Cloxacillin eugia

Package leaflet: Information for the user

Cloxacillin Eugia, 1 mg, powder for solution for injection/infusion
Cloxacillin Eugia, 2 mg, powder for solution for injection/infusion
Cloxacillinum
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 further questions, ask your doctor or nurse.
This medicine has been prescribed for a specific individual. 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, tell your doctor or nurse. See section 4.
Contents of this leaflet:

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

1. What Cloxacillin Eugia is and what it is used for

Cloxacillin Eugia contains cloxacillin as the active substance, which belongs to the beta-lactam family of penicillin M group antibiotics.
Cloxacillin Eugia works by eliminating bacteria responsible for infections. It acts only against certain specific bacterial strains.
Cloxacillin Eugia is indicated for use in adults and children for the treatment of the following infections:

• lung and bronchial infections
• ear, nose and throat infections
• urinary and genital tract infections
• brain infections
• bone and joint infections
• heart infections
• skin infections

It is also indicated for the prevention of postoperative infections in neurosurgery (e.g. during placement of an internal cerebrospinal fluid drainage).

2. Information before using Cloxacillin Eugia

When not to use Cloxacillin Eugia

• if the patient is allergic to cloxacillin or any of the other ingredients of this medicine (listed in section 6)
• if the patient is allergic to other beta-lactam antibiotics (penicillins and cephalosporins)
• for subconjunctival administration

Warnings and precautions
Before starting treatment with Cloxacillin Eugia, discuss this with your doctor or nurse.
Any allergic symptoms (skin rashes, itching, etc.) that occur during treatment must be reported immediately to the doctor.
If the patient has previously experienced an allergic reaction (such as urticaria or other skin eruptions, itching, sudden allergic swelling of the face and neck [angioedema]) while being treated with antibiotics (including antibiotics from other classes), inform the doctor before using this medicine (see section 4. "Possible side effects").
Diarrhoea may occur during treatment with antibiotics, including Cloxacillin Eugia, even several weeks after treatment has ended. If diarrhoea worsens or persists, or if blood or mucus appears in the stool, treatment with Cloxacillin Eugia must be stopped immediately, as this may be life-threatening.
Do not use medications intended to block or inhibit intestinal peristalsis and contact your doctor (see section 4. "Possible side effects").
Treatment with Cloxacillin Eugia may lead to decreased potassium levels in the blood (hypokalaemia). During treatment with Cloxacillin Eugia, your doctor may order blood tests to monitor potassium levels.
Inform your doctor if the patient has kidney or liver impairment.
Cases of kidney damage have been reported during treatment with Cloxacillin Eugia, particularly when higher doses were administered (see section 4. "Possible side effects"). Patients aged over 65 years, especially those with diabetes (also known as type II diabetes), high blood pressure, kidney problems, or those taking other medications, should consult their doctor before using Cloxacillin Eugia. These conditions and certain medications may increase the risk of kidney damage.
Administration of this medicine, like all antibiotics belonging to this therapeutic class, particularly in cases of overdose or inappropriate dose adjustment in patients with impaired renal function, may be associated with the risk of encephalopathy, which may cause disorientation, disturbances of consciousness, seizures, or unusual movements. If such problems occur, consult your doctor or pharmacist immediately (see sections 3 and 4).

Cloxacillin Eugia and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
It is especially important that the doctor knows if the patient is taking any of the following medicines:

• methotrexate (a medicine used in the treatment of cancer or rheumatism)
• probenecid (a medicine used in the treatment of gout)
• warfarin (a blood-thinning medicine)
• antibiotics (fluoroquinolones, macrolides, tetracyclines, cotrimoxazole, and certain cephalosporins)

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

Pregnancy
Cloxacillin may be considered for use during pregnancy, regardless of the stage of pregnancy, if clinically necessary. Clinical data from a limited number of pregnant patients and animal studies have not shown a risk of congenital malformations or fetal toxicity. Nevertheless, the patient should consult her doctor if she is pregnant or planning to become pregnant.

Breastfeeding
The medicine passes into breast milk in small amounts. Effects on breastfed infants are unlikely, although a risk of affecting the infant's intestinal and oral flora cannot be excluded. Small amounts of the active substance in breast milk may increase the risk of sensitization. Medical advice should be sought before breastfeeding.
Breastfeeding may be considered during treatment with this medicine. However, if diarrhoea or candidiasis occurs in the infant during breastfeeding, a decision must be made whether to discontinue breastfeeding or stop the medication.

Driving and using machines
Cloxacillin Eugia may have a major influence on the ability to drive and use machines, particularly due to the potential occurrence of encephalopathy (see sections 3 and 4).

Cloxacillin Eugia contains sodium
Cloxacillin Eugia 1 g, powder for solution for injection/infusion: This medicine contains 52.77 mg of sodium (the main component of table salt) per vial. This corresponds to 2.6% of the maximum recommended daily dietary sodium intake for adults.
Cloxacillin Eugia 2 g, powder for solution for injection/infusion: This medicine contains 105.55 mg of sodium per vial. This corresponds to 5.3% of the maximum recommended daily dietary sodium intake for adults.
The maximum recommended daily dose of this medicine contains 634.8 mg of sodium (present in table salt). This corresponds to 31.68% of the recommended maximum daily sodium intake for an adult.
If Cloxacillin Eugia is taken daily for a prolonged period, patients, especially those monitoring sodium intake in their diet, should consult their doctor or pharmacist.

3. How to use Cloxacillin Eugia

The medicine is administered by a doctor or nurse as an intravenous injection (into a vein) or infusion.
The doctor will determine the appropriate dose for the patient, as well as the method and timing of administration.
Dosage
Dosage depends on kidney and liver function, and in children, on body weight.
The usual doses for the indicated uses are:
Therapeutic use
Adults: 8 to 12 g/day, divided into 4 to 6 doses per day.
Children: 100 to 200 mg/kg per day, divided into 4 to 6 doses per day, not exceeding 12 g/day.
Prophylactic treatment
Prevention of postoperative infections in surgery: antibiotic prophylaxis should be short-term, most often limited to the intraoperative period, sometimes 24 hours, but never longer than 48 hours. 2 g intravenously during anaesthesia induction, followed by repeated 1 g intravenous injections every 2 hours during prolonged surgery.
The duration of treatment should cover the entire duration of the procedure up to skin closure.
Dosage may be adjusted in cases of renal impairment and/or associated hepatic impairment.
IN ALL CASES, THE DOCTOR'S INSTRUCTIONS MUST BE STRICTLY FOLLOWED.
Method of administration
Intravenous administration – infusion.
Each dose will be injected into the systemic circulation via one of the veins as a slow infusion.
The infusion lasts 60 minutes.
Duration of treatment
To ensure effectiveness, the antibiotic must be used regularly at the recommended doses and for as long as directed by the doctor.
The disappearance of fever or other symptoms does not mean complete recovery.
A feeling of fatigue may occur, but this is caused by the infection itself, not by the antibiotic treatment.
Reducing or stopping treatment will not affect this sensation and may delay recovery.
Overdose of Cloxacillin Eugia
Since the injection is administered by a doctor or nurse, it is unlikely that the patient will receive too high a dose. If the patient believes they have received an excessive dose, they must inform the person who administered the injection.
For antibiotics of the penicillin M group, to which this medicine belongs, cases of overdose have been reported with neurological disorders, kidney dysfunction, and gastrointestinal disturbances. If such disorders occur in the patient, immediate consultation with a doctor or pharmacist is required.
As with all antibiotics in the penicillin class, administration of Cloxacillin Eugia, especially in cases of overdose, may cause changes in mental status due to brain disease, damage, or impaired brain function (encephalopathy).
Symptoms may vary, but may include fever, neck stiffness, and/or headache. There may also be difficulties using hands and feet, speech problems, or disorientation. If such problems occur, immediate consultation with a doctor or pharmacist is required (see sections 2 and 4).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If any of the following potentially serious side effects occur,
you should contact your doctor immediately:
Rare (may affect up to 1 in 1,000 people):

• Severe acute allergic reactions (anaphylactic reaction). Such a reaction may be life-threatening. One or more of the following symptoms may occur: redness, itching or skin rash (urticaria), difficulty breathing and dizziness. Cloxacillin Eugia may cause a reduction in the number of granulocytes in the blood (agranulocytosis), and the patient's immunity to infections may be reduced. If the patient develops an infection with symptoms such as fever and severe deterioration in general condition, or fever with signs of local infection such as sore throat/oral cavity pain or urinary problems, medical advice must be sought immediately. A blood test will be performed to check for possible reduction in granulocyte count (agranulocytosis). It is important to inform the doctor about any medicines the patient is taking.
• Acute inflammation of the colon (pseudomembranous colitis).
• Superinfection / (secondary) bacterial infection.

Frequency not known (cannot be estimated from the available data):

• Severe hypersensitivity reactions with severe rash, which may be accompanied by fever, fatigue, facial swelling or swollen lymph nodes, increased number of eosinophils (a type of white blood cell), affecting the liver, kidneys or lungs (a reaction known as drug reaction with eosinophilia and systemic symptoms, DRESS).
• Quincke's oedema (subcutaneous swelling).
• Altered mental state caused by disease, damage or malfunction of the brain (encephalopathy).

Other possible side effects:
If any of the following side effects worsens or if any side effects not listed in this leaflet occur, inform your doctor or other healthcare professional.
Common (may affect up to 1 in 10 people):

• Malaise, diarrhoea
• Rash
• Inflammation of a blood vessel after intravenous injection (thrombophlebitis)

Uncommon (may affect up to 1 in 100 people):

• Increased number of a specific type of white blood cells (eosinophilia)
• Urticarial fever (urticaria)

Rare (may affect up to 1 in 1,000 people):

• Reduced number of white blood cells (leukopenia)
• Liver damage
• Kidney damage

Frequency not known (cannot be estimated from the available data):

• Reduced number of red blood cells (anaemia)
• Damage to blood cells, such as reduced number of platelets (thrombocytopenia)
• Nausea
• Vomiting
• Kidney inflammation
• Excessive growth of yeast in the mouth and vagina in women

Reporting of side effects
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor or pharmacist. 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, website:
https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Cloxacillin Eugia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and carton label after:
EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Instructions for storage of this medicine after reconstitution are provided in the section "Information
intended exclusively for healthcare professionals".
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Package and Other Information

What Cloxacillin Eugia Contains

• The active substance in this medicine is cloxacillin.

Each vial contains 1 g or 2 g of cloxacillin (as cloxacillin sodium monohydrate,
corresponding to 1.092 g or 2.184 g, respectively).

• The medicine does not contain any excipients.

What Cloxacillin Eugia Looks Like and Contents of the Pack
Powder for solution for injection/infusion.
Cloxacillin Eugia is a white or almost white crystalline powder contained in a colourless glass vial,
closed with a grey rubber stopper and sealed with an aluminium cap with a polypropylene flip-off seal.
PVC bags should be avoided for storage and dilution of the medicine.
Each cardboard box contains 1, 10 or 25 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Eugia Pharma (Malta) Limited
Vault 14, level 2
Valletta Waterfront
Floriana, FRN 1914
Malta
e-mail: [email protected]

Manufacturer/Importer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal
Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

This medicine is authorised for sale in the European Economic Area under the following names:
France: CLOXACILLINE ARROW 1g, poudre pour solution injectable / pour perfusion
CLOXACILLINE ARROW 2 g, poudre pour solution injectable / pour perfusion
Poland: Cloxacillin Eugia
Portugal: Cloxacilina Generis

Additional Information
Medical Advice/Education
Antibiotics are used to treat infections caused by bacteria. They do not work against infections caused by viruses.
Sometimes bacterial infections do not respond to antibiotic treatment. One of the most common reasons for this is that the bacteria causing the infection are resistant to the antibiotic being used. This means that they can survive, and even multiply, despite antibiotic treatment.
Bacteria can become resistant to antibiotics for various reasons. Careful use of antibiotics may help reduce the risk of bacterial resistance.
When a doctor prescribes an antibiotic, it is intended to treat only the current illness.
Following the recommendations below can help prevent the emergence of resistant bacteria, which could make antibiotics ineffective.

1. It is very important to take the antibiotic at the correct dose, at the right time, and for the prescribed duration. Read the instructions on the packaging carefully and, if anything is unclear, ask your doctor or pharmacist for clarification.
2. Do not take antibiotics unless they have been prescribed for a specific individual, and use them only to treat the infection for which they were prescribed.
3. Do not take antibiotics prescribed for another person, even if they had a similar infection.
4. Do not give antibiotics prescribed for a specific individual to other people.
5. If any antibiotic remains after completing the prescribed course, return the unused portion to a pharmacy for proper disposal.

Information intended exclusively for healthcare professionals:
Preparation of the Solution
Aseptic technique should be used for reconstitution.
Depending on the required dose, the powder should be dissolved using either Water for Injections or Sodium Chloride 9 mg/mL (0.9%) Solution for Injections.
The following volumes of solvent are recommended for reconstituting the powder to prepare a solution for injection/infusion:

Reconstitution for intravenous injection:
1 g reconstituted with 16 mL or 20 mL of Water for Injections (or 5% dextrose solution or 0.9% sodium chloride solution).
2 g reconstituted with 10 mL or 40 mL of Water for Injections (or 0.9% sodium chloride solution).

Dilution for infusion:
For 1 g:
Reconstituted solution of 1 g [in 16 mL or 20 mL of Water for Injections (or dextrose or 0.9% sodium chloride solution)] should be further diluted with 100 mL of 0.9% sodium chloride solution or 5% dextrose.
For 2 g:
Reconstituted solution of 2 g [in 10 mL or 40 mL of Water for Injections (0.9% sodium chloride solution)] should be further diluted with 90 mL of 0.9% sodium chloride solution or 5% dextrose.

Administration
After reconstitution, the solution must be clear. Do not use the solution if visible particles are present. Prepare only one dose at a time. Unused solution must be discarded.
This medicinal product must not be mixed with other medicines.

Stability
Reconstituted solution:
Chemical and physical in-use stability has been demonstrated for 12 hours at room temperature (25°C) under room light and for 24 hours at 2°C to 8°C protected from light.
Diluted solution:
The diluted solution should be used immediately.
From a microbiological standpoint, unless the method of opening/reconstitution/dilution excludes the risk of microbial contamination, the product should be used immediately.

"Medicines should not be disposed of via wastewater or household waste. Please ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment."