what it is used for

Humulin M3 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 sugar control. Humulin M3 is used to control blood sugar levels in the long term. It is a mixture of fast-acting and long-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 Humulin M3 and insulin with a longer duration of action. Each type of insulin has a different patient leaflet. Do not change 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 Humulin M3 (30/70)

Humulin M3 (30/70) in cartridges is intended for subcutaneous injection only, using a reusable insulin pen. If it is necessary to administer insulin by another method, consult a doctor.

When not to use Humulin M3 (30/70)

• If symptoms of hypoglycemia (low blood sugar) are felt.Information on how to proceed in case of mild hypoglycemia will be provided later in the leaflet (see subsection A 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 Humulin M3 (30/70), talk to a doctor, pharmacist, or nurse.

• If the current treatment provides good blood sugar control, warning signs of excessive blood sugar 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 and monitor blood sugar levels by performing frequent blood sugar tests.
• Some people who have changed from animal insulin to human insulin and have experienced hypoglycemia (low blood sugar) have reported that the warning signs of hypoglycemia were weaker or completely different than before. If hypoglycemia occurs frequently or there are difficulties in recognizing the warning signs of hypoglycemia, consult a doctor.
• Inform the diabetes nurse, doctor, or pharmacist in case of:
• -recently suffered illness;
• kidney or liver disease;
• increased physical exertion.
• The need for insulin may also change after consuming alcohol.
• Inform the diabetes nurse, doctor, or pharmacist about planned travel abroad. The time difference may require injections and meals to be taken at a different time.
• In some patients with type 2 diabetes who have been treated for a long time and have heart disease or have had a stroke, cases of heart failure have been reported when using pioglitazone and insulin at the same time. Inform the doctor as soon as possible if symptoms of heart failure occur, such as shortness of breath, sudden weight gain, or localized 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 Humulin M3 (30/70)"). If insulin is currently being injected into an area with lumps, consult a doctor before changing it. The doctor may recommend more frequent blood sugar monitoring and adjusting the insulin dose or other diabetes medications.

Humulin M3 (30/70) and other medicines

Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The body's need for insulin may change when using:

• corticosteroids,
• thyroid hormone replacement therapy,
• oral medicines that lower blood sugar (diabetes medicines),
• acetylsalicylic acid (aspirin),
• growth hormone,
• octreotide, lanreotide,
• selective beta-adrenergic receptor agonists (e.g., ritodrine, salbutamol, terbutaline),
• beta-blockers,
• thiazides or certain antidepressants (monoamine oxidase inhibitors),
• danazol,
• certain angiotensin-converting enzyme inhibitors (e.g., captopril, enalapril) or angiotensin II receptor antagonists.

Pregnancy, breastfeeding, and fertility

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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.

Driving and using machines

In case of hypoglycemia (low blood sugar), the patient's ability to concentrate and react may be impaired. This should be kept in mind in all situations where it could be a risk to the patient or others (e.g., when driving a vehicle or operating machinery).
Consult a diabetes nurse or doctor about driving a car if:

• hypoglycemia occurs frequently
• there are weak or no warning signs of hypoglycemia.

Important information about some ingredients of Humulin M3 (30/70)

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

3. How to use Humulin M3 (30/70)

The 3 ml cartridge is for use in 3 ml pens only. Do not use in 1.5 ml pens.

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

This medicine should always be used according to the doctor's or pharmacist's instructions. 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 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 instructions should be followed carefully 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 only apply to the first injection or may be introduced gradually over several weeks or months.
• Humulin M3 (30/70) in cartridges is intended for subcutaneous injection only, using a reusable insulin pen. If it is necessary to administer insulin by another method, consult a doctor.

Preparing Humulin M3 (30/70)

• Before each injection, the Humulin M3 (30/70) cartridges should be rotated between the palms of the hands 10 times and then inverted 10 times to obtain a uniformly cloudy or milky appearance of the suspension. If this does not happen, the described actions should be repeated until the ingredients are mixed. The cartridges contain a small glass ball that helps mix the ingredients. Do notshake, as this may cause foam to form, making it difficult to measure the dose correctly. The appearance of the insulin in the cartridge should be checked frequently. Do not use if there are lumps or white particles stuck to the bottom or walls of the cartridge, and the glass has a dull appearance. Check this before each injection.

Preparing the pen for use

• First, wash your hands. Disinfect the rubber membrane of the cartridge.
• Humulin M3 (30/70) cartridges should only be used in Lilly insulin pens to ensure the correct dose is administered.They must not be used with any other reusable pen. Follow the instructions provided with the pen. Insert the cartridge into the pen.
• Set the dose to 1 or 2 units. Then, holding the pen with the needle pointing upwards, tap the sides of the pen to make any air bubbles rise to the top. With the needle still pointing upwards, press the injection mechanism until a drop of Humulin M3 (30/70) appears at the needle tip. There may still be a few small air bubbles in the pen. These are harmless, but a large air bubble may cause an incorrect dose to be administered.

Injecting Humulin M3 (30/70)

• Before injecting, disinfect the skin according to the instructions received.
• Inject the medicine under the skin according to the instructions received. Do notinject the medicine directly into a vein. After injecting, leave the needle in the skin for five seconds to ensure the full dose is administered. Do not rub the injection site. Make sure the distance from the previous injection site is at least 1 cm. Change the injection sites according to the instructions received.

Do not administer Humulin M3 (30/70) intravenously.

Humulin M3 (30/70) should be injected according to the doctor's or diabetes nurse's instructions.

After injection

• After injecting the medicine, remove the needle from the pen using the outer needle cap. This will maintain the sterility of the medicine and prevent insulin from leaking out. It will also prevent air from entering the pen and clogging the needle. Do not lend your needles or pens to anyone.Put the cap back on the pen.

Subsequent injections

• Leave the cartridge in the pen. Before each injection, select 1 or 2 units and press the injection mechanism, holding the pen with the needle pointing upwards, until a drop of Humulin M3 (30/70) appears at the needle tip. You can check how much medicine is left by looking at the gauge on the side of the cartridge. The distance between the gauge marks corresponds to approximately 20 units. If the amount of medicine is less than the prescribed dose, change the cartridge.

Do not mix any other insulin in the Humulin M3 (30/70) cartridge. After the cartridge is empty, do not reuse it.

Using a higher dose of Humulin M3 (30/70) than recommended

If a higher dose of Humulin M3 (30/70) is administered than recommended, low blood sugar may occur. Check the blood sugar level (see subsection A in section 4).

Missing a dose of Humulin M3 (30/70)

If a lower dose of Humulin M3 (30/70) is administered than recommended, high blood sugar may occur. Check the blood sugar level. Do not inject a double dose to make up for a missed dose.

Stopping treatment with Humulin M3 (30/70)

If a lower dose of Humulin M3 (30/70) is administered than recommended, high blood sugar may occur. Do not change the insulin used unless the doctor recommends it.
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 sugar). See further information on hypoglycemia below in subsection "Common problems in diabetes".

Possible side effects

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

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

If such symptoms occur while using Humulin M3 (30/70), consult a doctor immediately.
Local allergyoccurs 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 any of the above symptoms occur, inform the 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 (cutaneous amyloidosis, frequency unknown). Insulin injected into an area with lumps may not work properly. Change the injection site each time to prevent these skin changes.
Edema (e.g., swelling of the arms, ankles; fluid retention) has been reported, especially at the start of insulin treatment 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 the patient:

• takes too much Humulin M3 (30/70) or other insulin;
• skips or delays a meal, or changes their diet;
• exercises too intensely or works just before or after a meal;
• is ill (especially with diarrhea or vomiting);
• has changing insulin needs, or
• has worsening kidney or liver problems.

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

• rapid heartbeat
• nausea
• cold sweats

If there is any uncertainty 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 Humulin M3 (30/70) if warning signs of hypoglycemia (low blood sugar) occur.

If the blood sugar level is low, eat glucose tablets, sugar, or drink a sweet drink. Then eat fruit, cakes, or a sandwich, as recommended by the doctor, and rest. This usually helps in case of mild hypoglycemia or minor insulin overdose. If the condition worsens, and there is shallow breathing, and the skin becomes pale, consult a doctor immediately. Glucagon injection may help in case of severe hypoglycemia. After injecting glucagon, eat glucose tablets or sugar. If there is no improvement after administering glucagon, go to the hospital. For more information about glucagon, ask the doctor.

B. Hyperglycemia and diabetic ketoacidosis

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

• not taking Humulin M3 (30/70) 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. They include:

• drowsiness
• loss of appetite
• redness of the face
• fruity smell from the mouth
• thirst
• nausea or vomiting.

Severe symptoms include difficulty breathing and rapid pulse. 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 pen and Humulin M3 (30/70) cartridge with you.
• Always carry something that informs others that you have diabetes.
• 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. Diabetics need insulin even when they are not eating their normal meals.Perform a urine or blood test, follow the general rules for treating illness, and consult a diabetes nurse or doctor.

• fatigue
• irritability or trembling
• headache

Reporting side effects

If any side effects occur, including any not listed in this leaflet, tell the 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: Al. Jerozolimskie 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 or its representative. By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Humulin M3 (30/70)

Keep the medicine out of the reach and sight of children.
Before first use, store Humulin M3 (30/70) in the refrigerator (2°C - 8°C).
Do not freeze.The used pen and cartridge should be stored at room temperature (below 30°C) and used within 28 days. Do not store the used pen or cartridges in the refrigerator. Do not put them near heat sources or in the sun.
Do not use this medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of the given month.
Do not use this medicine if you notice lumps or white particles stuck 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 the 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 Humulin M3 (30/70) contains

• The active substance of the medicine is human insulin, produced by recombinant DNA technology. It has the same structure as the natural hormone produced by the pancreas, so it differs from animal insulins. Humulin M3 (30/70) is a two-phase insulin mixture that contains 30% soluble insulin and 70% protamine sulfate insulin suspension.
• The other ingredients are: m-cresol, glycerol, phenol, protamine sulfate, disodium phosphate heptahydrate, zinc oxide, water for injections, 10% hydrochloric acid solution, and 10% sodium hydroxide solution (to adjust pH).

What Humulin M3 (30/70) looks like and contents of the pack

Humulin M3 (30/70) is a white, sterile suspension. One milliliter of suspension contains 100 international units of insulin (100 IU/ml). Each cartridge contains 300 units (3 ml suspension).
The cartridges are sold in packs of 5.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Netherlands
Manufacturer:
Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France
Eli Lilly Italia S.p.A., Via A. Gramsci 731-733, 50019 Sesto Fiorentino, Italy
To obtain more detailed information, contact the representative of the marketing authorization holder:
Eli Lilly Polska Sp.z o.o.
ul. Żwirki i Wigury 18A
02-092 Warsaw
+48 22 440 33 00

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Huminsulin "Lilly" Profil III 100 I.E./ml (Austria)
Humuline 30/70 (Belgium, Luxembourg, Netherlands)
Huminsulin Profil III für Pen 3 ml (Germany)
Humulin M3 (Bulgaria, Croatia, Cyprus, Ireland, Lithuania, Malta, Portugal, Romania, Slovenia, United Kingdom)
Humulin 30/70 (Italy)
Umuline profil 30 (France)
Humulin M3 (30/70) (Greece, Hungary, Poland)
Humulin M3 (30/70) Cartridge (Czech Republic, Slovakia)

Date of last revision of the leaflet: