Anaclosil 1000 mg powder for injection and for infusion solution

Patient Information Leaflet

Introduction

Patient Information Leaflet

Anaclosil 1000 mg powder for injectable solution

Cloxacillin (as the sodium salt)

Read the entire 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 you should not give it to other people, even if they have the same symptoms, as it may 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.

Leaflet contents:

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 side 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 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 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 cerebrospinal fluid internal 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 should be determined whether the patient has previously experienced immediate, moderate or severe allergic reactions to a cephalosporin, in which case it would be advisable 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).

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

• Have renal or hepatic disease.

• Have a history of seizures and/or epilepsy, especially in patients with renal or hepatic impairment.

• Are taking oral contraceptives: it is recommended to use an alternative, effective, and safe contraceptive method during treatment and for one week after, 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 administered 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 the treatment of psoriasis.
• 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 should be administered separately from Anaclosil.
• Probenecid, a medicine used to treat gout, as it 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 your baby. 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 52.8 mg of sodium (the main component of table salt) per vial. This corresponds to 2.7% of the maximum daily recommended dietary intake of sodium for an adult.

3. How to use Anaclosil

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

It will be given directly (direct intravenous injection) over 3–4 minutes or by infusion 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 the procedure is prolonged.

If you have severe impairment in 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 kidney function.

• Jaundice (yellowing of the skin or whites of the eyes), increased liver enzyme levels, and hepatitis (liver inflammation).

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

• Gastrointestinal tract disturbances 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 through 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

No special storage conditions are required.

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 observe the presence of particles or if the reconstituted solution is cloudy.

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

6. Package contents and other information

Composition of Anaclosil

The active substance is cloxacillin (as the sodium salt). Each vial contains 1,000 mg of cloxacillin (as the sodium salt).

Appearance of the product and contents of the pack

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

For direct intravenous administration, the powder should be reconstituted with 4 mL of water for injections.

For continuous infusion administration, the powder reconstituted with 4 mL of water for injections should be withdrawn from the vial and added to an infusion 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 packs 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 patient information leaflet was last reviewed 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 characteristics summary (SmPC) 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.

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

Mixing cloxacillin and aminoglycosides may result in 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 medications 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 medications, the line must be flushed before and after administration with 0.9% sodium chloride solution.

Reconstitution

To prepare the solution for slow intravenous administration (3–4 minutes), aseptic technique must be followed. Reconstitute the vial contents with 4 mL of water for injections and gently rotate the vial until the powder is completely dissolved. Avoid shaking or rapid movements, as these 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 via direct intravenous injection 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 infusion bag. The resulting solution is a clear, colourless or pale yellow solution.

Infusion

The reconstituted solution should be inspected visually to ensure it contains no particles before 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.