Label: Information for the User

Anaclosil 500 mg Powder for Injectable Solution

Cloxacillin (as sodium)

Read this label carefully before starting to use this medication, as it contains important information for you.ed.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms of the disease, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

1. What is Anaclosil and how is it used

2. What you need to know before starting to use Anaclosil

3. How to use Anaclosil

4. Possible adverse effects

5. Storage of Anaclosil

6. Contents of the package and additional information

The active ingredient of Anaclosil is cloxacillin.

Cloxacillin is an antibiotic belonging to the family of penicillins.

Anaclosil is indicated for the treatment of the following infections:

• Bone and joint infections.
• Sepsis: Severe infections with systemic repercussions.
• Endocarditis: Infections of a part of the heart called the endocardium.
• Meningitis: Infection of the membranes covering the Nervous System.
• Genitourinary and urinary tract infections.
• Respiratory infections.
• Skin and soft tissue infections.

Anaclosil is also indicated for the prevention of infections after neurosurgical interventions such as internal cerebrospinal fluid derivation.

Do not take Anaclosil:

• If you are allergic to the active ingredient.
• If you are allergic (hypersensitive) to penicillin.
• If you are allergic (hypersensitive) to cephalosporins. Although an allergy to cephalosporins does not imply the existence of an allergy to this penicillin, it should be determined if the patient has previously experienced immediate, moderate, or severe allergic reactions to a cephalosporin, in which case it would be recommended to avoid the use of this penicillin.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Anaclosil if you:

• Are allergic to a specific group of antibiotics called beta-lactams (penicillins or cephalosporins).

• If during a previous antibiotic treatment (including another family of antibiotics), you have had any type of allergic reaction such as urticaria or other rashes, itching, sudden swelling of the face and neck.

• Suffer from kidney or liver disease.

• If you have a history of seizures and/or epilepsy, especially in patients with renal impairment or liver impairment.

• Are taking oral contraceptives, it is recommended to use an alternative, effective, and safe method during treatment and for one week after, as the concomitant use of Cloxacillin and combined oral contraceptives may reduce the effectiveness of the contraceptive.

This medication may interfere with diagnostic tests: If you are to undergo any diagnostic test (including blood, urine, etc. tests) inform your doctor that you are taking this medication, as it may alter the test results.

Children and adolescents

This medication should be administered with caution in neonates, due to the risk of hyperbilirubinemia by competition at the binding sites of bilirubin to serum proteins.

Other medications and Anaclosil

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription. It is especially important to inform your doctor if you are taking:

• Metotrexate, which is a medication indicated for some forms of arthritis and for the treatment of psoriasis.
• Other antibiotics (medications used for infections caused by bacteria), such as chloramphenicol, tetracyclines, macrolides, or sulfonamides. These antibiotics may reduce the effect of Anaclosil.
• Aminoglycosides, as the treatment should be administered separately from Anaclosil.
• Probenecid, which is a medication for the treatment of gout, as it may increase the effect of Anaclosil.
• Warfarin or other anticoagulant medications.

Pregnancy,lactationand fertility

If you are pregnant or breastfeeding, or believe you may be pregnant or intend to become pregnant, consult your doctor before using this medication.

This medication passes into breast milk. Consult your doctor before breastfeeding your baby. Treatment should be interrupted in case of diarrhea, candidiasis, or skin eruptions in the baby.

Driving and operating machines

There is no evidence of effects on the ability to drive or operate machines.

Anaclosil contains sodium

This medication contains 26.4 mg of sodium (main component of table salt) in each vial. This is equivalent to 1.3% of the maximum recommended daily dietary intake of sodium for an adult.

Anaclosil will be administered by a qualified healthcare professional (doctor or nurse).

It will be administered directly (intravenous direct) for 3-4 minutes or through a drip in the vein (intravenous perfusion) for approximately 1 hour.

The recommended dose for adults that will be administered is as follows:

• For the treatment of infections: 2,000 mg every 4-6 hours.
• For the prevention of infections before a neurological operation: a dose of 2,000 mg of Anaclosil before the intervention, and 1,000 mg every 2 hours during the intervention if it is prolonged.

If you have a severe problem with the functioning of the kidneys and liver, the dose that will be administered will be half of the recommended dose.

Use in children and adolescents

The recommended dose is 100 to 200 mg per kilogram of body weight and per day, divided into 4-6 administrations, without exceeding 12 g per day.

If you are given more Anaclosil than you should

Inform your doctor or nurse immediately if you think you have been given too much Anaclosil.

If you forgot a dose of Anaclosil

Inform your doctor or nurse immediately if you think you may have missed a dose.

If you have any other questions about the use of this medication, ask your doctor or nurse.

Like all medications,Anaclosilmay cause adverse effects, although not everyone will experience them.

Very rare frequency (may affect up to 1 in 10,000 people): severe skin redness, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Unknown frequency (frequency cannot be estimated from currently available data):

• Skin allergic reactions: (pruritus, cutaneous rash, urticaria)
• Diarrhea, nausea, and vomiting.
• Decreased number of neutrophils and platelets in the blood.
• Neurological symptoms: seizures (mental disorder accompanied by muscle contractions). This effect is more frequent in people with a significant decrease in renal function.
• Jaundice(yellow discoloration of the skin or the white part of the eyes), increased liver enzyme values, and hepatitis (liver inflammation)

Similarly, in patients sensitized to penicillins, allergic reactions such asswelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema) may occur.

• Gastrointestinal tract alterations such as severe or persistent diarrhea, or if blood or mucus is observed in the stool.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

This medication does not require special conditions for conservation.

Do not usethis medicationafter the expiration date that appears onthe packaging,after CAD: The expiration date is the last day of the month indicated.

Keepthis medicationout of the sight and reach of children.

Once opened, this medication must be used immediately. The reconstituted and diluted solution must be used immediately.

Do not use this medication if you observe the presence of particles or if the reconstituted solution is cloudy.

Medications should not be throwndown the drains, or in the trash. Dispose of the packaging and medications you do not need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you do not need. In this way, you will help protect the environment.

Composition ofAnaclosil

The active principle iscloxacillin (as sodium salt). Each vial contains 500 mg of cloxacillin (as sodium salt).

Aspect of the product and contents of the package

Anaclosil is a white or almost white powder for injectable solution and for infusion, packaged in a 10 mL glass vial.

For direct intravenous administration, the powder will be reconstituted in 2.5 mL of water for injectable preparations.

For continuous infusion administration, the reconstituted powder in 2.5 mL of water for injectable preparations will be removed from the vial and added to a bag of at least 100 mL of sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) for infusion in the hospital.

Anaclosil is available in packages of 1 or 100 vials.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Laboratorio Reig Jofre, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

This leaflet was approved in August 2024

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/

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This information is intended solely for healthcare professionals:

Important: Consult the technical data sheet/summary of the product characteristics before prescribing the medicine.

Anaclosil must be reconstituted with water for injectable preparations (for slow intravenous administration) and then diluted in at least 100 mL of sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) for infusion.

Cloxacillin sodium should not be used in infusion bags that contain protein hydrolysates, lipid suspensions, amino acids, blood, or serum.

The mixture of cloxacillin and aminoglycosides may cause substantial mutual inactivation, so they should not be mixed in the same infusion bag.

Only limited data are available on the compatibility of Anaclosil with other substances for intravenous administration; consequently, no additives or other medications should be added to the Anaclosil vials for single use, nor should they be infused simultaneously. If the same intravenous line is used for the sequential infusion of different medications, the line should be flushed before and after infusion with a 0.9% sodium chloride solution.

Reconstitution

To prepare the solution for slow intravenous administration (3-4 min.), aseptic technique should be followed. Reconstitute the vial contents with 4 mL of water for injectable preparations, and gently rotate until the powder is completely dissolved. Avoid shaking or making rapid movements, as this could cause foam formation. The reconstituted product is stable for a period of up to 6 hours at 25°C. From a microbiological point of view, the reconstituted product should be administered immediately by direct intravenous injection or diluted immediately for continuous infusion administration.

Dilution

To administer by infusion, the reconstituted solution should be diluted in at least 100 mL of 0.9% sodium chloride solution or 5% glucose solution for infusion. Do not agitate the bag. The resulting solution is a transparent, colorless, or yellowish solution.

Infusion

Visual inspection should be performed to ensure that the reconstituted solution does not contain particles before administration. Solutions reconstituted with visible particles should be discarded.

Anaclosil should be administered as an intravenous infusion over approximately 1 hour.

Anaclosil should not be mixed with other medications.

Each vial is for single use only.