Debecylina

Patient Information Leaflet

DEBECYLINA, 1 200 000 IU, powder for suspension for injection
Benzathine benzylpenicillin
Please read all of this leaflet carefully before using this medicine, as it contains important information for you.

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

Contents of the leaflet

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

1. What Debecylina is and what it is used for

Benzathine benzylpenicillin is an antibiotic – a derivative of benzylpenicillin with prolonged action.

Indications
Benzathine benzylpenicillin is indicated for the treatment of the following infections caused by susceptible microorganisms when a moderately low but prolonged antibiotic blood concentration is required.

Adults

• Upper respiratory tract infections caused by penicillin-sensitive streptococci;
• Venereal diseases – syphilis;
• Prophylaxis of recurrent acute episodes of rheumatic fever, endocarditis, and glomerulonephritis.

Children

• Only for prophylaxis of rheumatic fever and endocarditis.

Before initiating treatment with benzathine penicillin, your doctor should order a test to determine the sensitivity of the causative microorganism to the antibiotic. Treatment may be started before the test results are available. After obtaining the results (antibiogram), your doctor may change the antibiotic.
In making the decision to treat, the doctor will take into account official guidelines on the use of antibacterial agents.

2. Important information before using Debecylina

When not to use Debecylina
If the patient is allergic to penicillins or to any of the other ingredients of this medicine
(listed in section 6).
Do not inject near a nerve or blood vessel.

Warnings and precautions
Caution! In cases of acute or severe infections, when high blood concentrations are required, potassium or sodium benzylpenicillin administered intramuscularly or intravenously is recommended.

Before starting treatment, inform the doctor:

• if the patient has previously experienced an allergic reaction to any antibiotic;
• if the patient has previously experienced any other allergic reaction. Hypersensitivity reactions to penicillin may occur more frequently in individuals with a tendency toward 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.
• if the patient has kidney disease. The doctor may adjust the dosage according to the degree of renal impairment. Consult a doctor, even if the above warnings refer to conditions that occurred in the past.

If the following symptoms occur during treatment with Debecylina, seek medical advice
immediately:

• skin reactions (e.g. urticaria, itching), which may indicate an allergic reaction—see section 4;
• severe and persistent diarrhoea occurring during or after completion of penicillin treatment—this may be a sign of pseudomembranous colitis, a complication associated with antibiotic use; do not take medications that inhibit intestinal peristalsis or other constipating agents, but consult a doctor who will recommend appropriate treatment;
• new fungal infections or bacterial infections caused by overgrowth of antibiotic-resistant bacterial or fungal strains during penicillin treatment; in such cases, discontinue the antibiotic immediately and contact the doctor;
• fever, general malaise, headache—these may be symptoms of the Jarisch-Herxheimer reaction. This reaction may occur during treatment of early syphilis—see section 4.

During prolonged treatment with benzathine benzylpenicillin, especially when high doses are used, the doctor may recommend periodic monitoring of kidney function and haematopoietic system.
Debecylina must be administered with great care to avoid injecting the medicine directly into an artery, in close proximity to an artery, or near nerves.

Debecylina with other medicines
Inform the doctor about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take.
In particular, inform the doctor if the patient is taking:

• Probenecid, which increases the concentration and prolongs the half-life of the drug in blood serum;
• Penicillin administered concomitantly with bacteriostatic agents (erythromycin, tetracyclines) may reduce the bactericidal effect of penicillin.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.

If the patient is pregnant or suspects she may be pregnant
This medicine may be administered to pregnant women only if clearly necessary.

If the patient is breastfeeding
The medicine passes into breast milk in small amounts; therefore, caution should be exercised when administering the medicine to women during breastfeeding.

Driving and operating machinery
There is no data available on the effect of the medicine on the ability to drive or operate mechanical equipment. In some patients, adverse effects such as visual disturbances, drowsiness, disturbances of consciousness, or hallucinations may occur, which could impair the ability to drive or operate machinery.

3. How to use Debecylina

This medicine should always be used as directed by the physician. In case of doubt, consult your doctor.
Debecylina must be administered by intramuscular injection only.
The dose depends on the severity of infection, sensitivity of the microorganism causing the infection, patient's condition, age, and body weight.
Recommended dose
Adults
The medicine is usually given in doses of 1,200,000 IU to 2,400,000 IU as a single dose or administered every 1 to 4 weeks.
The daily dose of Debecylina should not exceed 2,400,000 IU.
Children
For prevention of rheumatic fever recurrences and streptococcal endocarditis, the usual doses are:

• 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, potassium or sodium benzylpenicillin administered intramuscularly or intravenously is recommended.
If during treatment the patient feels that the medicine's effect is too strong or too weak, medical advice should be sought.
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 this leaflet, in the section "Information intended for healthcare professionals only".
Use of a higher than recommended dose of Debecylina
Administration of an excessive dose may lead to intensified adverse reactions, including central nervous system irritation and seizures. Since Debecylina will be administered by a doctor or nurse, incorrect dosing is unlikely. However, if the patient suspects that an excessive dose has been given, they should inform the doctor immediately.
Missed dose of Debecylina
If a dose is missed at the scheduled time, the medicine should be administered as soon as possible, provided that sufficient time remains before the next scheduled dose, or continue with the regular dosing schedule.
Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions following administration of Debecylina occur with unknown frequency (frequency cannot be estimated from the available data).

Serious adverse reactions
If any of the following serious adverse reactions occur, you should immediately inform your doctor.

Allergic reactions – allergic symptoms may include hives, itching, flushing, generalized skin inflammation, chills, fever, and muscle pain. Severe allergic reactions, including anaphylactic shock (a severe allergic reaction), angioedema (swelling usually localized around the face or throat, potentially life-threatening), and serum sickness (characterized by hives with a burning sensation, fever, muscle pain, redness and swelling of joints) occur rarely and typically affect patients who are sensitized to multiple allergens or who have bronchial asthma, vasomotor rhinitis, or urticaria.

Jarisch-Herxheimer reaction – this reaction occurs due to bacterial lysis and manifests as fever, general malaise, and headache. It most commonly occurs during treatment of early syphilis. The occurrence of the above symptoms during treatment of early syphilis does not constitute a danger. In patients with late-stage disease and organ involvement, the Jarisch-Herxheimer reaction is very rare, but its occurrence at this stage may exacerbate the disease and consequently lead to severe complications.

Severe, persistent diarrhoea lasting for a prolonged period or containing blood, accompanied by abdominal pain or fever. This may be a sign of severe intestinal inflammation (known as pseudomembranous colitis), which may occur following antibiotic use.

Other adverse reactions that may occur with Debecylina treatment

• Fungal infections caused by Candida species.
• Decreased number of neutrophils (a type of white blood cell), increased number of eosinophils, decreased platelet count, haemolytic anaemia (anaemia due to red blood cell destruction), enlarged lymph nodes.
• Headache, restlessness, tremor, drowsiness, disturbances in consciousness, sleep disorders, transverse myelitis, coma, hallucinations, sensation of impending death (Hoigne syndrome), peripheral neuropathy manifesting as numbness and tingling in limbs.
• Blurred vision, blindness.
• Cardiac arrhythmias, cardiac arrest.
• Drop in blood pressure.
• Breathing difficulties up to apnoea, tissue hypoxia.
• Nausea, vomiting.
• Transient increase in liver enzyme activity (alkaline phosphatase and aminotransferases).
• Excessive sweating.
• Joint disorders, periostitis, exacerbation of arthritis, muscle breakdown manifesting as muscle weakness, cramps, swelling and pain.
• Urinary disorders, haematuria, kidney diseases, renal failure, painful penile erection, impotence, increased blood urea and creatinine levels.
• Pain, irritation at the injection site; repeated injections into the same muscle may lead to fibrosis and muscle atrophy.

Reporting of adverse reactions
If any adverse reactions occur, including any 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, 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
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide 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 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Debecylina contains
The active substance is lecithinated benzathine benzylpenicillin.
One vial contains 1,200,000 I.U. of lecithinated benzathine benzylpenicillin.
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 Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga Street 2
03-176 Warsaw
Telephone number: 22 811-18-14
For further information, please contact the representative of the Marketing Authorisation Holder.

Information intended exclusively for healthcare professionals

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

Warnings regarding hypersensitivity reactions
Severe hypersensitivity reactions may occur in patients treated with penicillin, particularly in patients 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 does not rule out the possibility of such hypersensitivity.

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

In the event of anaphylactic shock or angioedema, epinephrine should be administered first, followed by an antihistamine, and corticosteroids last. Basic vital functions (respiration, pulse, blood pressure) should also be monitored.

Pharmaceutical incompatibilities
The suspension of Debecylina should not be mixed with other medicinal products in the same syringe.
The product is incompatible when mixed with: aminoglycosides, amphotericin B, cephalothin, metronidazole, vancomycin, phenytoin, and aminophylline.

Method of administration
Debecylina should be administered only by deep intramuscular injection into the upper outer quadrant of the buttock. Benzylbenzathine penicillin injections must be performed with great care to avoid puncturing a vein, injecting into an artery, or damaging peripheral nerves or blood vessels.

Preparation of the suspension
To prepare the suspension of benzathine benzylpenicillin for intramuscular injection, add approximately 8 ml of water for injections or 0.9% sodium chloride solution to the vial containing 1,200,000 IU.

The suspension should be administered immediately after preparation.