Polhumin r

Package leaflet: Information for the patient

Polhumin R, 100 IU/ml, injection solution
Insulinum humanum
Please read carefully the entire leaflet 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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are identical.
• If any adverse reactions occur in the patient, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

Polhumin R is human insulin used in the treatment of diabetes. This insulin is produced using genetic engineering techniques (recombinant DNA) in Escherichia coli bacteria. It is identical to human insulin naturally produced in the body.
Insulin is a hormone normally produced in the human body by the pancreas. It plays a role in the metabolism of carbohydrates, fats, and proteins, including lowering blood glucose (sugar) levels.
Diabetes is caused by the pancreas' inability to produce insulin in amounts sufficient to control blood glucose levels.
Polhumin R is used to provide long-term control of blood glucose levels. Polhumin R is a fast-acting insulin. This means that the onset of action, consisting of a reduction in blood glucose concentration, occurs approximately 30 minutes after injection, the peak effect occurs between 1 and 3 hours, and the total duration of action is approximately 8 hours.
The medicine is available in a 3 ml cartridge intended for use with an injection device.
Warning! Do not introduce any other preparations into insulin cartridges. Insulins must not be administered together with other medicines in the same syringe.

2. Important information before using Polhumin R

When not to use Polhumin R

• if the patient is allergic to this insulin or to any of the other ingredients of this medicine (listed in section 6).
• if the patient is experiencing symptoms suggesting an approaching hypoglycaemic state (low blood sugar).

Warnings and precautions

• If current treatment ensures good diabetes control, warning symptoms of excessive reduction in glucose concentration (hypoglycaemia – see below) in the blood may not be noticeable. It is necessary to carefully plan meal times, frequency of physical activity, and overall activity level.
  It is also important to monitor blood sugar levels by frequently testing blood glucose concentration.

• Some individuals who experienced hypoglycaemia (low blood glucose) after switching from animal to human insulin have reported that warning symptoms of hypoglycaemia were less pronounced or completely different than before. If hypoglycaemia occurs frequently or if there are difficulties recognizing its warning symptoms, consult a doctor.

• Insulin requirements may also change after alcohol consumption.

• If the patient plans to travel abroad, they should inform their doctor. Time zone differences may require injections and meals to be taken at different times.

• If the patient has kidney or liver disease, they should inform their doctor. The doctor will adjust the insulin dose accordingly. It should be remembered that in many medical conditions (e.g. liver, kidney, adrenal or pituitary gland disorders, colds) and during stressful situations, significant fluctuations in blood glucose levels may occur, potentially leading to insulin therapy complications: hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar).

Polhumin R cartridges are intended exclusively for use with a reusable insulin pen.
If insulin administration by another method is necessary, consult a doctor.
Skin changes at injection site
Injection sites should be rotated to prevent the development 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 insulin is currently being injected into an area with lumps, contact a doctor before changing the site.
The doctor may recommend more frequent blood glucose monitoring and adjustment of the insulin dose or other antidiabetic medications.

• Hypoglycaemia (low blood sugar) may result from administering too high an insulin dose, delayed or missed meals, meals with reduced carbohydrate content, increased physical activity, or faster insulin absorption (e.g. due to elevated skin temperature during sunbathing or bathing in hot water). Symptoms of hypoglycaemia include: excessive sweating, weakness, hunger, palpitations, feeling cold, anxiety, hand tremors, blurred vision, headache, and in severe cases – disorientation, seizures, or loss of consciousness. Warning! In case of recurrent hypoglycaemia, contact a doctor to determine the cause of low blood sugar and possibly adjust insulin dosage. Do not administer fluids or food orally to an unconscious person due to the risk of choking. Place the unconscious person in the recovery position and call a doctor immediately. If severe hypoglycaemia is not treated promptly, it may lead to temporary or permanent brain damage or death.
• Hyperglycaemia. Abnormally elevated blood glucose levels occurring during insulin therapy are most commonly caused by: failure to follow a diabetic diet, inadequate insulin therapy (insufficient insulin dose), increased insulin requirements (due to infections, surgery, trauma), lifestyle changes (reduced physical activity), or concomitant use of other medications, e.g. oral contraceptives, glucocorticosteroids, or thiazide diuretics. Symptoms of hyperglycaemia include: excessive thirst, loss of appetite, frequent urination of large volumes of urine, fatigue, drowsiness, dry skin and mucous membranes. Prolonged hyperglycaemia may lead to ketoacidosis (acetone breath, rapid and deep breathing, presence of ketone bodies in urine) or coma. The appearance of the above symptoms requires immediate medical intervention.

To avoid hypoglycaemia or hyperglycaemia:

• Always carry a spare insulin pen and a cartridge of Polhumin R.
• Always carry identification indicating that you have diabetes.
• Always carry sugar cubes.

Children
The doctor will recommend an appropriate dosage to achieve normal blood glucose levels (normoglycaemia), in accordance with physiological needs.
Polhumin R and other medicines
Inform your doctor about all medicines currently used or recently taken, as well as any medicines you plan to take.
It is essential to inform any doctor treating you for reasons other than diabetes that you are using insulin.
The body's insulin requirements may change when taking the following medicines concurrently:
Medicines that reduce insulin action:

• estrogens (including oral contraceptives, hormone replacement therapy),
• thyroid hormones,
• lithium compounds (used in the treatment of certain psychiatric disorders),
• danazol (used, among others, in the treatment of benign breast disorders (fibrocystic breast disease), endometriosis),
• sympathomimetic agents (e.g. epinephrine, terbutaline used in asthma treatment),
• nicotinic acid,
• steroids (used in inflammatory conditions),
• phenytoin (an anticonvulsant)

Medicines that enhance insulin action:

• β-adrenergic blockers (used in the treatment of heart diseases, hypertension – e.g. propranolol),
• certain antidepressants (e.g. monoamine oxidase inhibitors such as iproniazid),
• salicylates (e.g. aspirin),
• somatostatin analogues (e.g. octreotide),
• ethyl alcohol. Oral antidiabetic drugs reduce insulin requirements. Warning! Do not introduce other medications into insulin cartridges. Insulin must not be mixed with other medicines in the same syringe.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning pregnancy, she should consult a doctor or pharmacist before using this medicine.
In women of reproductive age with diabetes, it is essential to achieve normal blood glucose levels during insulin therapy.
Insulin does not cross the placenta into fetal blood.
Insulin requirements decrease during the first trimester of pregnancy but increase during the second and third trimesters. At the end of pregnancy, insulin requirements are approximately twice as high compared to the pre-pregnancy period.
Insulin requirements decrease at the onset of labour and after delivery (insulin dose approaches that used in non-pregnant diabetic women).
Insulin does not pass into breast milk. Patients treated with insulin may breastfeed. Insulin dosage or diet adjustments are often necessary.
Driving and operating machinery
Be aware of possible hypoglycaemic symptoms. The ability to concentrate and react is usually impaired during hypoglycaemia. Never drive a vehicle if symptoms suggest an approaching hypoglycaemic state. Consult a doctor to carefully evaluate the possibility of driving vehicles or operating machinery, especially in cases of frequent hypoglycaemic episodes or difficulty recognizing hypoglycaemia symptoms.
Polhumin R contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose unit, meaning the medicine is considered "sodium-free".

3. How to use Polhumin R

This medicine must always be used exactly as prescribed by your doctor. In case of doubt, consult your doctor.
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), and concomitant use of other medications. The exact insulin dose should be established according to regular monitoring of blood and urine glucose levels.
Whenever changing insulin—e.g., from porcine or bovine insulin to human insulin, changing formulation, or changing manufacturer—dosage adjustments may be necessary and must be carried out under medical supervision.
In patients who are well-controlled with highly purified porcine insulin or other highly purified human insulins, no dosage changes other than routine adjustments aimed at maintaining consistent patient control are anticipated.
It is essential to strictly adhere to the follow-up appointments scheduled by your doctor.
Regular monitoring of blood or urine glucose levels is required during treatment.
Polhumin R in cartridges is intended exclusively for use with a reusable insulin injection pen. If insulin must be administered by another method, consult your doctor.
Subcutaneous injections should be administered into the abdominal area, buttocks, thigh, or upper arm. Injection sites should be rotated to avoid lipohypertrophy.

Preparing insulin from cartridges
Inspect the cartridge containing insulin solution carefully before inserting it into the insulin pen. The solution should be colorless, clear, and watery in consistency. The appearance of the solution should be checked before each injection.
Do not use the insulin if the contents of the cartridge appear altered in any way.

Administering the injection

• Pinch the skin between two fingers, insert the needle at an angle of approximately 45° into the skin fold, and inject insulin subcutaneously;
• Withdraw the needle and gently press on the injection site for several seconds to prevent insulin leakage. Injection sites should be rotated according to your doctor’s instructions. Do not reuse used needles. Needles must be disposed of safely. Do not share needles or injection pens with other people. The cartridge may be used until its contents are fully depleted, after which it must be safely discarded. If you feel the medicine is too strong or too weak, consult your doctor.

Use of a higher than recommended dose of Polhumin R
If more than the recommended dose of Polhumin R has been administered, seek medical advice immediately.
Insulin overdose may lead to hypoglycemia (causes and symptoms of hypoglycemia—see section 2 “Important information before using Polhumin R”). Management of insulin overdose depends on the severity of hypoglycemia:

• In cases of mild to moderate hypoglycemia, immediately consume 2–5 sugar cubes or teaspoons of sugar dissolved in water, or a glass of sugary drink. Do not administer insulin if symptoms suggest hypoglycemia may occur. Always carry sugar, sweets, biscuits, or fruit juice;
• In severe hypoglycemia, when the patient loses consciousness, a trained person should administer glucagon. As soon as consciousness is regained, consume sugar or a snack containing sugar. If the patient does not regain consciousness after glucagon administration, immediate hospital treatment is required. After each glucagon administration, seek medical advice to determine the cause of hypoglycemia and how to prevent future episodes.
  Inform family members, friends, and coworkers that in case of unconsciousness, the person should be placed in the recovery position and immediate medical help should be obtained.
  Do not give food or drink to an unconscious person due to the risk of choking.
  In cases of hypoglycemia with loss of consciousness or frequent hypoglycemic episodes, contact your treating physician, as adjustment of insulin dose, timing of administration, diet, and physical activity may be necessary.

Missed dose of Polhumin R
If a dose of insulin is missed, contact your doctor.
Missing a dose may lead to hyperglycemia.
Do not administer a double dose to make up for a missed dose.
If a dose is missed at its usual scheduled time, the medicine should be administered as soon as possible, provided there is sufficient time before the next scheduled dose; otherwise, take the next dose at the usual time and continue regular administration.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
As with other insulins, hypoglycaemia is the most common complication associated with insulin therapy.

Adverse reactions reported commonly (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 resolve during continued treatment.

Skin changes at the injection site
If insulin is injected too frequently into the same site, fatty tissue may shrink (lipoatrophy) or thicken (lipohypertrophy) (uncommon - less than 1 in 100 patients). Lumps under the skin may also be caused by accumulation of a protein called amyloid (cutaneous amyloidosis, frequency unknown). Insulin injected into an area with such lumps may not work properly. The injection site should be rotated each time, which helps prevent these skin changes.

Adverse reactions reported very rarely (in less than 1 in 10,000 patients):
Generalized allergic reaction – may manifest as generalized skin rash, itching, sweating, gastrointestinal disturbances, angioedema, breathing difficulties, palpitations, drop in blood pressure, and fainting/loss of consciousness.

• If any of these symptoms occur during treatment with Polhumin R, contact a doctor immediately.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Polhumin R

Keep out of the 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 first opening, store the contents at a temperature below 25°C and use within 28 days.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Polhumin R contains
The active substance is biosynthetic highly purified human insulin.
1 ml of solution contains 100 IU of human insulin.
One cartridge contains 3 ml of solution, equivalent to 300 IU of soluble insulin.
Other components 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 contents of the pack
Colourless, neutral, sterile, aqueous solution of human insulin in a cartridge, with pH 6.9–7.8.

Packaging
5 cartridges of 3 ml each in a PVC/Aluminium blister, packed in a cardboard box.
The cartridges are made of colourless neutral glass, internally siliconized, sealed at both ends with a rubber stopper and an aluminium cap with a rubber disc made of bromobutyl rubber mixture.

Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga Street 2
03-176 Warsaw, Poland
Telephone number: +48 22 811-18-14
For further information, please contact the representative of the Marketing Authorisation Holder.