Anaclosil 500 mg capsules

It is indicated in adults and children for the treatment of uncomplicated skin and soft tissue infections, such as impetigo.

2. Before taking Anaclosil 500 mg hard capsules

Do not take Anaclosil 500 mg hard capsules

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

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 the patient has previously experienced immediate, moderate, or severe allergic reactions to a cephalosporin; in such cases, it would be advisable to avoid using this penicillin.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine if:

• You are allergic to penicillins or cephalosporins. In patients hypersensitive to cephalosporins, cross-allergic reactions should be considered as a possibility.

• You develop pseudomembranous colitis (persistent and/or severe diarrhoea during or after treatment with cloxacillin). If these symptoms occur, treatment must be discontinued.

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

• You have renal or hepatic disease.

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

• You 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 undergo any diagnostic tests (including blood and urine tests, 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 hyperbilirubinaemia caused by competition for bilirubin binding sites on serum proteins. See section 3 for dosing information in this population.

Taking ANACLOSIL 500 mg hard capsules with food and drink

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

Other medicines and Anaclosil 500 mg hard capsules

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.
• Other antibiotics (medicines used to treat 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, which may increase the effect of Anaclosil.
• Warfarin or other anticoagulant medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might 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 diarrhoea, candidiasis, or skin rashes.

Driving and using machines

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 on a low-sodium diet, as this medicine contains 26.4 mg (equivalent to 1.15 mmol) of sodium per capsule.

3. How to take Anaclosil 500 mg hard capsules

Follow exactly the instructions for use of this medicine as given by your doctor. If you have any doubts, consult your doctor or pharmacist.

The dose depends on body weight, as well as on 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 site of the infection.

The duration of treatment should not exceed 14 days.

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

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

As with antibiotic therapy in general, cloxacillin administration should continue for 48 to 72 hours after the fever has subsided, or until evidence of bacterial eradication has been obtained.

Children and adolescents:

-Normal renal function

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

-Impaired renal function

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

If you take more Anaclosil 500 mg capsules than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Anaclosil 500 mg capsules

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

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

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).

Oral administration of this medicine (cloxacillin) may cause gastrointestinal disturbances (diarrhea, nausea, and vomiting), usually mild and transient, which resolve upon discontinuation of the medication.

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

Other adverse effects may include:

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

• Decreased number of neutrophils and platelets in the blood.

• Neurological symptoms: seizures (this effect is more frequent in individuals with markedly reduced kidney function).

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

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Anaclosil 500 mg hard capsules

Store below 25°C. Keep in the original container.

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

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Anaclosil 500 mg hard capsules

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

The other components are magnesium stearate, colloidal silicon dioxide, and sodium carboxymethylstarch (type A) (derived from potato starch).

Appearance of the medicine and contents of the pack

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio Reig Jofré, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Manufacturer

Laboratorio Reig Jofré, S.A.

Jarama, 111 – 45007

Toledo (Spain)

Date of the most recent review of this leaflet: May 2020

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/