Flucloxacillin

Package leaflet: Information for the patient

FLUCLOXACILLIN K24 PHARMACEUTICALS 1g powder for injectable solution

Flucloxacillin

Please read all of this leaflet carefully before using 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 or pharmacist.
• This medicine has been prescribed for you/your child only. Do not give it to others, 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What FLUCLOXACILLIN K24 PHARMACEUTICALS is and what it is used for

FLUCLOXACILLIN K24 PHARMACEUTICALS is an antibiotic indicated for the treatment of all infections caused by microorganisms sensitive to flucloxacillin affecting various organs and systems.
Flucloxacillin blocks bacterial enzymes that inactivate the antibiotic and enhances the activity of other broad-spectrum penicillins such as amoxicillin, ampicillin, and other drugs of the same class.

2. What you should know before using FLUCLOXACILLIN K24 PHARMACEUTICALS

Do not use FLUCLOXACILLIN K24 PHARMACEUTICALS

• if you/your child are allergic to flucloxacillin or to any of the other ingredients of this medicine (listed in section 6),
• if you/your child are allergic to penicillins, cephalosporins, or other antibiotics,
• if you are pregnant, unless after careful evaluation by your doctor. (see "Pregnancy and breastfeeding")

Warnings and precautions
Talk to your doctor or pharmacist before using FLUCLOXACILLIN K24 PHARMACEUTICALS.
Discontinue administration of the medicine in case of allergic reactions to the product.
Before starting treatment with this medicine, check whether there have been previous allergic
reactions to drugs, especially penicillin and cephalosporin antibiotics.
In case of an allergic reaction, stop treatment immediately and contact your doctor or go to the
nearest hospital for appropriate therapy.
The onset of a rapid and severe allergic reaction (anaphylaxis) requires immediate emergency
measures, such as administration of adrenaline, corticosteroids, and antihistamines.
If during treatment you begin to experience colitis, and particularly if diarrhoea occurs, consult your
doctor, who will need to rule out pseudomembranous colitis. If this condition is diagnosed, therapy
must be stopped immediately and appropriate treatment initiated. In such cases, medicines that
slow gastrointestinal motility must not be taken.
Administration of sodium flucloxacillin may cause imbalances in the body's water and electrolyte
balance, with increased sodium levels, especially in patients with heart and/or kidney failure.
In case of renal impairment, elimination of flucloxacillin from the body is delayed; therefore, if
renal impairment is severe (with creatinine clearance values below 10 ml/min), or if there is no
regular urination, the dose must not exceed 2 g administered once daily.
Use of flucloxacillin, especially at high doses, may reduce potassium levels in the blood
(hypokalaemia). During therapy with higher doses of flucloxacillin, your doctor may regularly
monitor your potassium levels.
The use of high-dose antibacterial agents for short periods in the treatment of gonorrhoea may
mask symptoms of incubating syphilis infection; in such cases, it is advisable to test the patient for
syphilis.
Prolonged use of penicillins, as with other antibiotics, may promote the development of resistant
microorganisms (including fungi), requiring appropriate therapeutic measures.

• If you are taking or are about to take paracetamol, there is a risk of blood composition changes and electrolyte imbalance (metabolic acidosis with high anion gap), which occurs when plasma acidity increases, particularly when flucloxacillin is co-administered with paracetamol, especially in certain high-risk patient groups, such as patients with severe renal impairment, blood infection (septicaemia), or malnutrition, particularly if maximum daily doses of paracetamol are used. Metabolic acidosis with high anion gap is a serious condition requiring urgent treatment.

Other medicines and FLUCLOXACILLIN K24 PHARMACEUTICALS
Inform your doctor or pharmacist if you/your child are 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 of the "aminoglycoside" class, because they are often used together. However, in some combinations and with prolonged treatment, chemical inactivation of both compounds has been demonstrated. Therefore, when used concomitantly, the products must not be mixed, as a solid compound may form;

• probenecid, as it may prolong the presence of flucloxacillin in the blood;

• voriconazole (used to treat fungal infections).

FLUCLOXACILLIN K24 PHARMACEUTICALS must not be mixed with amino acid solutions (precipitate
formation), fat emulsions, or blood.
Treatment with penicillins may lead to false positive results in the Coombs test and in tests for
glycosuria (Fehling's reagent, Benedict's reagent, and "Clintest").

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine. During pregnancy, this medicine
should be administered only when clearly needed and under direct medical supervision. If you
intend to breastfeed, since flucloxacillin passes into breast milk, either avoid breastfeeding or
continue breastfeeding without taking the medicine.

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

Flucloxacillin K24 Pharmaceuticals contains sodium
This medicine contains 50.6 mg of sodium (the main component of table salt) per vial. This is
equivalent to 2.5% of the maximum daily dietary intake recommended for an adult.

3. How to use FLUCLOXACILLINA K24 PHARMACEUTICALS

Use this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The dose will be determined by the doctor according to the type of bacteria, the severity of the infection,
kidney function, and general health conditions.
Adults
The recommended dose of FLUCLOXACILLINA K24 PHARMACEUTICALS is 1 g, one vial every 8
hours, administered intramuscularly.
Paediatric population
In children, lower doses are used proportionally to body weight: for children aged between 2 and 10 years,
100 mg/kg/day administered intramuscularly in divided doses, not exceeding 33 mg/kg/dose per injection (1 ml = 250 mg); for children under 2 years of age, the dose should be halved.
Renal impairment
In cases of severe renal impairment (creatinine clearance less than 10 ml/min), lower doses or longer
intervals between doses than those indicated should be used. The total dose should not exceed 2 g within
24 hours (see "Warnings and precautions").
Since FLUCLOXACILLINA K24 PHARMACEUTICALS is not significantly removed by dialysis, dosage
adjustment is not required during or after dialysis.
Method of administration
Flucloxacillin sodium may be administered by intramuscular or intravenous route.
The product must be prepared and injections performed under strict aseptic conditions. The reconstituted
solution should be injected immediately, and any unused portion must be discarded and not reused.
Intramuscular administration
Dissolve 1 g of FLUCLOXACILLINA K24 PHARMACEUTICALS in 4 ml of solvent, an aqueous solution of 1% lidocaine hydrochloride.
NOTE: The solvent containing lidocaine hydrochloride must be used only for intramuscular administration.
Intravenous administration (only in hospital settings)
Intravenous injection
Dissolve 1 g of FLUCLOXACILLINA K24 PHARMACEUTICALS in 15–20 ml of water for injections. The injection should be administered over 3–4 minutes.
Intravenous infusion
Dissolve 1 g of FLUCLOXACILLINA K24 PHARMACEUTICALS in one of the common intravenous solutions, such as physiological saline, 5% glucose solution, physiological saline with 5% glucose, or sodium lactate solution.
If you are given more FLUCLOXACILLINA K24 PHARMACEUTICALS than you should
In case of accidental overdose with flucloxacillin sodium, contact your doctor immediately and/or go to the nearest hospital. The doctor will initiate appropriate treatment and supportive measures.
There are no known reports of toxic effects from flucloxacillin overdose. As with other penicillins, overdose may cause gastrointestinal disturbances and electrolyte imbalance, requiring symptomatic treatment and monitoring of electrolyte balance.
Neuromuscular irritability and seizures may also occur. FLUCLOXACILLINA K24 PHARMACEUTICALS is not dialyzable.
If you forget to take FLUCLOXACILLINA K24 PHARMACEUTICALS
If you miss an injection, do not take a double dose (two injections together) to make up for the missed dose.
Intermittent use is strongly discouraged, as it may render the treatment ineffective.
If you stop using FLUCLOXACILLINA K24 PHARMACEUTICALS
Do not stop taking FLUCLOXACILLINA K24 PHARMACEUTICALS 1 g unless instructed by your doctor. If you have any questions 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.
Below are the most likely side effects of flucloxacillin.
There are insufficient data available to establish the frequency of the individual side effects listed.
In rare cases, usually following injection, allergic reactions may occur that are very rapid and sometimes severe. In such cases, treatment must be discontinued and appropriate emergency measures must be initiated.
These reactions are more likely to occur in individuals who are allergic, or who suffer from asthma, hay fever, or urticaria.
The possible occurrence of severe or prolonged diarrhoea should raise suspicion of a potential onset of pseudomembranous colitis (see "Warnings and precautions").
Neutropenia has been more frequently observed in patients treated with antibiotics of this type at high doses and for prolonged periods (more than ten days). The onset of fever accompanied by a rapidly developing skin rash and eosinophilia constitutes a warning sign. Therefore, frequent monitoring of white blood cell count is recommended during long-term treatment with high doses.
Very rarely, during treatment with this type of antibiotic at high doses in patients with renal impairment, metabolic encephalopathy (toxicity affecting the brain) has been observed.
Other side effects observed with the use of penicillins are mostly represented by hypersensitivity reactions, most frequently skin rashes (erythema multiforme, urticaria, maculopapular or morbilliform rash) and pruritus.
Less frequently, other effects affecting the following systems may occur:
Gastrointestinal system
Inflammation of the tongue (glossitis), of the mouth (stomatitis), nausea, vomiting, diarrhoea, stomach pain, flatulence, loss of appetite.
Liver
Transient increases in blood levels of transaminases, lactate dehydrogenase and alkaline phosphatase have been observed, as well as rare cases of hepatitis and cholestatic jaundice, sometimes occurring some time after therapy.
Blood
Imbalances in blood cell concentrations (eosinophilia, neutropenia, agranulocytosis, thrombocytopenia and anaemia, sometimes haemolytic) may occur. These usually resolve upon discontinuation of treatment. These manifestations have also been considered expressions of hypersensitivity, sometimes with an autoimmune basis (neutropenia, haemolytic anaemia).
Kidney
Rarely, increases in blood urea nitrogen and serum creatinine have been observed, with isolated cases of interstitial nephritis (toxicity affecting the kidney).
Very rare cases of alterations in blood composition and electrolyte imbalance (metabolic acidosis with elevated anion gap) occurring when there is an increase in plasma acidity have been reported when flucloxacillin is co-administered with paracetamol, generally in the presence of risk factors (see section 2).
Other side effects (frequency not known):
Severe skin reactions
A red skin rash with crusts, swellings under the skin, and blisters (exanthematous pustulosis).
Low levels of potassium in the blood (hypokalaemia), which may cause muscle weakness, cramps, or an abnormal heart rhythm.
If you experience any of these symptoms, contact your doctor immediately.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://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 FLUCLOXACILLIN K24 PHARMACEUTICALS

Keep this medicine out of the sight and reach of children.
Store below 25°C. Keep in the original packaging to protect the medicine from light and moisture.
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.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What FLUCLOXACILLINA K24 PHARMACEUTICALS contains
One vial of powder for injectable solution contains:
Active substance: Flucloxacillin sodium monohydrate 1.088 g, equivalent to 1 g of anhydrous flucloxacillin acid.

Description of the appearance of FLUCLOXACILLINA K24 PHARMACEUTICALS and package contents
Carton pack containing 50 or 100 vials of powder for injectable solution.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
K24 PHARMACEUTICALS S.r.l. - Via G. Orsini, 46 - 80132 Naples, Italy

Manufacturer responsible for batch release
Biopharma S.r.l. - Via delle Gerbere - S. Palomba (RM) - Italy