Package Insert: Information for the User

Orbenin 125 mg/5ml Oral Suspension Powder

Cloxacillin (sodium)

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

• Keep this package insert as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication 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 an allergy to cephalosporins does not imply the existence of 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 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 the administration of cloxacillin). In the event of these symptoms appearing, 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 the concomitant use of Cloxacillin and combined oral contraceptives may reduce the effectiveness of the contraceptive.

Interference with diagnostic tests

Inform your doctor if you are to undergo any diagnostic tests (including blood, urine, etc... tests) as this medication 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 the dosage in this population.

Use of Orbenin with food

The oral suspension 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 certain 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.
• Oral contraceptives, as Orbenin suspension may reduce the effectiveness of the contraceptive. It is recommended to use an alternative, effective, and safe method during treatment and for one week after.

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 rashes 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 less than 1 mmol of sodium (23mg) per 5ml; this is essentially "sodium-free".

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains 5 mg of sodium benzoate in each 5 ml of suspension. The sodium benzoate salt may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

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

Use in children

With normal kidney function:

Children under 2 years:5 ml (125mg of cloxacillin (sodium)), 1 teaspoon every 6 hours.

Between 2 and 10 years:10 ml (250mg of cloxacillin (sodium)), 2 teaspoons every 6 hours.

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

If there is an association between hepatic and renal insufficiency, the daily dose should be reduced to half.

Adults, elderly patients, and children over 10 years:

It is recommended to administer in hard capsules of 500mg.

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

Instructions to prepare the suspension:

Invert the position of the bottle to detach the powder adhering to its bottom.

Add a little water and shake. Complete with water up to the line marked by the arrow. Shake before use.

If you take more Orbenin than you should

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 redness, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN).

Unknown frequency (frequency cannot be estimated from the data currently available):

-Skin allergic reactions: pruritus, cutaneous rash, urticaria.

-Diarrhea, nausea, and vomiting

-Decreased number of neutrophils and platelets in the blood

-Neurological symptoms: seizures (mental status disturbance accompanied by muscle contractions). This effect is more frequent in people with a marked decrease in renal function.

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

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

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 ofreach of children.

Orbenin 125 mg/5ml Powder for oral suspension: Store in a dry place.

Once reconstituted, the shelf life is 7 days in a refrigerator at 4°C to 8°C.

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 pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Orbenin 125mg Powder for oral suspension

The active ingredient is cloxacillin (sodium).

The other components are:

Sodium benzoate, sodium citrate, disodium edetate, ammonium glycyrrhizate, sodium glutamate, tutti fruti flavor, orange flavor, peppermint flavor, sodium saccharin, and sucrose.

Appearance of the product and content of the packaging

Each box contains a container of Powder for reconstitution and a 5ml spoon. Once reconstituted, it contains 60 ml of oral suspension. Each 5 ml spoonful contains 125mg of cloxacillin.

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: January 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/