Penicillinum procainicum L Tzf

Leaflet attached to the packaging: patient information

Penicillinum Procainicum L TZF, 1,200,000 IU, powder for suspension for injection
Penicillinum Procainicum L TZF, 2,400,000 IU, powder for suspension for injection
Benzylpenicillin procaine

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.
In case of any doubts, consult a doctor.
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 not listed in this leaflet, they should inform their doctor. See section 4.

Table of contents of the leaflet:

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

1. What is Penicillinum Procainicum L TZF and what is it used for

Penicillinum Procainicum L TZF contains the active substance benzylpenicillin procaine, which is a natural penicillin. Benzylpenicillin has a bactericidal effect on many Gram-negative and Gram-positive bacterial species.
Penicillinum Procainicum L TZF is used to treat infections that are or may be caused by bacteria susceptible to benzylpenicillin. This medicine is used to treat the following infections:

• infections caused by streptococci, pneumococci, without bacteremia, such as upper respiratory tract infections, lower respiratory tract infections (e.g., pneumonia - only caused by Streptococcus pneumoniae strains sensitive and moderately sensitive to penicillin), endocarditis (inflammation of the membrane lining the heart and valves, as well as large blood vessels in the chest), pericarditis (inflammation of the pericardium), scarlet fever, streptococcal skin and subcutaneous tissue infections (erysipelas);
• acquired or congenital syphilis (caused by Treponema pallidum);
• endemic treponematoses caused by Treponema pallidum endemicum (endemic syphilis, bejel), Treponema pallidum pertenue (yaws, frambesia), Treponema pallidum carateum (pinta);
• gonorrhea without bacteremia (caused by Neisseria gonorrhoeae - β-lactamase-negative strains);
• mixed throat, lower respiratory tract, genital infections caused by spirochetes and treponemes;
• erysipeloid (caused by Erysipelothrix rhusiopathiae; a contagious and infectious disease of pigs and poultry, dangerous to humans);
• anthrax (caused by Bacillus anthracis);
• rat-bite fever (caused by Streptobacillus moniliformis, Streptobacillus minor);
• and for the prevention of diphtheria (caused by Corynebacterium diphtheriae) in combination with antitoxin.

2. Important information before using Penicillinum Procainicum L TZF

Before starting treatment with penicillin, it is recommended to perform a drug sensitivity test on the isolated microorganism causing the infection, if indicated. Treatment may be initiated before the sensitivity test results are available, but after the results are obtained, it may be necessary to change the medication accordingly.

When not to use Penicillinum Procainicum L TZF

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

Warnings and precautions

Before starting Penicillinum Procainicum L TZF, discuss it with your doctor.

• If the patient has experienced an allergic reaction in the past, regardless of the cause, including any antibiotic belonging to the penicillin, cephalosporin, or other drug groups; Patients treated with penicillin may experience severe hypersensitivity reactions, especially those allergic to multiple allergens or suffering from asthma. If benzylpenicillin administration is necessary and the patient reports a history of allergic reactions (regardless of the cause), the doctor should perform an allergy test for this medicine.
• If the patient has kidney disease, the doctor may recommend regular check-ups to monitor kidney function and adjust the dose of the medicine accordingly. In patients with severe renal impairment, the doctor will consider reducing the dose, as the benzylpenicillin concentrations achieved in the central nervous system of these patients may cause brain irritation, seizures, or coma.
• In the case of elderly patients, the doctor will take into account the proper functioning of the kidneys, liver, and heart. The doctor may order kidney function tests.

During treatment, it is essential to inform the doctor about:

• In case of the first symptoms that may indicate an allergic reaction (e.g., hives, itching, rash, swelling of the face, lips, tongue, or throat) including anaphylactic shock (confusion, paleness, blood pressure drop, sweating, decreased urine production, rapid breathing, weakness, and fainting), the medicine should be discontinued, and the doctor should be consulted.
• In patients treated with penicillin for syphilis, the most common reaction during treatment of early syphilis is headache, fever, and general malaise. These may be symptoms of a Jarisch-Herxheimer reaction, which requires consultation with a doctor. The occurrence of these symptoms during early syphilis treatment does not pose a threat. In patients with late-stage disease and organ damage, the Jarisch-Herxheimer reaction is very rare, but its occurrence at this stage may lead to worsening of the disease and potentially severe complications.
• Administering antibiotics may cause an overgrowth of non-susceptible bacteria. If symptoms of fungal or new bacterial infections occur during penicillin treatment, the medicine should be discontinued, and the doctor should be consulted.
• Patients who experience diarrhea during antibiotic treatment or shortly after its discontinuation should not self-medicate but consult a doctor. They should not use medications that slow down bowel movements or have a constipating effect. Penicillins are broad-spectrum antibiotics and may disrupt the normal bacterial flora in the intestines.

This can lead to the multiplication of Clostridium difficile bacteria, whose toxins cause clinical symptoms of pseudomembranous colitis. In case of severe, persistent diarrhea and suspected pseudomembranous colitis, the doctor will immediately discontinue penicillin administration and initiate appropriate treatment.

• In some patients, especially when a large single dose (4,800,000 IU) is administered, a sudden procaine reaction may occur, known as the Hoigné syndrome. The syndrome is characterized by mental disturbances, such as anxiety, disorientation, agitation, motor excitement, depression, restlessness, fear of death, behavioral disturbances, and weakness, seizures, visual and auditory hallucinations. These symptoms usually resolve within 15 to 30 minutes. The occurrence of the Hoigné syndrome in the past is not a contraindication to repeated use of penicillin.
• Accidental intravascular injection of penicillin in the form of a powder for suspension for injection and other products containing penicillin, directly into an artery or injection into a site directly adjacent to an artery, may cause severe neurovascular damage, including transverse myelitis with permanent paralysis, gangrene requiring amputation of the affected area, necrosis, and sloughing around the injection site. These severe adverse reactions have been reported with injections performed in the buttocks, thighs, and shoulder area. Other serious complications possibly related to intravenous administration include sudden pallor, petechiae, cyanosis of the limbs, followed by blistering; severe edema requiring surgical intervention. These severe adverse reactions and complications occur in infants and young children. If there is a disruption of blood circulation, proximal or distal to the injection site, it is essential to consult a specialist immediately.

In cases where there is a suspicion of concurrent syphilis, serological tests should be performed once a month for at least four months.
If the patient is taking penicillin, they should inform their doctor if a blood test is ordered, as it may cause a false-positive Coombs test result used in transfusions, anemia detection, and bacterial infection tests.
In elderly patients, who are more prone to kidney function disorders, the risk of adverse reactions is increased, and the doctor will assess the need for kidney function tests.
For patients receiving large doses of penicillin over an extended period, the doctor usually recommends testing kidney, liver, and blood functions.

Penicillinum Procainicum L TZF and other medicines

Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Particularly, inform your doctor if you are taking any of the following medicines:

• probenecid (a medicine used for gout);
• other bacteriostatic antibiotics (e.g., tetracycline, chloramphenicol, erythromycin, sulfonamides);
• oral contraceptives - during penicillin treatment, it is recommended to use an additional, non-hormonal method of contraception. To avoid unplanned pregnancy, use an additional non-hormonal contraceptive method.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.

Pregnancy Consult your doctor before using the medicine.

The medicine may be administered to pregnant women only if absolutely necessary.

Breastfeeding Consult your doctor before using the medicine.

The medicine passes into breast milk in small amounts, so caution is advised when administering benzylpenicillin to breastfeeding women.

Driving and using machines

There is no data on the effect of the medicine on the ability to drive and use machines.
However, some patients may experience side effects that impair their ability to drive.

3. How to use Penicillinum Procainicum L TZF

Penicillinum Procainicum L TZF should always be used as directed by your doctor. If you have any doubts, consult your doctor.
Penicillinum Procainicum L 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.

Adults and children over 4 years old

In most infections, depending on their severity, procaine penicillin is administered at a dose of 600,000 IU to 1,200,000 IU per day, divided into two doses.
In streptococcal infections, treatment should be continued for at least 10 days.
Gonorrhea - 4,800,000 IU per day. The penicillin dose should be divided into two parts and administered at two separate sites. Additionally, 1 g of probenecid should be administered orally.
Syphilis - 600,000 IU per day. In tertiary syphilis of the nervous system - 2,400,000 IU per day, and 2.5 g of probenecid orally.
Warning!In cases of severe infections, when high blood levels of the medicine are necessary, it is recommended to administer benzylpenicillin potassium or sodium intramuscularly or intravenously.

Children under 4 years old

Procaine penicillin is not recommended for children under 4 years old.

Patients with renal impairment

In patients with severe renal impairment, it is necessary to reduce the dose based on the creatinine clearance.

Method of administration

Procaine penicillin should only be administered intramuscularly.
Intramuscular injections of procaine penicillin should be performed with great caution to avoid injecting the needle into a vein or administering the medicine intravenously, as well as to avoid damaging peripheral nerves or blood vessels. The penicillin suspension should be administered immediately after preparation.
It is essential to inject with great caution to avoid administering the medicine directly into an artery or in the immediate vicinity of an artery or nerve.
Accidental intravascular injection of penicillin in the form of a powder for suspension for injection and other products containing penicillin, directly into an artery or injection into a site directly adjacent to an artery, may cause severe neurovascular damage, including transverse myelitis with permanent paralysis, gangrene requiring amputation of the affected area, necrosis, and sloughing around the injection site. These severe adverse reactions have been reported with injections performed in the buttocks, thighs, and shoulder area. Other serious complications possibly related to intravenous administration include sudden pallor, petechiae, cyanosis of the limbs, followed by blistering; severe edema requiring surgical intervention. These severe adverse reactions and complications occur in infants and young children. If there is a disruption of blood circulation, proximal or distal to the injection site, it is essential to consult a specialist immediately.
Preparation of the suspension and pharmaceutical incompatibilities - see "Information intended exclusively for healthcare professionals" at the end of the leaflet.
If the patient feels that the effect of the medicine is too strong or too weak during treatment, they should consult their doctor.

Using a higher dose of Penicillinum Procainicum L TZF than recommended

Since Penicillinum Procainicum L TZF will be administered by a doctor or nurse, it is unlikely that an incorrect dose will be administered.
If the patient has received a higher dose of the medicine, they should immediately contact their doctor or go to the nearest emergency department in a hospital. They should bring the medicine in its original packaging so that the medical staff can accurately check which medicine was used.

Missing a dose of Penicillinum Procainicum L TZF

Do not take a double dose to make up for a missed dose of the medicine.

Stopping Penicillinum Procainicum L TZF treatment

It is essential to use the medicine as directed for the recommended treatment cycle. Do not stop treatment just because you feel better. If the treatment cycle is stopped too early, the infection may recur.

4. Possible side effects

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

Severe side effects

Side effects that occur rarely(in 1 to 10 out of 10,000 patients):
severe allergic reactions, including anaphylactic shock;
sudden difficulty breathing, speaking, or swallowing;
swelling of the lips, tongue, face, or throat;
severe dizziness or fainting, significant drop in blood pressure;
fever, chills, general malaise, headache (Jarisch-Herxheimer reaction; see also "Warnings and precautions" in section 2)
Side effects with an unknown frequency (frequency cannot be determined based on available data):

• severe skin reactions (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis): rash with blisters all over the body, ulcers in the mouth, eyes, genitals, and skin, red spots on the torso, often with blisters in the center, large blisters that rupture, sloughing of large skin areas, weakness, fever, and joint pain; seizures as severe toxic symptoms - observed in patients receiving large doses of penicillin and (or) with severe renal impairment; severe, prolonged, or bloody diarrhea, abdominal pain, fever: may be a symptom of severe colitis - pseudomembranous colitis;
• If any of the above severe side effects occur, the medicine should be discontinued, and the doctor should be informed immediately.

Other side effects that may occur during treatment

Side effects that occur rarely (in 1 to 10 out of 10,000 patients):

• decreased levels of certain types of white blood cells, thrombocytopenia, anemia (shortened lifespan of red blood cells) - occur especially in patients who have received large doses of the medicine for an extended period;
• muscle pain, joint pain;
• fever, chills.

Side effects that occur very rarely (in less than 1 out of 10,000 patients):

• Candidafungal infections.

Side effects with an unknown frequency (frequency cannot be determined based on available data):

• transient increase in blood urea and creatinine levels;
• transient increase in liver enzyme activity (alkaline phosphatase and aminotransferases);
• rash, urticaria, petechiae (dark red rash);
• pain at the injection site, after multiple injections in the same muscle, fibrosis and muscle atrophy may occur,
• anxiety, disorientation, agitation, motor excitement, depression, restlessness, fear of death, behavioral disturbances, and weakness, seizures, visual and auditory hallucinations (Hoigné syndrome, see also "Warnings and precautions" in section 2).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform 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
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Penicillinum Procainicum L

Store the medicine out of sight and reach of children.

Do not use the medicine after the expiration date stated on the packaging.

Store at a temperature below 25°C. Protect from light.
Do not use the medicine after the expiration date stated on the packaging. The expiration date is 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 Penicillinum Procainicum L TZF contains

The active substance of the medicine is benzylpenicillin procaine.
Penicillinum Procainicum L TZF, 1,200,000 IU.
One vial contains 1,200,000 IU of benzylpenicillin procaine.
Penicillinum Procainicum L TZF, 2,400,000 IU.
One vial contains 2,400,000 IU of benzylpenicillin procaine.
The medicine does not contain any other ingredients.

What Penicillinum Procainicum L TZF looks like and what the packaging contains

Penicillinum Procainicum L TZF, 1,200,000 IU.
White or almost white crystalline powder.
Penicillinum Procainicum L TZF, 2,400,000 IU.
White or almost white crystalline powder.
Packaging:1 vial of 20 ml in a cardboard box.

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, contact the marketing authorization holder's representative.

Date of the last update of the leaflet:

Information intended exclusively for healthcare professionals

Refer to the detailed information about this product (Summary of Product Characteristics), which is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.

Procedure in patients with hypersensitivity

Patient treated with penicillin may experience severe hypersensitivity reactions, especially those allergic to multiple allergens or suffering from asthma. Ensure that the patient is not allergic to penicillin, cephalosporins, or other medicines, and gather information about any past allergic reactions, regardless of their cause. The lack of data on hypersensitivity to beta-lactam antibiotics does not mean that such hypersensitivity does not occur in the patient.
If benzylpenicillin administration is necessary and the patient reports a history of allergic reactions (regardless of the cause), and a diagnostic test for hypersensitivity to this medicine is available, perform the test according to the instructions for use of the diagnostic test. It is not recommended to perform a test with penicillin, as administering too high a dose may lead to shock or even death.
In case of anaphylactic shock or angioedema, first administer epinephrine, then an antihistamine, and finally a corticosteroid.
Monitor basic life functions (breathing, pulse, blood pressure).

Treatment of severe infections

In cases of severe infections, when high blood levels of the medicine are necessary, it is recommended to administer benzylpenicillin potassium or sodium intramuscularly or intravenously.
Infections caused by Streptococcusbacteria
In case of suspected infection caused by Streptococcusbacteria, it is recommended to perform relevant diagnostic tests, including a drug sensitivity test on the isolated microorganism causing the infection.

Pharmaceutical incompatibilities

Benzylpenicillin is inactivated in alkaline and acidic environments; it should not be mixed in the same syringe with other medicines.

Preparation of the suspension

Add approximately 5 ml or 8 ml of 0.9% sodium chloride solution or water for injection to a vial containing 1,200,000 IU or 2,400,000 IU, respectively.
The procaine penicillin suspension should be administered immediately after preparation.