ANACLOSIL 500 mg CAPSULES

Introduction

Package Leaflet: Information for the User

Anaclosil 500 mg Hard Capsules

Cloxacillin (as sodium salt)

Read all of this leaflet carefully before you start taking 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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What Anaclosil 500 mg Hard Capsules are and what they are used for
2. Before you take 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 further information

1. What Anaclosil 500 mg Hard Capsules are and what they are used for

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

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

2. Before you take Anaclosil 500 mg Hard Capsules

Do not take Anaclosil 500mg Hard Capsules

• If you are allergic (hypersensitive) to the active substance or any of the other ingredients of Anaclosil 500mg Hard Capsules.
• If you are allergic (hypersensitive) to penicillins.

If you are allergic (hypersensitive) to cephalosporins. Although allergy to cephalosporins does not necessarily imply 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 medicine if:

-you are allergic to penicillins or cephalosporins. In patients hypersensitive 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, treatment should be discontinued.

-during a previous antibiotic treatment (even with another family of antibiotics), you have had any 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 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. See section 3 for the dose in this population.

Taking ANACLOSIL 500 mg Hard Capsules with Food and Drinks

It is recommended that the intake of the capsules be done outside of the digestive phases.

Other Medicines and Anaclosil 500mg Hard Capsules

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, 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 the 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. Consult your doctor before breastfeeding your baby. Treatment should be discontinued 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 500 mg Hard Capsules contain Sodium

Consult your doctor in case 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 administration instructions of this medicine as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The dose depends on the body weight, as well as the state of kidney and liver function.

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 treatment duration should not exceed 14 days.

The dose may be adjusted in case of severe kidney or 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 the bacteria.

Children and Adolescents:

-Normal Renal Function

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

-Impaired Renal Function

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

If you take more Anaclosil 500mg Hard Capsules than you should

If you (or someone else) swallow many capsules at the same time or if you think a child has swallowed some, contact your doctor or pharmacist immediately.

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

If you forget to take Anaclosil 500 mg Hard Capsules

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

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

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).

The oral administration of this medicine (cloxacillin) may cause gastrointestinal disorders (diarrhea, nausea, and vomiting), which are usually mild and disappear when the medication is discontinued.

In subjects 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).

Other side effects may include:

-Allergic reactions on the skin (itching, skin rash, urticaria).

-Decrease in the number of neutrophils and platelets in the blood.

-Neurological symptoms: seizures (this effect is more frequent in people with significantly impaired kidney function).

-Jaundice (yellowing of the skin), increased liver enzyme values, and hepatitis (inflammation of the liver).

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Anaclosil 500 mg Hard Capsules

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

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

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.

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicinal products in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicinal products. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Anaclosil 500 mg Hard Capsules

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

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

Appearance of the Product and Contents of the Pack

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

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 Last Revision of this Leaflet: May 2020

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