ORBENIN 500 MG HARD CAPSULES

Introduction

Package Leaflet: Information for the User

ORBENIN 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 pack and other information:

1. What is Orbenin and what is it used for
2. What you need to know before you take Orbenin
3. How to take Orbenin
4. Possible side effects
5. Storage of Orbenin
6. Contents of the pack and further information

1. What is Orbenin and what is it used for

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

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

2. What you need to know before you take Orbenin

Do not take Orbenin

• If you are allergic to cloxacillin or any of the other components of this medicine (listed in section 6).
• If you are allergic to penicillins.
• If you are allergic 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 is recommended 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 allergic to cephalosporins, the possibility of cross-allergic reactions should be considered.

-during treatment, you suffer from pseudomembranous colitis (persistent and/or severe diarrhea during or after the administration of cloxacillin). In case of appearance 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

Interference with laboratory tests

If you are going to undergo any diagnostic test (including blood, urine, etc...), inform your doctor that you are taking this medicine, as it may alter the results.

Children

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.

Use of Orbenin with food

The hard capsules should be swallowed whole with water and their administration should be spaced at least 1 hour before or 2 hours after food intake.

Other medicines and Orbenin

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 produced by bacteria), such as chloramphenicol, tetracyclines, macrolides, or sulfonamides. These antibiotics may decrease the effect of Orbenin.
• Aminoglycosides, as treatment should be administered separately from Orbenin.
• Probenecid, which is a medicine for the treatment of gout, as it may increase the effect of Orbenin.

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 or pharmacist 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.

Orbenin contains Sodium:

This medicine contains 25.3 mg (main component of table salt/cooking salt) in each capsule. This is equivalent to 1.26% of the maximum recommended daily intake of sodium for an adult.

3. How to Take Orbenin

Follow exactly the administration instructions of this medicine as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The dose depends on body weight, as well as 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 duration of treatment should not exceed 14 days.

The dose may be adjusted in case of severe kidney or liver function impairment.

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.

Use in Children

For administration in children under 10 years, an oral suspension of cloxacillin may be used.

The recommended doses range from 50 to 100 mg/kg/day, in divided doses.

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

If you take more Orbenin than you should

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

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

If you forget to take Orbenin

Do not take a double dose to make up for forgotten doses.

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

4. Possible Side Effects

Like all medicines, Orbenin can cause side effects, although not everybody gets them.

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

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

-Allergic reactions on the skin: itching, skin rash, urticaria.

-Diarrhea, nausea, and vomiting

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

-Neurological symptoms: seizures (disorder of the mental state accompanied by muscle contractions). This effect is more frequent in people with significantly impaired kidney function.

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

Also, 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).

Gastrointestinal tract disorders such as severe or persistent diarrhea, or if blood or mucus is observed in the stool.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet.

You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Orbenin

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

Orbenin 500mg hard capsules pack of 20, 40, and 500 capsules: Store below 25°C. Keep in the original packaging to protect from moisture.

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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Orbenin 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

Appearance of the product and pack contents

Box containing 20, 40, or 500 hard gelatin capsules with orange body and black cap, with the imprint "Orbenin 500".

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: July 2025

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.gob.es/