Penicillin crystallised tzf

Package leaflet: Information for the patient

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
Potassium benzylpenicillin
Please read carefully the entire leaflet before using the medicine, 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, please consult your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or nurse immediately. See section 4.

Table of contents

1. What Penicillinum Crystallisatum TZF is and what it is 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
6. Contents of the pack and other information

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

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

• Tonsillitis, pneumonia, bronchitis, pericarditis, chronic endocarditis, caused by streptococci including group A, pneumococci, staphylococci;
• Septicaemia (sepsis – systemic inflammatory response syndrome);
• Meningococcal meningitis;
• Skin and soft tissue infections;
• Diphtheria (in combination with antitoxin);
• Lung abscess;
• Acute episode of rheumatic fever caused by streptococcal infection, arthritis;
• Osteomyelitis;
• Neurosyphilis, ocular syphilis;
• Gonorrhoea;
• Infections of the throat, lower respiratory tract and genital organs caused by Fusobacterium spp.;
• Anthrax, Lyme disease (borreliosis), infections caused by Clostridium spp. (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 a known allergy (hypersensitivity) to penicillin or other beta-lactam antibiotics.

Warnings and precautions
If any of the following situations apply to the patient, the doctor should be informed before taking the medicine:

• Previous allergic reaction to any antibiotic;
• Previous occurrence of any other allergic reaction. Hypersensitivity reactions to penicillin may be more common in individuals with a history of allergic reactions to various substances. These reactions may vary in symptoms and severity – from skin rashes to anaphylactic shock (a severe allergic reaction) – see section 4 "Possible side effects";
• Renal and/or cardiac disease has been diagnosed.

If the patient experiences any of the following symptoms during or after treatment with the medicine,
medical advice should be sought immediately:

• Severe and persistent diarrhoea occurring during or after penicillin treatment – this may be a sign of pseudomembranous colitis, a complication associated with antibiotic use. Do not take drugs that inhibit intestinal peristalsis or other constipating agents; instead, consult a doctor who will recommend appropriate treatment;
• New bacterial or fungal infections caused by overgrowth of antibiotic-resistant bacterial strains or fungi as a result of penicillin therapy, particularly in chronically ill patients or those with renal impairment. In such cases, the antibiotic should be discontinued immediately and the doctor contacted.

In patients receiving high doses of penicillin, the doctor usually recommends monitoring of
kidney and liver function as well as blood tests.
Penicillinum Crystallisatum TZF and other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient intends to take.
In particular, inform the doctor if the patient is taking:

• probenecid (a medicine used in gout);
• other antibiotics with bacteriostatic action (e.g. chloramphenicol, erythromycin, sulfonamides);
• oral contraceptives – during penicillin treatment, use of an additional non-hormonal method of contraception is recommended.

Effect on laboratory test results
Penicillinum Crystallisatum TZF may affect the results of certain blood tests (Coombs test), especially in patients receiving high doses.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
Penicillinum Crystallisatum TZF may be used during pregnancy if the doctor considers it absolutely necessary.
Benzylpenicillin passes into breast milk in small amounts and may cause sensitisation
in the nursing infant. Breastfeeding women should exercise caution when using
Penicillinum Crystallisatum TZF.
Driving and operating machinery
There are no data on the effect of the medicine on the ability to drive or operate mechanical devices.
Penicillinum Crystallisatum TZF contains potassium
1,000,000 IU of potassium benzylpenicillin contains 63 mg of potassium, which should be taken into account
in patients with impaired renal function and in those controlling dietary potassium intake.
If the patient has electrolyte imbalances or renal failure, they should inform the doctor before taking the medicine.
3. How to use Penicillinum Crystallisatum TZF
Penicillinum Crystallisatum TZF should always be used as directed by the doctor. If in doubt, consult the doctor.
Penicillinum Crystallisatum TZF is administered by a doctor or nurse. The dose depends on
the severity of infection, the type of microorganism causing the infection, and the patient's age and body weight.
1 million IU corresponds to 600 mg of potassium benzylpenicillin.
Adults
Typical recommended doses:
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 staphylococcal infections (penicillin-sensitive) 5 to 24 million IU per day in divided doses every 4–6 hours.
Due to its short half-life, Penicillinum Crystallisatum is usually administered in divided doses every 4–6 hours, except in meningitis/septicaemia, when the antibiotic should be given every 2 hours.
Tonsillitis, pneumonia, bronchitis, 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 as a continuous infusion for 4–6 weeks.
Meningococcal meningitis and/or septicaemia
24 million IU, 2 million IU every 2 hours.
Skin and soft tissue infections
2–4 million IU every 4–6 hours; use in combination with clindamycin; continue treatment until clinical improvement, with the patient afebrile 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 due to streptococcal infection, arthritis
Streptococcus Group A (S. pyogenes) , Streptococcus Group B (S. agalactiae) : 2 million IU every
4 hours.
Osteomyelitis
Enterococcus spp (penicillin-sensitive) or streptococci (beta-haemolytic): 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-sensitive Enterococcus spp., addition of an aminoglycoside is recommended for 4 to 6 weeks.
Neurosyphilis, ocular syphilis
18–24 million IU/day i.v., administered as 3–4 million IU every 4 hours, or as a 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 organism sensitivity).
Lyme disease
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/day in divided doses every 4–6 hours.
Listeriosis
adults – 15–20 million IU in divided doses every 4–6 hours daily 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.
Prophylaxis of perinatal Group B streptococcal infections (Streptococcus agalactiae)
initial 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 with body weight < 1 kg, the 12-hour dosing interval 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 24 million IU per day.
If during treatment the patient feels the effect of the medicine is too strong or too weak,
they should consult the doctor.
Dosage in patients with renal impairment
Dosage adjustments for this patient group are provided at the end of the leaflet, in the section "Information intended exclusively for healthcare professionals".
Duration of treatment
The duration of treatment depends on the severity and type of infection.
The doctor will determine the appropriate duration of treatment, which should be strictly followed.
Method of administration
Benzylpenicillin may be administered intramuscularly or intravenously by injection or intravenous infusion.
Detailed information on administration and preparation of solutions is provided at the end
of the leaflet, in the section "Information intended exclusively for healthcare professionals".
Use of a higher than recommended dose of Penicillinum Crystallisatum TZF
Since Penicillinum Crystallisatum TZF will be administered by a doctor or nurse, the likelihood of an incorrect dose being given is low. However, if the patient suspects that an excessive dose has been administered, they should immediately inform the doctor or go to the nearest hospital emergency department.
Missed dose of Penicillinum Crystallisatum TZF
Do not use a double dose to make up for a missed dose.
Stopping treatment with Penicillinum Crystallisatum TZF
It is important that the medicine is used according to the recommended treatment schedule. Do not stop treatment just because the patient feels better. Premature discontinuation of treatment may lead to recurrence of infection.
If the patient feels worse during treatment or does not feel well after completing the recommended course of treatment, they should consult the doctor.

• If there are any further doubts regarding the use of the medicine, consult the doctor.

4. Possible adverse reactions

Like all medicines, Penicillinum Crystallisatum TZF can cause adverse reactions, although they
do not occur in everyone.
Serious adverse reactions
The following serious adverse reactions occur very rarely (occur in fewer than 1 in
10,000 patients):
sudden difficulty in breathing, speaking, or swallowing;
painful swelling of lips, tongue, face, or neck;
severe dizziness or collapse;
severe skin reactions with itchy rash, erosions in the mouth, eyes, genital organs, and on the
skin, red spots on the trunk, often with blisters in the center, bursting of large blisters, peeling of
large skin sheets, weakness, fever, and joint pain.
The following serious adverse reactions occur with unknown frequency (cannot be estimated
from the available data):
severe, prolonged, or bloody diarrhoea: this may be a symptom of pseudomembranous colitis.
If any of the above-mentioned serious adverse reactions occur, contact a doctor immediately or
go directly to hospital.
Other adverse reactions that may occur during treatment
The following adverse reactions occur not very frequently (occur in 1 to 10 out of 1,000
patients):
skin rashes, urticaria, itching.
The following adverse reactions occur rarely (occur in 1 to 10 out of 10,000 patients):
reduction in the number of red blood cells or white blood cells and platelets (increased tendency
to bleeding, bruising, or infections), abnormal breakdown of red blood cells (haemolytic anaemia).
The following adverse reactions occur very rarely (occur in fewer than 1 in 10,000
patients):
heart rhythm disturbances;
kidney function disturbances (mainly in patients receiving high doses of the drug or in patients
with pre-existing kidney function disorders).
The following adverse reactions occur with unknown frequency (cannot be estimated from
the available data):
Jarisch-Herxheimer reaction, whose symptoms include fever, general malaise, headache, may
occur in patients during treatment of syphilis;
fungal infections of the skin and mucous membranes;
excessive motor activity, restlessness, agitation, drowsiness, disorientation, dizziness (resolve
after discontinuation of the drug);
slight, transient increase in liver enzyme activity;
increased reflexes, seizures, coma may be symptoms of potassium toxicity; mainly occurring in
patients with renal failure and (or) receiving high doses of potassium benzylpenicillin;
at the injection site: redness, pain, fibrosis, tissue atrophy, thrombophlebitis – mainly after
repeated administration.

• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor.

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

5. How to store Penicillinum Crystallisatum TZF

Keep the medicine out of the 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

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

What Penicillinum Crystallisatum TZF looks like and contents of the pack
White or almost white crystalline powder.
Packaging: 1 vial in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga 2
03-176 Warsaw
Telephone number: 22 811-18-14
For further information, please contact the marketing authorisation holder's representative.

Information intended exclusively for healthcare professionals

Hypersensitivity reactions
Severe hypersensitivity reactions may occur in patients treated with penicillin, particularly in
patients who are allergic to multiple allergens. It is essential to determine whether the patient is allergic to penicillin,
cephalosporins, or other drugs, and to obtain a history of any previous allergic reactions, regardless of their cause.
The absence of reported hypersensitivity to β-lactam antibiotics in the patient's history is not proof that such
hypersensitivity does not exist.

If administration of benzylpenicillin is necessary, and the patient reports a history of previous allergic reactions (regardless of the triggering agent), and a diagnostic test kit for hypersensitivity to this drug is available, a test should be performed according to the instructions for use of the test product. Performing a skin test using penicillin is not recommended, because administration of too high a dose may lead to shock or even death.

If an anaphylactic shock or angioedema occurs, epinephrine should be administered first, followed by an antihistamine, and corticosteroids as the last step. Basic vital functions (respiration, 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: 500,000 IU.

Administration method
Penicillin solutions should be administered immediately after preparation.

Benzylpenicillin may be administered intramuscularly (no more than 2 million IU per single injection) or intravenously (by injection over 3 to 5 minutes or by intravenous infusion).

Doses exceeding 2 million IU should be administered slowly intravenously (no faster than 500,000 IU/min).
Doses of 20 million IU and higher should be administered only by intravenous infusion.

Intramuscular injections of penicillin must be performed with great care to avoid damaging peripheral nerves or blood vessels.

Caution should be exercised during intravenous administration due to the risk of thrombophlebitis.

Instructions for preparation of solutions
Intramuscular injection
Dissolve the contents of a 1 million IU vial in 2 ml of water for injections.

Intravenous injection
Dissolve the contents of a 1 million IU vial in 5 to 10 ml of water for injections or sodium chloride solution for injections.

Intravenous infusion
Dissolve the contents of a 1 million IU, 3 million IU, or 5 million IU vial in at least 10 ml, 30 ml, or 50 ml, respectively, of water for injections or sodium chloride solution for injections, then dilute to the appropriate volume with sodium chloride solution for injections.

Pharmaceutical incompatibilities
Benzylpenicillin is inactivated in alkaline and acidic environments and in carbohydrate solutions; it should not be mixed in the same syringe with other drugs.