PENICILLINUM 5000000 IU Powder

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. Table of contents of the leaflet
   2. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
2. What is Penicillinum Crystallisatum TZF and what is it used for
3. Important information before using Penicillinum Crystallisatum TZF
   1. When not to use Penicillinum Crystallisatum TZF
   2. Warnings and precautions
   3. If the patient has any of the following conditions, they should inform their doctor before taking the medicine:
   4. If the patient experiences any of the following symptoms while using the medicine, they should immediately consult their doctor:
   5. Penicillinum Crystallisatum TZF and other medicines
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Penicillinum Crystallisatum TZF contains potassium
4. How to use Penicillinum Crystallisatum TZF
   1. Adults
   2. Children
   3. Dosing in patients with renal impairment
   4. Treatment duration
   5. Method of administration
   6. Use of a higher dose of Penicillinum Crystallisatum TZF than recommended
   7. Missing a dose of Penicillinum Crystallisatum TZF
   8. Stopping the use of Penicillinum Crystallisatum TZF
5. Possible side effects
   1. Severe side effects
   2. Reporting side effects
6. How to store Penicillinum Crystallisatum TZF
7. Package contents and other information
   1. What Penicillinum Crystallisatum TZF contains
   2. What Penicillinum Crystallisatum TZF looks like and what the package contains
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:
   5. Information intended exclusively for healthcare professionals
   6. Hypersensitivity reactions
   7. Dosing in patients with impaired renal function
   8. Creatinine clearance Maximum dose Dosing interval (ml/min)
   9. Method of administration
   10. Instructions for preparing solutions Intramuscular injection
   11. Pharmaceutical incompatibilities

Leaflet attached to the packaging: patient information

Penicillinum Crystallisatum TZF, 1,000,000 IU, powder for solution for injection
Penicillinum Crystallisatum TZF, 3,000,000 IU, powder for solution for injection
Penicillinum Crystallisatum TZF, 5,000,000 IU, powder for solution for injection
Benzylpenicillin potassium

Table of contents of the leaflet

• 1. What is Penicillinum Crystallisatum TZF and what is it used for
• 2. Important information before using Penicillinum Crystallisatum TZF
• 3. How to use Penicillinum Crystallisatum TZF
• 4. Possible side effects
• 5. How to store Penicillinum Crystallisatum TZF

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 you can read it again if you need to.
• If you have any doubts, you should consult a doctor or nurse.
• 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.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or nurse. See section 4.

• 6. Package contents and other information

1. What is Penicillinum Crystallisatum TZF and what is it used for

The active substance of Penicillinum Crystallisatum TZF is benzylpenicillin potassium.
Benzylpenicillin is a natural penicillin that has a bactericidal effect on many species of Gram-negative and Gram-positive bacteria.
Penicillinum Crystallisatum TZF is indicated for the treatment of the following severe infections caused by bacteria susceptible to benzylpenicillin:

• tonsillitis, pneumonia, bronchitis, pericarditis, chronic endocarditis, caused by streptococci, including group A, pneumococci, staphylococci;
• sepsis (severe systemic inflammatory response syndrome);
• meningococcal meningitis;
• skin and soft tissue infections;
• diphtheria (in combination with antitoxin);
• lung abscess;
• acute rheumatic fever caused by streptococcal infection, arthritis;
• osteomyelitis;
• neurosyphilis, ocular syphilis;
• gonorrhea;
• infections of the throat, lower respiratory tract, and genital organs caused by Fusobacteriumspp.;
• anthrax, borreliosis, infections caused by Clostridiumspp .(including tetanus), listeriosis, pasteurellosis, actinomycosis;
• perinatal prophylaxis of group B streptococcal infections (Streptococcus agalactiae).

2. Important information before using Penicillinum Crystallisatum TZF

When not to use Penicillinum Crystallisatum TZF

• If the patient has been found to be allergic (hypersensitive) to penicillin or other beta-lactam antibiotics.

Warnings and precautions

If the patient has any of the following conditions, they should inform their doctor before taking the medicine:

• a history of allergic reaction to any antibiotic;
• a history of other allergic reactions. Hypersensitivity reactions to penicillin may occur more frequently in people with a tendency to allergic reactions to many different substances. These reactions can have various symptoms and severity - from skin changes to anaphylactic shock (severe allergic reaction) - see section 4 "Possible side effects";
• known kidney and/or heart disease.

If the patient experiences any of the following symptoms while using the medicine, they should immediately consult their doctor:

• severe and persistent diarrhea, occurring during or after completion of penicillin treatment - this may be a symptom of pseudomembranous colitis, a complication associated with antibiotic use; do not take medications that slow down intestinal motility or other constipating medications, just consult a doctor who will prescribe appropriate treatment;
• new bacterial or fungal infections, caused by the overgrowth of non-susceptible strains of bacteria or fungi as a result of penicillin use, especially in chronically ill patients and patients with kidney problems; in this case, the antibiotic should be discontinued immediately and a doctor should be consulted.

In patients receiving high doses of penicillin, the doctor usually recommends performing kidney and liver function tests and blood tests.

Penicillinum Crystallisatum TZF and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to use.
In particular, the patient should inform their doctor if they are taking:

• probenecid (a medicine used in gout);
• other antibiotics that act bacteriostatically (e.g., chloramphenicol, erythromycin, sulfonamides);
• oral contraceptives - during penicillin treatment, it is recommended to use an additional, non-hormonal method of contraception.

Effect on laboratory test results
Penicillinum Crystallisatum TZF may affect the results of tests for certain substances in the blood (Coombs test), especially in patients receiving high doses.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
Penicillinum Crystallisatum TZF may be used during pregnancy if the doctor considers the use of the medicine to be absolutely necessary.
Benzylpenicillin passes into breast milk in small amounts and may cause an allergic reaction in the breastfed infant. Breastfeeding women should exercise caution when treated with Penicillinum Crystallisatum TZF.

Driving and using machines

There is no data on the effect of the medicine on the ability to drive and use machines.

Penicillinum Crystallisatum TZF contains potassium

1,000,000 IU of benzylpenicillin potassium contains 63 mg of potassium, which should be taken into account in patients with impaired kidney function and in patients controlling their potassium intake.
If the patient has electrolyte disturbances or kidney failure, they should inform their doctor before taking the medicine.

3. How to use Penicillinum Crystallisatum TZF

Penicillinum Crystallisatum TZF should always be used in accordance with the doctor's recommendations. If in doubt, the patient should consult their doctor.
Penicillinum Crystallisatum TZF is administered by a doctor or nurse. The dose depends on the severity of the infection, the type of microorganism causing the infection, the patient's age, and weight.
1 million IU is equivalent to 600 mg of benzylpenicillin potassium.

Adults

Recommended dose:
In severe infections caused by streptococci and pneumococci, such as pneumonia, endocarditis, meningitis, 12 to 24 million IU per day in divided doses every 2-6 hours.
In severe infections caused by staphylococci (susceptible to penicillin), 5 to 24 million IU per day in divided doses every 4-6 hours.
Due to the short half-life of Penicillinum Crystallisatum, it is administered in divided doses, usually every 4-6 hours, except for meningitis/sepsis, when the antibiotic should be administered every 2 hours.
Tonsillitis, pneumonia, bronchitis, lung abscess, pericarditis, chronic endocarditis, caused by streptococci, including group A, pneumococci, staphylococci
at least 5 million IU to 24 million IU, depending on the infection and severity, in divided doses, every 4 to 6 hours.
in streptococcal endocarditis: 12-18 million IU in divided doses every 4-6 hours or in continuous infusion for 4-6 weeks.
Meningococcal meningitis and/or sepsis.
24 million IU after 2 million IU every 2 hours.
Skin and soft tissue infections
2-4 million IU every 4-6 hours; to be used in combination with clindamycin, treatment to be continued until clinical improvement of the patient, patient without fever for 48 to 72 hours.
Diphtheria (in combination with antitoxin)

• 2-3 million IU in divided doses every 4-6 hours for 10 to 12 days.

Cellulitis (erysipelas )
2-4 million IU every 4 hours; treatment duration 10 days.
Acute rheumatic fever caused by streptococcal infection, arthritis
StreptococcusGroup A (S. pyogenes), StreptococcusGroup B (S. agalactiae): 2 million IU every 4 hours.
Osteomyelitis
Enterococcusspp (susceptible to penicillin) or streptococci (beta-hemolytic): 20 to 24 million IU per day as a continuous infusion or in divided doses every 4 hours for 6 weeks. Note: In patients with concomitant endocarditis caused by penicillin-susceptible Enterococcusspp, it is recommended to add an aminoglycoside for 4 to 6 weeks.
Neurosyphilis, ocular syphilis
18-24 million IU per day i.v. administered every 3-4 million IU every 4 hours, or in continuous infusion for 10-14 days.
Infections of the throat, lower respiratory tract, and genital organs caused by Fusobacterium
spp.
5-10 million IU in divided doses every 4-6 hours.
Anthrax
8 million IU in divided doses every 6 hours (higher doses may be required depending on the susceptibility of the organism).
Borreliosis
18-24 million IU in divided doses every 4 hours, treatment duration 14-28 days.
Infections caused by Clostridium spp. (including tetanus)
20 million IU per day in divided doses every 4-6 hours.
Listeriosis
adults - 15-20 million IU in divided doses every 4-6 hours per day for 2-4 weeks.
Actinomycosis
1-6 million IU per day, in divided doses, every 4-6 hours – cervicofacial actinomycosis
10-20 million IU per day, in divided doses, every 4-6 hours – abdominal actinomycosis.
Perinatal prophylaxis of group B streptococcal infections (Streptococcus agalactiae)
first dose 5 million IU, then: 2.5 million IU every 4 hours until delivery.

Children

Newborns
≤7 days
25,000 to 50,000 IU/kg body weight every 12 hours intramuscularly or intravenously
>7 days
25,000 to 50,000 IU/kg body weight every 8 hours intramuscularly or intravenously
In newborns weighing less than 1 kg, the dosing schedule every 12 hours may be maintained until the end of the second week of life.
Infants and children
Mild to moderate infections: 100,000 to 150,000 IU/kg body weight per day in divided doses every 4-6 hours intramuscularly or intravenously (maximum 8 million IU per day).
Severe infections– 200,000 to 300,000 IU/kg body weight per day in 4 to 6 divided doses.
Do not exceed a dose of 24 million IU per day.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Dosing in patients with renal impairment

Modification of dosing in this patient group is given at the end of the leaflet, in the section "Information intended exclusively for healthcare professionals".

Treatment duration

The treatment duration depends on the severity and type of infection.
The doctor will determine the appropriate treatment duration, which should be followed.

Method of administration

Benzylopenicylin can be administered intramuscularly or intravenously in injection or intravenous infusion.
Detailed information on the administration of the medicine and the preparation of solutions is given at the end of the leaflet, in the section "Information intended exclusively for healthcare professionals".

Use of a higher dose of Penicillinum Crystallisatum TZF than recommended

Since Penicillinum Crystallisatum TZF will be administered by a doctor or nurse, it is unlikely that an incorrect dose will be administered. However, if the patient suspects that they have been given too much medicine, they should immediately tell their doctor or go to the emergency department of the nearest hospital.

Missing a dose of Penicillinum Crystallisatum TZF

A double dose should not be used to make up for a missed dose of the medicine.

Stopping the use of Penicillinum Crystallisatum TZF

It is important to use the medicine in accordance with the recommended treatment cycle. The treatment should not be discontinued because the patient feels better. If the treatment cycle is interrupted too early, the infection may recur.
If the patient feels worse during treatment or does not feel well after completing the recommended treatment cycle, they should consult their doctor.

• In case of any further doubts related to the use of the medicine, the patient should consult their doctor.

4. Possible side effects

Like all medicines, Penicillinum Crystallisatum TZF can cause side effects, although not everybody gets them.

Severe side effects

The following severe side effects occur veryrarely(they occur less frequently than in 1 in 10,000 patients ):
sudden difficulty breathing, speaking, and swallowing;
painful swelling of the lips, tongue, face, or throat;
very severe dizziness or fainting;
severe skin reactions with itchy rash, ulcers in the mouth, eyes, genital organs, and skin, red spots on the torso, often with blisters in the center, bursting large blisters, peeling off large flakes of skin, weakness, fever, and joint pain.
The following severe side effects occur with unknown frequency(they cannot be determined based on available data ):
severe, prolonged, or bloody diarrhea: this may be a symptom of pseudomembranous colitis, a complication associated with antibiotic use;
If any of the above severe side effects occur, the patient should immediately contact their doctor or go to the hospital.
Other side effects that may occur during treatment
The following side effects occur not veryoften(they occur in 1 to 10 out of 1000 patients):
skin rashes, urticaria, itching.
The following side effects occur rarely(they occur in 1 to 10 out of 10,000 patients):
decrease in the number of red or white blood cells and platelets (increased tendency to bleeding, bruising, or infections), abnormal breakdown of red blood cells (hemolytic anemia).
The following side effects occur veryrarely(they occur less frequently than in 1 in 10,000 patients):
heart rhythm disorders;
kidney function disorders (mainly in patients receiving high doses of the medicine or in patients with pre-existing kidney function disorders).
The following side effects occur with unknown frequency(they cannot be determined based on available data):
Jarisch-Herxheimer reaction, whose symptoms are fever, feeling of general malaise, headache, may occur in patients during the treatment of syphilis;
fungal infections of the skin and mucous membranes;
excessive restlessness, excitement, anxiety, drowsiness, disorientation, dizziness (subsiding after withdrawal of the medicine);
mild, transient increase in liver enzyme activity;
increased reflexes, seizures, coma may be symptoms of potassium poisoning; mainly occurring in patients with kidney failure and (or) taking high doses of benzylpenicillin potassium;
at the injection site, redness of the skin, pain, fibrosis, tissue atrophy, thrombophlebitis - mainly after multiple administrations.

• If any side effects occur, including any possible side effects not listed in this leaflet, the patient should consult their doctor.

Reporting side effects

If any side effects occur, including any possible side effects not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Penicillinum Crystallisatum TZF

The medicine should be stored out of sight and reach of children.
Store at a temperature not exceeding 25°C. Protect from light.
Do not use the medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Penicillinum Crystallisatum TZF contains

The active substance of the medicine is benzylpenicillin potassium.
Penicillinum Crystallisatum TZF, 1,000,000 IU: one vial contains 1,000,000 IU of benzylpenicillin potassium.
Penicillinum Crystallisatum TZF, 3,000,000 IU: one vial contains 3,000,000 IU of benzylpenicillin potassium.
Penicillinum Crystallisatum TZF, 5,000,000 IU: one vial contains 5,000,000 IU of benzylpenicillin potassium.
The medicine does not contain any other ingredients.

What Penicillinum Crystallisatum TZF looks like and what the package contains

White or almost white crystalline powder.
Package:1 vial in a cardboard box.

Marketing authorization holder and manufacturer

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

Date of last revision of the leaflet:

Information intended exclusively for healthcare professionals

Hypersensitivity reactions

Patients treated with penicillin may experience severe hypersensitivity reactions, especially those allergic to many allergens. It should be ensured that the patient is allergic to penicillin, cephalosporins, or other medicines, and a history of allergic reactions should be collected, regardless of their cause. The lack of data on hypersensitivity to beta-lactam antibiotics does not prove that such hypersensitivity does not occur in the patient.
If the administration of benzylpenicillin is necessary, the patient has a history of allergic reactions (regardless of the cause), and a diagnostic preparation for hypersensitivity to this medicine is available, the test should be performed in accordance with the instructions for the preparation. It is not recommended to perform a test with the use of penicillin, as the administration of too high a dose may lead to shock, and even death of the patient.
If the patient experiences anaphylactic shock or angioedema, they should first be given epinephrine, then an antihistamine, and finally a corticosteroid. The patient's vital functions (breathing, pulse, blood pressure) should also be monitored.

Dosing in patients with impaired renal function

Creatinine clearance Maximum dose Dosing interval (ml/min)

50-30
1,500,000 IU
4 hours
30-10
1,000,000 IU
4 hours
<10
500,000 IU
8 hours
Supplemental dose after hemodialysis is 500,000 IU.

Method of administration

Penicillin solutions should be administered immediately after preparation.
Benzylopenicylin can be administered intramuscularly (no more than 2 million IU in a single injection) or intravenously (in an injection lasting 3 to 5 minutes or in intravenous infusion).
Doses above 2 million IU should be administered intravenously slowly (no faster than 500,000 IU/min).
Doses of 20 million IU and above should be administered only in intravenous infusion.
Intramuscular injections of penicillin should be performed with great caution to avoid damaging peripheral nerves or blood vessels.
During intravenous administration, caution should be exercised due to the possibility of phlebitis.

Instructions for preparing solutions Intramuscular injection

The contents of the vial of 1 million IU should be dissolved in 2 ml of water for injections.
Intravenous injection
The contents of the vial of 1 million IU should be dissolved in 5 to 10 ml of water for injections or sodium chloride solution for injection.
Intravenous infusion
The contents of the vial of 1 million IU, 3 million IU, or 5 million IU should be dissolved in at least 10 ml, 30 ml, or 50 ml of water for injections or sodium chloride solution for injection, and then diluted to the appropriate volume with sodium chloride solution for injection.

Pharmaceutical incompatibilities

Benzylopenicylin is inactivated in alkaline and acidic environments and in carbohydrate solutions; it should not be combined in the same syringe with other medicines.