Polhumin R

Leaflet attached to the packaging: patient information

Polhumin R, 100 IU/ml, solution for injection
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.
• If you have any doubts, consult your doctor or pharmacist.
• 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 you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

Polhumin R 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 by the human body in the pancreas. It participates 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 for blood glucose control.
Polhumin R is used to control blood glucose levels in the long term. Polhumin R is a fast-acting insulin. This means that the onset of action, which reduces blood sugar levels, occurs about 30 minutes after injection, the maximum effect occurs after

• 1-3 hours, and the total duration of action is about 8 hours. The medicine is available in a 3 ml cartridge and is intended for use with an injector.

Warning!Other preparations must not be added to the insulin cartridges. Insulins must not be administered with other medicines in the same syringe.

2. Important information before using Polhumin R

When not to use Polhumin R

• 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 an impending hypoglycemic state (low blood sugar level).

Warnings and precautions

• If your current treatment provides good diabetes control, warning signs of excessive blood glucose 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 glucose levels by performing frequent blood glucose tests.

Some people who have changed from animal insulin to human insulin and have experienced hypoglycemia (low blood sugar) have reported that the symptoms warning of hypoglycemia were less pronounced or different from before. If hypoglycemia occurs frequently or if there are difficulties in recognizing the symptoms of hypoglycemia, you should consult your doctor.

• Your insulin requirements may also change after consuming alcohol.
• If you plan to travel abroad, you should inform your doctor. The time difference may require you to inject and eat at different times.
• If you have kidney or liver disease, you should inform your doctor. The doctor will adjust the insulin dose accordingly. Remember that in many disease states (e.g., liver, kidney, adrenal, pituitary, or during colds) and stressful situations, significant fluctuations in blood glucose levels may occur, leading to complications of insulin therapy: hypoglycemia (reduced blood sugar level) or hyperglycemia (elevated blood glucose level).

Polhumin R in cartridges is intended for use only with a reusable injector. If it is necessary to administer insulin by another method, you should consult your doctor.
Skin changes at the injection site
You should change the injection site to prevent the formation of skin changes, such as lumps under the skin. Insulin injected into an area with lumps may not work properly (see "How to use Polhumin R"). If you are currently injecting insulin into an area with lumps, you should contact your doctor before changing it. The doctor may recommend closer monitoring of blood glucose levels and adjusting the 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, trembling hands, vision disturbances, headaches, and in more severe cases - disorientation, convulsions, or 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 changes to your insulin dosage. 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 initiated, it may cause temporary or permanent brain damage or death.
• Hyperglycemia.Abnormal, elevated blood glucose levels during insulin treatment are most often the result of: not following a diabetic diet, inadequate insulin therapy (too low an insulin dose), increased body 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, 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. If the above symptoms occur, immediate medical attention is required.

To avoid hypoglycemia or hyperglycemia:

• Always carry a spare injector and Polhumin R 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 dosage to achieve normal blood glucose levels (normoglycemia), according to your physiological needs.

Polhumin R and other medicines

Tell your doctor about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Be sure to tell your doctor if you are taking insulin, especially if you are seeing them for a reason other than diabetes.
The body's demand for insulin may change when taking such medicines 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 (fibrocystic breast disease), endometriosis (growth of 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, hypertension - 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 demand for insulin. Warning!Other medicines must not be added to the insulin cartridges. Insulins must not be administered with other medicines in the same syringe.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to become pregnant, you should consult your doctor or pharmacist before using this medicine.
In women with diabetes, during the childbearing period, it is essential to strive for normal blood glucose levels during insulin treatment.
Insulin does not pass through the placenta into the fetus's blood.
The demand for insulin decreases during the first trimester of pregnancy and increases during the next two trimesters. In the final stage of pregnancy, the demand for insulin is about twice as high as before pregnancy.
The demand for insulin decreases during labor and after delivery (the insulin dose approaches the dose 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

Be aware of the possible symptoms of hypoglycemia. The ability to concentrate and react is usually impaired during hypoglycemia. Never drive mechanical vehicles if you experience symptoms that may indicate an impending hypoglycemic state. Consult your doctor to carefully consider the possibility of driving vehicles or operating machinery in case of frequent hypoglycemic states or difficulties in recognizing their symptoms.

Polhumin R 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 R

This medicine should always be used according to your doctor's recommendations. If you have any doubts, consult your 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 insulin dose should be determined based on regular monitoring of blood glucose levels and urine tests.
During each change of insulin: e.g., from mixed insulin (porcine-bovine) or bovine insulin to human insulin, change of formulation, as well as change of 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 other dosage changes are expected than those that are routinely made to maintain control of the patient's condition.
You must strictly adhere to the control visit schedules recommended by your doctor.
During treatment, regular monitoring of blood glucose levels or urine tests is necessary.
Polhumin R in cartridges is intended for use only with a reusable injector. If it is necessary to administer insulin by another method, you should consult your 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
The cartridge containing the insulin solution should be carefully examined before inserting it into the injector. The solution should be colorless, clear, and have a water-like consistency. The appearance of the solution should be checked before each insulin injection.
If the contents of the packaging have changed, the insulin should not be used.
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 your doctor's recommendation. Do not reuse used needles. The needle should be disposed of safely. 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 disposed of safely. If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Using a higher dose of Polhumin R than recommended

If you have taken a higher dose of the medicine 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 R").
The procedure for overdosing on insulin depends on the severity of the 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, cakes, or fruit juice with you;
• In severe hypoglycemia, when the patient loses consciousness, a trained person should administer glucagon. As soon as the patient regains consciousness, they should consume sugar or a snack containing sugar. 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 the hypoglycemia and possible ways to prevent it in the future.
  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 hypoglycemic states, 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 R

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, if 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 transient 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 (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 a generalized skin rash, itching, sweating, gastrointestinal disorders, angioedema, breathing difficulties, palpitations, decreased blood pressure, and fainting/loss of consciousness.

• If you experience such symptoms while using Polhumin R, consult your doctor immediately.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, 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 R

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 given month.
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 packaging and other information

What Polhumin R contains

The active substance of the medicine is biosynthetic highly purified human insulin
1 ml of the solution contains 100 IU of human insulin.
One cartridge for the injector contains 3 ml of the solution, which corresponds to 300 IU of soluble insulin.
Other ingredients of the medicine are: phenol, glycerol, hydrochloric acid (0.1 mol/l solution), sodium hydroxide (0.1 mol/l solution), and water for injections.

What Polhumin R looks like and what the packaging contains

A colorless, neutral, sterile, aqueous solution of human insulin in a cartridge with a pH of 6.9-7.8.

Packaging

5 cartridges of 3 ml each in a PVC/Aluminum 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.

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, contact the representative of the marketing authorization holder.

Date of the last update of the leaflet: