Orbenin 500 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ORBENIN 500 mg hard capsules

Cloxacillin (as the sodium salt)

Read the entire package leaflet carefully before you start taking the medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

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

1. What Orbenin is and what it is 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 taking Orbenin

Do not take Orbenin

• If you are allergic to cloxacillin or to any of the other ingredients 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 allergy to this penicillin, it is important to determine whether you have previously experienced immediate, moderate or severe allergic reactions to a cephalosporin, in which case it would be advisable to avoid using this penicillin.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if:

• You are allergic to penicillins or cephalosporins. In patients allergic to cephalosporins, cross-allergic reactions should be taken into account.

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

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

• You have renal or hepatic disease.

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

• You are taking oral contraceptives; it is recommended to use another effective and reliable contraceptive method during treatment and for one week afterwards, as concomitant use of cloxacillin and combined oral contraceptives may reduce contraceptive efficacy.

Interference with diagnostic tests

If you are due to have any diagnostic tests (including blood or urine tests), inform your doctor that you are taking this medicine, as it may alter test results.

Children

This medicine should be used 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 in this population.

Use of Orbenin with food

Hard capsules should be swallowed whole with water. 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 need to take any other medicines, including those obtained without a prescription. It is especially important that you inform your doctor if you are taking:

• Methotrexate, a medicine used for certain forms of arthritis and for the treatment of psoriasis.
• Other antibiotics (medicines used to treat bacterial infections), such as chloramphenicol, tetracyclines, macrolides or sulfonamides. These antibiotics may reduce the effect of Orbenin.
• Aminoglycosides, as treatment should be administered separately from Orbenin.
• Probenecid, a medicine used to treat gout, which may increase the effect of Orbenin.

? 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 or pharmacist before using this medicine.

This medicine passes into breast milk. Consult your doctor before breastfeeding your baby.

Treatment should be discontinued if diarrhoea, candidiasis or skin rashes occur in the baby.

Driving and operating machinery

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

Orbenin contains sodium:

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

3. How to take Orbenin

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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.

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

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

Use in children

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

The recommended doses range between 50 and 100 mg/kg/day, given in divided doses.

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

If you take more Orbenin than you should

If you (or someone else) swallow 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 immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Orbenin

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

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

4. Possible adverse effects

Like all medicines, Orbenin may cause adverse effects, although not everyone experiences them.

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

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

• Skin allergic reactions: pruritus, skin rash, urticaria.

• Diarrhea, nausea, and vomiting.

• Decreased number of neutrophils and platelets in the blood.

• Neurological symptoms: seizures (mental status disorder accompanied by muscle contractions). This effect is more frequent in people with markedly decreased kidney function.

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

In addition, in subjects sensitized to penicillins, allergic reactions may 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 or pharmacist, even if it involves possible adverse effects not listed in this leaflet.

You may also report them directly through the Spanish System of Pharmacovigilance 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 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 stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Orbenin 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

Appearance of the medicine and contents of the pack

Box containing 20, 40 or 500 hard gelatin capsules with an orange body and black cap, printed with "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 Jofre, S.A.

Jarama 111 - 45007

Toledo (Spain)

Date of the most recent review of this leaflet: July 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/