Package Leaflet: Information for the User

Anaclosil 500 mg Hard Capsules

Cloxacillin (as sodium salt)

Read this leaflet carefully before you start taking 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Anaclosil 500 mg Hard Capsules and what it is used for

2. Before taking Anaclosil 500 mg Hard Capsules

3. How to take Anaclosil 500 mg Hard Capsules

4. Possible side effects

5. Storage of Anaclosil 500 mg Hard Capsules

6. Contents of the pack and additional information

This medicine contains cloxacillin, which is an antibiotic belonging to the family of penicillins.

It is indicated for adults and children to treat uncomplicated skin and soft tissue infections, such as impetigo.

Do not take Anaclosil 500mg hard capsules

- If you are allergic (hypersensitive) to the active ingredient or to any of the other components of Anaclosil 500mg hard capsules.

- If you are allergic (hypersensitive) to penicillins.

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 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 or pharmacist before starting to take this medication if:

- You are allergic to penicillins or cephalosporins. In hypersensitive patients to cephalosporins, the possibility of cross-allergic reactions should be taken into account.

- During treatment, you suffer from pseudomembranous colitis (persistent and/or severe diarrhea during or after the administration of cloxacillin). In the event of these symptoms appearing, treatment should be interrupted.

- During a previous antibiotic treatment (even with another family of antibiotics), you have had some type of allergic reaction such as urticaria or other rashes, itching, sudden swelling of the face and neck.

- You have kidney or liver disease.

- You have a history of seizures and/or epilepsy, especially in patients with renal or hepatic impairment.

- If you 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. See section 3 for the dose in this population.

Administration of ANACLOSIL 500 mg hard capsules with food and beverages

It is advisable to take the capsules outside of the digestive phases.

Other medications and Anaclosil 500mg hard capsules

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:

• Methotrexate, which is a medication used 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, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

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

Driving and operating machinery

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

ANACLOSIL 500 mg hard capsules contain sodium

Consult your doctor if you are taking a low-sodium diet, as this medication contains 26.4 mg (equivalent to 1.15 mmol) of sodium per capsule.

Follow exactly the administration instructions for this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The dose depends on body weight, as well as the functioning of the kidneys and liver.

Adults

The usual recommended dose in adults with normal kidney function is 500 mg every 4-6 hours, depending on the severity and location of the infection.

The treatment duration should not exceed 14 days.

The dose may be adjusted in case of severe kidney and liver function problems. The usual recommended dose in children with normal kidney function ranges from 50 to 100 mg/kg/day in divided doses.

It should be administered preferably on an empty stomach (1 hour before or 2 hours after meals).

As with antibiotic therapy in general, the administration of cloxacillin will continue for 48 to 72 hours after the disappearance of fever, or after obtaining evidence of eradication of bacteria.

Children and adolescents:

-Normal renal function

In children, the recommended doses range from 50 to 100 mg/kg/day, in divided doses.

-Altered renal function

The dosage in children with renal and/or hepatic insufficiency has not been sufficiently studied.

If you take more Anaclosil 500mg capsules than you should

If you (or someone) ingest many capsules at once or if you think a child has swallowed some capsules, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to take Anaclosil 500 mg capsules

Do not take a double dose to make up for the missed doses of Anaclosil 500mg capsules.

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

Like all medications, Anaclosil may produce 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 the available data).

Oral administration of this medication (cloxacillin) may produce gastrointestinal disturbances (diarrhea, nausea, and vomiting), generally mild and resolving upon discontinuation of the medication.

In subjects sensitized to penicillins, allergic reactions such as facial swelling, lips, mouth, tongue, or throat may occur, causing difficulty swallowing or breathing (angioedema).

Other adverse effects may include:

-Skin allergic reactions (pruritus, cutaneous rash, urticaria).

-Decreased neutrophil and platelet counts in the blood.

-Neurological symptoms: seizures (this effect is more frequent in individuals with significant renal dysfunction).

-Jaundice (yellow discoloration of the skin), elevated liver enzyme values, and hepatitis (inflammation of the liver).

Reporting Adverse Effects

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

Store below 25°C. Store in the original packaging.

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

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Anaclosil 500 mg hard capsules

The active ingredient is cloxacillin (as sodium salt). Each capsule contains 500mg of cloxacillin (as sodium salt).

The other components are magnesium stearate, colloidal silica, and sodium carboxymethylcellulose (type A) (derived from potato starch).

Appearance of the product and content of the packaging

Box containing 20, 40, or 500 hard gelatin capsules, with colored body and cap, with the name Anaclosil 500mg printed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Reig Jofré, S.A. Laboratory

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Responsible for manufacturing

Reig Jofré, S.A. Laboratory

Jarama, 111 – 45007

Toledo (Spain)

Last review date of this leaflet: May 2020

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