Anaclosil 500 mg powder for injection and for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Anaclosil 500 mg powder for injectable solution

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, as 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 and must not be given to other people, even if they have the same symptoms, as it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Anaclosil is and what it is used for

2. What you need to know before using Anaclosil

3. How to use Anaclosil

4. Possible adverse effects

5. How to store Anaclosil

6. Contents of the pack and other information

1. What Anaclosil is and what it is used for

The active substance in Anaclosil is cloxacillin.

Cloxacillin is an antibiotic belonging to the penicillin family.

Anaclosil is indicated in the treatment of the following infections:

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

Anaclosil is also indicated for the prevention of infections following neurological procedures such as internal cerebrospinal fluid shunting.

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 necessarily imply allergy to this penicillin, it is important to determine whether you have previously experienced immediate, moderate or severe allergic reactions to a cephalosporin; in such cases, the use of this penicillin should be avoided.

Warnings and precautions

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

• You are allergic to a specific group of antibiotics known as beta-lactams (penicillins or cephalosporins).

• You have previously experienced any type of allergic reaction (such as urticaria or other rashes, itching, sudden swelling of the face and neck) during antibiotic treatment (even with another class of antibiotics).

• You have kidney or liver disease.

• You have a history of seizures and/or epilepsy, especially if you have renal or hepatic impairment.

• You are taking oral contraceptives. It is recommended to use an alternative, effective, and reliable method of contraception during treatment and for one week after treatment, as concomitant use of Cloxacillin and combined oral contraceptives may reduce contraceptive efficacy.

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

Children and adolescents

This medicine should be used with caution in neonates due to the risk of hyperbilirubinemia caused by competition for bilirubin binding sites on serum proteins.

Other medicines and Anaclosil

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

• Methotrexate, a medicine used for certain forms of arthritis and psoriasis treatment.
• Other antibiotics (medicines used for bacterial infections), such as chloramphenicol, tetracyclines, macrolides, or sulfonamides. These antibiotics may reduce the effect of Anaclosil.
• Aminoglycosides, as treatment with these should be administered separately from Anaclosil.
• Probenecid, a medicine used to treat gout, which may increase the effect of Anaclosil.
• Warfarin or other anticoagulant medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

This medicine passes into breast milk. Consult your doctor before breastfeeding. Treatment should be discontinued if the infant develops diarrhea, candidiasis, or skin rashes.

Driving and using machines

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

Anaclosil contains sodium

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

3. How to use Anaclosil

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

It will be given directly into a vein (intravenous bolus) over 3-4 minutes or as a drip into a vein (intravenous infusion) over approximately 1 hour.

The recommended dose for adults is as follows:

• For the treatment of infections: 2,000 mg every 4-6 hours.
• For the prevention of infections prior to neurosurgical procedures: a single dose of 2,000 mg of Anaclosil before surgery, and 1,000 mg every 2 hours during surgery if it is prolonged.

If you have severe problems with kidney or liver function, the dose administered will be half the recommended dose.

Use in children and adolescents

The recommended dose is 100 to 200 mg per kilogram of body weight per day, divided into 4-6 doses, 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 may have been given too much Anaclosil.

If you miss a dose of Anaclosil

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

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

4. Possible adverse effects

Like all medicines, Anaclosil may cause adverse effects, although not everyone experiences them.

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

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

• Skin allergic reactions: (Pruritus, cutaneous rash, urticaria)
• Diarrhea, nausea, and vomiting.
• Decrease in the number of neutrophils and platelets in the blood.
• Neurological symptoms: Seizures (disturbance of mental status accompanied by muscle contractions). This effect is more frequent in individuals with markedly reduced renal function.
• Jaundice (yellowing of the skin or whites of the eyes), increased liver enzyme levels, and hepatitis (inflammation of the liver).

In addition, in patients sensitized to penicillins, allergic reactions may occur such as swelling of the face, lips, mouth, tongue, or throat, which may 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 adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the container, after EXP: The expiry date refers to the last day of the month indicated.

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

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

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

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE Point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Anaclosil

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

Appearance of the product and contents of the container

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

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

For continuous infusion, the powder reconstituted in 2.5 mL of water for injections should be withdrawn from the vial and added to a bag containing at least 100 mL of sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) for infusion in hospital settings.

Anaclosil is available in pack sizes of 1 or 100 vials.

Only certain 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 last approved in August 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.es/

This information is intended for healthcare professionals only:

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

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

Cloxacillin sodium must not be used in infusion bags containing protein hydrolysates, lipid emulsions, amino acids, blood, or serum.

Mixing cloxacillin and aminoglycosides may lead to substantial mutual inactivation; therefore, they must not be mixed in the same infusion bag.

Only limited data are available on the compatibility of Anaclosil with other intravenous substances; consequently, additives or other medicines must not be added to single-use Anaclosil vials, nor should they be infused simultaneously. If the same intravenous line is used for sequential infusion of different medicines, the line must be flushed before and after infusion with 0.9% sodium chloride solution.

Reconstitution

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

Dilution

For infusion administration, the reconstituted solution must be diluted in at least 100 mL of 0.9% sodium chloride solution or glucose 50 mg/mL (5%) for infusion. Do not shake the bag. The resulting solution is a clear, colorless or pale yellow solution.

Infusion

The reconstituted solution must be inspected visually for the presence of particles prior to administration. Reconstituted solutions containing visible particles must be discarded.

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

Anaclosil must not be mixed with other medicines.

Each vial is for single use only.