Package Insert: Information for the User

ORBENIN 500 mg Hard Capsules

Cloxacillin (as sodium salt)

Read this package insert carefully before starting to take the medicine, as it contains important information for you.

• Keep this package insert as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, 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 not listed in this package insert. See section 4.

This medication 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 Orbenin

• If you are allergic to cloxacillin or any of the other components of this medication (listed in section 6).
• If you are allergic to penicillins.
• If you are allergic to cephalosporins. Although allergy to cephalosporins does not imply the existence of allergy to this penicillin, it should be determined if the patient has previously experienced immediate, moderate, or severe allergic reactions to a cephalosporin, in which case it would be recommended 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 patients allergic to cephalosporins, the possibility of cross-allergic reactions should be taken into account.

-during treatment, you experience pseudomembranous colitis (persistent and/or severe diarrhea during or after administration of cloxacillin). In case of appearance of these symptoms, treatment should be interrupted.

-during a previous antibiotic treatment (including 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 for one week after, as concomitant use of Cloxacillin and combined oral contraceptives may reduce the effectiveness of the contraceptive.

Interference 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 results.

Children

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 dosage in this population.

Use of Orbenin with food

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

Other medications and Orbenin

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:

• Metotrexate, which is a medication indicated 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 Orbenin.
• Aminoglycosides, as treatment should be administered separately from Orbenin.
• Probenecid, which is a medication for the treatment of gout, as it may increase the effect of Orbenin.

?Warfarin or other anticoagulant medications.

Pregnancy, breastfeeding, and fertility

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

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

Treatment should be interrupted in case of diarrhea, candidiasis, or skin rash 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 medication contains 25.3 mg (main component of table salt/for cooking) in each capsule. This is equivalent to 1.26% of the recommended daily maximum sodium intake for an adult.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The dose depends on body weight, as well as the functioning state 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.

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 bacterial eradication.

Use in children

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

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

The pediatric dosing 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) have ingested many tablets at once or if you think a child has swallowed a tablet, contact your doctor or pharmacist immediately.

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

If you forgot to take Orbenin

Do not take a double dose to compensate for the missed doses.

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

Like all medications, Orbenin may produce adverse effects, although not all people will experience them.All people will not experience 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).

Unknown frequency (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 state disorder accompanied by muscle contractions). This effect is more frequent in people with a significant decrease in renal function.

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

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

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear 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.

Keepthis medicationout ofsightand out of reach of children.

Orbenin 500mg Hard Capsules pack of 20 and 40 capsules: Store below 25ºC. Store in the original packaging to protect it from moisture.

Orbenin 500mg Hard Capsules pack of 500 capsules: Store in a dry place.

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.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Orbenin 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

Appearance of the product and content of the packaging

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

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: October 2024

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.gob.es/