Humulin m3 (30/70)

Package leaflet: Information for the user

Humulin M3 (30/70) 100 IU/mL suspension for injection in cartridge
(Insulin human)
Please read all of this leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

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 pack 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 in the treatment of diabetes. Diabetes is caused by the inability of the pancreas to produce insulin in amounts sufficient to control blood glucose (blood sugar) levels. Humulin M3 is used to provide long-term control of glucose levels. It is a mixture of fast-acting and long-acting insulin. The duration of action of this insulin has been prolonged by the addition of protamine sulfate in the suspension.
Your doctor may recommend using Humulin M3 together with an insulin having a longer duration of action. The choice of insulin is determined by your doctor. When switching from one insulin to another, great caution must be exercised. Each type of insulin has a different symbol and colour on the packaging and cartridge to help distinguish them easily.

2. Important information before using Humulin M3 (30/70)

Humulin M3 (30/70) in cartridges is intended exclusively for subcutaneous
injection using a reusable injection device. If insulin must be administered by another method,
consult a doctor.
When not to use Humulin M3 (30/70)

• if symptoms indicating hypoglycaemia (low blood glucose levels) are experienced. Information on managing mild hypoglycaemia is provided later in this leaflet ( see section A in point 4 ).
• if the patient is 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 Humulin M3 (30/70), talk to your doctor, pharmacist, or nurse.

• If current treatment provides good glycaemic control, warning symptoms of low blood glucose levels may become less noticeable. Warning symptoms are listed later in this leaflet. It is important to plan meal times carefully, the frequency of physical activity, and overall activity level. Blood glucose levels should also be monitored regularly by frequent blood glucose testing.
• Some people who experienced hypoglycaemia (low blood glucose) after switching from animal to human insulin have reported that warning symptoms were less pronounced or different than before. If hypoglycaemia occurs frequently or if you have difficulty recognizing the warning symptoms of hypoglycaemia, consult your doctor.
• Inform your diabetes nurse, doctor, or pharmacist if:
  • you have recently been ill;
  • you have kidney or liver disease;
  • you plan to increase physical exertion.
• Insulin requirements 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 injection times and meal schedules.
• 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 together with insulin. Contact your doctor immediately if symptoms of heart failure occur, such as shortness of breath, sudden weight gain, or localised swelling.

Skin changes at the injection site
Rotate injection sites 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, contact your doctor before changing the site. Your doctor may recommend more frequent blood glucose monitoring and may adjust the insulin dose or other antidiabetic medications.

Humulin M3 (30/70) 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 requirements may change when used together with:

• corticosteroids,
• thyroid hormone replacement therapy,
• oral glucose-lowering agents (antidiabetic drugs),
• acetylsalicylic acid (aspirin),
• growth hormone,
• octreotide, lanreotide,
• selective β-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, breastfeeding and fertility
Insulin requirements usually decrease during the first trimester of pregnancy and increase during the following six months. Women who are breastfeeding may require changes in insulin dosage or dietary habits.
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery
In the case of hypoglycaemia (low blood glucose), your ability to concentrate and reaction speed may be reduced. Keep this in mind in any situation where this could pose a risk to yourself or others (e.g. when driving a vehicle or operating mechanical equipment).
Consult your diabetes nurse or doctor about driving if:

• you frequently experience hypoglycaemia;
• you have weak or no warning signs of hypoglycaemia.

Important information about some of the ingredients of Humulin M3 (30/70)
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. is essentially "sodium-free".

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

The 3 ml cartridge is intended exclusively for use in 3 ml syringes. Do not use it
in 1.5 ml syringes.
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 Humulin medicine prescribed by your doctor.
This medicine should always be used exactly as recommended by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist. To avoid possible transmission of diseases, each cartridge must be used by only 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 injections. These instructions are intended solely for the specific patient. Follow your doctor's advice strictly and visit your diabetes clinic regularly.
• Changing the type of insulin used (for example, from animal 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.
• Humulin M3 (30/70) in cartridges is intended exclusively for subcutaneous injection using a reusable insulin pen. If insulin must be administered by another method, consult your doctor.

Preparing Humulin M3 (30/70) medicine

• Before each injection, rotate the Humulin M3 (30/70) cartridges gently between your palms 10 times, then invert them 10 times to obtain a uniformly cloudy or milky appearance of the suspension. If this is not achieved, repeat these steps until the contents are fully mixed. The cartridges contain a small glass bead to help mix the components. Do not shake, as this may cause foaming, which can make accurate dose measurement difficult. Frequently check the appearance of the insulin in the cartridge. Do not use if clumps or white particles adhering to the bottom or sides are visible, or if the glass has a dull appearance. Check this before each injection.

Preparing the pen for use

• Wash your hands first. Disinfect the rubber membrane of the cartridge.
• Humulin M3 (30/70) cartridges must be used only with Lilly insulin pens to ensure proper dose delivery. They cannot be used with any other reusable insulin 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 side of the pen gently so that air bubbles move to the top. With the needle still pointing upwards, press the injection button until a drop of Humulin M3 (30/70) appears at the needle tip. A few small air bubbles may still remain inside the pen. These are harmless, but a large air bubble may result in an inaccurate dose.

Injecting Humulin M3 (30/70) medicine

• Before injection, disinfect the skin according to the instructions you have received.
• Inject the medicine subcutaneously as instructed. Do not inject the medicine directly into a vein. After injection, leave the needle in the skin for five seconds to ensure the full dose has been delivered. Do not rub the injection site. Make sure the distance from the previous injection site is at least 1 cm. Rotate injection sites according to the instructions provided.

Do not administer Humulin M3 (30/70) intravenously.
Humulin M3 (30/70) should be injected according to instructions from your doctor or diabetes nurse.

After injection

• After injecting the medicine, remove the needle from the pen using the outer needle cap. This will help maintain the sterility of the medicine, prevent insulin leakage, prevent air from entering back into the pen, and avoid needle blockage. Do not share your needles or pen with anyone else. Replace the cap on the pen.

Subsequent injections

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

Do not mix any other insulin into the Humulin M3 (30/70) cartridge. After the cartridge is empty,
do not reuse it.
Using a higher than recommended dose of Humulin M3 (30/70)
If a higher than recommended dose of Humulin M3 (30/70) is administered, low blood glucose levels may occur. Check your blood glucose level (see section A in point 4). Missing a dose of Humulin M3 (30/70)
If a lower than recommended dose of Humulin M3 (30/70) is administered, high blood glucose levels may occur. Check your blood glucose level. Do not inject a double dose to make up for a missed dose. Stopping Humulin M3 (30/70)
If less than the recommended dose of Humulin M3 (30/70) is used, blood glucose levels may increase. Do not change the insulin you are using unless your doctor advises you to do so. If you have any further questions about 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 experiences 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 allergy occurs very rarely (in fewer than 1 in 10,000 patients). Symptoms include:

• drop in blood pressure • rash over the whole body
• difficulty breathing • wheezing
• rapid heartbeat • sweating

If any of these symptoms occur while using Humulin M3 (30/70), contact your doctor immediately.
Local allergy occurs commonly (in fewer 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) (less frequently than in 1 in 100 patients). Lumps under the skin may 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 rotate your injection site—this will help prevent these skin changes.
Oedema (e.g. swelling of arms, ankles; fluid retention) has been reported, particularly at the beginning of insulin treatment or during changes in therapy aimed at improving blood glucose control.
Common problems in diabetes
A. Hypoglycaemia
Hypoglycaemia (low blood glucose) is a condition in which there is too little sugar in the blood. It may occur if the patient:

• has taken too high a dose of Humulin M3 (30/70) or another insulin;
• has missed or delayed a meal, or changed their diet;
• has exercised or worked too intensely just before or after a meal;
• is ill (especially with an illness involving diarrhoea or vomiting);
• has changed insulin requirements, or
• has worsening kidney or liver function.

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

• fatigue • rapid heartbeat
• nervousness or trembling • nausea
• headache • 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 Humulin M3 (30/70) if you are experiencing warning signs of hypoglycaemia (low blood glucose).
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. Injection of glucagon may help in cases of severe hypoglycaemia. After glucagon injection, consume glucose tablets or sugar. If there is no improvement after glucagon administration, go to hospital. For information about glucagon, consult your doctor.
B. Hyperglycaemia and diabetic ketoacidosis
Hyperglycaemia (too high blood glucose) means the body is not receiving enough insulin. Hyperglycaemia may be caused by:

• not taking Humulin M3 (30/70) 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. Initial symptoms develop slowly over several hours or days. These symptoms include:

• drowsiness • loss of appetite
• flushed face • fruity odour of breath
• thirst • nausea or vomiting.

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

• Always carry a spare injection device and a cartridge of Humulin M3 (30/70) insulin.
• 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, your body's insulin requirements may change. People with diabetes need insulin even when they are unable to eat normal meals. Check your urine or blood, follow general illness management guidelines, and contact your diabetes nurse or doctor.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell 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 or its representative. Reporting adverse reactions helps provide more information on the safety of this medicine.

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

Keep this medicine out of the sight and reach of children.
Before first use, store Humulin M3 (30/70) in a refrigerator (2°C - 8°C).
Do not freeze. The used injection pen and cartridge should be stored at room temperature
(below 30°C) and used within 28 days. Do not store the used injection pen or
cartridges in the refrigerator. Do not place them near heat sources or in direct sunlight.
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 specified month.
Do not use this medicine if you notice clumps or white particles attached to the bottom or sides of the cartridge, or if the glass appears cloudy. Check the appearance of the insulin before each injection.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. Following this advice helps protect the environment.

6. Contents of the package and other information

What Humulin M3 (30/70) contains

• The active substance is human insulin produced by recombinant DNA technology. It has the same structure as the natural hormone produced by the pancreas and therefore differs from animal insulins. Humulin M3 (30/70) is a biphasic mixture of insulin containing 30% soluble insulin and 70% protamine sulfate insulin suspension.
• Other ingredients: m-cresol, glycerol, phenol, protamine sulfate, disodium phosphate heptahydrate, zinc oxide, water for injections, 10% hydrochloric acid solution and 10% sodium hydroxide solution (used 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 millilitre of suspension contains 100 international units of insulin (100 IU/ml). Each cartridge contains 300 units (3 ml of suspension).
Cartridges are supplied in packs of 5.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Manufacturers:
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

For further information, please contact the representative of the Marketing Authorisation 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 authorised in the European Economic Area member states under the following names:
Huminsulin „Lilly“ Profil III 100 I.E./ml (Austria)
Humuline 30/70 (Belgium, Luxembourg, The 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)