Benzylpenicillin potassium K24 Pharmaceuticals

Package leaflet: Information for the patient

BENZILPENICILLIN POTASSICUM K24 PHARMACEUTICALS

1,000,000 IU/4 ml powder and solvent for injectable solution
BENZILPENICILLIN POTASSICUM K24 PHARMACEUTICALS
1,000,000 IU powder for injectable solution
benzylpenicillin potassium
Generic medicine
Please read all of this leaflet carefully before you use this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What BENZILPENICILLIN POTASSICUM K24 PHARMACEUTICALS is and what it is used for
2. What you need to know before using BENZILPENICILLIN POTASSICUM K24 PHARMACEUTICALS
3. How to use BENZILPENICILLIN POTASSICUM K24 PHARMACEUTICALS
4. Possible side effects
5. How to store BENZILPENICILLIN POTASSICUM K24 PHARMACEUTICALS
6. Contents of the pack and other information

1. What BENZILPENICILLIN POTASSICUM K24 PHARMACEUTICALS is and what it is used for

BENZILPENICILLIN POTASSICUM K24 PHARMACEUTICALS contains the active substance
benzylpenicillin potassium, an antibiotic used to treat serious infections caused by
bacteria sensitive to penicillin G.
Contact your doctor if you do not feel better or if you feel worse.

2. What you should know before using BENZILPENICILLINA POTASSICA K24 PHARMACEUTICALS

PHARMACEUTICALS
Do not use BENZILPENICILLINA POTASSICA K24 PHARMACEUTICALS

• if you are allergic to potassium benzylpenicillin or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to penicillins, cephalosporins, or other beta-lactam antibiotics (the same class of antibiotics to which BENZILPENICILLINA POTASSICA K24 PHARMACEUTICALS belongs).

Warnings and precautions
Talk to your doctor or pharmacist before using BENZILPENICILLINA POTASSICA K24 PHARMACEUTICALS. As with all antibiotics, its use must be carefully evaluated based on your specific illness and your general health condition, especially if:

• you have previously experienced allergic reactions to medicines, or if any allergic symptoms occur during treatment; in such cases, administration of the antibiotic must be stopped immediately.
• you have kidney problems or other conditions affecting kidney function.
• you suffer from heart or cardiovascular system disorders.
• you have other diseases, such as asthma or diabetes.
• you are on a low-potassium diet.
• you are using this medicine to treat gonorrhoea; in this case, follow-up tests, including blood tests, are required to rule out the simultaneous presence of another disease, syphilis, which would require different treatment.
• you are taking medicines that inhibit blood coagulation.
• you experience severe watery diarrhoea during or after treatment, possibly accompanied by fever or abdominal pain; consult your doctor immediately, as this may be due to a serious intestinal disease (pseudomembranous colitis).
• a bodily reaction to bacterial toxins occurs during treatment and persists for several days (Jarisch-Herxheimer reaction, see section 4).
• you are hypersensitive to other beta-lactam antibiotics (e.g. cephalosporins, carbapenems), since cross-allergy may occur.
• you are scheduled to undergo laboratory diagnostic tests (see also section 4), as this medicine may affect the results of such tests.

Prolonged and repeated use may lead to overgrowth of bacteria and yeasts that are not sensitive to the antibiotic.
Skin sensitization is possible; caution is advised and direct contact should be avoided.
Particular care must be taken when administering BENZILPENICILLINA POTASSICA K24 PHARMACEUTICALS by intravenous route: the administration must be performed slowly.

Other medicines and BENZILPENICILLINA POTASSICA K24 PHARMACEUTICALS
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• antibiotics that act by inhibiting bacterial growth (e.g. erythromycin, tetracycline).
• probenecid, as it may prolong the presence of BENZILPENICILLINA POTASSICA K24 PHARMACEUTICALS in the blood.
• methotrexate, used in chemotherapy. Combination with methotrexate is not recommended.
• anticoagulants, used to thin the blood; you may need additional blood tests.
• anti-inflammatory, antirheumatic, and antipyretic agents: high-dose salicylates, indomethacin, and phenylbutazone, used to relieve pain.
• digoxin, as there is a risk of bradycardia.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before this medicine is administered.
If you are pregnant or breastfeeding, BENZILPENICILLINA POTASSICA K24 PHARMACEUTICALS should only be administered when strictly necessary and under direct medical supervision.

Driving and using machines
BENZILPENICILLINA POTASSICA K24 PHARMACEUTICALS does not impair the ability to drive or operate machinery.

BENZILPENICILLINA POTASSICA K24 PHARMACEUTICALS contains potassium
This medicine contains 1.7 mmol (or 65.6 mg) of potassium per vial, which should be taken into account in patients with impaired renal function or in those on a low-potassium diet.

BENZILPENICILLINA POTASSICA K24 PHARMACEUTICALS contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e., essentially “sodium-free”.

3. How to use BENZILPENICILLIN POTASSICUM K24 PHARMACEUTICALS

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The dose will be determined by your doctor according to the type of bacteria, the severity of your infection,
your kidney function, and your general condition.
The recommended daily dose for adults is 1–2 million units divided over 24 hours.
The vial can be reconstituted by adding the contents of a 4 ml ampoule of water for injections,
to obtain a clear liquid which may be administered intramuscularly or by infusion, as directed by the doctor.

Use in children and adolescents
The doctor will determine the recommended dose based on the child's age, weight, severity and type of infection, and kidney function.

Use in patients with liver or kidney problems
You may be given a different dose than usual. The doctor will decide the amount of
BENZILPENICILLIN POTASSICUM K24 PHARMACEUTICALS you need and will monitor you closely, depending on the severity of your liver or kidney disease.

If you use more BENZILPENICILLIN POTASSICUM K24 PHARMACEUTICALS than you should
It is very unlikely that you will be administered a higher dose of BENZILPENICILLIN POTASSICUM K24 PHARMACEUTICALS than recommended.
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.
Neurological effects due to accumulation of the medicine in certain brain tissues may occur.
The doctor will initiate appropriate treatment and supportive measures.
Note that benzylpenicillin can be removed from the blood (it is dialyzable).

If you forget to use BENZILPENICILLIN POTASSICUM K24 PHARMACEUTICALS
If you miss an injection, do not use a double dose (two injections together) to make up for the missed dose.
Interrupted use is strongly discouraged, as it may render the treatment ineffective.

If you stop using BENZILPENICILLIN POTASSICUM K24 PHARMACEUTICALS
Do not stop taking BENZILPENICILLIN POTASSICUM K24 PHARMACEUTICALS unless instructed by your doctor.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If, during administration of Benzylpenicillin Potassium K24 Pharmaceuticals, you experience any of the following serious side effects, which may be life-threatening, contact your doctor immediately; the doctor will discontinue treatment:

• severe allergic reactions (anaphylactic reactions or angioedema) which may present as: skin rash or itching, difficulty in breathing or chest tightness, swelling of the eyelids, face or lips, swelling or redness of the tongue, fever, joint pain, swollen lymph nodes.
• conditions characterized by brain intoxication (metabolic encephalopathy) which may cause neurological disturbances with seizures (violent, involuntary contractions of certain muscles) and loss of consciousness or coma,
• abnormal movements,
• marked increase in reflexes (hyperreflexia)

Listed below are the side effects of Benzylpenicillin Potassium:
There are insufficient data available to determine the frequency of individual listed side effects:

Side effects affecting the skin and underlying tissue

• appearance of red patches on the skin with blisters (maculopapular rash)
• appearance of raised lesions of varying shape and size, accompanied by itching (urticaria)
• swelling, sometimes rapid, of the skin and underlying tissue (edema)
• AGEP - Acute Generalized Exanthematous Pustulosis, with symptoms such as severe drug-related skin reactions with or without skin redness, fever, pustules
• maculopapular rash (flat, red area on the skin)
• morbilliform rash (measles-like skin rash)
• itching
• erythema (inflammatory redness of the skin)
• skin inflammation with shedding of the superficial layer (exfoliative dermatitis)

Side effects affecting the blood

• form of anemia characterized by destruction of red blood cells (hemolytic anemia)
• reduction in the number of white blood cells in the blood (leukopenia, neutropenia, agranulocytosis)
• reduction in blood platelet levels (thrombocytopenia)
• prolonged blood clotting time compared to normal. This effect may become apparent during bleeding episodes

Side effects affecting the immune system (the body's defense system)

• appearance of raised lesions of varying shape and size, accompanied by itching (urticaria)
• a reaction called "serum sickness" with onset of chills
• during treatment of syphilis, presence of toxic substances in the body following the death of bacteria causing the infection (Jarisch-Herxheimer reaction)
• angioedema (swelling of the skin, mucous membranes, and subcutaneous tissue, usually localized on the face, mouth, or tongue)

Side effects affecting the joints

• joint pain (arthralgia)

Side effects affecting the nervous system

• nerve damage (neuropathy)
• metabolic encephalopathy (neurological disturbances with seizures and loss of consciousness)

Side effects affecting the kidneys

• kidney damage (nephropathy)

General side effects

• pain at the injection site, fever, chills, worsening of existing wounds or infections, or new onset during therapy

Side effects affecting the gastrointestinal system

• inflammation of the tongue (glossitis)
• inflammation of the mucous membrane lining the oral cavity (stomatitis)
• nausea
• vomiting
• diarrhea (frequency: "rare")

Side effects affecting the liver

• hepatitis
• cholestasis

Diagnostic tests

• increased transaminases (liver enzymes)
• positive direct Coombs test (a test to detect blood-related problems)
• false positives in tests to detect the presence of proteins in urine using precipitation techniques (Folin-Ciocalteu-Lowry method, biuret method)
• false positives in tests to detect the presence of proteins in urine (ninhydrin method)
• simulation of pseudobisalbuminemia (transient changes in blood protein properties (albumin)) when electrophoresis methods are used to determine albumin
• false positives in non-enzymatic tests to detect glucose and urobilinogen in urine
• elevated levels during determination of 17-ketosteroids (using the Zimmermann reaction) in urine (see section 2)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You may also report side effects directly via the national reporting system at the website
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store BENZILPENICILLINA POTASSICA K24 PHARMACEUTICALS

This medicinal product does not require any special storage conditions.
The reconstituted solution must be injected immediately after reconstitution.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp.".
The expiry date refers to the last day of that month.
The reconstituted solution is stable for 7 days at a temperature between 2°C and 8°C; however, due to the risk of microbiological contamination, it should instead be used immediately. The storage times and conditions after reconstitution are the responsibility of the user and under no circumstances should exceed 24 hours at a temperature between 2°C and 8°C, unless reconstitution takes place under strictly controlled and sterile conditions.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What BENZILPENICILLINA POTASSICA K24 PHARMACEUTICALS contains
BENZILPENICILLINA POTASSICA K24 PHARMACEUTICALS 1,000,000 IU/4 ml powder and
solvent for injectable solution.
Vial of powder:

• The active substance is potassium benzylpenicillin 624.9 mg (equivalent to benzylpenicillin 1,000,000 IU)
• The other components are: anhydrous sodium citrate and citric acid.
  The solvent vial contains water for injections.

BENZILPENICILLINA POTASSICA K24 PHARMACEUTICALS 1,000,000 IU powder for
injectable solution.
Vial of powder:

• The active substance is potassium benzylpenicillin 624.9 mg (equivalent to benzylpenicillin 1,000,000 IU)
• The other components are: anhydrous sodium citrate and citric acid.

Description of the appearance of BENZILPENICILLINA POTASSICA K24
PHARMACEUTICALS and package contents
BENZILPENICILLINA POTASSICA K24 PHARMACEUTICALS 1,000,000 IU/4 ml powder and
solvent for injectable solution
Pack containing 1 vial of powder and 1 vial of solvent (4 ml)
BENZILPENICILLINA POTASSICA K24 PHARMACEUTICALS 1,000,000 IU powder for
injectable solution
Box containing 100 vials of powder

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
K24 Pharmaceuticals S.r.l.
Via Generale Orsini 46 - 80132 Naples
Manufacturer
Biopharma S.r.l.
Via delle Gerbere, 20-22 - 00040 S. Palomba (Rome)