Polhumin Mix-3

Leaflet attached to the packaging: patient information

Polhumin Mix-3, 100 IU/ml, suspension for injection
Human insulin

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for a particular person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Polhumin Mix-3 and what is it used for
• 2. Important information before using Polhumin Mix-3
• 3. How to use Polhumin Mix-3
• 4. Possible side effects
• 5. How to store Polhumin Mix-3
• 6. Contents of the packaging and other information

1. What is Polhumin Mix-3 and what is it used for

Polhumin Mix-3 is human insulin used to treat diabetes. This insulin is produced using genetic engineering techniques (DNA recombination) in Escherichia colibacteria. It is identical to the insulin produced by the human body.
Insulin is a hormone produced in the human body in the pancreas. It is involved in carbohydrate, fat, and protein metabolism, causing, among other things, a decrease in blood glucose levels.
The cause of diabetes is the pancreas's inability to produce insulin in quantities that allow blood glucose levels to be controlled.
Polhumin Mix-3 is a medium-acting insulin. This means that the onset of action, which is the reduction of blood sugar levels, occurs about 30 minutes after injection, the maximum effect occurs after 2-8 hours, and the total duration of action is up to 24 hours.
The medicine is available in a 3 ml cartridge and is intended for use with an injector.
Warning!Other products should not be added to insulin cartridges. Insulins should not be administered with other medicines in the same syringe.

2. Important information before using Polhumin Mix-3

When not to use Polhumin Mix-3

Warnings and precautions

• If the current treatment provides good control of diabetes, warning signs of excessive blood sugar reduction (hypoglycemia - see below) may not be felt. Meal times, frequency of physical activity, and overall activity level should be planned carefully. Blood sugar levels should also be monitored by performing frequent blood glucose tests.

and overall activity level should be planned carefully. Blood sugar levels should also be monitored by performing frequent blood glucose tests.

• Some people who have changed from animal insulin to human insulin and have experienced hypoglycemia (low blood sugar levels) have reported that the symptoms warning of hypoglycemia were less pronounced or different from before. If hypoglycemia occurs frequently or there are difficulties in recognizing the symptoms of hypoglycemia, you should consult a doctor.
• The need for insulin may also change after consuming alcohol.
• If the patient plans to travel abroad, they should inform their doctor. The time difference may require injections and meals to be taken at different times.
• If the patient has been diagnosed with kidney or liver disease, they should inform their doctor. The doctor will adjust the insulin dose accordingly. It should be remembered that in many disease states (e.g., liver disease, kidney disease, adrenal gland disease, pituitary disease, colds) and stressful situations, significant fluctuations in blood sugar levels may occur, which can lead to complications of insulin therapy: hypoglycemia (low blood sugar levels) or hyperglycemia (high blood sugar levels).

Polhumin Mix-3 in cartridges is intended for subcutaneous injection only using a reusable injector. If it is necessary to administer insulin by another method, you should consult a doctor.
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 Polhumin Mix-3"). If insulin is currently being injected into an area with lumps, you should contact your doctor before changing the site. The doctor may recommend more frequent blood sugar monitoring and adjustment of the insulin dose or other anti-diabetic medicines.

• Hypoglycemia(low blood sugar) may be caused by administering too much insulin, delaying or missing a meal, reducing carbohydrate intake, increasing physical activity, or increasing the rate of insulin absorption (e.g., due to increased skin temperature during sunbathing or taking a hot bath). Symptoms of hypoglycemia include excessive sweating, weakness, hunger, palpitations, feeling cold, feeling anxious, trembling hands, vision disturbances, headaches, and in more severe cases - disorientation, convulsions, and loss of consciousness. Warning!In case of recurring hypoglycemia, you should consult a doctor to determine the cause of the low blood sugar and possible adjustment of the insulin dose. A person who is unconscious should not be given anything to eat or drink orally due to the risk of choking. An unconscious person should be placed on their side and immediate medical attention should be sought. If treatment for severe hypoglycemia is not started, it may cause temporary or permanent brain damage or death.
• Hyperglycemia.Abnormal, elevated blood glucose levels that occur during insulin treatment are usually due to: not following a diabetic diet, inadequate insulin therapy (too low a dose of insulin), increased demand for insulin (infectious diseases, surgery, injuries), changes in lifestyle (reduced physical activity), as well as taking other medicines, such as oral contraceptives, glucocorticosteroids, or thiazide diuretics. Symptoms of hyperglycemia include excessive thirst, loss of appetite, frequent urination, feeling tired, sleepiness, dryness of the skin and mucous membranes. Prolonged hyperglycemia can cause the development of ketoacidosis (acetone smell from the mouth, rapid and deep breathing, presence of ketone bodies in the urine) or coma. The occurrence of these symptoms requires immediate medical attention.

To avoid hypoglycemia or hyperglycemia:

• You should always carry a spare injector and a cartridge of Polhumin Mix-3 insulin with you.
• You should always carry something with you that informs others that you have diabetes.
• You should always carry sugar cubes with you.

Children

The doctor will recommend the appropriate dosage to achieve proper blood sugar levels (normoglycemia), in accordance with the patient's physiological needs.

Polhumin Mix-3 and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken
and also about medicines you plan to take.
You must inform your doctor about taking insulin if you are seeing them for a reason other than diabetes.
The body's need for insulin may change when taking such medicines as:

• estrogens (including oral contraceptives, hormone replacement therapy),
• thyroid hormones,
• lithium compounds (used to treat certain mental illnesses),
• danazol (used to treat, among other things, benign breast diseases (fibrocystic breast disease), endometriosis (growth of the uterine lining outside the uterus)),
• sympathomimetic agents (e.g., epinephrine, terbutaline used to treat asthma),
• nicotinic acid,
• corticosteroids (used in inflammatory conditions),
• phenytoin (an antiepileptic drug)

Medicines that enhance the effect of insulin:

• beta-blockers (used to treat heart diseases, high blood pressure - e.g., propranolol),
• certain antidepressants (e.g., monoamine oxidase inhibitors, e.g., iproniazid),
• salicylates (e.g., aspirin),
• somatostatin analogs (e.g., octreotide),
• ethyl alcohol. Oral anti-diabetic medicines reduce the need for insulin. Warning!Other medicines should not be added to insulin cartridges. Insulins should not be administered with other medicines in the same syringe.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor or pharmacist before using this medicine.
In women with diabetes, in the reproductive period, it is essential to strive for proper blood sugar levels during insulin treatment.
Insulin does not pass through the placenta into the fetus's blood.
The need for insulin decreases in the first trimester of pregnancy and increases in the next two trimesters. In the final stage of pregnancy, the need for insulin is about twice as high as before pregnancy.
The need for insulin decreases when labor starts and after delivery (the insulin dose is similar to that used in non-pregnant women with diabetes).
Insulin does not pass into breast milk. Patients treated with insulin can breastfeed. Often, a change in insulin dose or diet is necessary.

Driving and using machines

You should be aware of the possible symptoms of hypoglycemia. The ability to concentrate and react is usually impaired during hypoglycemia. You should never drive a vehicle if you have symptoms that indicate impending hypoglycemia. You should consult a doctor to carefully consider the possibility of driving a vehicle or operating machinery if you experience frequent episodes of hypoglycemia or have difficulty recognizing its symptoms.

Polhumin Mix-3 contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose unit, which means the medicine is considered "sodium-free".

3. How to use Polhumin Mix-3

This medicine should always be used according to the doctor's recommendations. In case of doubts, you should consult a doctor.
The insulin dosage is individual for each patient. The insulin dose is determined based on the patient's age, physical activity, health status (e.g., presence of kidney failure), as well as the use of other medicines. The exact dose of insulin should be determined based on regular monitoring of blood sugar levels and urine tests.
During each change of insulin: e.g., from mixed (porcine-bovine) or bovine insulin to human insulin, change of form, as well as change of manufacturer, a change in dosage may be necessary, which should be done under medical supervision.
In patients who have well-controlled blood sugar levels with highly purified porcine or human insulin, no other changes in dosage are expected other than routine ones aimed at constant control of the patient's condition.
You should strictly follow the scheduled control visits recommended by your doctor.
During treatment, systematic monitoring of blood sugar levels or urine tests is necessary.
Polhumin Mix-3 in a filled injector is intended for subcutaneous injection only. If it is necessary to administer insulin by another method, you should consult a doctor.
Subcutaneous administration should be performed in the abdominal area, buttocks, thigh, or upper arm.
You should change the injection sites to avoid thickening.
Preparing the insulin in cartridges
Before inserting the cartridge containing insulin into the injector, the cartridge should be turned upside down and back several times, so that the glass ball can move freely from one end of the cartridge to the other. This action should be performed several times (about 10 times) until a uniform, cloudy or milky suspension is obtained. If the cartridge is already in the injector, it should be turned several times as described above.
These actions should be performed before each insulin injection.
Performing the injection

• holding the skin between two fingers and then inserting the needle into the skin fold at an angle of about 45° and injecting the insulin under the skin;
• withdrawing the needle and gently pressing the injection site for a few seconds to prevent insulin from leaking out. The injection site should be changed according to the doctor's recommendation. Used needles should not be reused. The needle should be disposed of safely. Injectors and needles should not be shared with other people. The cartridge can be used until its contents are used up, and then it should be disposed of safely. If you feel that the effect of the medicine is too strong or too weak, you should consult a doctor.

Using a higher dose of Polhumin Mix-3 than recommended

In case of taking a higher dose of the medicine than recommended, you should immediately consult a doctor.
As a result of overdosing on insulin, hypoglycemia may occur (causes and symptoms of hypoglycemia - see section 2 "Important information before using Polhumin Mix-3").
The procedure in case of insulin overdose depends on the severity of hypoglycemia:

Missing a dose of Polhumin Mix-3

In case of missing a dose of insulin, you should consult a doctor.
In case of missing a dose of the medicine, hyperglycemia may occur.
You should not take a double dose to make up for the missed dose.
In case of missing a dose of the medicine at a fixed, specified time, you should take the medicine as soon as possible, if the time to the next dose is long enough, or take the next dose at the right time and continue regular administration of the medicine.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
As with other insulins, hypoglycemia is the most common complication of insulin therapy.
Side effects reported often(in less than 1 in 10 patients)
Local allergic reaction - symptoms at the injection site (redness, swelling, itching, pain, and bruising at the injection site) may occur during insulin treatment. Most of these symptoms are usually temporary and resolve during treatment.
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) (not very common - less than 1 in 100 patients). Lumps under the skin may also be caused by the accumulation of a protein called amyloid (skin amyloidosis, frequency of occurrence unknown). Insulin injected into an area with lumps may not work properly. You should change the injection site every time - this will help prevent these skin changes.
Side effects reported very rarely(in less than 1 in 10,000 patients)
Generalized allergic reaction - may manifest as: generalized skin rash, itching, sweating, gastrointestinal disorders, angioedema, difficulty breathing, palpitations, decreased blood pressure, and fainting/loss of consciousness.
➢ If you experience such symptoms while using Polhumin Mix-3, you should immediately consult a doctor.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your 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
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 Polhumin Mix-3

Keep out of sight and reach of children.
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Store in the original packaging to protect from light.
After opening, the cartridge can be stored for a maximum of 28 days at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Do not use this medicine if you notice a change in the appearance of the packaging contents.
Medicines should not be disposed of via wastewater or household waste. You should 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 Polhumin Mix-3 contains

The active substance of the medicine is biosynthetic highly purified human insulin.
1 ml of the suspension contains 100 IU of human insulin.
One cartridge for the injector contains 3 ml of the suspension, which corresponds to 300 IU of biphasic insulin in a ratio of 3 parts of soluble insulin and 7 parts of isophane insulin.
Other ingredients of the medicine are protamine sulfate, disodium phosphate dodecahydrate, phenol, metacresol, glycerol, zinc chloride (4% solution), hydrochloric acid (0.1 mol/l solution), sodium hydroxide (0.1 mol/l solution), and water for injections.

What Polhumin Mix-3 looks like and what the packaging contains

White or almost white, neutral, sterile, aqueous suspension of human insulin in a cartridge.

Packaging

5 cartridges of 3 ml each in a PVC/Al blister pack in a cardboard box.
The cartridges are cylindrical glass containers made of neutral, colorless glass, internally siliconized on both sides, closed with a rubber stopper and an aluminum cap with a rubber disk, made of a bromobutyl mixture. Each cartridge contains 2 glass balls.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A.
ul. A. Fleminga 2
03-176 Warsaw
Phone number: 22 811-18-14
To obtain more detailed information, you should contact the representative of the marketing authorization holder.

Date of last revision of the leaflet: