ANACLOSIL 500 mg powder for injectable solution and for infusion

Introduction

Package Leaflet: Information for the User

Anaclosil 500 mg Powder for Solution for Injection

Cloxacillin (as sodium)

Read all of this leaflet carefully before you start 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Anaclosil is and what it is used for

2. What you need to know before you use Anaclosil

3. How to use Anaclosil

4. Possible side effects

1. Storage of Anaclosil
2. Contents of the pack and further information

1. What Anaclosil is and what it is used for

The active substance of Anaclosil is cloxacillin.

Cloxacillin is an antibiotic belonging to the penicillin family.

Anaclosil is indicated for the treatment of the following infections:

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

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

2. Before taking Anaclosil

Do not take Anaclosil:

• If you are allergic to the active substance.
• If you are allergic (hypersensitive) to penicillin.
• If you are allergic (hypersensitive) to cephalosporins. Although allergy to cephalosporins does not presuppose 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 is 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 (even with another family of antibiotics), you have had any type of allergic reaction such as hives 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 impaired renal or hepatic function.

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

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

Children and adolescents

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

Other medicines and Anaclosil

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

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

This medicine passes into breast milk. Ask your doctor for advice before breastfeeding your baby. Treatment should be interrupted in case of diarrhea, candidiasis, or skin rashes in the baby.

Driving and using machines

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

Anaclosil contains sodium

This medicine contains 26.4 mg of sodium (a major component of kitchen/table salt) per vial. This is equivalent to 1.3% of the maximum recommended daily dietary intake of sodium for an adult.

3. How to use Anaclosil

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

It will be administered directly (by intravenous direct route) over 3-4 minutes or by drip into a vein (intravenous infusion) over approximately 1 hour.

The recommended dose for adults will be as follows:

• In the treatment of infections: 2,000 mg every 4-6 hours.
• In 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.

In case of severe kidney and liver problems, the dose 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, not exceeding 12 g per day.

If you are given too much Anaclosil

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

If you miss a dose of Anaclosil

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

If you have any further questions on the use of this product, ask your doctor or nurse.

4. Possible side effects

Like all medicines, Anaclosil can cause side effects, although not everybody gets them.

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

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

• Allergic reactions on the skin: (Itching, skin rash, hives)
• Diarrhea, nausea, and vomiting.
• Decrease in the number of neutrophils and platelets in the blood.
• Neurological symptoms: Seizures (disorder of mental status accompanied by muscle contractions). This effect is more frequent in people with significantly impaired renal function.
• Jaundice (yellowing of the skin or the white part of the eyes), increased liver enzyme values, and hepatitis (inflammation of the liver)

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

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

Reporting of side effects

If you experience any side effect, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) online platform: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Anaclosil

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton, after EXP: The expiry date is the last day of the month stated.

Keep this medicine out of the sight and reach of children.

Once opened, this medicine should be used immediately. The reconstituted and diluted solution should be used immediately.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Anaclosil

The active substance is cloxacillin (as sodium salt). Each vial contains 500 mg of cloxacillin (as sodium salt).

Appearance of the product and pack contents

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

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

For continuous infusion administration, the powder reconstituted in 2.5 mL of water for injections will be withdrawn 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 packs of 1 or 100 vials.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Laboratorio Reig Jofre, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

This leaflet was approved in August 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.es

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This information is intended only for healthcare professionals:

Important: Consult the summary of product characteristics before prescribing the medicine.

Anaclosil should be reconstituted with water for injections (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.

Sodium cloxacillin should not be used in infusion bags containing protein hydrolysates, lipid suspensions, amino acids, blood, or serum.

The mixture of cloxacillin and aminoglycosides can 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 medicines should be added to the Anaclosil single-dose vials, nor should they be infused simultaneously. If the same intravenous line is used for the sequential infusion of different medicines, the line should be flushed before and after the infusion with a 0.9% sodium chloride solution.

Reconstitution

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

Dilution

For infusion administration, 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 shake the bag. The resulting solution is a clear, colorless, or pale yellow solution.

Infusion

Before administration, it should be visually checked that the reconstituted solution does not contain particles. Reconstituted solutions containing visible particles should be discarded.

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

Anaclosil should not be mixed with other medicines.

Each vial is for single use only.