Polhumin N

Package Leaflet: Information for the Patient

Polhumin N, 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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet:

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

1. What is Polhumin N and what is it used for

Polhumin N is human insulin used to treat diabetes. This insulin is produced using genetic engineering techniques (DNA recombination) in Escherichia coli bacteria. It is identical to the insulin produced by the human body.
Insulin is a hormone produced in the human body by 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' inability to produce insulin in amounts that allow for blood glucose control.
Polhumin N is a medium-acting insulin. This means that the onset of action, which reduces blood sugar levels, occurs about 1.5 hours after injection, the maximum effect occurs after 4-12 hours, and the total duration of action is about 24 hours.
The medicine is available in a 3 ml cartridge and is intended for use with an injector.
Warning!Other products must not be mixed with insulin in the cartridge. Insulin must not be administered with other medicines in the same syringe.

2. Important information before using Polhumin N

When not to use Polhumin N

• if you are allergic to this insulin or any of the other ingredients of this medicine (listed in section 6).
• if you are experiencing symptoms that may indicate impending hypoglycemia (low blood sugar levels).

Warnings and precautions

• If your current treatment provides good control of diabetes, warning signs of excessive blood sugar reduction (hypoglycemia - see below) may not be felt. You should plan your meals, physical activity, and overall activity level carefully. You should also monitor your blood sugar levels by performing frequent blood glucose tests.
• Some people who have changed from animal insulin to human insulin have reported that the warning signs of hypoglycemia were less pronounced or different than before. If hypoglycemia occurs frequently or if you have difficulty recognizing the warning signs of hypoglycemia, you should consult your doctor.
• Your insulin requirements may also change if you drink alcohol.
• If you are planning to travel abroad, you should inform your doctor. Time zone differences may require you to perform injections and eat meals at different times.
• If you have kidney or liver disease, you should inform your doctor. Your doctor will adjust your insulin dose accordingly. Remember that many conditions (e.g., liver disease, kidney disease, adrenal gland disease, pituitary disease, colds) and stressful situations can lead to significant fluctuations in blood sugar levels, which can cause complications of insulin therapy: hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar).

Polhumin N in cartridges is intended for subcutaneous injection only using a reusable injector. If it is necessary to administer insulin by a different method, you should consult your 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 N"). If you are currently injecting insulin into an area with lumps, you should consult your doctor before changing the injection site. Your doctor may recommend more frequent blood glucose monitoring and adjustment of your insulin dose or other anti-diabetic medicines.
➢ Hypoglycemia(low blood sugar) can 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, shaking hands, vision disturbances, headaches, and in severe cases - disorientation, seizures, loss of consciousness.
Warning!If you experience recurring hypoglycemia, you should consult your doctor to determine the cause of the low blood sugar and possible adjustment of your insulin dose. Do not give anything to eat or drink to an unconscious person, as this may cause 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 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, drowsiness, dry skin and mucous membranes.
Prolonged hyperglycemia can lead to 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 intervention.

To avoid hypoglycemia or hyperglycemia:

• Always carry a spare injector and Polhumin N cartridge with you.
• Always carry something that informs others that you have diabetes.
• Always carry sugar cubes with you.

Children

Your doctor will recommend the appropriate dose to achieve normal blood sugar levels (normoglycemia), according to your physiological needs.

Polhumin N and other medicines

Tell your doctor about all the medicines you are taking or have recently taken, and about any medicines you plan to take.
It is especially important to tell your doctor if you are taking insulin and you visit another doctor for any other reason than diabetes.
Your body's insulin requirements may change if you are taking medicines such as:
Medicines that reduce the effect of insulin:

• 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, endometriosis),
• sympathomimetic agents (e.g., epinephrine, terbutaline used to treat asthma),
• nicotinic acid,
• steroids (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),
• ethanol. Oral anti-diabetic medicines reduce the need for insulin. Warning!Other medicines must not be mixed with insulin in the cartridge. Insulin must 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 baby, ask your doctor or pharmacist for advice before using this medicine.
In women with diabetes, during the childbearing period, it is essential to strive for normal blood sugar levels during insulin treatment.
Insulin does not pass through the placenta into the fetus's blood.
The need for insulin decreases during the first trimester of pregnancy and increases in the next two trimesters. At the end 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 approaches that used in non-pregnant women with diabetes).
Insulin does not pass into breast milk. Women treated with insulin can breastfeed. Often, a change in insulin dose or diet is necessary.

Driving and using machines

Be aware of the potential symptoms of hypoglycemia. The ability to concentrate and react is usually impaired during hypoglycemia. Never drive a vehicle if you experience symptoms that may indicate impending hypoglycemia. Consult your 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 N contains sodium

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

3. How to use Polhumin N

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor.

The insulin dose 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 insulin dose should be determined based on regular monitoring of blood glucose and urine levels.
When changing insulin: e.g., from mixed insulin (porcine-bovine) or bovine insulin to human insulin, changing the form, or changing the manufacturer, a change in dosage may be necessary, which should be done under medical supervision.
In patients who have been well-controlled on highly purified porcine insulin or other highly purified human insulins, no dose adjustment is expected.
Patient should follow the regimen of regular check-ups as recommended by the doctor.
During treatment, regular monitoring of blood glucose levels is necessary.
Polhumin N in a filled injector is intended for subcutaneous injection only. If it is necessary to administer insulin by a different method, you should consult your doctor.
Subcutaneous injection should be performed in the abdominal wall, buttocks, thigh, or upper arm.
You should change the injection site to avoid lumps.
Preparing the insulin in cartridges
Before inserting the cartridge containing insulin into the injector, the cartridge should be turned upside down and back again 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 in the same way as described above.
These actions should be performed before each insulin injection.
Performing the injection

• Hold the skin between two fingers, then insert the needle into the skin fold at an angle of about 45° and inject the insulin under the skin;
• Withdraw the needle and gently press 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. Do not reuse used needles. The needle should be removed in a safe manner. Do not share needles and injectors with other people. The cartridge can be used until its contents are used up, and then it should be removed in a safe manner. If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Using a higher dose of Polhumin N than recommended

If you have taken more Polhumin N than recommended, consult your doctor immediately.
As a result of overdosing on insulin, hypoglycemia may occur (causes and symptoms of hypoglycemia - see section 2 "Important information before using Polhumin N").
The procedure in case of insulin overdose depends on the severity of hypoglycemia:

• In cases of mild and moderate hypoglycemia, you should immediately consume 2-5 sugar cubes or teaspoons dissolved in water or a glass of sugary drink. Do not take insulin if the symptoms indicate possible hypoglycemia. Always carry sugar, sweets, biscuits, or fruit juice with you;
• In severe hypoglycemia, when the patient loses consciousness, a trained person should administer glucagon. As soon as consciousness is regained, sugar or a snack containing sugar should be consumed. If the patient does not regain consciousness after glucagon administration, they should be treated in a hospital. After each glucagon administration, medical advice should be sought to determine the cause of hypoglycemia and possible ways to prevent it in the future. You should inform your relatives, friends, and colleagues that in case of loss of consciousness, the unconscious person should be placed on their side and immediate medical attention should be sought. Do not give anything to eat or drink to an unconscious person, as this may cause choking. In case of hypoglycemia with loss of consciousness or frequent episodes of hypoglycemia, you should consult your doctor, as a change in insulin dose and administration time, as well as a change in diet and physical activity, may be necessary.

Missing a dose of Polhumin N

If you miss a dose of insulin, consult your doctor.
If you miss a dose of the medicine, hyperglycemia may occur.
Do not take a double dose to make up for the missed dose.
If you miss a dose of the medicine at a fixed, specified time, take the medicine as soon as possible, provided that the time to the next dose is long enough, or take the next dose at the right time and continue the 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 disappear 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 can also be caused by the accumulation of a protein called amyloid (cutaneous amyloidosis, frequency of occurrence unknown). Insulin injected into an area with lumps may not work properly. You should always change the injection site - 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 any of these symptoms while using Polhumin N, consult your doctor immediately.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 N

Keep out of the sight and reach of children.
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Store in the original package 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 package. 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 package contents.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Polhumin N contains

The active substance of the medicine is biosynthetic, highly purified human insulin isophane.
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 isophane insulin.
Other ingredients of the medicine are: protamine sulfate, disodium phosphate dodecahydrate, phenol, metacresol, glycerol, zinc chloride (4% solution Zn), hydrochloric acid (0.1 mol/l solution), sodium hydroxide (0.1 mol/l solution), and water for injections.

What Polhumin N looks like and what the pack contains

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

Packaging

5 cartridges of 3 ml in a PVC/Aluminum blister pack, in a cardboard box..
The cartridges are cylindrical glass containers made of neutral, colorless glass, internally siliconized, with a double seal, 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" Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Phone number: 22 811-18-14
To obtain more detailed information, please contact the representative of the marketing authorization holder.

Date of last revision of the leaflet: