Debecilina

Leaflet attached to the packaging: patient information

DEBECYLINA, 1,200,000 IU, powder for suspension for injection
Benzylopenicillin benzathine

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Debecylina and what is it used for

Benzylopenicillin benzathine is a long-acting penicillin antibiotic.
Indications for use
Benzylopenicillin benzathine is indicated for the treatment of the following infections caused by susceptible microorganisms, when a low but prolonged blood antibiotic concentration is required.
Adults

• upper respiratory tract infections caused by susceptible streptococci;
• venereal diseases - syphilis;
• prevention of recurrences of acute rheumatic fever, endocarditis, and glomerulonephritis. Children
• exclusively for the prevention of rheumatic disease and endocarditis.

Before starting treatment with benzathine penicillin, the doctor should order a sensitivity test of the microorganism causing the infection. Treatment may be initiated before the test results are available. Once the results are available (antibiogram), the doctor may change the antibiotic.
When deciding on treatment, the doctor will take into account the official guidelines for the use of antibacterial agents.

2. Important information before using Debecylina

When not to use Debecylina

If you are allergic to penicillins or any of the other ingredients of this medicine (listed in section 6).
Do not inject into the area of a nerve or blood vessel.

Warnings and precautions

Warning!In cases of acute or severe infections, when high blood concentrations are required, it is recommended to administer benzylpenicillin potassium or sodium intramuscularly or intravenously.
Before starting treatment, tell your doctor:

• if you have ever had an allergic reaction to any antibiotic;
• if you have ever had any other allergic reaction. Allergic 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.
• if you have kidney disease. Your doctor may adjust the dose of the medicine according to the degree of kidney failure. You should consult your doctor, even if the above warnings refer to past situations.

If you experience any of the following symptoms while using Debecylina, seek medical attention immediately:

• if skin changes (e.g., hives, itching) occur, which may be symptoms of an allergic reaction - see section 4.
• severe and persistent diarrhea, occurring during or after treatment with penicillin - may be a sign of pseudomembranous colitis, a complication associated with antibiotic use; do not take medications that slow down intestinal motility or other constipating medications, just consult your doctor, who will prescribe appropriate treatment.
• new fungal or bacterial infections caused by the overgrowth of non-susceptible strains of bacteria or fungi during penicillin treatment; in this case, discontinue the antibiotic and contact your doctor immediately.
• if you experience fever, general malaise, headache. These may be symptoms of a Jarisch-Herxheimer reaction. This reaction may occur during the treatment of early syphilis - see section 4.

During long-term treatment with benzathine penicillin, especially if high doses are used, your doctor will recommend periodic monitoring of kidney function and the hematopoietic system.
Debecylina should be administered with great caution to avoid injecting the medicine directly into an artery or its immediate vicinity or into the area of nerves.

Debecylina and other medicines

Tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
In particular, inform your doctor if you are taking:

• Probenecid increases the concentration and prolongs the half-life of the medicine in the blood serum.
• Administering penicillin with bacteriostatic agents (erythromycin, tetracyclines) may reduce the bactericidal effect of penicillin.

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.
If you are pregnant or think you may be pregnant
The medicine may be administered to pregnant women only if absolutely necessary.
If you are breastfeeding
The medicine passes into breast milk in small amounts, so caution should be exercised when administering the medicine 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. Some patients may experience side effects that impair the ability to drive, such as vision disturbances, drowsiness, consciousness disorders, hallucinations.

3. How to use Debecylina

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor.

Debecylina should only be administered intramuscularly.

The dose depends on the severity of the infection, the susceptibility of the microorganism, the patient's condition, age, and weight.
Recommended dose
Adults
The medicine is usually administered in doses of 1,200,000 IU to 2,400,000 IU, either as a single dose or in doses administered every 1 to 4 weeks.
Do not exceed the daily dose of 2,400,000 IU of Debecylina.
Children
In the prevention of recurrences of rheumatic fever and endocarditis caused by streptococci, the following doses are usually administered:

• age 2 to 3 years
• 600,000 IU, every 8 to 14 days;
• age 4 to 18 years
• 1,200,000 IU, every 14 to 21 days.

Warning!In cases of acute or severe infections, when high blood concentrations are required, it is recommended to administer benzylpenicillin potassium or sodium intramuscularly or intravenously.
If you experience any side effects, such as excessive or insufficient effect of the medicine, consult your doctor.
Duration of treatment
The duration of treatment depends on the type and severity of the infection.
Method of administration
The method of administration and preparation of the suspension is described at the end of the leaflet, in the section "Information intended for healthcare professionals only".

Using a higher dose of Debecylina than recommended

Administering too high a dose of the medicine may cause severe side effects, including central nervous system irritation and seizures. Since Debecylina will be administered by a doctor or nurse, it is unlikely that an incorrect dose will be administered. However, if you think you have been given too high a dose, inform your doctor immediately.

Missing a dose of Debecylina

If you miss a dose of the medicine at the scheduled time, administer it as soon as possible, unless the time to the next dose is too short, or continue with the regular administration of the medicine.

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

4. Possible side effects

Like all medicines, Debecylina can cause side effects, although not everybody gets them.
Side effects after administration of Debecylina occur with an unknown frequency (the frequency cannot be determined from the available data).

Severe side effects

If you experience any of the following severe side effects, inform your doctor immediately.
Allergic reactions -allergic symptoms may occur in the form of hives, itching, rash, generalized skin inflammation, chills, fever, muscle pain. Severe allergic reactions, including anaphylactic shock (severe allergic reaction), angioedema (localized swelling, usually in the face or throat, which can be life-threatening), and serum sickness (characterized by hives with a burning sensation, fever, muscle pain, redness, and swelling of the joints) occur rarely and usually affect patients allergic to many allergens or with a history of asthma, rhinitis, or urticaria.
Jarisch-Herxheimer reaction - this reaction occurs due to the breakdown of bacteria and is characterized by fever, general malaise, and headache. It most often occurs during the treatment of early syphilis.
The appearance of the above symptoms during the treatment of early syphilis is not a threat. In patients with late-stage disease and organ damage, the Jarisch-Herxheimer reaction occurs very rarely, but its occurrence at this stage may lead to worsening of the disease and, consequently, to severe complications.
Severe diarrhea, persistent for a longer period or containing blood, accompanied by abdominal pain or fever. This may be a sign of severe colitis (pseudomembranous colitis), which may occur after antibiotic use.

Other side effects that may occur after treatment with Debecylina

• Fungal infections of the genus Candida.
• Decreased number of neutrophils, increased number of eosinophils, decreased platelet count, hemolytic anemia, lymphadenopathy.
• Headache, excitement, tremors, drowsiness, consciousness disorders, sleep disturbances, transverse myelitis, coma, hallucinations, fear of death (Hoignè syndrome), peripheral neuropathy characterized by numbness, tingling of the limbs.
• Blurred vision, blindness.
• Arrhythmias, cardiac arrest.
• Decreased blood pressure.
• Respiratory disorders up to apnea, tissue hypoxia.
• Nausea, vomiting.
• Transient increase in liver enzyme activity (alkaline phosphatase and aminotransferases).
• Excessive sweating.
• Joint disorders, periostitis, exacerbation of arthritis, muscle breakdown characterized by muscle weakness, cramps, swelling, and pain.
• Urinary disorders, hematuria, kidney disease, renal failure, painful erection, impotence, increased urea and creatinine levels in the blood.
• Pain, irritation at the injection site; after repeated injections into the same muscle, fibrosis and muscle atrophy may occur.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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
e-mail: ndl@urpl.gov.pl
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 Debecylina

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Protect from light.
Do not use this 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Debecylina contains

The active substance of the medicine is benzathine penicillin G.
One vial contains 1,200,000 IU of benzathine penicillin G.
The medicine does not contain any other ingredients.

What Debecylina looks like and contents of the pack

White or almost white powder.
Packaging:1 vial 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

Date of last revision of the leaflet:

Information intended for healthcare professionals only

Please refer to the detailed information about this medicine, which is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products (www.urpl.gov.pl).

Warnings regarding allergic reactions

Patients treated with penicillin may experience severe hypersensitivity reactions, especially those allergic to many allergens. 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 the administration of benzathine penicillin is necessary, and the patient has 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 test. It is not recommended to perform a test with penicillin, as the administration of too high a dose may lead to shock or even death.

Pharmaceutical incompatibilities

Do not mix the suspension of Debecylina with other medicines in the same syringe.
The medicine is incompatible with: aminoglycosides, amphotericin B, cefalotin, metronidazole, vancomycin, phenytoin, and aminophylline.

Method of administration

Debecylina should only be administered deep intramuscularly, in the upper outer quadrant of the buttock.
Injections of benzathine penicillin should be performed with great caution to avoid injecting the medicine into a vein or artery and to avoid damaging peripheral nerves or blood vessels.

Preparation of the suspension

The suspension of benzathine penicillin for intramuscular injection should be prepared by adding approximately 8 ml of water for injection or 0.9% sodium chloride solution to the vial containing 1,200,000 IU.
The suspension should be administered immediately after preparation.